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VENLALIC XL 150MG PROLONGED RELEASE TABLETS

Active substance(s): VENLAFAXINE

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Other medicines and Venlalic XL
Package Leaflet: Information For The User

®

Venlalic XL 150mg
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 medicin e is Venlalic XL 150mg prolonged-release tablets but it will be referred to as
Venlalic XL throughout this leaflet. Please note that the leaflet also contains information about other strengths
Venlalic XL 37.5mg, 75mg and 225mg prolonged-release tablets.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Venlalic XL is and what it is used for
What you need to know before you take Venlalic XL
How to take Venlalic XL
Possible side effects
How to store Venlalic XL
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.

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

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.

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

Dry mouth

If you take more Venlalic XL than you should

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.

Call your doctor or pharmacist immediately if you take more than the amount of Venlalic XL prescribed by
your doctor.

Diabetes

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.

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.

Do not stop taking Venlalic XL without talking to your doctor (see the section ‘If you stop taking Venlalic XL’).

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 gastro-intestinal 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 over-excited; 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.
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 store above 30ºC.
Store in the original package in order to protect from moisture.
Do not take the medicine after the expiry date which is stated on the carton and blister label after ‘Exp’.
The expiry date refers to the last day of that month.
If the tablet becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Venlalic XL contains
The active substance in Venlalic XL is venlafaxine.
Each prolonged-release tablet contains 150mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: mannitol, povidone K-90, macrogol 400, microcrystalline cellulose, colloidal anhydrous silica and
magnesium stearate.
Coat: cellulose acetate (3205 NF), cellulose acetate (398-10NF), macrogol 400 and
Opadry White Y-30-18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin).
What Venlalic XL looks like and contents of the pack
Venlalic XL is white, round, biconvex tablets, plain on one side with a laser hole on the other.
Venlalic XL is available in blisters of 28 tablets.
Manufactured by: Laboratorios LICONSA S.A., Avda. Miralcampo no 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Venlalic® XL 150mg prolonged-release tablets;
PL 18799/2901
Leaflet date: 07.07.2016

POM

Other medicines and Axyven XL
Package Leaflet: Information For The User

Axyven XL 150mg
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 XL 150mg prolonged-release tablets but it will be referred to as Axyven
XL throughout this leaflet. Please note that the leaflet also contains information about other strengths Axyven
XL 37.5mg, 75mg and 225mg prolonged-release tablets.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Axyven XL is and what it is used for
What you need to know before you take Axyven XL
How to take Axyven XL
Possible side effects
How to store Axyven XL
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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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)
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.
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.
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.
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.
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.
Driving and using machines
Do not drive or use any tools or machines until you know how Axyven XL affects you.
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 75mg per day. The dose can be raised by your doctor gradually, and if needed, even up to
a maximum dose of 375mg daily for depression. If you are being treated for panic disorder, your doctor will
start with a lower dose (37.5mg) and then increase the dose gradually. The maximum dose for generalised
anxiety disorder, social anxiety disorder and panic disorder is 225mg/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.

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.

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

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.

If you take more Axyven XL than you should

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

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.

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.

Do not stop taking Axyven XL without talking to your doctor (see the section ‘If you stop taking Axyven XL’).
Call your doctor or pharmacist immediately if you take more than the amount of Axyven XL prescribed by
your doctor.

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 gastro-intestinal 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 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 Axyven XL, if you stop taking Axyven 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 over-excited; 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.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any of the 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 XL
Keep out of the sight and reach of children.
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
Do not take the medicine after the expiry date which is stated on the carton and blister label after ‘Exp’.
The expiry date refers to the last day of that month.
If the tablet becomes discoloured or show any signs of deterioration, seek the advice of 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 XL contains
The active substance in Axyven XL is venlafaxine.
Each prolonged-release tablet contains 150mg venlafaxine (as hydrochloride).
The other ingredients are:
Core: mannitol, povidone K-90, macrogol 400, microcrystalline cellulose, colloidal anhydrous silica and
magnesium stearate.
Coat: cellulose acetate (3205 NF), cellulose acetate (398-10NF), macrogol 400 and
Opadry White Y-30-18037 (hypromellose, lactose monohydrate, titanium dioxide (E171) and triacetin).
What Axyven XL looks like and contents of the pack
Axyven XL white, round, biconvex tablets, plain on one side with a laser hole on the other.
Axyven XL is available in blisters of 28 tablets.
Manufactured by: Laboratorios LICONSA S.A., Avda. Miralcampo no 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Axyven XL 150mg prolonged-release tablets;
PL 18799/2901
Leaflet date: 07.07.2016

POM

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Source: Medicines and Healthcare Products Regulatory Agency

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

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