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AXYVEN XL 225 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE

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PATIENT INFORMATION LEAFLET

2739
03.08.15[1]

Venlalic® XL 225 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.
Your medicine is available using the above name but will be referred to as
Venlalic XL throughout this leaflet.
Venlalic XL prolonged-release tablets are also available in 37.5 mg,
75 mg and 150 mg strengths.
What is in this leaflet:
1. What Venlalic XL is and what it is used for
2. What you need to know before you take Venlalic XL
3. How to take Venlalic XL
4. Possible side effects
5. How to store Venlalic XL
6. Contents of the pack and other information
1. What Venlalic XL is and what it is used for
Venlalic XL is an antidepressant that belongs to a group of medicines
called serotonin and norepinephrine reuptake inhibitors (SNRIs). This
group of medicines is used to treat depression and other conditions such
as anxiety disorders. It is thought that people who are depressed and/or
anxious have lower levels of serotonin and noradrenaline in the brain. It is
not fully understood how antidepressants work, but they may help by
increasing the levels of serotonin and noradrenaline in the brain.
Venlalic XL is a treatment for adults with depression. Venlalic XL is also a
treatment for adults with the following anxiety disorders: generalised
anxiety disorder, social anxiety disorder (fear or avoidance of social
situations) and panic disorder (panic attacks). Treating depression or
anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious
and more difficult to treat.
2. What you need to know before you take Venlalic XL
Do not take Venlalic XL
 If you are allergic to venlafaxine or any of the other ingredients of this
medicine (listed in section 6).
 If you are also taking or have taken any time within the last 14 days any
medicines known as irreversible monoamine oxidase inhibitors
(MAOIs), used to treat depression or Parkinson’s disease. Taking an
irreversible MAOI together with Venlalic XL, can cause serious or even
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, 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)

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

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.

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.

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.

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).

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.

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

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.

 Eye problems, such as blurred vision, dilated pupils
 Nerve problems, such as dizziness, pins and needles, movement

Venlafaxine passes into breast milk. There is a risk of an effect on the
baby, which may cause symptoms such as crying, irritability 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.

 Prolonged bleeding - if you cut or injure yourself, it may take slightly

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

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”)

longer than usual for bleeding to stop

Complete side effect listing
Very common (may affect more than 1 in 10 people)

 Dizziness; headache
 Nausea; dry mouth
 Sweating (including night sweats)

Common (may affect up to 1 in 10 people)
 Appetite decreased
 Confusion; feeling separated (or detached) from yourself; lack of
orgasm; decreased libido; nervousness; insomnia; abnormal dreams
 Drowsiness; tremor; pins and needles; increased muscle tonus
 Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
 Ringing in the ears (tinnitus)
 Palpitations
 Increase in blood pressure; flushing
 Yawning
 Vomiting; constipation; diarrhoea
 Increased frequency in urination; difficulties passing urine
 Menstrual irregularities such as increased bleeding or increased
irregular bleeding; abnormal ejaculation/orgasm (males); erectile
dysfunction (impotence)
 Weakness (asthenia); fatigue; chills
 Increased cholesterol
Uncommon (may affect up to 1 in 100 people)

 Hallucinations; feeling separated (or detached) from reality; agitation;







abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
Fast heart beat; feeling dizzy (particularly when standing up too quickly)
Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be
present; sensitivity to sunlight; bruising; rash; abnormal hair loss
Inability to pass urine
Weight gain; weight loss

Rare (may affect up to 1 in 1,000 people)

