Document: leaflet MAH BRAND_PL 31750-0027 change

• leaflet MAH BRAND_PL 31750-0027
• leaflet MAH GENERIC_PL 31750-0027

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044BP

Package leaflet: Information for the user

Sunveniz XL 37.5 mg prolonged-release tablets

Sunveniz XL 75 mg prolonged release tablets

Sunveniz XL 150 mg prolonged release tablets

Venlafaxine

What is in this leaflet:

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

2.    What you need to know before you take Sunveniz XL

3.    How to take Sunveniz XL

4.    Possible side effects

5.    How to store Sunveniz XL

6.    Contents of the pack and other information

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

Sunveniz 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 noradrenalin in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenalin in the brain.

Sunveniz XL is a medicine to treat adults with depression. Sunveniz is also used to treat 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.    What you need to know before you take Sunveniz XL Do not take Sunveniz XL

-    if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in 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 (irreversible MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with other medicines, including Sunveniz XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Sunveniz XL before you take any irreversible MAOI (see also “Taking other medicines”).

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sunveniz XL

-    if you use other medicines that taken concomitantly with Sunveniz XL could increase the risk of developing serotonin syndrome (see the section “ Other medicines and Sunveniz XL”)

-    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 (feeling over-excited or euphoric) or bipolar disorder

-    if you have a history of aggressive behaviour

-    if you have liver or kidney problems.

If any of these conditions apply to you, please talk with your doctor before taking Sunveniz XL.

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 first starting 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 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.

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.

Dental hygiene

Dry mouth is reported in 10% of patients treated with Sunveniz XL.

This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.

Children and adolescents

Sunveniz XL should normally not be used for children and adolescents under 18 years. The long-term safety effects concerning growth, maturation and behavioural development of Sunveniz XL in this age group have not yet been demonstrated. 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 medicines such as Sunveniz XL. Despite this, your doctor may prescribe Sunveniz XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Sunveniz XL 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 Sunveniz XL.

Other medicines and Sunveniz XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should decide whether you can take Sunveniz XL with other medicines. When Sunveniz XL is taken in combination with other medicines, this may lead to the so-called 'serotonin syndrome'. For information about the symptoms of this syndrome, see section 4 under 'Other serious side effects'. The serotonin syndrome is a potentially life-threatening condition which may be caused when Sunveniz XL is used in combination with other medicines such as:

-    irreversible monoamine oxidase inhibitors (see also under “Do not take Sunveniz XL”)

-    medicines containing moclobemide, which is a newer, reversible MAOI (used to treat depression)

-    triptans (used for migraine)

-    medicines to treat depression, for instance SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium

-    medicines containing linezolid, an antibiotic (used to treat infections)

-    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).

Certain other medicines may also interact with Sunveniz 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).

Sunveniz XL with food, drink and alcohol

Take Sunveniz XL with food. Do not drink alcohol during treatment with Sunveniz XL.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant, or if you are trying to become pregnant. You should use Sunveniz 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 knows you are on Sunveniz XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (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.

Breast-feeding

Sunveniz XL passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss breast-feeding with your doctor, and he/she will decide whether you should stop breast-feeding or stop taking Sunveniz XL.

Driving and using machines

Sunveniz XL may impair mental concentration and alertness.

Therefore, you should be careful when driving motor vehicles or operating machinery. Your doctor will evaluate your ability to drive or use machines by taking into account the degree of the underlying disease, response to treatment and possible undesirable effects.

Sunveniz XL contains lactose

This medicine contains lactose. 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 Sunveniz XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

It may take several days or more before you feel your medicine is working. You may need to take Sunveniz XL for several months.

Dosage

The 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.

Method of administration

Take this medicine at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not crushed, chewed or dissolved.

If you take more Sunveniz XL than you should

If you may have taken more Sunveniz XL than you should you must seek immediate medical attention. Remember to take the packet with you.

The symptoms of a possible overdose may include 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 Sunveniz 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 Sunveniz XL that has been prescribed for you in one day.

