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AXYANTAPID XL 150 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlalic® XL 150 mg
prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Venlalic® XL 150 mg prolonged-release
tablets but will be referred to as Venlalic XL throughout the remainder of
this leaflet.
• Venlalic XL is also available in other strengths.
What is in this leaflet:
1. What Venlalic XL is and what it is used for
2. What you need to know before you take Venlalic XL
3. How to take Venlalic XL
4. Possible side effects
5. How to store Venlalic XL
6. Contents of the pack and other information
1. WHAT VENLALIC XL IS AND WHAT IT IS USED FOR
Venlalic XL is an antidepressant that belongs to a group of medicines called
serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of
medicines is used to treat depression and other conditions such as anxiety
disorders. It is thought that people who are depressed and/or anxious have
lower levels of serotonin and noradrenaline in the brain. It is not fully
understood how antidepressants work, but they may help by increasing the
levels of serotonin and noradrenaline in the brain.
Venlalic XL is a treatment for adults with depression. Venlalic XL is also a
treatment for adults with the following anxiety disorders: generalised anxiety
disorder, social anxiety disorder (fear or avoidance of social situations) and
panic disorder (panic attacks). Treating depression or anxiety disorders
properly is important to help you get better. If it is not treated, your condition
may not go away and may become more serious and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENLALIC XL
Do not take Venlalic XL
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Venlalic XL, can cause serious or even lifethreatening side effects. Also, you must wait at least 7 days after you stop
taking Venlalic XL before you take any MAOI (see also the sections
entitled “Other medicines and Venlalic XL” and the information in that
section about “Serotonin syndrome”).

Venlalic XL may cause a sensation of restlessness or an inability to sit or
stand still during the first few weeks of treatment. You should tell your
doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Venlalic XL.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venlalic XL. Therefore, the
dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venlalic XL should normally not be used for children and adolescents under
18 years. Also, you should know that patients under 18 have an increased
risk of side effects, such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe this
medicine for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Venlalic XL for a patient under
18, and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Venlalic XL. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Venlalic XL in this age group has not yet been
demonstrated.
Other medicines and Venlalic XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Venlalic XL with other
medicines.

Warnings and precautions
Talk to your doctor before taking Venlalic XL

Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.

• If you use other medicines that taken concomitantly with Venlalic XL
could increase the risk of developing serotonin syndrome (see the section
“Other medicines and Venlalic XL”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Venlalic XL. Tell your
doctor if you have taken these medicines within the last 14 days. (MAOIs:
see the section “What you need to know before you take Venlalic XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Venlalic XL at approximately the same time each day, either in the
morning or in the evening. Tablets must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Venlalic XL may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venlalic XL and should be
used with caution. It is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Venlalic XL with food, drink and alcohol
Venlalic XL should be taken with food (see section 3 “How to take
Venlalic XL”).
You should avoid alcohol while you are taking Venlalic XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Venlalic XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venlalic XL. When
taken during pregnancy, similar drugs (SSRIs) may increase the risk of a
serious condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours after the baby is born. If
this happens to your baby you should contact your midwife and/or doctor
immediately.
If you are taking Venlalic XL during pregnancy, let your midwife and/or
doctor know, as your baby might have some symptoms when it is born.
These symptoms usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Venlalic XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Venlalic XL
affects you.
Important information about some of the ingredients of Venlalic XL
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE VENLALIC XL
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Venlalic XL should be taken with food.

Do not stop taking Venlalic XL without talking to your doctor (see the
section “If you stop taking Venlalic XL”).
If you take more Venlalic XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Venlalic XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Venlalic XL
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Venlalic XL that has been
prescribed for you in one day.
If you stop taking Venlalic XL
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Venlalic XL, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people
stop using Venlalic XL, especially when Venlalic XL is stopped suddenly or
the dose is reduced too quickly. Some patients may experience symptoms
such as tiredness, dizziness, light-headedness, headache, sleeplessness,
sensation that everything around you is spinning or moving (vertigo),
nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness,
agitation, confusion, ringing in the ears, tingling or rarely electric shock
sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue
Venlalic XL treatment. If you experience any of these or other symptoms
that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venlalic XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Venlalic XL. As the tablet travels the length of your gastrointestinal tract,
venlafaxine is slowly released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though you may see a
tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venlalic XL. Tell your
doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Venlalic XL, if you stop
taking Venlalic XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Venlalic XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venlalic XL sometimes causes unwanted effects that you may not be aware
of, such as increases in blood pressure or abnormal heart beat; slight
changes in blood levels or liver enzymes, sodium or cholesterol. More
rarely, Venlalic XL may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding. Therefore, your doctor
may wish to do blood tests occasionally, particularly if you have been taking
Venlalic XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE VENLALIC XL
• Keep out of the sight and reach of children.
• Do not use Venlalic XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Venlalic XL contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Venlalic XL looks like and contents of the pack
Venlalic XL 150 mg prolonged-release tablets are white, round, biconvex,
film coated prolonged release tablets, plain on one side with a laser hole on
the other’.
Venlalic XL 150 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467

