PATIENT INFORMATION LEAFLET

VENLANEO® XL 37.5 mg, 75 mg & 150 mg

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 further questions, please ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Venlaneo XL Prolonged Release Capsules are and what they are used for

2.    Before you take Venlaneo XL Prolonged Release Capsules

3.    How to take Venlaneo XL Prolonged Release Capsules

4.    Possible side effects

5.    How to store Venlaneo XL Prolonged Release Capsules

6.    Further information

1. WHAT VENLANEO XL PROLONGED RELEASE CAPSULES ARE AND WHAT THEY ARE USED FOR

Venlaneo XL Prolonged Release Capsules contain the active ingredient venlafaxine hydrochloride. Venlafaxine hydrochloride 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.

Venlaneo XL Prolonged Release Capsules are used to treat adults with depression. Venlaneo XL Prolonged Release Capsules are 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. BEFORE YOU TAKE VENLANEO XL PROLONGED RELEASE CAPSULES

Do not take Venlaneo XL Prolonged Release Capsules if:

♦    You are allergic (hypersensitive) to venlafaxine hydrochloride, or to any of the other ingredients of Venlaneo XL Prolonged Release Capsules.

♦    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 Venlaneo XL Prolonged Release Capsules, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlaneo XL Prolonged Release Capsules before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Take special care with Venlaneo XL Prolonged Release Capsules

♦    If you use other medicines that taken concomitantly with Venlaneo XL Prolonged Release Capsules 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.

♦    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.

♦    If you have been told by your doctor that you have an intolerance to some sugars (e.g. sucrose).

Venlaneo XL Prolonged Release Capsules may cause a sensation of restlessness or an inability to sit or stand still. 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 Venlaneo XL Prolonged Release Capsules.

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 yourself or harming yourself.

♦    If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

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

Dry mouth

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

Use in children and adolescents under 18 years of age Venlaneo XL Prolonged Release Capsules 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 Venlaneo XL Prolonged Release Capsules for patients under 18 because he/she decides that this

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is in their best interests. If your doctor has prescribed Venlaneo XL Prolonged Release Capsules 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 Venlaneo XL Prolonged Release Capsules. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venlaneo XL Prolonged Release Capsules in this age group has not yet been demonstrated.

Taking 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 Venlaneo XL Prolonged Release Capsules 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 (MAOIs: see the section “Before you take Venlaneo XL Prolonged Release Capsules”).

♦    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)

♦    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)

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.

The following medicines may also interact with Venlaneo XL Prolonged Release Capsules 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)

Taking your medicine with food and alcohol

Venlaneo XL Prolonged Release Capsules should be taken with food (see section 3 “HOW TO TAKE VENLANEO XL PROLONGED RELEASE CAPSULES”).

You should avoid alcohol while you are taking Venlaneo XL Prolonged Release Capsules.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should take Venlaneo XL Prolonged Release Capsules only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

If you are taking Venlaneo XL Prolonged Release Capsules 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 not feeding properly and trouble with breathing. 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.

Make sure your midwife and/or doctor know you are on Venlaneo XL Prolonged Release Capsules. 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.

Venlafaxine hydrochloride 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 Venlaneo XL Prolonged Release Capsules.

Driving and using machines

Do not drive or use any tools or machines until you know how Venlaneo XL Prolonged Release Capsules affect you.

Important information about some of the ingredients of Venlaneo XL Prolonged Release Capsules

Some of the colourants in Venlaneo XL Prolonged Release Capsules may cause allergic reactions. 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 VENLANEO XL PROLONGED RELEASE CAPSULES

Dosage

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

Take Venlaneo XL Prolonged Release Capsules 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. Venlaneo XL Prolonged Release Capsules should be taken with food.

The usual adult doses for different conditions are as follows:

Depression:

♦ The usual recommended starting dose for treatment of depression is 75 mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg per day.

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4. POSSIBLE SIDE EFFECTS

Blood disorders

Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding

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

Metabolism/nutritional disorders

Common: weight loss; increased cholesterol Uncommon: weight gain

Not known: slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk production

Nervous system disorders

Very common: dry mouth; headache

Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality

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Uncommon: lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance Rare: a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling over-excited or euphoric

Notknown: 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 serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself

♦    Sight and hearing disorders

Common: blurred vision

Uncommon: altered taste sensation; ringing in the ears (tinnitus)

Notknown: severe eye pain and decreased or blurred vision

♦    Heart or circulation disorders

Common: increase in blood pressure; flushing; palpitations

Uncommon: feeling dizzy (particularly when standing up too quickly), fainting,

fast heartbeat

Not known: decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting

♦    Breathing disorders

Common: yawning

Not known: 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)

♦    Digestive disorders

Very common: nausea

Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea

Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)

♦    Skin disorders

Very common: sweating (including night sweats)

Uncommon: rash; abnormal hair loss

Not known: skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

♦    Muscle disorders

Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

♦    Urinary system disorders

Common: difficulties passing urine; increased frequency in urination Uncommon: inability to pass urine

♦    Reproductive and sexual disorders

Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)

♦    General

Common: weakness (asthenia); chills Uncommon: sensitivity to sunlight

Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

Venlaneo XL Prolonged Release Capsules 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, Venlaneo XL Prolonged Release Capsules 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 Venlaneo XL Prolonged Release Capsules for a 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. HOW TO STORE VANLANEO XL PROLONGED RELEASE CAPSULES

Keep your capsules in the pack in which they are supplied to protect them from moisture. Store the pack below 30°C. Do not use them after the expiry date which is shown on the pack after EXP. The expiry date refers to the last day of that month.

Keep all medicines out of the reach and sight of children.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Venlaneo XL Prolonged Release Capsules contain:

The active ingredient in Venlaneo XL Prolonged Release Capsules is venlafaxine hydrochloride.

The inactive ingredients are: sucrose, maize starch, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, talc, ethyl cellulose, dibutyl sebacate, oleic acid, colloidal anhydrous silica, sodium lauryl sulphate and gelatin (capsule shell only). Colouring agents included in the 37.5 mg capsule shells are Ponceau 4R (E124), quinoline yellow (E104) and titanium dioxide (E171). Colouring agents included in the 75 mg capsule shells are sunset yellow (E110), quinoline yellow and titanium dioxide. Colouring agents included in the 150 mg shells are sunset yellow, quinoline yellow, patent blue (E131) and titanium dioxide.

What Venlaneo XL Prolonged Release Capsules look like and contents of the pack:

Venlaneo XL Prolonged Release Capsules come in three strengths. Venlaneo XL 37.5 mg Capsules are orange/clear capsules. Venlaneo XL 75 mg Capsules are yellow/clear capsules. Venlaneo XL 150 mg Capsules are buff/clear capsules. All three strengths of capsules are filled with white to off-white pellets. Your medicine is available in blister packs containing 14 or 28 capsules. Not all pack sizes may be marketed

Marketing Authorisation Holder:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, NN8 6GT, UK

Manufacturer responsible for batch release: Fannin (UK) Limited 42-46 Booth Drive, Park Farm South, Wellingborough, NN8 6GT, UK

This leaflet was last approved in October 2012.