PACKAGE LEAFLET: INFORMATION FOR THE USER

Vensir XL 75mg & 150mg prolonged release capsules

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, 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 symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What VensirXL is and what it is used for

2.    Before you use VensirXL

3.    Howto use VensirXL

4.    Possible side effects

5.    Howtostore VensirXL

6.    Further information

1. WHATVENSIRXLISANDWHATIT IS USED FOR

Vensir XL is an antidepressant and one of a group of medicines called serotonin- noradrenaline reuptake inhibitors (SNRIs). It is thought that people who are depressed may have lower levels of serotonin and noradrenaline in their brain. Whilst it is not fully understood how antidepressants work, Vensir XL may help to relieve the symptoms of depression by increasing the levels of these substances (neurotransmitters) in the brain.

VensirXL is used for:

• Major depression

2. BEFORE YOU USE VENSIRXL

Do not use VensirXL if:

•    You have had any allergic reaction to venlafaxine or to any of the other ingredients in the product.

•    If you are also taking, or have taken 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 Vensir XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Vensir XL before you take any MAOI (see also the section entitled “Taking other medicines” and the information in that section about 'Serotonin Syndrome').

Take special care with Vensir XL if:

If any of the following apply to you, please tell your doctor before taking VensirXL:

•    If you use other medicines that taken together with Vensir XL could increase the risk of developing serotonin syndrome (see the section “Taking other medicines”).

• 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 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.

• If you have diabetes

Vensir 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.

Thoughts of suicide and worsening of your depression

If you are depressed 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 straightaway.

You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Use in children and adolescents under 18 years of age

Vensir 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 this medicine 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 Vensir XL. Also, the long-term safety effects of this medicine concerning growth, maturation and cognitive and behavioural development of this medicine in this age group has not yet been demonstrated.

Dry mouth

Dry mouth is reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take special care in your dental hygiene.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor should decide whether you can take VensirXL 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 Vensir XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Vensir XL”).

•    Serotonin syndrome:

A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

•    Triptans(usedformigraine)

•    Other medicines to treat depression, for instance SNRIs, SSRIs, tricyclics, or medicines containing lithium

•    Medicines containing linezolid, an antibiotic (used to treat infections)

•    Medicines containing moclobemide, a MAOI (used to treat depression)

•    Medicines containing sibutramine (used for weight loss)

•    Medicines containing tramadol (a pain-killer)

•    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, such as clozapine (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 Vensir 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 (an antifungal medicine)

•    Haloperidol or risperidone (to treat psychiatric conditions)

•    Metoprolol (a beta blocker to treat high blood pressure and heart problems)

If you are having Electroconvulsive therapy (ECT) please inform yourdoctor.

Taking VensirXL with food and drink

Food:

The capsules should be taken with food.

Alcohol:

The combination of Vensir XL and alcohol is not recommended.

Pregnancy and breast-feeding

Tell yourdoctor if you become pregnant, or you are trying to become pregnant. You should use Vensir 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 know you are on Vensir XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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 this medicine during pregnancy, other symptoms your baby might have when it is born is not feeding properly, in addition to having trouble breathing. If your baby has these symptoms when it is bom and you are concerned, contact your doctor and/or midwife who will be able to advise you.

Vensir XL passes into breast milk. There is a risk of an effect on the baby. Your baby may experience irritability, shaking, floppiness, persistent crying and difficulty in sleeping. 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 this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Vensir XL may make you feel drowsy. Be careful driving or operating dangerous machinery until you know how it affects you

Important information about some of the ingredients of VensirXL

The colour Sunset yellow FCF (E110) in VensirXL 150mg prolonged release hard capsules may cause allergic reactions.

3. HOWTO USE VENSIR XL

Always take Vensir XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose for the treatment of depression is 75mg taken once daily. If necessary, after three-four weeks, your doctor may increase your dose.

Swallow each capsule whole with a drink of water at approximately the same time each day, either in the morning or in the evening. Do not break open, crush or chew the capsules, or put them in water before swallowing. This may damage the film coating of

the mini-tablets inside the capsule, which slow down release of the drug.

Children and adolescents

The use of Vensir XL in children and adolescents (underthe age of 18) is not recommended (see also section 2).

Impairment of the liver or kidneys

If you suffer from liver or kidney problems, the dosage may be reduced by your doctor.

If you take more VensirXL than you should

If you have taken too much Vensir XL you should contact yourdoctorora hospital.

Symptoms of overdose: A rapid heartbeat, changes in level of alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take VensirXL

Do not take a double dose to make up for a forgotten dose.

If you stop taking VensirXL

Do not discontinue the treatment without consulting yourdoctor.

When one stops taking Vensir XL , withdrawal reactions may occur e.g. tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, feeling or being sick, diarrhoea, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling or rarely electric shock sensations, weakness, poor co-ordination, tremor, sweating or seizures.