POM

Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX
Venlalic® is a registered trademark of Dallas Burston Ashbourne
Holdings Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Axyven® 150 mg prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Axyven® 150 mg prolonged-release tablets
but will be referred to as Axyven throughout the remainder of this leaflet.
• Axyven is also available in other strengths.
What is in this leaflet:
1. What Axyven is and what it is used for
2. What you need to know before you take Axyven
3. How to take Axyven
4. Possible side effects
5. How to store Axyven
6. Contents of the pack and other information
1. WHAT AXYVEN IS AND WHAT IT IS USED FOR
Axyven is an antidepressant that belongs to a group of medicines called
serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of
medicines is used to treat depression and other conditions such as anxiety
disorders. It is thought that people who are depressed and/or anxious have
lower levels of serotonin and noradrenaline in the brain. It is not fully
understood how antidepressants work, but they may help by increasing the
levels of serotonin and noradrenaline in the brain.
Axyven is a treatment for adults with depression. Axyven is also a treatment
for adults with the following anxiety disorders: generalised anxiety disorder,
social anxiety disorder (fear or avoidance of social situations) and panic
disorder (panic attacks). Treating depression or anxiety disorders properly
is important to help you get better. If it is not treated, your condition may not
go away and may become more serious and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXYVEN
Do not take Axyven
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Axyven, can cause serious or even life-threatening
side effects. Also, you must wait at least 7 days after you stop taking
Axyven before you take any MAOI (see also the sections entitled “Other
medicines and Axyven” and the information in that section about
“Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axyven
• If you use other medicines that taken concomitantly with Axyven could
increase the risk of developing serotonin syndrome (see the section
“Other medicines and Axyven”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

Axyven may cause a sensation of restlessness or an inability to sit or stand
still during the first few weeks of treatment. You should tell your doctor if this
happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Axyven.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axyven. Therefore, the
dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axyven should normally not be used for children and adolescents under 18
years. Also, you should know that patients under 18 have an increased risk
of side effects, such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe this
medicine for patients under 18 because he/she decides that this is in their
best interests. If your doctor has prescribed Axyven for a patient under 18,
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any of the symptoms listed above develop or worsen
when patients under 18 are taking Axyven. Also, the long-term safety
effects concerning growth, maturation and cognitive and behavioural
development of Axyven in this age group has not yet been demonstrated.
Other medicines and Axyven
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Axyven with other
medicines.
Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Axyven. Tell your doctor if
you have taken these medicines within the last 14 days. (MAOIs: see the
section “What you need to know before you take Axyven”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Axyven at approximately the same time each day, either in the
morning or in the evening. Tablets must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Axyven may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axyven and should be used
with caution. It is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Axyven with food, drink and alcohol
Axyven should be taken with food (see section 3 “How to take Axyven”).
You should avoid alcohol while you are taking Axyven.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Axyven only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axyven. When
taken during pregnancy, similar drugs (SSRIs) may increase the risk of a
serious condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN), making the baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours after the baby is born. If
this happens to your baby you should contact your midwife and/or doctor
immediately.
If you are taking Axyven during pregnancy, let your midwife and/or doctor
know, as your baby might have some symptoms when it is born. These
symptoms usually begin during the first 24 hours after the baby is born.
They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Axyven.
Driving and using machines
Do not drive or use any tools or machines until you know how Axyven
affects you.
Important information about some of the ingredients of Axyven
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE AXYVEN
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Axyven should be taken with food.

