PACKAGE LEAFLET: INFORMATION FOR THE USER VANLALUPEN XL 37.5 mg, 75 mg AND 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 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 gets serious, or if you notice any side effects not listed on this leaflet, please tell your doctor or pharmacist.

In This Leaflet:

1    What Vanlalupen XL is and what it is used for.

2    Before you take Vanlalupen XL.

3    How to take Vanlalupen XL.

4    Possible side effects.

5    How to store Vanlalupen XL.

6    Further information.

1.    WHAT VANLALUPEN XL IS AND WHAT IT IS USED FOR

Vanlalupen 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 (a chemical that can affect your mood) and noradrenaline in the brain. While it is not fully understood how antidepressants work, Vanlalupen XL may help to relieve the symptoms of depression by increasing the levels of serotonin and noradrenaline in the brain.

This medicine is a treatment

•    For adults with depression.

•    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 VANLALUPEN XL Do not take Vanlalupen XL

•    If you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of Vanlalupen XL (see 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 Vanlalupen XL can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Vanlalupen XL before you take any MAOI (see also the sections entitled “Taking other medicines” and the information in that section about “Serotonin syndrome”).

Take special care with Vanlalupen XL

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

•    If you use other medicines that taken together with Vanlalupen 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.

Vanlalupen 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 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.

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

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.

Diabetes

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

Use in children and adolescents under 18 years of age

Vanlalupen XL should normally not be used by children and adolescents under 18 years of age. 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 Vanlalupen XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine 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 Vanlalupen 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 Vanlalupen XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take Vanlalupen 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 (used for migraine)

•    Other 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)

•    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 Vanlalupen 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) Taking Vanlalupen XLwith food and drink

Vanlalupen XL should be taken with food (see section 3 “HOW TO TAKE VANLALUPEN XL”).

Do not drink alcohol while you are taking Vanlalupen XL.

Pregnancy and lactation

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Vanlalupen XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

When taken during pregnancy, this medicine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). This makes 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 contact your 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 born and you are concerned, contact your doctor who will be able to advise you.

Vanlalupen XL passes into breast milk. There is a risk of an effect on the baby. Ask your doctor for advice. He/she will decide whether you should stop breast-feeding or stop the therapy with Vanlalupen XL.

Driving and using machines

This medicine may impair judgement, thinking and motor skills.

Do not drive or use any tools or machines until you know how Vanlalupen XL affects you.

3. HOW TO TAKE VANLALUPEN XL

Always take Vanlalupen XL 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 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 daily for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.

Take Vanlalupen XL 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.

Vanlalupen XL should be taken with food.

If you suffer from liver or kidney problems, talk to your doctor. He may reduce your dose.

Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Vanlalupen XL”).

If you take more Vanlalupen XL than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than the amount prescribed by your doctor.

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.

If you forget to take Vanlalupen 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 Vanlalupen XL that has been prescribed for you in one day.

If you stop taking Vanlalupen 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 Vanlalupen XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. When you stop taking this medicine, side effects may occur especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, 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 Vanlalupen 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, Vanlalupen XL can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department at your nearest hospital if you have any of the following symptoms:

•    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 possible 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 VANLALUPEN XL, if you stop taking Vanlalupen XL”).

Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Vanlalupen XL capsules are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule into your stomach. As they travel through your stomach and intestines, venlafaxine is slowly released. The spheroid “shell” does not dissolve and is passed out in your stools. So, even though you may see spheroids in your stools, your dose of medicine has been absorbed. Complete side effect listing

If any of the following symptoms are severe or become troublesome, you should tell your doctor or pharmacist.

Very common (affects more than 1 in 10 users)

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

•    Nausea

Common (affects 1 to 10 users in 100)

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

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

•    Tremor; increased muscle tonus

•    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

•    Weight gain; diarrhoea

•    Altered taste sensation

•    Lack of feeling or emotion; 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 over-excited or euphoric.

•    Inability to control urination

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; 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)

•    Excessive water intake (known as SIADH)

•    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 heart beat, 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

Vanlalupen 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, Vanlalupen 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 Vanlalupen XL 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 VANLALUPEN XL

Keep out of the reach and sight of children.

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

Store below 25°C.

If your doctor decides to stop treatment, return any leftover capsules to your pharmacist. Only keep them if your doctor tells you to.

REMEMBER this medicine is only for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

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 Vanlalupen XL contains

The active substance is Venlafaxine Hydrochloride The other ingredients are:

Povidone, calcium hydrogen phosphate dihydrate, magnesium stearate (E470b), ethylcellulose, hypromellose, gelatin, red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172), Titanium dioxide (E171) and printing inks. What Vanlalupen XL look like and the contents of the pack Hard prolonged-release capsules Vanlalupen XL is available in three strengths.

-    37.5 mg are size 3, light grey coloured cap and flesh coloured body, imprinted with ‘VENLA’ in red ink on cap and ‘37.5 mg’ in red ink on body, containing four white to off white tablets, which contain venlafaxine 37.5 mg.

-    75 mg are size 1, flesh coloured cap and flesh coloured body, imprinted with ‘VENLA’ in red ink on cap and ‘75 mg’ in red ink on body, containing eight white to off white tablets which contain venlafaxine 75 mg.

-    150 mg are size 0, with brown coloured cap and brown coloured body, imprinted with ‘VENLA’ in white ink on cap and ‘150 mg’ on body, containing sixteen white to off white tablets, which contain venlafaxine 150 mg.

Vanlalupen XL is available in the following pack sizes:

37.5 mg: 7, 10, 14, 20, 28, 30, 50, 56, 100 75 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 150 mg: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited,

Victoria Court,

Bexton Road,

Knutsford,

Cheshire, WA16 0PF,

United Kingdom

This leaflet was last approved in

Date of preparation: March 2012

Code No. GO/DRUGS/654    ID#: xxxxxx