PACKAGE LEAFLET: INFORMATION FOR THE USER

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Bonilux® XL 75 mg Prolonged-release Capsules Bonilux® XL 150 mg Prolonged-release Capsules

Venlafaxine    A SANDOZ

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 Bonilux XL is and what it is used for

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

3.    How to take Bonilux XL

4.    Possible side effects

5.    How to store Bonilux XL

6.    Contents of the pack and other information

What Bonilux XL is and what it is used for

Bonilux XL contains the active ingredient venlafaxine. Venlafaxine 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.

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

What you need to know before you take Bonilux XL

Do not take Bonilux 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, at 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 Bonilux XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Bonilux XL before you take any MAOI (see also the sections "Serotonin syndrome” and "Other medicines and Bonilux XL”).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Bonilux XL

•    If you use other medicines that taken concomitantly with Bonilux XL could increase the risk of developing serotonin syndrome (see the section "Other medicines and Bonilux 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 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.

Bonilux 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.

If any of these conditions apply to you, please talk with your doctor before taking Bonilux 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 these 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 Bonilux XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.

Use in children and adolescents under 18 years of age

Bonilux 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 Bonilux XL for patients under 18 because he/she decides that

this is in their best interests. If your doctor has prescribed Bonilux 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 in this leaflet develop or worsen when patients under 18 are taking Bonilux XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Bonilux XL in this age group have not yet been demonstrated.

Other medicines and Bonilux 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 Bonilux 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 Bonilux XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section "What you need to know before you take Bonilux XL”).

•    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, 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 heartbeat, 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 heartbeat, 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 Bonilux 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).

Bonilux XL with food and drink:

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

You should avoid alcohol while you are taking Bonilux XL.

Pregnancy, breast-feeding and fertility:

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

Bonilux 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 Bonilux XL.

Driving and using machines:

Do not drive or use any tools or machines until you know how Bonilux XL affects you.

3 How to take Bonilux 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 per day.

Take Bonilux 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.

Bonilux XL should be taken with food.

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

Do not stop taking Bonilux XL without talking to your doctor (see the section "If you stop taking Bonilux XL”).

If you take more Bonilux XL than you should:

Call your doctor or pharmacist immediately if you take more than the amount of Bonilux XL prescribed by your doctor.

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 Bonilux 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 Bonilux 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 Bonilux 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 Bonilux 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 Bonilux XL, especially when Bonilux 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 Bonilux 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.

4 Possible side effects

Like all medicines, this medicine 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 Bonilux XL. Inside Bonilux XL 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.

If any of the following happen, do not take more Bonilux XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:

Uncommon (may affect up to 1 in 100 people)

•    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

Not known (frequency cannot be estimated from available data)

•    Difficulty breathing, dizziness (severe allergic reaction)

•    Muscle stiffness, high fever, impaired consciousness

•    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.

•    Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, fast changes in blood pressure, overactive reflexes, euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, feeling of being drunk, sweating or rigid muscles, 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 heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Other side effects:

Very common (may affect more than 1 in 10 people)

•    Dizziness, headache

•    Nausea, dry mouth

•    Excessive and profuse sweating (including night sweats)

Common (may affect up to 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)

•    Feeling a strong heartbeat (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 up to 1 in 100 people)

•    Hallucinations, feeling separated (or detached) from reality, agitation, abnormal orgasm (females), lack of feeling or emotion, hyperactivity and euphoria (feeling unusually 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 gastrointestinal bleeding

•    Sensitivity to sunlight, bruising, rash, abnormal hair loss

•    Inability to pass urine

•    Weight gain, weight loss

Rare (may affect up to 1 in 1,000 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 available data)

•    Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding

•    Blood disorders which may lead to fever, sore throat, weakness, bruising, an increased risk of infection

•    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, What you need to know before you take Bonilux XL)

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

•    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 heartbeat, which could lead to fainting

•    Unexpected bleeding (mucous membrane 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)

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

•    Abnormal breast milk production

Venlafaxine sometimes causes unwanted effects which you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, venlafaxine 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 Bonilux 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 (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 Bonilux XL

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, on the blister or on the bottle after EXP. The expiry date refers to the last day of that month. Use all the capsules within 2 months of opening the bottle.

Do not store above 30°C.

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 Bonilux XL contains

The active substance is: venlafaxine.

Bonilux XL 75 mg Capsules:

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

Bonilux XL 150 mg Capsules:

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

The other ingredients are:

Capsule contents:

Microcrystalline cellulose, hypromellose, cetostearyl alcohol, ethylacrylate - methyl methacrylate copolymer, nonoxynol, macrogol, talc. Capsule shell:

Gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

What Bonilux XL looks like and contents of the pack

Prolonged release capsules, hard.

Bonilux XL 75 mg Capsules are light pink coloured hard gelatin capsules containing white to off white pellets.

Bonilux XL 150 mg Capsules are brown-red coloured hard gelatin capsules containing white to off white pellets.

Bonilux XL 75 mg Capsules and Bonilux XL 150 mg Capsules are available in:

- Blisters (PVC/PVDC//Aluminium). Pack sizes of 7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 100 x 1 prolonged release capsules, hard. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or S.C. Sandoz S.R.L, Str. Livezeni nr . 7A, 540472 Targu-Mures, Romania.

This leaflet was last revised in 11/2014.

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