These disorders are mild and temporary.

Vensir XL should not be stopped abruptly. In order to avoid withdrawal effects, the dose should be reduced gradually, underthe doctor's supervision.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Vensir XL can cause side effects, although not everybody gets them.

If any of the following happen, do not take more Vensir 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, orfeet

•    Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and/ora 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).

•    Muscle stiffness, weakness or aching and producing less urine than usual.

•    Sudden fever, sore throat, mouth ulcers or bleeding gums.

•    Withdrawal effects (see the section “HOW TO TAKE VENSIR XL, if you stop taking Vensir XL”).

Complete side effect listing

Very common faffects more than 1 in 10 users!

•    Headache; dry mouth; sweating (including night sweats)

•    Nausea

Common faffects 1 to 10 users in 1001

•    Weight loss; appetite decreased; constipation; vomiting; increased cholesterol

•    Feeling separated (or detached) from yourself and reality; nervousness; confusion; abnormal dreams; insomnia

•    Tremor; increase in .muscle tension

•    Pins and needles

•    Increase in blood pressure; flushing; palpitations

•    Increased frequency in urination; difficulties passing urine

•    Decreased libido; abnormal ejaculation/ orgasm (males); lack of orgasm; erectile dysfunction (impotence)

•    Menstrual irregularities such as increased bleeding or increased irregular bleeding

•    Weakness (asthenia); dizziness; sedation; chills

•    Blurred vision

•    Yawning

Uncommon (affects 1 to 10 users in 1.000)

•    Bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding

•    Grinding of the teeth; involuntary movement of the muscles

•    Hallucinations

•    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; abnormal hair loss; rash

•    Impaired coordination and balance; feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat

•    Weightgain; diarrhoea

•    Altered taste sensation

•    Lackoffeeling oremotion; agitation

•    Ringing in the ears (tinnitus)

•    Inability to pass urine;

•    Abnormal orgasm (females)

Rare (affects 1 to 10 users in 10.000)

•    A sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling overexcited or euphoric.

•    Inability to control urination

Frequency not known

•    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; slight changes in blood levels of liver enzymes; decrease in blood sodium levels

• Itchiness, yellow skin or eyes, dark urine, or flulike symptoms, which are symptoms of inflammation of the liver (hepatitis)

•    Excessive water intake leading to low blood sodium levels

•    Abnormal breast milk production

•    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

•    Disorientation and confusion often accompanied by hallucination (delirium)

•    Stiffness, spasms and involuntary movements of the muscles

•    Thoughts of harming or killing yourself

•    Severe eye pain and decreased or blurred vision

•    Decrease in blood pressure; abnormal, rapid or irregular heartbeat, which could lead to fainting

•    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)

•    Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

•    Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

•    Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

•    Confusion

•    Vertigo

•    Aggression

VensirXL 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, VensirXL 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 Vensir XL fora long time.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOWTO STORE VENSIRXL

Do not store above 25°C. Store in the original container to protect from moisture. Keep out of the reach and sight of children.

Do not use Vensir XL after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use Vensir XL if you notice that the capsules are sticky or other visible signs of deterioration.

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. FURTHER INFORMATION

What VensirXL capsules contains

The active substance is venlafaxine hydrochloride equivalent to 75 mg or 150mg venlafaxine.

The other ingredients are: microcrystalline cellulose, copovidone, ethyl cellulose, magnesium stearate, povidone, colloidal anhydrous silica, talc.

The capsule shell for 75mg contains gelatine, titanium dioxide (E171), Black iron oxide (E172), Red iron oxide (E172).The printing ink contains the following: shellac, propylene glycol, red iron oxide (E172).

The capsule shell for 150mg contains gelatine, titanium dioxide (E171), Brilliant blue FCF (E133), Allura red (E129), Sunset yellow FCF (E110). The printing ink contains the following: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171)

The active substance and ingredients are used to make white to off-white round biconvex film coated mini tablets of 12.5mg. The 75mg capsule contains 6 mini tablets and the 150mg capsule contains 12 mini tablets.

What VensirXL capsules look like and contents of the pack

The 75mg capsules are opaque, peach coloured, prolonged release hard capsules having red coloured thick and thin radial circular bands on both ends of the capsules. The 150 mg capsules are opaque, dark orange hard gelatin capsules having white coloured thick and thin radial circular bands on both ends of the capsules.

VensirXL 75 mg and 150mg capsules are available in blister packs of 10, 14, 15 20, 28, 30, 56, 60 or 100 capsules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road, Leicester LE30PA.U.K.

Manufacturer

Morningside Pharmaceuticals Ltd 5 Pavilion Way, Loughborough.

LE115GW.U.K.

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

Ireland VensirXL UK VensirXL

This leaflet was revised in 07/2013

20009705