 Seizures or fits
 Inability to control urination
 Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
 Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
 Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
 Excessive water intake (known as SIADH)
 Decrease in blood sodium levels
 Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, Before you take
Venlalic XL)
 Disorientation and confusion often accompanied by hallucination
(delirium); aggression
 A high temperature with rigid muscles, confusion or agitation, and
sweating, or if you experience jerky muscle movements which you can’t
control, these may be symptoms of serious conditions known as
neuroleptic malignant syndrome; euphoric feelings, drowsiness,
sustained rapid eye movement, clumsiness, restlessness, feeling of
being drunk, sweating or rigid muscles, which are symptoms of
serotonin syndrome; stiffness, spasms and involuntary movements of
the muscles
 Severe eye pain and decreased or blurred vision
 Vertigo
 Decrease in blood pressure; abnormal, rapid or irregular heart beat,
which could lead to fainting; unexpected bleeding, e.g. bleeding gums,
blood in the urine or in vomit, or the appearance of unexpected bruises
or broken blood vessels (broken veins)
 Coughing, wheezing, shortness of breath and a high temperature,
which are symptoms of inflammation of the lungs associated with an
increase in white blood cells (pulmonary eosinophilia)
 Severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
 Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which
are symptoms of inflammation of the liver (hepatitis); slight changes in
blood levels of liver enzymes
 Skin rash, which may lead to severe blistering and peeling of the skin;
itching; mild rash
 Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
 Abnormal breast milk production
Venlalic XL sometimes causes unwanted effects that you may not be
aware of, such as increases in blood pressure or abnormal heart beat;
slight changes in blood levels or liver enzymes, sodium or cholesterol.
More rarely, Venlalic XL may reduce the function of platelets in your
blood, leading to an increased risk of bruising or bleeding. Therefore, your
doctor may wish to do blood tests occasionally, particularly if you have
been taking Venlalic XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 30ºC.
Store in the original package in order to protect from moisture.
If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Venlalic XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 225 mg venlafaxine (as
hydrochloride).
The other ingredients are
Core: mannitol (E421), povidone K90, macrogol 400, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate.
Coat: cellulose acetate, macrogol 400, opadry white Y-30-18037
(hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin)
What Venlalic XL looks like and contents of the pack
Venlalic XL are white, round, biconvex, prolonged-release tablets, plain
on one side with a laser hole on the other.
Venlalic XL is available in blisters pack sizes of 14 or 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by Laboratorios LICONSA S.A., Avda. Miralcampo no 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares
(Guadalajara), Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2739

Leaflet revision and issue date (Ref) 03.08.15[1]
Venlalic is a trademark of Dallas Burston Ashbourne Holdings Limited.

PATIENT INFORMATION LEAFLET

2739
03.08.15[1]

Axyven® XL 225 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.
Your medicine is available using the above name but will be referred to as
Axyven XL throughout this leaflet.
Axyven XL prolonged-release tablets are also available in 37.5 mg,
75 mg and 150 mg strengths.
What is in this leaflet:
1. What Axyven XL is and what it is used for
2. What you need to know before you take Axyven XL
3. How to take Axyven XL
4. Possible side effects
5. How to store Axyven XL
6. Contents of the pack and other information
1. What Axyven XL is and what it is used for
Axyven 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.
Axyven XL is a treatment for adults with depression. Axyven XL is also a
treatment for adults with the following anxiety disorders: generalised
anxiety disorder, social anxiety disorder (fear or avoidance of social
situations) and panic disorder (panic attacks). Treating depression or
anxiety disorders properly is important to help you get better. If it is not
treated, your condition may not go away and may become more serious
and more difficult to treat.
2. What you need to know before you take Axyven XL
Do not take Axyven 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 Axyven XL, can cause serious or even
life-threatening side effects. Also, you must wait at least 7 days after
you stop taking Axyven 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 Axyven XL
 If you use other medicines that taken concomitantly with Axyven 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.
Axyven 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 Axyven 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 Axyven XL. Therefore,
the dosages of your diabetes medicines may need to be adjusted.

Use in children and adolescents under 18 years of age
Axyven 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
Axyven 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 Axyven
XL. Also, the long-term safety effects concerning growth, maturation and
cognitive and behavioural development of Axyven XL in this age group
has not yet been demonstrated.
Other medicines and Axyven XL
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines.
Your doctor should decide whether you can take Axyven 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 Axyven XL. Tell your
doctor if you have taken these medicines within the last 14 days.
(MAOIs: see the section “Before you take Axyven 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 Axyven 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)

Important information about some of the ingredients of Axyven 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 Axyven 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
generalised anxiety disorder and social anxiety disorder is 75 mg per day.
The dose can be raised by your doctor gradually, and if needed, even up
to a maximum dose of 375 mg daily for depression. If you are being
treated for panic disorder, your doctor will start with a lower dose (37.5
mg) and then increase the dose gradually. The maximum dose for
generalised anxiety disorder, social anxiety disorder and panic disorder is
225 mg/day.
Take Axyven 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.
Axyven XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose
of Axyven XL may need to be different.
Do not stop taking Axyven XL without talking to your doctor (see the
section “If you stop taking Axyven XL”).
If you take more Axyven XL than you should
Call your doctor or pharmacist immediately if you take more than the
amount of Axyven 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 Axyven 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 Axyven XL that has
been prescribed for you in one day.
If you stop taking Axyven 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 Axyven 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 Axyven XL, especially when Axyven 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
Axyven 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, Axyven XL can cause side effects, although not
everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Axyven
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.

