567_FR02232_V3_DEPEFEX_567_FR02232_V3 16/06/15 08:28 Pagel

INFORMATION FOR THE USER

“ Depefex® 75 mg XL Capsules    —

Depefex® 150 mg XL Capsules

(Venlafaxine)

SIX IMPORTANT THINGS YOU NEED TO KNOW ABOUT DEPEFEX

■    Depefex treats depression. Like all medicines it can also have unwanted effects. It is important that you and your doctor discuss the benefits of taking Depefex and the harmful effects before you start treatment.

■    Depefex are not for use in children and adolescents under 18. See section 2 of the leaflet.

■    Some people who are depressed think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straightaway.

See section 2, Thoughts of harming yourself.

■    Depefex will not work straightaway. Some people taking the medicine feel worse before feeling better. Your doctor should see you a few weeks after starting treatment. Tell your doctor if you do not feel better. See section 3, How to take Depefex.

■    Do not stop taking Depefex without talking to your doctor. If you stop taking Depefex suddenly or miss a dose, you may get withdrawal effects. See section 3, If you stop taking Depefex.

■    If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy and Breast-feeding.

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 Depefex is and what it is used for

2.    What you need to know before you take Depefex

3.    How to take Depefex

4.    Possible side effects

5.    How to store Depefex

6.    Contents of the pack and other information

The name of this medicine is Depefex 75 mg XL Capsules and Depefex 150 mg XL Capsules. For convenience, this leaflet will call it Depefex.

1. WHAT DEPEFEX IS AND WHAT IT IS USED FOR

Depefex belongs to a group of medicines called antidepressants. They are one of a group of medicines called a selective serotonin and noradrenaline reuptake inhibitor (SNRI). It is thought that people who are depressed 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.

Depefex are used for the treatment of depression. Your doctor may continue to give you Depefex when you are feeling better to stop your symptoms coming back or stop you becoming depressed in the future. Treating your depression properly is important to help you get better. If not treated your condition may not go away or may be more difficult to treat.

You may find it helpful to tell a friend or relative that you are depressed and ask them to read this leaflet as well. You might ask them to tell you if they are worried about any changes in your behaviour.

2. WHAT YOU NEED TO KNOW

BEFORE YOU TAKE DEPEFEX

! DO NOT TAKE DEPEFEX IF:

•    you have previously had an allergic reaction to venlafaxine or any of the other ingredients listed in section 6 at the end of this leaflet.

•    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 Depefex can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Depefex before you take any MAOI (see also the section “Taking Depefex with other medicines”).

•    you suffer from heart disease

•    you have high blood pressure (hypertension) which is not being lowered by treatment

•    you have severe liver or kidney problems

If any of these apply to you, tell your doctor or pharmacist immediately, as the capsules may not be suitable for you.

! USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE

Depefex should not normally be used in children and adolescents under the age of 18 years.

•    Also, you should know that patients under 18 have an increased risk of side effects such as suicidal attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this type of medicine. Despite this, your doctor may occasionally prescribe Depefex for patients under 18 because he/she decides that this is in their best interests.

•    If your doctor has prescribed Depefex for someone 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 these capsules.

•    The long-term safety effects of Depefex on growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.

Take special care and tell your doctor or pharmacist before taking Depefex if:

•    You use other medicines that taken concomitantly with Depefex could increase the risk of developing serotonin syndrome (see the section “Taking Depefex with other medicines”).

•    You have a history of epilepsy, fits or seizures.

•    You suffer from, or have a history of, mania or bipolar disorder (feeling over-excited or euphoric).

•    You have eye problems or suffer from, or have a history of, narrow angle glaucoma (increased pressure in the eye).

•    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.

•    Your cholesterol levels get higher.

•    You have high blood pressure which is being treated.

•    You have a history of aggressive behaviour.

•    You have a history of low sodium levels in your blood (hyponatraemia).

•    You have a history of heart problems.

•    You have diabetes.

Depefex 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 you have any of the above, please talk with your doctor before taking Depefex.

Thoughts of harming yourself:

People who are depressed can sometimes have thoughts of harming or killing themselves. These may be increased when you first start taking antidepressants since these medicines 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 adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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. 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.

Taking Depefex with 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 Depefex 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 Depefex”).

•    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 Depefex 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 Depefex with food, drink and alcohol

You should swallow each capsule whole with food and with a drink of water.

You should avoid drinking alcohol while you are taking the capsules. Alcohol may make your symptoms or side effects worse.

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Pregnancy, breast-feeding and fertility

You must tell your doctor if you are pregnant or plan to become pregnant, so that another medicine can be considered. You should use Depefex 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 Depefex. 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 or if your baby is not feeding properly, you should contact your midwife and/or doctor immediately.

Breast-feeding is not recommended as venlafaxine in Depefex can pass into the breast milk, and there would be risk of an effect on the baby. Therefore, you should discuss this matter with your doctor, and he/she will decide whether you should stop breast-feeding or stop the therapy with Depefex.

