Document: leaflet MAH GENERIC_PL 31750-0026 change

• leaflet MAH BRAND_PL 31750-0026
• leaflet MAH GENERIC_PL 31750-0026

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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

In this leaflet

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

2.    Before you take Sunveniz XL

3.    How to take Sunveniz XL

4.    Possible side effects

5.    How to store Sunveniz XL

6.    further information

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

SunvenizXL 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 otherconditions such as anxiety disorders. It is thought that people who are depressed arxV'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.

SunvenizXL is a medicine »treat adults with depression. Sunveniz XL is also used »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, yourcondibon may not go away and may become more serious and more difficult»treat.

2. BEFORE YOU TAKE Sunveniz XL

Do not take Sunveniz XL

-    If you are allergic (hypersensitive) to venlafaxine or to any of the other ingredients of SunvenizXL prolonged-release tablets

-    If you are also Qking or have taken any time withinthe last 14 days any medicines known as irreversible monoamine oxidase inhibitors (irreversible MAOIs). used to treat depression or Parkinson's disease. Taking an irreversible MAO I together with other medicines, including Sunveniz XL, can cajse serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop Qking SunvenizXL before you take any irreversible MAOI (see also ‘Takingother medicines').

If you think any of these apply to you, do not take the Qblets.Talkto

your doctor first and follow the advice given.

Take special care with Sunveniz XL

-    If you use other medicines that taken concomiQntly with Sunveniz XL could increase the risk of developing serotonin syndrome (see the section ‘Taking other medicines').

-    If you have eye problems, such as cerQin 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 have a history of low sodium levels in your blood (hyponatraemia).

-    If you have a tendency » develop bruises ora 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.

Ifanyofthese conditio ns apply to you, please talk wifi your doctor

before Qking SunvenizXL.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and,for have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first sorting antidepressants, since these medicines all Qke time © work, usually about two weeks but sometimes longer, 'fou may be more likely to think like this:

-    If you have previously had thoughts about killi ng 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 tel a relative or close friend that you are depressed or have an anxiety disorder, and ask them »read this leaflet 'fou 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.

Use in chidren and adolescents under 18 years of age

SunvenizXL 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 Qke medicines such as Sunveniz XL. Despite this, your doctor may prescribe venlafaxine 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 ©discuss this, please go back to your doctor. Ybu should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are Qking SunvenizXL.

Taking other medicines

Please tell your doc©ror pharmacist if you are taking or have recently Qken any other medicines, including medicines obtained without a prescription, and herbal products.

'four doctor should decide whether you can Qke Sunveniz XL with other medicines. When Sunveniz XL is Qken in combination with other medicines, this may lead © the so-called serotonin syndrome:. For informatfon about the symptoms of this syndrome, see section4 under 'Other serious side effects'. The serotonin syndrome is a potentially life-threatening condition which may be caused when SunvenizXL is used in combination with other medicines such as:

-    Irreversible monoamine oxidase inhibitors (see atsounder *Do not take SunvenizXL').

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

-    TripQns (used for migraine)

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

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

- Med icines containi ng sibutramine (used for weight loss)

-    Med icines containi ng tramadol (a pain- killer)

-    Producs conQining St John's Wort (also called Hypericum perforatum, a naforal or herbal remedy used to treat mild depression)

-    Products conQining 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 imporQntto 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 blockerto treat high blood pressure and heart problems).

Taktog Sunveniz XL with food and drink

Take SunvenizXL with food. Do not drink alcohol during treatment with SunvenizXL.

Pregnancy and breast-feedmg

Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy

Tel I your doctor if you are pregnant, or if you are trying © become preg nant. You should use Sunveniz XL only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

If you are taking SunvenizXL during pregnancy, let your midwife and'or doctor know as your baby might have some symptoms when it is born. These symptoms usually beg in during the first 24 hours after the baby is bom. They include not feeding properly and trouble with breathing. If your baby has these symptoms when it is bom and you are concerned, contact your doctor and'or midwife who will be able to advise you.

Breast-feeding

SunvenizXL 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 wfl decide whether you shou Id stop breast-feeding or stop Qking Sunveniz XL.

Drivtog and using machines

Sunveniz XL may impair mental concentration and alertness. Therefore, you should be carefol 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 © treatment and possible undesirable effects.

Important information about some of the fogredients of Sunveniz XL

This medicine conQins lactose. If you have been told by your doctor that you have an intolerance © some sugars, contact your doctor before taking this medicinal product

3. HOW TO TAKE SunvenizXL

Always Qke Sunveniz XL exactly as yourdoctor has told you. You should 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 © take Sunveniz XL for several months.