Do not stop taking Axyven without talking to your doctor (see the section “If
you stop taking Axyven”).
If you take more Axyven than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Axyven prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Axyven
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Axyven that has been
prescribed for you in one day.
If you stop taking Axyven
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Axyven, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people
stop using Axyven, especially when Axyven is stopped suddenly or the
dose is reduced too quickly. Some patients may experience symptoms such
as tiredness, dizziness, light-headedness, headache, sleeplessness,
sensation that everything around you is spinning or moving (vertigo),
nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness,
agitation, confusion, ringing in the ears, tingling or rarely electric shock
sensations, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue
Axyven treatment. If you experience any of these or other symptoms that
are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Axyven can cause side effects, although not everybody
gets them.
Do not be concerned if you see a tablet in your stools after taking Axyven.
As the tablet travels the length of your gastrointestinal tract, venlafaxine is
slowly released. The shape of the tablet remains undissolved and is
eliminated in your stools. Therefore, even though you may see a tablet in
your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axyven. Tell your doctor
immediately, or go to the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Axyven, if you stop
taking Axyven”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Axyven)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axyven sometimes causes unwanted effects that you may not be aware of,
such as increases in blood pressure or abnormal heart beat; slight changes
in blood levels or liver enzymes, sodium or cholesterol. More rarely, Axyven
may reduce the function of platelets in your blood, leading to an increased
risk of bruising or bleeding. Therefore, your doctor may wish to do blood
tests occasionally, particularly if you have been taking Axyven for a long
time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE AXYVEN
• Keep out of the sight and reach of children.
• Do not use Axyven after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Axyven contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Axyven looks like and contents of the pack
Axyven 150 mg prolonged-release tablets are white, round, biconvex, film
coated prolonged release tablets, plain on one side with a laser hole on the
other’.
Axyven 150 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467
Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX
Axyven® is a registered trademark of Axxon Sp. z o. o.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Axyantapid XL 150 mg
prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Axyantapid XL 150 mg prolonged-release
tablets but will be referred to as Axyantapid XL throughout the remainder
of this leaflet.
• Axyantapid XL is also available in other strengths.
What is in this leaflet:
1. What Axyantapid XL is and what it is used for
2. What you need to know before you take Axyantapid XL
3. How to take Axyantapid XL
4. Possible side effects
5. How to store Axyantapid XL
6. Contents of the pack and other information
1. WHAT AXYANTAPID XL IS AND WHAT IT IS USED FOR
Axyantapid XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group
of medicines is used to treat depression and other conditions such as
anxiety disorders. It is thought that people who are depressed and/or
anxious have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Axyantapid XL is a treatment for adults with depression. Axyantapid XL is
also a treatment for adults with the following anxiety disorders: generalised
anxiety disorder, social anxiety disorder (fear or avoidance of social
situations) and panic disorder (panic attacks). Treating depression or
anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious
and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AXYANTAPID XL
Do not take Axyantapid XL
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Axyantapid XL, can cause serious or even lifethreatening side effects. Also, you must wait at least 7 days after you stop
taking Axyantapid XL before you take any MAOI (see also the sections
entitled “Other medicines and Axyantapid XL” and the information in that
section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axyantapid XL
• If you use other medicines that taken concomitantly with Axyantapid XL
could increase the risk of developing serotonin syndrome (see the section
“Other medicines and Axyantapid XL”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

Axyantapid XL may cause a sensation of restlessness or an inability to sit or
stand still during the first few weeks of treatment. You should tell your
doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Axyantapid XL.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axyantapid XL. Therefore,
the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axyantapid XL should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have an
increased risk of side effects, such as suicide attempt, suicidal thoughts and
hostility (predominantly aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite this, your doctor may
prescribe this medicine for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed Axyantapid XL for
a patient under 18, and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are taking Axyantapid XL. Also,
the long-term safety effects concerning growth, maturation and cognitive
and behavioural development of Axyantapid XL in this age group has not
yet been demonstrated.
Other medicines and Axyantapid XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Axyantapid XL with other
medicines.
Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Axyantapid XL. Tell your
doctor if you have taken these medicines within the last 14 days. (MAOIs:
see the section “What you need to know before you take Axyantapid
XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Axyantapid XL at approximately the same time each day, either in the
morning or in the evening. Tablets must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Axyantapid XL may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axyantapid XL and should
be used with caution. It is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Axyantapid XL with food, drink and alcohol
Axyantapid XL should be taken with food (see section 3 “How to take
Axyantapid XL”).
You should avoid alcohol while you are taking Axyantapid XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Axyantapid XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axyantapid XL.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk
of a serious condition in babies, called persistent pulmonary hypertension of
the newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your midwife and/or
doctor immediately.
If you are taking Axyantapid XL during pregnancy, let your midwife and/or
doctor know, as your baby might have some symptoms when it is born.
These symptoms usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Axyantapid XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Axyantapid
XL affects you.
Important information about some of the ingredients of Axyantapid XL
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE AXYANTAPID XL
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Axyantapid XL should be taken with food.

