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VEXARIN XL 75MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Vexarin XL75 mg prolonged-release capsules, hard
Vexarin XL150 mg prolonged-release capsules, hard
(venlafaxine)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. 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. See section 4.
What is in this leaflet:
1.
What Venlafaxine is and what it is used for
2.
What you need to know before you take Venlafaxine
3.
How to take Venlafaxine
4.
Possible side effects
5.
How to store Venlafaxine
6.
Contents of the pack and other information
1.
What Venlafaxine is and what it is used for
Venlafaxine contains the active ingredient venlafaxine, which 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.
Venlafaxine is a treatment for adults with depression or to prevent the recurrence of major
depressive episodes. Venlafaxine 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 Venlafaxine

Do not take Venlafaxine:
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 other medicines,
including venlafaxine, can cause serious or even life-threatening side effects. Also, you
must wait at least 7 days after you stop taking venlafaxine before you take any MAOI
(see also the sections “Serotinin syndrome” and “Other medicines and Venlafaxine”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine:
 if you are taking certain medicines that taken with venlafaxine could increase the risk of
developing a potentia l seri ou s si d e - ef fec t calle d serotonin syndrome (see the section
“Other medicines and venlafaxine”).
 if you have eye problems, such as certain kinds of glaucoma (increased pressure in the
eye) or if your optician has told you that you may be at increased risk of developing
glaucoma.
 if you have a history of high blood pressure or if you have recently had a heart attack .
 if you, or someone in your family, have a history of heart or heart rhythm problems.
 if you have a history of fits (seizures).
 if you have a history of low sodium levels in your blood (hyponatraemia). Also, if you are
elderly, are taking diuretics (water tablets that may cause increased production of urine) or
are dehydrated (e.g. due to severe diarrhoea or being sick).
 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 thin the blood and may
increase the risk of bleeding.
 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. You may feel aggressive especially during the
early stages of treatment with venlafaxine, if your dose is changed or when you stop
 taking.if you have diabetes (this medicine may affect blood sugar levels).
 if you are taking any medicine to lose weight.






During treatment
This medicine may cause an increase in blood pressure or cholesterol levels. Your doctor
may check your blood pressure and cholesterol levels regularly.
If you get a sensation of restlessness or an inability to sit or stand still, which may occur
during early stages of treatment, talk to your doctor or pharmacist.
If you need to have a urine screen to check for certain medicines this medicine may affect the
results. Tell your doctor or hospital staff that you are taking this medicine.
Venlafaxine capsules contains spheroids, the insoluble portion of which is eliminated and
may be seen in faeces.

Thoughts of suicide and worsening of your depression or anxiety disorder
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 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 1 in 10 people taking venlafaxine. This may increase the risk of tooth
decay. Therefore, you should take special care in your dental hygiene.
Children and adolescents under the age of 18
Venlafaxine should normally not be used in children and adolescents under 18 years. Also, you
should know that patients under the age of 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 Venlafaxine for patients under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed Venlafaxine 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 mentioned above develop or worsen when patients under 18 are taking
Venlafaxine. Also, the long-term safety effects concerning growth, maturation, and cognitive
and behavioural development of venlafaxine in this age group have not yet been demonstrated.
Other medicines and Venlafaxine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription, natural and herbal
remedies.
Your doctor should decide whether you can take Venlafaxine with other medicines.



Do not take monoamine oxidase inhibitors (MAOIs) which are used to treat depression

or Parkinson’s disease with venlafaxine. Tell your doctor if you have taken these
medicines within the last 14 days. (MAOIs: see the section “What you need to know
before you take Venlafaxine”).
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 e.g, sumatriptan, zolmitriptan )
 Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines
containing lithium
 Medicines containing linezolid, an antibiotic (used to treat infections)
 Medicines containing sibutramine (used for weight loss)
 Medicines containing tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to
 treat severe pain )
 Medicines containing dextromethorphan (used to treat coughing)
 Medicines containing methadone (used to treat opioid drug addiction or severe pain)
 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 mental health conditions 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. Get
medical care right away if you think serotonin syndrome is happening to you.

