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 potential serious side - effect called 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 H-2900 Komarom, Mylan utca 1 Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Venlafaxin Arcana retard - Kapseln
Belgium and The Netherlands	Venlafaxine Retard Mylan

Sweden, Czech Republic and Slovakia	Venlafaxin Mylan
France	VENLAFAXINE Mylan gelule a liberation prolongee
Germany	Venlafaxin dura 37,5 <75> <150> mg Hartkapseln, retardiert
Greece	Venlafaxine/Mylan 75mg/CAP KayaKio napaxsxapevng anoSsopsuopg, oK^ppo Venlafaxine/Mylan 150mg/CAP KayaKio napaxsxapevng anoSsopsuopg, oK^ppo
Ireland	Venlofex
Italy	Venlafaxina Mylan
Poland	Faxigen XL
Portugal	VENLAFAXINA MYLAN
Spain	Venlamylan Retard capsulas duras de liberation prolongada EFG
United Kingdom	Vexarin XL 75mg prolonged release capsules, hard

This leaflet was last revised in 06/2016