If you stop taking Sunveniz XL

Do not stop taking this medicine or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Sunveniz XL, he/she may reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using Sunveniz XL, especially when Sunveniz XL 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 Sunveniz XL. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious allergic reactions

If you notice any of the following symptoms, stop taking Sunveniz 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, tongue, throat, hands, or feet

-    feeling nervous or anxious, dizziness, throbbing sensations in the head, 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)

Other serious side effects

If you notice any of the following symptoms, you may need urgent medical attention as this may be an indication of very serious conditions, such as the serotonin syndrome or the neuroleptic malignant syndrome:

-    heart problems, such as fast or irregular heart rate, increased blood pressure

-    eye problems, such as blurred vision, dilated pupils, sustained rapid eye movements

-    nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits

-    other physical symptoms, such as high temperature, sweating, feeling of being drunk, rigid muscles or jerky muscle movements

-    psychiatric problems, such as euphoric feelings, confusion, agitation, or restlessness

-    treatment withdrawal (see the information under 'If you stop taking Sunveniz XL ' in the section “How to take Sunveniz XL ”).

Other side effects

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

248 mm

Size: 248x375 mm Patient Information SUN EUROPE EUUK - UNITED KINGDOM

FONTS SPECIFICATION

Patient info. Leaflet	Swiss 721 CN BT - 10 pt
Title and Tiltle Heading	Swiss 721 CN BT - 13 pt and 11 pt
Body Text V_	Swiss 721 CN BT - 8 pt _y

Very common: may affect more than 1 in 10 people

-    dry mouth

-    headache

-    nausea

-    sweating (including night sweats).

Common: may affect up to 1 in 10 people

-    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

-    decreased appetite, 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: may affect up to 1 in 100 people

-    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.

Rare: may affect up to 1 in 1,000 people

-    a sensation of restlessness or an inability to sit or stand still

-    seizures or fits

-    feeling over-excited or euphoric.

Frequency 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

-    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; if this occurs, contact your doctor immediately).

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 Yellow Card 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 Sunveniz XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Sunveniz XL contains

The active substance is venlafaxine.

Each prolonged-release tablet contains 37.5 mg, 75 mg or 150 mg venlafaxine (as venlafaxine hydrochloride).

The other ingredients are:

Tablet core

Sustained release layer: hypromellose, povidone (K-30), lactose monohydrate,

methacrylic acid-ethyl acrylate (1:1) co-polymer, talc,

magnesium stearate.

Openable layer:

silicified microcrystalline cellulose, crospovidone Type A, colloidal anhydrous silica, sodium lauryl sulphate, lake allura red (E129), talc,

magnesium stearate.

Coating:

ethyl cellulose aqueous dispersion,

mannitol,

povidone (K-30),

dibutyl sebacate,

triethyl citrate,

polysorbate 20,

opadry II 85F 19250 clear, which consists of talc,

macrogol 3350, polysorbate 80, polyvinyl alcohol.

Printing ink (opacode-s-1-17823 black): shellac,

black iron oxide (E172), propylene glycol.

What Sunveniz XL looks like and contents of the pack

Sunveniz XL 37.5 mg: This medicinal product is presented as a round, pink and white coloured biconvex bilayer coated prolonged-release tablet imprinted with “760” with black ink on one side and plain on the other side.

Sunveniz XL 75 mg: This medicinal product is presented as a round, pink and white coloured bilayer coated prolonged-release tablet imprinted with “759” with black ink on one side and plain on the other side.

Sunveniz XL 150 mg: This medicinal product is presented as an oval, pink and white coloured biconvex bilayer coated tablet imprinted with “758” with black ink on one side and plain on the other side.

Blister: Pack sizes 14, 15, 20, 28, 30, 50 or 100 prolonged-release tablets.

Tablet container: Pack sizes: 30 and 1000 (for dispensing only) prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

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

Venlafaxine SUN LP 37,5 mg / 75 mg / 150 mg, comprime a liberation prolongee Venlafaxin SUN 37,5 mg / 75 mg/ 150 mg, Retardtabletten

Venlafaxina SUN 37,5 mg / 75 mg / 150 mg, compressa a rilascio prolungatoSpain: Venlafaxina SUN 37,5 mg / 75 mg / 150 mg, comprimido de liberation prolongada Venlafaxine SUN 37,5 mg / 75 mg / 150 mg, tablet met verlengde afgifte Sunveniz XL 37.5 mg / 75 mg / 150 mg, prolonged-release tablets

This leaflet was last revised in 05/2014.

Blisters: Store in the original package in order to protect from moisture. Tablet container: Keep the tablet container tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Sunveniz XL-37_5-75-150mg-PIL-248x375mm-EUUK-carved out-REV2-27-10-14

27 October 2014 15:42:01