In its most severe form, serotonin syndrome can resemble another potential serious side
effect called Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may
include a combination of as above with increased sweating, severe muscle stiffness,
confusion, mood changes, 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 or NMS is happening to you.
You must tell your doctor if you are taking medicines that can affect your heart rhythm.
Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat
abnormal heart rhythm)
• Antipsychotics such as thioridazine (see also Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with venlafaxine and should be used with caution.
It is especially important to mention to your doctor or pharmacist if you are taking:


Medicines which inhibit certain enzymes (CYP3A4) such as
- atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat
HIV),
- ketoconazole, itraconazole, voriconazole, posaconazole ( antifungal medicines)
- clarithromycin and telithromycin (antibiotics)
- Haloperidol or risperidone (to treat psychiatric conditions)
- Metoprolol (a beta blocker to treat high blood pressure and heart problems)

Venlafaxine with alcohol
You should avoid alcohol while you are taking Venlafaxine.
Pregnancy and breast-feeding
Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a
baby. You should use venlafaxine 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 venlafaxine. When taken during
pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in
babies, called persistent pulmonary hypotension 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 venlafaxine during pregnancy, other symptoms your baby might have when
it is born in addition to breathing faster, are irritability, tremor, floppy muscle ( 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.

If you are breast-feeding ask your doctor for advice. Venlafaxine passes into breast milk.
There is a risk of an effect on the baby. 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 venlafaxine.
Driving and using machines
Do not drive or use any tools or machines until you know how venlafaxine affects you as
this medicine may affect your judgement, thinking and ability to drive or use machines.
3.

How to take Venlafaxine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended starting dose for treatment of depression, generalised anxiety disorder and
social anxiety disorder is 75 mg per day. The dose can be increased 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 (37.5mg) and then increase the
dose gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and
panic disorder is 225 mg/day. Your doctor may recommend that you to take this medicine for
several months depending on your condition and may check on you regularly during treatment.
Take Venlafaxine at approximately the same time each day, either in the morning or in the
evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or
dissolved.
Venlafaxine should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of venlafaxine may
need to be adjusted.

Use in children and adolescents
Venlafaxine is normally not recommended for use in children and adolescents (see
section 2).
Do not stop taking Venlafaxine without talking to your doctor (see the section “If you stop
taking Venlafaxine”).
If you take more Venlafaxine than you should
Call your doctor or pharmacist immediately if you take more than the amount of venlafaxine
prescribed by your doctor. The symptoms of a possible overdose may include a rapid or slow
heart beat, or changes in the electrical activity of your heart which may be seen in tests,
low blood pressure, dizziness, changes in level of alertness (ranging from sleepiness to
coma), blurred vision, seizures or fits, vomiting.
If you forget to take Venlafaxine
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 a double dose to
make up for a forgotten dose.

If you stop taking Venlafaxine
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 venlafaxine, he/she may ask you to
reduce your dose slowly before stopping treatment altogether. Side effects are known to occur
when people stop using venlafaxine, especially when Venlafaxine is stopped suddenly or the
dose is reduced too quickly. Some patients may experience symptoms such as tiredness,
dizziness, light-headedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite,
feeling or being sick, diarrhoea, feeling anxious, nervousness, agitation, confusion, ringing in
the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, shaking or
flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue Venlafaxine 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 medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately, or go to the casualty department at your nearest hospital:
















Swelling of the face, lips, tongue, throat, hands, feet or other parts of the body, rash,
itching or hives on the skin, chest tightness, wheezing, trouble swallowing or breathing
A reduction in your red or white blood cells or platelets which may lead to more
frequent infections (such as sore throat and mouth ulcers), fever, weakness, easy
bruising, bleeding or prolonged bleeding.
Signs and symptoms of serotonin syndrome which may include restlessness,
hallucinations, loss of coordination, fast heartbeat, 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 as above
with increased sweating, mood changes, severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).
Changes in your vision caused by increase fluid pressure in your eye (glaucoma). The
other signs may include sudden pain the eyes, loss of vision, seeing halos around lights and
dilated pupil
Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of
internal bleeding
Inability to pass urine
Pain in the upper abdomen and back, feeling or being sick which may be caused by
inflammation of pancreas (Pancreatitis)
Seizures or fits
Reddening of the skin with blisters or peeling. There may also be severe blisters and
bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson
syndrome’ or ‘toxic epidermal necrolysis’
Decreased level of sodium in blood, feeling sick, muscle aches, fits, difficulty in
breathing, confusion, tiredness, loss of appetite, excessive water intake (all these are
symptoms caused by inappropriate secretion of a specific hormone called antidiuretic
hormone, SIADH )
Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal
behaviours have been reported during venlafaxine therapy or early after treatment
discontinuation (see section 2,What you need to know before you take Venlafaxine)
Abnormal, rapid or irregular heart beat, which could lead to fainting or changes in the
electrical activity of heart which may be seen in tests
Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

