teva UK Ref: 231-30-86688-Y LEA VENLAFAXINE (RODOMEL) A/S CAP TUK <KRKA Version: 3    22 March 2016

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RODOMEL XL 37.5 mg PROLONGED RELEASE CAPSULES, HARD RODOMEL XL 75 mg PROLONGED RELEASE CAPSULES, HARD RODOMEL XL 150 mg PROLONGED RELEASE CAPSULES, HARD Venlafaxine

Package leaflet: Information for the user

IMPORTANT THINGS YOU SHOULD KNOW ABOUT RODOMEL XL

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

•    Rodomel 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)

•    Rodomel XL is not 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 worried 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.

•    Rodomel 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 themself. 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 Rodomel XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Rodomel XL abruptly you may get withdrawal reactions - see in section 3 'If you stop taking Rodomel XL'

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

•    Taking certain other medicines with Rodomel XL may cause problems. You should tell your doctor if you are taking any other medicines -

see in section 2 'Before you take Rodomel XL 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 and Rodomel XL.'

More information on all of these points is provided in the rest of this leaflet.

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 Rodomel XL is and what it is used for

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

3.    How to take Rodomel XL

4.    Possible side effects

5.    How to store Rodomel XL

6.    Contents of the pack and other information

OWHAT RODOMEL XL IS AND WHAT IT IS USED FOR

Rodomel 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 social anxiety disorder. 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.

Rodomel XL is a treatment for adults with depression. Rodomel XL is also a treatment for adults with social anxiety disorder (fear or avoidance of social situations). Treating depression or anxiety 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.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE RODOMEL XL

Do NOT take Rodomel XL

• If you are allergic to venlafaxine or to 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 (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with other medicines, including Rodomel XL can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Rodomel XL before you take any MAOI (see also the sections "Serotonin syndrome" and "Other medicines and Rodomel XL").

Warnings and precautions

Talk to your doctor or pharmacist before taking Rodomel XL

• If you use other medicines that taken together with Rodomel XL could increase the risk of developing serotonin syndrome (see the section "Other medicines and Rodomel 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 been told you have an abnormal heart rhythm.

• 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 your cholesterol levels get higher.

• 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.

Rodomel XL may cause a sensation of restlessness or an inability to sit or stand still. 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 disorder 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 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 tooth decay (caries). Therefore, you should take special care in your dental hygiene.

Diabetes

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

Rodomel 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 Rodomel XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Rodomel 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 Rodomel XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Rodomel XL in this age group has not yet been demonstrated.

Other medicines and Rodomel 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 Rodomel 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 Rodomel XL . Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section "Before you take Rodomel 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 to treat 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), fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)

•    Medicines containing dextromethorphan (used to treat coughing)

•    Medicines containing methadone (used to treat opioid drug addiction or severe pain)

•    Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)

•    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.

You must tell your doctor if you are taking medicines that can affect your heart rhythm.

Examples of these medicines include:

•    Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal heart rhythm)

•    Antipsychotics such as thioridazine (See also Serotonin syndrome above)

•    Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)

•    Antihistamines (used to treat allergy)

The following medicines may also interact with Rodomel 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)

Tell your doctor if you are taking oral contraceptives.

Rodomel XL with food, drink and alcohol

Rodomel XL should be taken with food (see section 3 "How to take Rodomel XL")

You should avoid alcohol while you are taking Rodomel 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. You should use Rodomel 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 Rodomel 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.

If you are taking this medicine during pregnancy, let your doctor know as your baby might have other symptoms when it is born. These symptoms usually being within 24 hours after the baby is born and include 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.

Rodomel 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 Rodomel XL.

Driving and using machines

Do not drive or use any tools or machines until you

know how Rodomel XL affects you.

Rodomel XL contains sucrose

This medicine 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.

S HOW TO TAKE RODOMEL XL

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

The usual recommended starting dose for treatment of depression 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. The maximum dose for social anxiety disorder is 225 mg/day.

Take Rodomel 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.

Rodomel XL should be taken with food.

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

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

If you take more Rodomel XL than you should

Call your doctor or pharmacist immediately if you take more than the amount of Rodomel XL 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 Rodomel XL

If you miss a dose of your medicine then 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 Rodomel XL that has been prescribed for you in one day.