Do not stop taking Axyantapid XL without talking to your doctor (see the
section “If you stop taking Axyantapid XL”).
If you take more Axyantapid XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Axyantapid XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Axyantapid XL
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Axyantapid XL that has
been prescribed for you in one day.
If you stop taking Axyantapid XL
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Axyantapid XL, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people
stop using Axyantapid XL, especially when Axyantapid XL is stopped
suddenly or the dose is reduced too quickly. Some patients may experience
symptoms such as tiredness, dizziness, light-headedness, headache,
sleeplessness, sensation that everything around you is spinning or moving
(vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea,
nervousness, agitation, confusion, ringing in the ears, tingling or rarely
electric shock sensations, weakness, sweating, seizures, or flu-like
symptoms.
Your doctor will advise you on how you should gradually discontinue
Axyantapid XL treatment. If you experience any of these or other symptoms
that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Axyantapid XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Axyantapid XL. As the tablet travels the length of your gastrointestinal tract,
venlafaxine is slowly released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though you may see a
tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axyantapid XL. Tell your
doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Axyantapid XL, if you
stop taking Axyantapid XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Axyantapid XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axyantapid XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat; slight
changes in blood levels or liver enzymes, sodium or cholesterol. More
rarely, Axyantapid XL may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding. Therefore, your doctor
may wish to do blood tests occasionally, particularly if you have been taking
Axyantapid XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE AXYANTAPID XL
• Keep out of the sight and reach of children.
• Do not use Axyantapid XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Axyantapid XL contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Axyantapid XL looks like and contents of the pack
Axyantapid XL 150 mg prolonged-release tablets are white, round,
biconvex, film coated prolonged release tablets, plain on one side with a
laser hole on the other’.
Axyantapid XL 150 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467
Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Axydepitab XL 150 mg
prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Axydepitab XL 150 mg prolonged-release
tablets but will be referred to as Axydepitab XL throughout the remainder
of this leaflet.
• Axydepitab XL is also available in other strengths.
What is in this leaflet:
1. What Axydepitab XL is and what it is used for
2. What you need to know before you take Axydepitab XL
3. How to take Axydepitab XL
4. Possible side effects
5. How to store Axydepitab XL
6. Contents of the pack and other information
1. WHAT AXYDEPITAB XL IS AND WHAT IT IS USED FOR
Axydepitab XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group
of medicines is used to treat depression and other conditions such as
anxiety disorders. It is thought that people who are depressed and/or
anxious have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Axydepitab XL is a treatment for adults with depression. Axydepitab XL is
also a treatment for adults with the following anxiety disorders: generalised
anxiety disorder, social anxiety disorder (fear or avoidance of social
situations) and panic disorder (panic attacks). Treating depression or
anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious
and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AXYDEPITAB XL
Do not take Axydepitab XL
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Axydepitab XL, can cause serious or even lifethreatening side effects. Also, you must wait at least 7 days after you stop
taking Axydepitab XL before you take any MAOI (see also the sections
entitled “Other medicines and Axydepitab XL” and the information in that
section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Axydepitab XL
• If you use other medicines that taken concomitantly with Axydepitab XL
could increase the risk of developing serotonin syndrome (see the section
“Other medicines and Axydepitab XL”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

Axydepitab XL may cause a sensation of restlessness or an inability to sit or
stand still during the first few weeks of treatment. You should tell your
doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Axydepitab XL.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Axydepitab XL. Therefore,
the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Axydepitab XL should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have an
increased risk of side effects, such as suicide attempt, suicidal thoughts and
hostility (predominantly aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite this, your doctor may
prescribe this medicine for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed Axydepitab XL for
a patient under 18, and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are taking Axydepitab XL. Also,
the long-term safety effects concerning growth, maturation and cognitive
and behavioural development of Axydepitab XL in this age group has not
yet been demonstrated.
Other medicines and Axydepitab XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Axydepitab XL with other
medicines.
Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Axydepitab XL. Tell your
doctor if you have taken these medicines within the last 14 days. (MAOIs:
see the section “What you need to know before you take
Axydepitab XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Axydepitab XL at approximately the same time each day, either in the
morning or in the evening. Tablets must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Axydepitab XL may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Axydepitab XL and should
be used with caution. It is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Axydepitab XL with food, drink and alcohol
Axydepitab XL should be taken with food (see section 3 “How to take
Axydepitab XL”).
You should avoid alcohol while you are taking Axydepitab XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Axydepitab XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Axydepitab XL.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk
of a serious condition in babies, called persistent pulmonary hypertension of
the newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your midwife and/or
doctor immediately.
If you are taking Axydepitab XL during pregnancy, let your midwife and/or
doctor know, as your baby might have some symptoms when it is born.
These symptoms usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Axydepitab XL.
Driving and using machines
Do not drive or use any tools or machines until you know how
Axydepitab XL affects you.
Important information about some of the ingredients of Axydepitab XL
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE AXYDEPITAB XL
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Axydepitab XL should be taken with food.