Dosage

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.

Method of administration

Take SunvenizXL at approximately the same time eachday, 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 Qken more Sunveniz XL than you should you must seek immediate medical attention. Remember © 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, Qke it as soon as you remember. However, if it is time foryour next dose, skip the misseddose and take only a single dose as usual. Do not Qke 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 tooccur when people stop using Sunveniz XL, especially when Sunveniz XL is stopped suddenly or the dose is reduced ©oquickly. Some patients may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agiQtion. confusion, ringing in the ears, tingling or rarely electric shock sensations, weakness, sweating, seizures, or flu-like symptoms.

ftur 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 forfurther advice.

If you have any further questions on the use of this product, ask your doctoror pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Serious alergic reactions

If you notice any of the following symptoms, stop Qking SunvenizXL 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 anrVor 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 lf you stop Qking Sunveniz XL' ©the section 'How to take Sunveniz XL').

If any of the following side effects gets serious, or if you notice any

side effects not listed in this leaflet, please tell yourdocar or

pharmacist.

Very common:

•    dry mouth

-    headache

•    nausea

-    sweating (including night sweats)

Common:

•    weight loss

-    increased cholesterol

-    abnormal dreams, decreased libido, dizziness, increased muscle lonus, insomnia, nervousness, pins and needles, sedation, tremor, confusion, feeling separated (ordetached) 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 ejaculatiorv'orgasm (males), lack of orgasm, erectile dysfunction (impotence), menstrual irregularities such as increased bleeding or increased irregular bleeding

-    weakness (asthenia), chills

Uncommon:

-    bruising, black arry 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:

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

•    seizures or fits

-    fee ling over-excited or euphoric

Frequency not known:

-    reduced numberof platelets in your blood, leading toan increased risk of bruising or bleeding; blood disorders which may lead © an increased risk of infection

-    slight changes in blood levels of liver enzymes; decrease in blood sodium levels; ilchiness. yellow skin or eyes, dark urine, or flu-like symptoms, which are symp©ms of inflam mat© n of the liver (hepatitis); confusion, excessive wafer intake (known as SIADH); abnormal breast milk production

-    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 symp©ms of serotonergic syndrome; disorienationand 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 © 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 © severe blistering and peeling of the skin; itehing; mild rash

-    unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

-    swollen face or tongue, shortness of breath or d ifficutty b reathing, often with skin rashes (this may be a serous allergic reacton; if this occurs, contact your doctor immediately)

If any of the side effects gets serous, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist

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 © protect the environment.

6. FURTHER INFORMATION

What Sunveniz XL contains

The active subsance 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:

Susained 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.

col toidal anhydrous si lica,

sodium lauryl sulphate,

lake allura red (E129),

talc,

magnesium stearate.

Coating:

ethyl cellulose aqueous dispersion,

mannitol,

povidone (K-30).

di butyl sebacate,

triethyl citrate,

polysorbate 20,

opadry II85F 19250 clear, which consists of talc,

macrogol 3350, polysorbate 80. polyvinyl alcohol.

Printing ink (opacods-s-1-27794 black): shellac,

black i ron oxide (E172), propylene glycol.

What Sunveniz XL looks Ike 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 proto nged-re lease tablet imprinted with “TBO* 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 coaled prolonged-release tablet imprinted with *759* with black ink on one side and plain on 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 other side.

Blister: Pack sizes 14,15.20.28,30.50 or 100 prolonged-release tables.

Tablet conainer: 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 authorisedin the Member States of the EEA under the following names:

Venlafaxine SUN 37,5 mg / 75 mg /150 mg, Comprime a liberation protongee Venlafaxin SUN 37,5 mg/ 75 mg' 150 mg, Reardtabletten

Venlafaxina SUN 37.5 mg/ 75 mg /150 mg, Compressa a rilascio prolung alo Venlafaxina SUN 37,5 mg/' 75 mg /150 mg, Comprimidode liberacton protongada Venlafaxine SUN 37,5 mg/75 mg /150 mg, tabletten metverlengde afgifte Sunveniz XL 375 mg / 75 mg/150 mg, prolonged -release tablets

This leaflet was last approved in 10/2010.

5. HOW TO STORE Sunveniz XL

Keep out of the reachand sight of children.

Do not use Sunveniz XL after the expiry date which is stated on the carton after *EXP\ The expiry date refers to the last day of that month.

Blisters: Store inthe original package in orderto protect from moisture. Tablet confainer Keep the tablet container tightly closed in order © protect from moistere.

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