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

If you stop taking Rodomel XL

Do not stop taking your treatment or reduce the dose without the advice of your doctor first, even if you feel better. If your doctor thinks that you no longer need Rodomel 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 Rodomal XL especially when Rodomel XL 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 Rodomel 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 medicine, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

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

If any of the following happen, do not take more Rodomel XL, talk to 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 Rodomel XL, If you stop taking Rodomel XL”)

•    Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.

Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Rodomel XL 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 Very common: may affect more than 1 in 10 people

•    Dizziness, headache;

•    Nausea, dry mouth;

•    Sweating (including night sweats)

Common: may affect upto 1 in 10 people

•    Appetite decreased

•    Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams

•    Drowsiness; tremor; pins and needles; increased muscle tonus

•    Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects

•    Ringing in the ears (tinnitus)

•    Palpitations

•    Increase in blood pressure; flushing

•    Yawning

•    Vomiting; constipation; diarrhoea

•    Increased frequency in urination; difficulties passing urine

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

•    Weakness (asthenia); fatigue; chills

•    Increased cholesterol

Uncommon: may affect upto 1 in 100 people

•    Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or emotion; feeling over-excited; grinding of the teeth

•    A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired coordination and balance; altered taste sensation

•    Fast heartbeat; feeling dizzy (particularly when standing up too quickly)

•    Shortness of breath

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

•    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; bruising; rash; abnormal hair loss

•    Inability to pass urine;

•    Weight gain; weight loss

Rare: may affect upto 1 in 1000 people

•    Seizures or fits

•    Inability to control urination

•    Over activity, racing thoughts and decreased need for sleep (mania)

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

•    Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

•    Excessive water intake (known as SIADH)

•    Decrease in blood sodium levels

•    Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2, Before you take Rodomel XL)

•    Disorientation and confusion often accompanied by hallucination (delirium); aggression

•    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; stiffness, spasms and involuntary movements of the muscles

•    Severe eye pain and decreased or blurred vision

•    Vertigo

•    Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)

•    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)

•    Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); slight changes in blood levels of liver enzymes

•    Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

•    Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

•    Abnormal breast milk production

Rodomel 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 Rodomel 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 Rodomel XL for a long time.

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.

HOW TO STORE RODOMEL 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.

This medicinal product does not require any special storage conditions.

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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Rodomel XL contains

•    The active substance is venlafaxine.

Rodomel XL 37.5 mg prolonged release capsules hard:

Each prolonged release capsule, hard, contains

37.5    mg venlafaxine (as 42.43 mg venlafaxine hydrochloride).

Rodomel XL 75 mg prolonged release capsules hard:

Each prolonged release capsule, hard, contains 75 mg venlafaxine (as 84.85 mg venlafaxine hydrochloride).

Rodomel XL 150 mg prolonged release capsules hard:

Each prolonged release capsule, hard, contains 150 mg venlafaxine (as 169.70 mg venlafaxine hydrochloride).

•    The other ingredients are:

Capsule contents:

Sugar spheres (saccharose, maize starch), hydroxypropylcellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc.

37.5    mg prolonged release capsules hard contain gelatin, titanium dioxide, red iron oxide (E172).

75 mg prolonged release capsules hard contain gelatin, titanium dioxide, red iron oxide (E172), yellow iron oxide (E171).

150 mg prolonged release capsules hard contain gelatin, titanium dioxide, red iron oxide (E172), yellow iron oxide (E171).

What Rodomel XL looks like and contents of the pack

Rodomel XL 37.5 mg prolonged release capsules, hard: opaque capsules, the upper part is brownish-pink, the lower part is white.

Rodomel XL 75 mg prolonged release capsules, hard: opaque, pale pink capsules.

Rodomel XL 150 mg prolonged release capsules, hard: opaque, brownish-orange coloured capsules.

Pack sizes:

Boxes of 10, 14, 20, 28, 30, 50, 98, 100, 100x1 prolonged-release, capsules, hard, in blister packs. Boxes of 50, 100 and 250 prolonged-release capsules, hard, in HDPE capsule container.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture: KRKA, d.d., Novo mesto, Smarjeska cesta 6, Novo mesto, 8501 Slovenia.

This leaflet was last approved in March 2016

PL 00289/1111-3    86688-Y

242907.02-GB

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