Do not stop taking Axydepitab XL without talking to your doctor (see the
section “If you stop taking Axydepitab XL”).
If you take more Axydepitab XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Axydepitab XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Axydepitab XL
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Axydepitab XL that has
been prescribed for you in one day.
If you stop taking Axydepitab XL
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Axydepitab XL, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people
stop using Axydepitab XL, especially when Axydepitab XL is stopped
suddenly or the dose is reduced too quickly. Some patients may experience
symptoms such as tiredness, dizziness, light-headedness, headache,
sleeplessness, sensation that everything around you is spinning or moving
(vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhoea,
nervousness, agitation, confusion, ringing in the ears, tingling or rarely
electric shock sensations, weakness, sweating, seizures, or flu-like
symptoms.
Your doctor will advise you on how you should gradually discontinue
Axydepitab XL treatment. If you experience any of these or other symptoms
that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Axydepitab XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Axydepitab XL. As the tablet travels the length of your gastrointestinal tract,
venlafaxine is slowly released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though you may see a
tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Axydepitab XL. Tell your
doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Axydepitab XL, if you
stop taking Axydepitab XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Axydepitab XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Axydepitab XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat; slight
changes in blood levels or liver enzymes, sodium or cholesterol. More
rarely, Axydepitab XL may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding. Therefore, your doctor
may wish to do blood tests occasionally, particularly if you have been taking
Axydepitab XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE AXYDEPITAB XL
• Keep out of the sight and reach of children.
• Do not use Axydepitab XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Axydepitab XL contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Axydepitab XL looks like and contents of the pack
Axydepitab XL 150 mg prolonged-release tablets are white, round,
biconvex, film coated prolonged release tablets, plain on one side with a
laser hole on the other’.
Axydepitab XL 150 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467
Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venantdepitab XL 150 mg
prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Venantdepitab XL 150 mg prolongedrelease tablets but will be referred to as Venantdepitab XL throughout the
remainder of this leaflet.
• Venantdepitab XL is also available in other strengths.
What is in this leaflet:
1. What Venantdepitab XL is and what it is used for
2. What you need to know before you take Venantdepitab XL
3. How to take Venantdepitab XL
4. Possible side effects
5. How to store Venantdepitab XL
6. Contents of the pack and other information
1. WHAT VENANTDEPITAB XL IS AND WHAT IT IS USED FOR
Venantdepitab XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group
of medicines is used to treat depression and other conditions such as
anxiety disorders. It is thought that people who are depressed and/or
anxious have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Venantdepitab XL is a treatment for adults with depression.
Venantdepitab XL is also a treatment for adults with the following anxiety
disorders: generalised anxiety disorder, social anxiety disorder (fear or
avoidance of social situations) and panic disorder (panic attacks). Treating
depression or anxiety disorders properly is important to help you get better.
If it is not treated, your condition may not go away and may become more
serious and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VENANTDEPITAB XL
Do not take Venantdepitab XL
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Venantdepitab XL, can cause serious or even lifethreatening side effects. Also, you must wait at least 7 days after you stop
taking Venantdepitab XL before you take any MAOI (see also the
sections entitled “Other medicines and Venantdepitab XL” and the
information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venantdepitab XL
• If you use other medicines that taken concomitantly with
Venantdepitab XL could increase the risk of developing serotonin
syndrome (see the section “Other medicines and Venantdepitab XL”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

