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«Alventa Xl 37.5 mg prolonged-release capsules, hard Alventa Xl 75 mg prolonged-release capsules, hard Alventa Xl 150 mg prolonged-release capsules, ...»

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PACKAGE lEAFlET: InFORMATIOn FOR THE USER

Alventa Xl 37.5 mg prolonged-release capsules, hard

Alventa Xl 75 mg prolonged-release capsules, hard

Alventa Xl 150 mg prolonged-release capsules, hard

Venlafaxine

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.

In this leaflet:

1. What Alventa XL is and what it is used for 2. Before you take Alventa XL 3. How to take Alventa XL 4. Possible side effects 5. How to store Alventa XL 6. Further information

1. WHAT AlvenTA Xl IS AnD WHAT IT IS USeD FOR Alventa 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 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.

Alventa XL is a treatment for adults with depression. Alventa XL is also a treatment for adults with the following anxiety disorder: 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.

2. BeFORe YOU TAKe AlvenTA Xl Do not take Alventa Xl • If you are allergic to venlafaxine or any of the other ingredients of Alventa XL.

• 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 Alventa XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Alventa XL before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Take special care with Alventa Xl • If you use other medicines that taken concomitantly with Alventa XL 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.

Alventa 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 Alventa 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 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.

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





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.

Your doctor should decide whether you can take Alventa 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 (MAOIs: see the section “Before you take Alventa 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 (a pain-killer) • 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) 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. Get medical care right away if you think serotonin syndrome is happening to you.

The following medicines may also interact with Alventa 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) Taking Alventa Xl with food and drink Alventa XL should be taken with food (see section 3 “How to take Alventa XL”).

You should avoid alcohol while you are taking Alventa XL.

Pregnancy and breast-feeding Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Alventa 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 Alventa 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 Alventa XL during pregnancy, let your midwife and/or doctor know, as 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.

Alventa 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 Alventa XL.

Driving and using machines Do not drive or use any tools or machines until you know how Alventa XL affects you.

Important information about some of the ingredients of Alventa Xl 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.

3. HOW TO TAKE AlvEnTA Xl Always take Alventa XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual recommended starting dose for treatment of depression, 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 Alventa 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.

Alventa XL should be taken with food.

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

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

If you take more Alventa Xl than you should Call your doctor or pharmacist immediately if you take more than the amount of Alventa 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 Alventa 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 Alventa XL that has been prescribed for you in one day.

If you stop taking Alventa 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 Alventa 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 Alventa XL, especially when Alventa 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 Alventa 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 product, ask your doctor or pharmacist.

4. POSSIBlE SIDE EFFECTS

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

Allergic reactions If any of the following happen, do not take more Alventa XL. 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 Alventa XL, if you stop taking Alventa XL”).

Complete side effect listing

The frequency (likelihood of occurring) of side effects is classified as follows:

Very common Affects more than 1 user in 10 Common Affects 1 to 10 users in 100 Uncommon Affects 1 to 10 users in 1,000 Rare Affects 1 to 10 users in 10,000 Not known Frequency cannot be estimated from the available data



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