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Venlafaxin Hexal

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Document: Venlafaxin HEXAL tablet ENG PL change


PACKAGE LEAFLET: INFORMATION FOR THE USER


Venlafaxin HEXAL 37.5 mg tablets

Venlafaxin HEXAL 50 mg tablets


Venlafaxine


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet:

1. What Venlafaxin HEXAL is and what it is used for

2. What you need to know before you take Venlafaxin HEXAL

3. How to take Venlafaxin HEXAL

4. Possible side effects

5. How to store Venlafaxin HEXAL

6. Contents of the pack and other information


1What Venlafaxin HEXAL is and what it is usedfor


Venlafaxin HEXAL 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.


Venlafaxin HEXAL 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.


2What you need to know before you take Venlafaxin HEXAL


Do not take Venlafaxin HEXAL

• if you are allergicto venlafaxineor 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 Venlafaxin HEXAL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlafaxin HEXAL before you take any irreversible MAOI (see also the sections “Serotonin syndrome” and “Other medicines and Venlafaxine HEXAL”).


Warnings and precautions

Talk to your doctor or pharmacist before taking Venlafaxine HEXAL


Venlafaxin HEXAL 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 Venlafaxin HEXAL.


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.

Youmay be more likely to think like this:

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 friendthat you are depressed or havean 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 Venlafaxine HEXAL. Therefore, the dosage of your diabetes medicines may need to be adjusted.


Use in children and adolescents under 18 years of age

Venlafaxin HEXAL 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 Venlafaxin HEXAL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Venlafaxin HEXAL 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 Venlafaxin HEXAL.

Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Venlafaxin HEXAL in this age group have not yet been demonstrated.


Other medicines and Venlafaxin HEXAL

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 Venlafaxin HEXAL 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.



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 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 Venlafaxin HEXAL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:


Venlafaxin HEXAL with food and drink


Venlafaxin HEXAL should be taken with food (see section 3 “How to take Venlafaxin HEXAL”).

You should avoid alcohol while you are taking Venlafaxin HEXAL.


Pregnancy and breast-feeding and fertility


If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.You should use Venlafaxin HEXAL 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 Venlafaxin HEXAL.

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 Venlafaxin HEXAL during pregnancy, your baby might have some other symptoms when it is born in addition to breathing faster. They include irritability, tremor, hypotonia, constant crying, sleeping difficulties, 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.


Venlafaxin HEXAL 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 Venlafaxin HEXAL.


Driving and using machines


Do not drive or use any tools or machines until you know how Venlafaxin HEXAL affects you.


Venlafaxin HEXAL 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 Venlafaxin HEXAL


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 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 Venlafaxin HEXAL at approximately the same time each day, in the morning and in the evening.


Venlafaxin HEXAL should be taken with food.


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


Do not stop taking Venlafaxin HEXAL without talking to your doctor (see the section “If you stop taking Venlafaxin HEXAL”).


If you take more Venlafaxin HEXAL than you should

Call your doctor or pharmacist immediately if you take more than the amount of Venlafaxin HEXAL 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 Venlafaxin HEXAL


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 Venlafaxin HEXAL 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 Venlafaxin HEXAL


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 Venlafaxin HEXAL, he/she may ask you to reduce your dose slowly, before stopping treatment altogether. Side effects are known to occur when people stop using Venlafaxin HEXAL, especially when Venlafaxin HEXAL 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 Venlafaxin HEXAL 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.


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

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 that you should tell your doctor about include:



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 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)

• 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; 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 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 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, What you need to know before you take Venlafaxine HEXAL)

• 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


Venlafaxin HEXAL 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, Venlafaxin HEXAL 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 Venlafaxin HEXAL for a long time.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly see details below. By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]


5. How to store VENLAFAXIN HEXAL


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


Do not use Venlafaxin HEXAL after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.


Venlafaxin HEXAL 37.5 mg:

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


Venlafaxin HEXAL 50 mg:

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


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


6. Contents of the pack and other information


What Venlafaxin HEXAL contains

• The active substance is venlafaxine


Venlafaxin HEXAL 37.5 mg:

One tablet contains 37.5 mg venlafaxine as venlafaxine hydrochloride.


Venlafaxin HEXAL 50 mg:

One tablet contains 50 mg venlafaxine as venlafaxine hydrochloride.


• The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycollate (type A), ma­gnesium stearate, anhydrous, colloidal silicon dioxide, brown ferric oxide (E172).


What Venlafaxin HEXAL looks like and contents of the pack


Venlafaxin HEXAL 37.5 mg: Pale, red-brown or brownish, oblong tablet coded 3.


Venlafaxin HEXAL 50 mg: Pale, red-brown or brownish, oblong tablet, scored and coded 5 on each half. The tablet can be divided into two equal halves.


Polyethylene tablet container and closure (tamper evident)

Pack sizes: 28, 30, 42, 50, 56, 60, 90, 98, 100, 250


Blister (Al/PVC)

Pack sizes: 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 60, 90, 98, 98x1, 100, 100x1, 250


Not all package sizes or types may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

<To be completed nationally>


Manufacturer

<To be completed nationally>


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


Sweden

Venlafaxin HEXAL 37,5 mg tablett

Venlafaxin HEXAL 50 mg tablett

Austria

Venlafaxin Hexal 50 mg -Tabletten

Germany

Venlafaxin Sandoz 37,5 mg Tabletten

This leaflet was last revised in 2014-10-30