Venantdepitab XL may cause a sensation of restlessness or an inability to
sit or stand still during the first few weeks of treatment. You should tell your
doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Venantdepitab XL.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venantdepitab XL.
Therefore, the dosages of your diabetes medicines may need to be
adjusted.
Use in children and adolescents under 18 years of age
Venantdepitab XL should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have an
increased risk of side effects, such as suicide attempt, suicidal thoughts and
hostility (predominantly aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite this, your doctor may
prescribe this medicine for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed Venantdepitab XL
for a patient under 18, and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are taking Venantdepitab XL.
Also, the long-term safety effects concerning growth, maturation and
cognitive and behavioural development of Venantdepitab XL in this age
group has not yet been demonstrated.
Other medicines and Venantdepitab XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Venantdepitab XL with
other medicines.
Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Venantdepitab XL. Tell
your doctor if you have taken these medicines within the last 14 days.
(MAOIs: see the section “What you need to know before you take
Venantdepitab XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Venantdepitab XL at approximately the same time each day, either in
the morning or in the evening. Tablets must be swallowed whole with fluid
and not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Venantdepitab XL may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venantdepitab XL and
should be used with caution. It is especially important to mention to your
doctor or pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Venantdepitab XL with food, drink and alcohol
Venantdepitab XL should be taken with food (see section 3 “How to take
Venantdepitab XL”).
You should avoid alcohol while you are taking Venantdepitab XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Venantdepitab XL only after discussing the
potential benefits and the potential risks to your unborn child with your
doctor.
Make sure your midwife and/or doctor knows you are on Venantdepitab XL.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk
of a serious condition in babies, called persistent pulmonary hypertension of
the newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your midwife and/or
doctor immediately.
If you are taking Venantdepitab XL during pregnancy, let your midwife
and/or doctor know, as your baby might have some symptoms when it is
born. These symptoms usually begin during the first 24 hours after the baby
is born. They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Venantdepitab XL.
Driving and using machines
Do not drive or use any tools or machines until you know how
Venantdepitab XL affects you.
Important information about some of the ingredients of
Venantdepitab XL
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE VENANTDEPITAB XL
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Venantdepitab XL should be taken with food.

Do not stop taking Venantdepitab XL without talking to your doctor (see the
section “If you stop taking Venantdepitab XL”).
If you take more Venantdepitab XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Venantdepitab XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Venantdepitab XL
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Venantdepitab XL that has
been prescribed for you in one day.
If you stop taking Venantdepitab XL
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Venantdepitab XL, he/she may ask you to reduce your dose slowly
before stopping treatment altogether. Side effects are known to occur when
people stop using Venantdepitab XL, especially when Venantdepitab XL is
stopped suddenly or the dose is reduced too quickly. Some patients may
experience symptoms such as tiredness, dizziness, light-headedness,
headache, sleeplessness, sensation that everything around you is spinning
or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea,
diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or
rarely electric shock sensations, weakness, sweating, seizures, or flu-like
symptoms.
Your doctor will advise you on how you should gradually discontinue
Venantdepitab XL treatment. If you experience any of these or other
symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venantdepitab XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Venantdepitab XL. As the tablet travels the length of your gastrointestinal
tract, venlafaxine is slowly released. The shape of the tablet remains
undissolved and is eliminated in your stools. Therefore, even though you
may see a tablet in your stools, your dose of venlafaxine has been
absorbed.
Allergic reactions
If any of the following happen, do not take more Venantdepitab XL. Tell
your doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Venantdepitab XL, if you
stop taking Venantdepitab XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Venantdepitab XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venantdepitab XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat; slight
changes in blood levels or liver enzymes, sodium or cholesterol. More
rarely, Venantdepitab XL may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding. Therefore, your doctor
may wish to do blood tests occasionally, particularly if you have been taking
Venantdepitab XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE VENANTDEPITAB XL
• Keep out of the sight and reach of children.
• Do not use Venantdepitab XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Venantdepitab XL contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Venantdepitab XL looks like and contents of the pack
Venantdepitab XL 150 mg prolonged-release tablets are white, round,
biconvex, film coated prolonged release tablets, plain on one side with a
laser hole on the other’.
Venantdepitab XL 150 mg prolonged-release tablets are available in packs
of 28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467
Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venantapid XL 150 mg
prolonged-release tablets
(venlafaxine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
• The name of your medicine is Venantapid XL 150 mg prolonged-release
tablets but will be referred to as Venantapid XL throughout the remainder
of this leaflet.
• Venantapid XL is also available in other strengths.
What is in this leaflet:
1. What Venantapid XL is and what it is used for
2. What you need to know before you take Venantapid XL
3. How to take Venantapid XL
4. Possible side effects
5. How to store Venantapid XL
6. Contents of the pack and other information
1. WHAT VENANTAPID XL IS AND WHAT IT IS USED FOR
Venantapid XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group
of medicines is used to treat depression and other conditions such as
anxiety disorders. It is thought that people who are depressed and/or
anxious have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Venantapid XL is a treatment for adults with depression. Venantapid XL is
also a treatment for adults with the following anxiety disorders: generalised
anxiety disorder, social anxiety disorder (fear or avoidance of social
situations) and panic disorder (panic attacks). Treating depression or
anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious
and more difficult to treat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
VENANTAPID XL
Do not take Venantapid XL
• If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
• If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease. Taking an irreversible
MAOI together with Venantapid XL, can cause serious or even lifethreatening side effects. Also, you must wait at least 7 days after you stop
taking Venantapid XL before you take any MAOI (see also the sections
entitled “Other medicines and Venantapid XL” and the information in that
section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venantapid XL
• If you use other medicines that taken concomitantly with Venantapid XL
could increase the risk of developing serotonin syndrome (see the section
“Other medicines and Venantapid XL”).
• If you have a swallowing, stomach or intestinal disorder that reduces your
ability to swallow or pass foods by normal bowel movements.
• If you have eye problems, such as certain kinds of glaucoma (increased
pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily
(history of bleeding disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g. warfarin (used to prevent blood
clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family has had, mania or
bipolar disorder (feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

