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AXYVEN 75MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE

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Patient Information Leaflet

Axyantapid XL 75 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 75 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 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 life-threatening 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 “Taking other medicines” 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 “Taking other medicines”).
• 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, or 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 “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)
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.
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).
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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Axyantapid XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Axyantapid XL may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Axyantapid XL looks like and contents of the pack
Axyantapid XL 75 mg prolonged-release tablets are white, round,
biconvex tablets with a laser hole on one side.
Axyantapid XL 75 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466
Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX

POM

Patient Information Leaflet

Axydepitab XL 75 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 75 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 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 life-threatening 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 “Taking other medicines” 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 “Taking other medicines”).
• 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, or 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 “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)
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.
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).
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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Axydepitab XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Axydepitab XL may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Axydepitab XL looks like and contents of the pack
Axydepitab XL 75 mg prolonged-release tablets are white, round,
biconvex tablets with a laser hole on one side.
Axydepitab XL 75 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466
Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX

POM

Patient Information Leaflet

Axyven® 75 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 75 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 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 lifethreatening 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 “Taking other medicines” 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
“Taking other medicines”).
• 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.

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, or 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 “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)
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.
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).
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.

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.

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.

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.

Driving and using machines
Do not drive or use any tools or machines until you know how Axyven
affects you.

Diabetes
Your blood glucose levels may be altered due to Axyven. Therefore, the
dosages of your diabetes medicines may need to be adjusted.

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.

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.

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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Axyven should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Axyven may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Axyven looks like and contents of the pack
Axyven 75 mg prolonged-release tablets are white, round, biconvex
tablets with a laser hole on one side.
Axyven 75 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466
Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX
®

Axyven is a registered trademark of Axxon Sp. z o. o.

POM

Patient Information Leaflet

Venantapid XL 75 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 75 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 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 life-threatening 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 “Taking other medicines” 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 “Taking other medicines”).
• 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, or 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 “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)
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.
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).
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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Venantapid XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Venantapid XL may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Venantapid XL looks like and contents of the pack
Venantapid XL 75 mg prolonged-release tablets are white, round,
biconvex tablets with a laser hole on one side.
Venantapid XL 75 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466
Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX

POM

Patient Information Leaflet

Venantdepitab XL 75 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 75 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 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 life-threatening 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 “Taking other medicines” 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 “Taking other medicines”).
• 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, or 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 “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)
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.
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).
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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Venantdepitab XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Venantdepitab XL may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Venantdepitab XL looks like and contents of the pack
Venantdepitab XL 75 mg prolonged-release tablets are white, round,
biconvex tablets with a laser hole on one side.
Venantdepitab XL 75 mg prolonged-release tablets are available in packs
of 28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466
Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX

POM

Patient Information Leaflet

Venlalic® XL 75 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 75 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 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
life-threatening 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 “Taking other medicines” and the information in that
section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venlalic XL
• If you use other medicines that taken concomitantly with Venlalic XL
could increase the risk of developing serotonin syndrome (see the
section “Taking other medicines”).
• 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.
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, or have recently taken
any other medicines.
Your doctor should decide whether you can take Venlalic 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 Venlalic XL. Tell your
doctor if you have taken these medicines within the last 14 days.
(MAOIs: see the section “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)
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.
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).
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.
The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is
225 mg/day.
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.
Venlalic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Venlalic XL may need to be different.
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 heartbeat; 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, 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.
If you get any of the side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 30°C.
• 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
Each prolonged-release tablet contains 75 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, Cellulose acetate 320s, Cellulose acetate
398-10, Macrogol 400, Opadry Y 30 18037 (hypromellose, lactose
monohydrate, titanium dioxide (E171) and triacetin)
What Venlalic XL looks like and contents of the pack
Venlalic XL 75 mg prolonged-release tablets are white, round, biconvex
tablets with a laser hole on one side.
Venlalic XL 75 mg prolonged-release tablets are available in packs of
28 tablets.
Manufacturer
Laboratorios LICONSA, S.A., Avda. Miralcampo, No 7, Polígono
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 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL 33532/0466

POM

Leaflet date: 23 June 2014
Leaflet code: XXXXXXXXXX
®

Venlalic is a registered trademark of Dallas Burston Ashbourne
Holdings Ltd.

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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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