Driving and using machines

Possible side effects of Depefex are dizziness, confusion and eye sight changes such as blurred vision. If you get these or feel that your judgement, thinking or co-ordination is affected when you take Depefex do not drive or use machines.

Important information about some of the ingredients of Depefex

This product contains sucrose. 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 DEPEFEX

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

The usual starting dose is one 75 mg capsule a day. However, your doctor may start with a different dose, particularly if you are elderly or have liver or kidney problems. Your doctor may also change your dose during the course of your treatment. Your dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375 mg daily for depression.

You should swallow each capsule whole at approximately the same time each day, either in the morning or evening. Do not break open, crush or chew the capsules, or put them in water before swallowing.

Depefex should be taken with food.

Do not stop taking Depefex without talking to your doctor (see the section “If you stop taking Depefex”).

If you take more Depefex than you should

Never take more capsules than your doctor tells you. If you accidentally take too many capsules contact your doctor or hospital immediately. Remember to take the packet with you, even if it is empty.

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 Depefex

If you forget to take a capsule, you can take it up to 12 hours after you usually take it, and then take your next capsule at the usual time. If the period after the missed dose is more than 12 hours, you should miss the dose altogether and just take your next capsule at the usual time.

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

If you stop taking Depefex

Do not stop taking your capsules or reduce the dose without the advice of your doctor, even if you feel better. If your doctor thinks you no longer need Depefex, your dose will be reduced gradually before stopping treatment altogether. Side effects are known to occur when people stop using Depefex, especially when the capsules are stopped suddenly or the dose 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, nervousness, agitation, confusion, tinnitus (ringing in the ears), tingling, weakness, sweating, fits/ seizures, or flu-like symptoms. These symptoms are generally non-serious and disappear within a few days.

Your doctor will advise you on how you should gradually stop Depefex and if you suffer any of these or other symptoms that are troublesome, return to your doctor for further advice.

If you require any further information on Depefex please consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Do not be concerned if you see small white granules or balls in your stools after taking Depefex. Inside Depefex capsules are spheroids or small white balls that contain the venlafaxine active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. The spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.

Allergic reactions

If any of the following happen, do not take more

Depefex. 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)

Serious side effects

If you notice any signs of the following, you may

need urgent medical attention:

•    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

•    Treatment withdrawal (see the section “How to take Depefex”, if you stop taking Depefex).

Other reported side effects Very common (affects more than 1 person in 10 users):

•    dry mouth; headache

•    nausea

•    sweating (including night sweats)

Common (affects less than 1 person in 10 users):

•    weight loss; increased cholesterol

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

•    blurred vision

•    increase in blood pressure; flushing; palpitations

•    yawning

•    appetite decreased; constipation; vomiting

•    difficulties passing urine; increased frequency in urination

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

•    weakness (asthenia); chills Uncommon (affects less than 1 person in 100 users):

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

•    weight gain

•    lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance

•    altered taste sensation; ringing in the ears (tinnitus)

•    feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat

•    grinding of the teeth; diarrhoea

•    rash; abnormal hair loss

•    inability to pass urine

•    abnormal orgasm (females)

•    sensitivity to sunlight

•    serious allergic reaction which causes swelling of the face and throat

Rare (affects less than 1 person in 1000 users):

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

or euphoric

•    inability to control your bladder

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); confusion, 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 serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself; a feeling of dizziness or “spinning”; aggression

•    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)

Depefex sometimes causes unwanted effects which you may not be aware of, such as increases in blood pressure or abnormal heart beat, or slight changes in blood levels of liver enzymes, sodium or rarely cholesterol (fats). More rarely, Depefex may reduce the function of platelets in your blood, leading to increased chance of bruising or bleeding. Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking the capsules for a long time.

!TELL YOUR DOCTOR OR PHARMACIST IF:

•    Any side effect gets serious

• You notice any side effects which are not listed in this leaflet

Reporting of side effects If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard 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 DEPEFEX

!KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN Do not use Depefex after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

Do not store Depefex above 25°C. Store in the original package in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist how to dispose of medicines no longer required.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Depefex Capsules contain

Each Capsule contains 75 mg or 150 mg of venlafaxine as venlafaxine hydrochloride.

The other ingredients in the capsules are: stearic acid, ethylcellulose, talc, gelatin, sucrose and maize starch. The 75mg capsules also contain Titanium dioxide What Depefex Capsules look like and contents of the pack Depefex Capsules come in two strengths.

Depefex 75 mg XL Capsules are white opaque capsules containing white or whitish pellets.

Depefex 150 mg XL Capsules are natural transparent capsules cbontaining white or whitish pellets. They come in packs containing 28 capsules.

Marketing Authorisation Holder and Manufacturer Chiesi Limited, 333 Styal Road, Manchester,

M22 5LG, UK.

This leaflet was last approved in 07/2015

FR02232.V3 / CP0034/7

“Is this leaflet hard to see or read? Telephone: 0161 488 5555 for help”

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