Venantapid XL may cause a sensation of restlessness or an inability to sit
or stand still during the first few weeks of treatment. You should tell your
doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before
taking Venantapid XL.
Thoughts of suicide and worsening of your depression or feelings of
anxiety
If you are depressed and/or have anxiety disorders, you can sometimes
have thoughts of harming or killing yourself. These may be increased when
you first start taking antidepressants, since these medicines all take time to
work, usually about two weeks, but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing yourself or harming
yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in young adults (less than 25 years
old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with venlafaxine. This may
increase the risk of caries. Therefore, you should take special care in your
dental hygiene.
Diabetes
Your blood glucose levels may be altered due to Venantapid XL. Therefore,
the dosages of your diabetes medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venantapid XL should normally not be used for children and adolescents
under 18 years. Also, you should know that patients under 18 have an
increased risk of side effects, such as suicide attempt, suicidal thoughts and
hostility (predominantly aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite this, your doctor may
prescribe this medicine for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed Venantapid XL for
a patient under 18, and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are taking Venantapid XL. Also,
the long-term safety effects concerning growth, maturation and cognitive
and behavioural development of Venantapid XL in this age group has not
yet been demonstrated.
Other medicines and Venantapid XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Venantapid XL with other
medicines.
Do not start or stop taking any medicines, including those bought without a
prescription, natural and herbal remedies, before checking with your doctor
or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or
Parkinson’s disease must not be taken with Venantapid XL. Tell your
doctor if you have taken these medicines within the last 14 days. (MAOIs:
see the section “What you need to know before you take
Venantapid XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition (see the
section “Possible Side Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or
medicines containing lithium
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat
depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol (a pain-killer)
• Medicines containing methylene blue (used to treat high levels of
methaemoglobin in the blood)

• Products containing St. John’s Wort (also called Hypericum
perforatum, a natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and
depression)
• Antipsychotics (used to treat a disease with symptoms such as
hearing, seeing or sensing things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and becoming withdrawn)

The usual recommended starting dose for treatment of depression,
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375 mg daily for depression. If you are being treated for
panic disorder, your doctor will start with a lower dose (37.5 mg) and then
increase the dose gradually. The maximum dose for generalised anxiety
disorder, social anxiety disorder and panic disorder is 225 mg/day.

Signs and symptoms of serotonin syndrome may include a combination of
the following:
restlessness, hallucinations, loss of coordination, fast heart beat, increased
body temperature, fast changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Take Venantapid XL at approximately the same time each day, either in the
morning or in the evening. Tablets must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).

If you have liver or kidney problems, talk to your doctor, since your dose of
Venantapid XL may need to be different.

Tell your doctor immediately, or go to the casualty department at your
nearest hospital if you think serotonin syndrome is happening to you
The following medicines may also interact with Venantapid XL and should
be used with caution. It is especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole, Itraconazole, Voriconazole, Posaconazole (antifungal
medicines)
• Clarithromycin, telithromycin (antibiotics used to treat infections)
• Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV
infection)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart
problems)
Venantapid XL with food, drink and alcohol
Venantapid XL should be taken with food (see section 3 “How to take
Venantapid XL”).
You should avoid alcohol while you are taking Venantapid XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Venantapid XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venantapid XL.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk
of a serious condition in babies, called persistent pulmonary hypertension of
the newborn (PPHN), making the baby breathe faster and appear bluish.
These symptoms usually begin during the first 24 hours after the baby is
born. If this happens to your baby you should contact your midwife and/or
doctor immediately.
If you are taking Venantapid XL during pregnancy, let your midwife and/or
doctor know, as your baby might have some symptoms when it is born.
These symptoms usually begin during the first 24 hours after the baby is
born. They include irritability, tremor, hypotonia, constant crying, sleeping
difficulties and, not feeding properly. If your baby has these symptoms when
it is born and you are concerned, contact your doctor and/or midwife who
will be able to advise you.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby,
which may cause symptoms such as crying, irritabilty and abnormal sleep
patterns. Symptoms consistent with venlafaxine drug discontinuation can
also occur after stopping breast-feeding. Therefore, you should discuss the
matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Venantapid XL.
Driving and using machines
Do not drive or use any tools or machines until you know how
Venantapid XL affects you.
Important information about some of the ingredients of Venantapid XL
This medicine contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO TAKE VENANTAPID XL
Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.