Other possible side effects:
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; lack of interest in
sex; nervousness; difficulty sleeping; abnormal dreams
 Drowsiness; tremor; pins and needles; increased muscle tone
 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)
 Increased heart beat (palpitation)
 Increase in blood pressure; flushing
 Yawning
 Being sick (vomiting); constipation; diarrhoea
 Increased frequency in urination; difficulty 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 in the blood
Uncommon (may affect up to 1 in 100 people)
 Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasms in
women; 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 heartbeat; feeling dizzy (particularly when standing up too quickly) due to low blood
pressure
 Shortness of breath
 Sensitivity to sunlight; bruising (ecchymosis); rash; abnormal hair loss
 Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)
 Inability to control urination
 Over activity, racing thoughts and decreased need for sleep (mania)
 Uncontrollable, involuntary passing of urine
Not known: frequency cannot be estimated from the available data
 Decrease in blood sodium levels which may be seen in blood tests
 Disorientation and confusion often accompanied by hallucination (delirium); aggression
 Stiffness, spasms and involuntary movements of the muscles
 Spinning sensation
 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)
 Low blood pressure


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)
 Changes in blood levels of liver enzymes which may be seen in blood test
 Sudden onset of a measle like rash. This may be associated with a high fever and joint
pains (Erythema multiforme)
 Abnormal or increased production of certain hormones called prolactin which may be
seen in blood tests
• increased cholesterol;

Additional side effects in children and adolescents
Although this medicine is not normally recommended in children and adolescents,
hostility,
self-harm, stomach aches, indigestion and heartburn and muscle pain have additionally
been
reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to Store Venlafaxine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the label/carton after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Venlafaxine contains
The active substance is venlafaxine.
Each prolonged release capsule hard contains venlafaxine hydrochloride, equivalent to 75 mg
or 150 mg of venlafaxine (as the hydrochloride).
The other ingredients are:
hypromellose
ammonio methacrylate copolymer
sodium laurisulfate
magnesium stearate
basic butylated methacrylate copolymer

The Capsule shell contains:
titanium dioxide E171 gelatin
Red iron oxide (For 75 mg strength only)]
Erythrosine E127 and indigocarmine E132 (For 150mg strength only)

Printing Ink:
shellac glaze iron
oxide black
What Venlafaxine looks like and contents of the pack
[75 mg strength:]
Opaque, flesh capsules, hard, marked with ‘VEN’ on cap of the capsule and ‘75’ on the
body.
[150 mg strength:]
Opaque, scarlet capsules, hard, marked with ‘VEN’ on cap of the capsule and ‘150’
on the body.
Venlafaxine prolonged release capsules is available in blister packs of 7, 10, 14, 20, 25, 28,
30, 50, 56, 70, 90, 100, 500 and 1000 capsules and HDPE bottles containing 7, 10, 14,
20, 25, 28, 30, 50, 56, 70, 90, 100 and 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Generics
[UK] Limited t/a Mylan, Potters Bar,
Hertfordshire, EN6 1TL, UK.
Manufacturer
McDermott Laboratories t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL.
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attikis Greece
Mylan Hungary Kft H2900 Komárom, Mylan
utca 1
Hungary
This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria
Belgium and The Netherlands

Venlafaxin Arcana retard - Kapseln
Venlafaxine Retard Mylan

Sweden, Czech Republic and
Slovakia

Venlafaxin Mylan

France

VENLAFAXINE Mylan gélule à libération prolongée

Germany
Greece

Venlafaxin dura 37,5 <75> <150> mg Hartkapseln,
retardiert
Venlafaxine/Mylan 75mg/CAP Καψάκιο παρατεταμένης
αποδέσμευσης, σκληρό
Venlafaxine/Mylan 150mg/CAP Καψάκιο παρατεταμένης
αποδέσμευσης, σκληρό

Ireland
Italy
Poland
Portugal

Venlofex
Venlafaxina Mylan
Faxigen XL
VENLAFAXINA MYLAN

Spain

Venlamylan Retard cápsulas duras de liberación prolongada
EFG
Vexarin XL 75mg prolonged release capsules, hard

United Kingdom

This leaflet was last revised in 06/2016

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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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