VENLAFAXINE 37.5 MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Venlafaxine

Venlafaxine 37.5 mg Tablets Venlafaxine 75 mg Tablets

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In this leaflet: 1. What Venlafaxine is and what it is used for 2. Before you take Venlafaxine 3. How to take Venlafaxine 4. Possible side effects 5. How to store Venlafaxine 6. Further information

Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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. Venlafaxine is a treatment for adults with depression. Treating depression 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.

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What Venlafaxine is and what it is used for

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 Venlafaxine) 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. Johns 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 and vomiting. Get medical care right away if you think serotonin syndrome is happening to you.

Your doctor should decide whether you can take Venlafaxine with other medicines.

Taking 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.

Do not take Venlafaxine if you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of Venlafaxine 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 Parkinsons disease. Taking an irreversible MAOI together with other medicines, including Venlafaxine, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxine before you take any irreversible MAOI (see also the sections Serotonin syndrome and Taking other medicines). Take special care with Venlafaxine If you use other medicines that taken concomitantly with Venlafaxine could increase the risk of developing serotonin syndrome (see the section Taking other medicines) 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 or bipolar disorder (feeling over-excited or euphoric) If you have a history of aggressive behaviour If you have diabetes. Venlafaxine may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.

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Before you take Venlafaxine

The following medicines may also interact with Venlafaxine 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 Venlafaxine with food and drink Venlafaxine should be taken with food (see section 3 How to take Venlafaxine). You should avoid alcohol while you are taking Venlafaxine.

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 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 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 caries. Therefore, you should take special care in your dental hygiene.

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

If you are taking Venlafaxine during pregnancy your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not feeding properly and trouble with 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. 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.

Make sure your midwife and/or doctor knows you are on Venlafaxine.

Pregnancy and breast-feeding Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlafaxine only after discussing the potential benefits and the potential risks to your unborn child with your doctor.

Venlafaxine passes into breast milk. There is a risk of an effect on the baby e.g. constant crying, irritability and abnormal sleep-patterns. 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 Venlafaxine. Driving and using machines Do not drive or use any tools or machines until you know how Venlafaxine affects you.

Diabetes If you have diabetes, your doctor might need to adjust your insulin and/or oral antidiabetic dosage after starting treatment with venlafaxine.

Use in children and adolescents under 18 years of age Venlafaxine 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 hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. 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 Venlafaxine 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 Venlafaxine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venlafaxine in this age group has not yet been demonstrated.

Important information about some of the ingredients of Venlafaxine 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.

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

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How to take Venlafaxine

The usual recommended starting dose is 75 mg per day in divided doses, two or three times a 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.

Take Venlafaxine at approximately the same time each day, in the morning and in the evening. If you have liver or kidney problems, talk to your doctor, since your dose of Venlafaxine may need to be different. Venlafaxine should be taken with food.

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

If you take more Venlafaxine than you should Call your doctor or pharmacist immediately if you take more than the amount of Venlafaxine 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.

Heart or circulation disorders Common: increase in blood pressure, flushing, palpitations Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat Not known: decrease in blood pressure, abnormal, rapid or irregular heart beat, which could lead to fainting Breathing disorders Common: yawning Not known: 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) Digestive disorders Very common: nausea Common: appetite decreased, constipation, vomiting Uncommon: grinding of the teeth, diarrhoea Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)

If you forget to take Venlafaxine 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 Venlafaxine that has been prescribed for you in one day.

If you stop taking Venlafaxine 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 Venlafaxine, he/she may ask you to reduce your dose slowly, before stopping treatment altogether. Side effects are known to occur when people stop using Venlafaxine, especially when Venlafaxine 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 Venlafaxine 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 product, ask your doctor or pharmacist.

Skin disorders Very common: sweating (including night sweats) Uncommon: rash; abnormal hair loss Not known: skin rash, which may lead to severe blistering and peeling of the skin, itching, mild rash Muscle disorders Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

Urinary system disorders Common: difficulties passing urine, increased frequency in urination Uncommon: inability to pass urine Rare: inability to control urination Reproductive and sexual disorders Common: abnormal ejaculation/orgasm (males), lack of orgasm, erectile dysfunction (impotence), menstrual irregularities such as increased bleeding or increased irregular bleeding Uncommon: abnormal orgasm (females)

Allergic reactions If any of the following happen, do not take more Venlafaxine. 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 take Venlafaxine, If you stop taking Venlafaxine). Complete side effect listing The frequency (likelihood of occurring) of side effects is classified as follows: Very common Common Uncommon Rare Not known

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

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Possible side effects

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

General Common: weakness (asthenia), chills Uncommon: sensitivity to sunlight, swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction called angioedema)

Keep out of the reach and sight of children.

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How to store Venlafaxine

Do not use Venlafaxine after the expiry date stated on the packaging. The expiry date is the last day of the stated month.

This medicinal product does not require any special storage conditions (tablet container and blister).

Blood disorders Uncommon: bruising, black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding Not known: 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 Metabolism/nutritional disorders Common: weight loss, increased cholesterol Uncommon: weight gain Not known: 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

Affects more than 1 user in 10 Affects 1 to 10 users in 100 Affects 1 to 10 users in 1,000 Affects 1 to 10 users in 10,000 Frequency cannot be estimated from the available data

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 to protect the environment.

Venlafaxine 37.5 mg Tablets: One tablet contains 37.5 mg venlafaxine as venlafaxine hydrochloride. Venlafaxine 75 mg Tablets: One tablet contains 75 mg venlafaxine as venlafaxine hydrochloride.

What Venlafaxine contains The active substance is venlafaxine.

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Further information

The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycollate (type A), magnesium stearate, anhydrous, colloidal silicon dioxide and brown ferric oxide (E172). What Venlafaxine looks like and contents of the pack Venlafaxine 37.5 mg Tablets: Pale, red-brown or brownish, oblong tablet coded 3.

Nervous system disorders Very common: dry mouth, headache Common: abnormal dreams, decreased libido, dizziness, increased muscle tonus, insomnia, nervousness, pins and needles, sedation, tremor, confusion, feeling separated (or detached) from yourself and reality Uncommon: lack of feeling or emotion, hallucinations, involuntary movement of the muscles, agitation, impaired coordination and balance Rare: a sensation of restlessness or an inability to sit or stand still, seizures or fits, feeling over-excited or euphoric Not known: 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; cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 2 Take special care with Venlafaxine): aggression; spinning sensation. Sight and hearing disorders Common: blurred vision Uncommon: altered taste sensation, ringing in the ears (tinnitus) Not known: severe eye pain and decreased or blurred vision

Venlafaxine 75 mg Tablets: Pale, red-brown or brownish, oblong tablet, scored and coded 7 on each half. The tablet can be divided into two equal halves.

Blister (Al/PVC) Pack sizes: 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 60, 90, 98, 98 x 1, 100, 100 x 1, 250 Not all package sizes or types may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Polyethylene tablet container and closure (tamper evident) Pack sizes: 28, 30, 42, 50, 56, 60, 90, 98, 100, 250

Manufacturer Salutas Pharma GmbH, Otto-van-Guericke-Allee, D-39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Verovkova 57, SL- 1526 Ljubljana, Slovenia or LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland or Rowa Pharmaceuticals Ltd, Bantry, Co. Cork, Ireland. This leaflet was last approved in 03/2012.

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