Venantapid XL should be taken with food.

Do not stop taking Venantapid XL without talking to your doctor (see the
section “If you stop taking Venantapid XL”).
If you take more Venantapid XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Venantapid XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat,
changes in level of alertness (ranging from sleepiness to coma), blurred
vision, seizures or fits, and vomiting.
If you forget to take Venantapid XL
If you miss a dose, take it as soon as you remember. However, if it is time
for your next dose, skip the missed dose and take only a single dose as
usual. Do not take more than the daily amount of Venantapid XL that has
been prescribed for you in one day.
If you stop taking Venantapid XL
Do not stop taking your treatment or reduce the dose without the advice of
your doctor even if you feel better. If your doctor thinks that you no longer
need Venantapid XL, he/she may ask you to reduce your dose slowly
before stopping treatment altogether. Side effects are known to occur when
people stop using Venantapid XL, especially when Venantapid XL is
stopped suddenly or the dose is reduced too quickly. Some patients may
experience symptoms such as tiredness, dizziness, light-headedness,
headache, sleeplessness, sensation that everything around you is spinning
or moving (vertigo), nightmares, dry mouth, loss of appetite, nausea,
diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling or
rarely electric shock sensations, weakness, sweating, seizures, or flu-like
symptoms.
Your doctor will advise you on how you should gradually discontinue
Venantapid XL treatment. If you experience any of these or other symptoms
that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venantapid XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking
Venantapid XL. As the tablet travels the length of your gastrointestinal tract,
venlafaxine is slowly released. The shape of the tablet remains undissolved
and is eliminated in your stools. Therefore, even though you may see a
tablet in your stools, your dose of venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venantapid XL. Tell your
doctor immediately, or go to the casualty department at your nearest
hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, sudden
reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that
often itch)
• Signs and symptoms of serotonin syndrome which may include
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure, overactive
reflexes, diarrhoea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic
Malignant Syndrome (NMS). Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and a high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which may be symptoms of
inflammation of the liver (hepatitis)
• Heart problems, such as fast or irregular heart rate, increased blood
pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles, movement
disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)
• Withdrawal effects (see the section “How to take Venantapid XL, if you
stop taking Venantapid XL”)
• Prolonged bleeding - if you cut or injure yourself, it may take slightly
longer than usual for bleeding to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm;
decreased libido; nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased muscle tonus
• Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular
bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction
(impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect up to 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation;
abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
• Fast heart beat; feeling dizzy (particularly when standing up too quickly)
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine
• Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, What you need to
know before you take Venantapid XL)
• Disorientation and confusion often accompanied by hallucination
(delirium); aggression

• A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of being
drunk, sweating or rigid muscles, which are symptoms of serotonin
syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises or
broken blood vessels (broken veins)
• Coughing, wheezing, shortness of breath and a high temperature, which
are symptoms of inflammation of the lungs associated with an increase in
white blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could indicate a serious problem
in the gut, liver or pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are
symptoms of inflammation of the liver (hepatitis); slight changes in blood
levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Venantapid XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat; slight
changes in blood levels or liver enzymes, sodium or cholesterol. More
rarely, Venantapid XL may reduce the function of platelets in your blood,
leading to an increased risk of bruising or bleeding. Therefore, your doctor
may wish to do blood tests occasionally, particularly if you have been taking
Venantapid XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE VENANTAPID XL
• Keep out of the sight and reach of children.
• Do not use Venantapid XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store in the original package in order to protect from moisture.
• If the tablets become discoloured or show any sign of deterioration return
them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Venantapid XL contains
The active ingredient is venlafaxine. Each prolonged-release tablet contains
150 mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: Mannitol, Povidone K-90, Macrogol 400, Microcrystalline cellulose,
Colloidal anhydrous silica, Magnesium stearate.
Coating: Cellulose acetate 398-10NF, Cellulose acetate 320SNF,
Macrogol 400, Opadry white Y-30-18037.
What Venantapid XL looks like and contents of the pack
Venantapid XL 150 mg prolonged-release tablets are white, round,
biconvex, film coated prolonged release tablets, plain on one side with a
laser hole on the other’.
Venantapid XL 150 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturered by
Laboratorios LICONSA, S.A., Avda. Miralcampo No 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares, Spain

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0467
Leaflet dated 6th November 2015
Leaflet coded XXXXXXXXXX

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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