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UK PIL DATED APRIL 2011

Pg 4

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 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 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

EfexorXL 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, EfexorXL 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 Efexor 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 Efexor XL

EfexorXL 75mg Capsules should be stored in a dry place. Do not store above 25°C.

Do not remove the capsules from the blister strip until you are ready to take your medicine.

Do not use after the expiry date printed on the carton, label or blister strip.

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

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

If the capsules become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

REMEMBER this medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. 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.

6. Further information

What Efexor XL 75mg capsules contain

Your medicine is called Efexor XL 75mg Capsules. Each opaque peach capsule contains 75mg of the active ingredient, venlafaxine, as the hydrochloride in a modified release formulation. The capsule is marked with '75' on the body and ‘W' on the cap.

EfexorXL 75mg Capsules also contain the following inactive ingredients:

Hypromellose, macrocrystalline cellulose, ethyl cellulose, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and talc.

The printing ink contains: shellac, red iron oxide (E172), hydroxide ammonium, simethicone, propylene glycol.

Pg 1

EFEXOR® XL 75mg CAPSULES (venlafaxine hydrochloride)

Patient Information Leaflet

This product is known as the above name but will be referred to as Efexor XL throughout this leaflet. IMPORTANT THINGS YOU SHOULD KNOW ABOUT EFEXOR XL

Please read all of this leaflet before you start to take your medicine as it contains important information about Efexor XL

•    Efexor XL is used to treat depression, severe and persistent anxiety, known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks)

•    Efexor XL is not recommended for use in children and adolescents - see in section 2 'Use in children and adolescents'

If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor - even if you feel anxious or worry about doing so.

You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and that you have been prescribed this medication; it might be useful to show them this leaflet.

•    Efexor XL may not start to work immediately. Some people taking antidepressants may feel worse before feeling better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.

•    Some people who are depressed may think of harming or killing themselves. If this happens you should see your doctor or go to a hospital straight away - see in section 2 'Thoughts of suicide and worsening of your depression or anxiety disorder'.

•    If you take too many capsules it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects.

•    Do not stop taking Efexor XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Efexor XL abruptly you may get withdrawal reactions - see in section 3 'If you stop taking EfexorXL'.

•    If you have heart problems such as fast or irregular heart rate or high blood pressure you should talk to your doctor before taking Efexor XL - see in section 2 'Before you take Efexor XL'.

•    Taking certain other medicines with Efexor XL may cause problems. You should tell your doctor if you are taking any other medicines - see in section 2 'Before you take EfexorXL '.

•    See your doctor without delay if you feel restless and feel like you can't keep still, feel 'high' or very over-excited, have jerky muscle movements which you can't control. See section 4 - 'Possible Side effects' for other important information.

•    If you are pregnant or intend to become pregnant, or breast feeding, you should talk to your doctor - see in section 2 'Pregnancy, breast feeding'.

More information on all of these points is provided in the rest of this leaflet. Read all this leaflet carefully before you start to take your 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 in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Efexor XL

3.    How to take Efexor XL

4.    Possible side effects

5.    How to store Efexor XL

6.    Further Information

Efexor XL 75mg Capsules are available as blister packs of 28 capsules.

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

PL No: 6464/2142

This product is manufactured by Pfizer Ireland Pharmaceuticals, Newbridge, Ireland and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 18.03.2013 Efexor is a registered trademark of Wyeth LLC

Efexor 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 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.

Efexor XL is a treatment for adults with depression. Efexor XL 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.

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 tooth decay (caries). Therefore, you should take special care in your dental hygiene.

Diabetes

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

Use in children and adolescents under 18 years of age

Efexor 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 fora 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 Efexor 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 Efexor 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 Efexor XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section "Before you take Efexor 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 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 Efexor 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 Efexor XL with food and drink

Efexor XL should be taken with food (see section 3 "How to take Efexor XL”).

You should avoid alcohol while you are taking Efexor XL.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Efexor 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 Efexor 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 born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

Efexor XL 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 this medicine.

Driving and using machines

Do not drive or use any tools or machines until you know how this medicine affects you.

3. How to take Efexor XL

Always take Efexor 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 Efexor 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.

Efexor XL should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of this medicine may need to be different.

Do not stop taking this medicine without talking to your doctor (see the section "If you stop taking Efexor XL”). If you take more Efexor XL than you should

Call your doctor or pharmacist immediately if you take more than 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 Efexor 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 Efexor XL that has been prescribed for you in one day.

If you stop taking Efexor 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 Efexor XL, he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using this medicine, especially when it 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, 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 Efexor 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, Efexor XL can cause side effects, although not everybody gets them.

If any of the following happen, do not take Efexor 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, 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 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 Efexor XL”, if you stop taking Efexor XL”).

Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Efexor 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 effects listing

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    I I

•    Weight gain; diarrhoea

•    Altered taste sensation

•    Lack of feeling or emotion; agitation

•    Ringing in the ears (tinnitus)

•    Inability to pass urine

•    Abnormal orgasm (females)