Axyven XL with food, drink and alcohol
Axyven XL should be taken with food (see section 3 “How to take Axyven
XL”).
You should avoid alcohol while you are taking Axyven XL.

Allergic reactions
If any of the following happen, do not take more Axyven 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.

Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should use Axyven XL only after discussing the potential
benefits and the potential risks to your unborn child with your doctor.

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).

Make sure your midwife and/or doctor knows you are on Axyven 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.

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

If you are taking Axyven 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.

 Eye problems, such as blurred vision, dilated pupils
 Nerve problems, such as dizziness, pins and needles, movement

Venlafaxine passes into breast milk. There is a risk of an effect on the
baby, which may cause symptoms such as crying, irritability 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
XL.

 Prolonged bleeding - if you cut or injure yourself, it may take slightly

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

disorder, seizures or fits

 Psychiatric problems, such as hyperactivity and euphoria (feeling
unusually overexcited)

 Withdrawal effects (see the section “How to take Axyven XL, if you stop
taking Axyven XL”)

longer than usual for bleeding to stop

Complete side effect listing
Very common (may affect more than 1 in 10 people)

 Dizziness; headache
 Nausea; dry mouth
 Sweating (including night sweats)

Common (may affect up to 1 in 10 people)
 Appetite decreased
 Confusion; feeling separated (or detached) from yourself; lack of
orgasm; decreased libido; nervousness; insomnia; abnormal dreams
 Drowsiness; tremor; pins and needles; increased muscle tonus
 Visual disturbance including blurred vision; dilated pupils; inability of the
eye to automatically change focus from distant to near objects
 Ringing in the ears (tinnitus)
 Palpitations
 Increase in blood pressure; flushing
 Yawning
 Vomiting; constipation; diarrhoea
 Increased frequency in urination; difficulties passing urine
 Menstrual irregularities such as increased bleeding or increased
irregular bleeding; abnormal ejaculation/orgasm (males); erectile
dysfunction (impotence)
 Weakness (asthenia); fatigue; chills
 Increased cholesterol
Uncommon (may affect up to 1 in 100 people)

 Hallucinations; feeling separated (or detached) from reality; agitation;







abnormal orgasm (females); lack of feeling or emotion; feeling overexcited; grinding of the teeth
A sensation of restlessness or an inability to sit or stand still; fainting;
involuntary movements of the muscles; impaired coordination and
balance; altered taste sensation
Fast heart beat; feeling dizzy (particularly when standing up too quickly)
Vomiting blood, black tarry stools (faeces) or blood in stools; which can
be a sign of internal bleeding
General swelling of the skin especially the face, mouth, tongue, throat
area or hands and feet and/or a raised itchy rash (hives) may be
present; sensitivity to sunlight; bruising; rash; abnormal hair loss
Inability to pass urine
Weight gain; weight loss

Rare (may affect up to 1 in 1,000 people)

 Seizures or fits
 Inability to control urination
 Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)
 Reduced number of platelets in your blood, leading to an increased risk
of bruising or bleeding; blood disorders which may lead to an increased
risk of infection
 Swollen face or tongue, shortness of breath or difficulty breathing, often
with skin rashes (this may be a serious allergic reaction)
 Excessive water intake (known as SIADH)
 Decrease in blood sodium levels
 Suicidal ideation and suicidal behaviours; cases of suicidal ideation and
suicidal behaviours have been reported during venlafaxine therapy or
early after treatment discontinuation (see section 2, Before you take
Axyven 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
Axyven 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, Axyven 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 Axyven XL for a long time.
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 XL
Keep out of the sight and reach of children.
Do not use Axyven XL after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
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 XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 225 mg venlafaxine (as
hydrochloride).
The other ingredients are
Core: mannitol (E421), povidone K90, macrogol 400, microcrystalline
cellulose, colloidal anhydrous silica, magnesium stearate.
Coat: cellulose acetate, macrogol 400, opadry white Y-30-18037
(hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin)
What Axyven XL looks like and contents of the pack
Axyven XL are white, round, biconvex, prolonged-release tablets, plain on
one side with a laser hole on the other.
Axyven XL is available in blisters pack sizes of 14 or 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by Laboratorios LICONSA S.A., Avda. Miralcampo no 7,
Poligono Industrial Miralcampo, 19200 Azuqueca de Henares
(Guadalajara), Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2739

Leaflet revision and issue date (Ref) 03.08.15[1]
Axyven is a trademark of Axxon Sp. z o.o.

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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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