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Alventa Xl 75 Mg Prolonged Release Capsule Hard

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Document: leaflet CONSILIENT HEALTH (UK)_PL 01656-0044 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


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CONSILIENT HEALTH iw.

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 Common Uncommon Rare

Not known


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

• 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

• 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 overexcited 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; thoughts of harming or killing yourself, a feeling of dizziness or "spinning” (vertigo); aggression

•    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

•    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)

•    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)

• General

Common: weakness (asthenia); chills Uncommon: sensitivity to sunlight

Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction)

Alventa 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, Alventa 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 Alventa XL 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.

5. HOW TO STORE ALvENTA XL


Keep out of the reach and sight of children.

Do not use Alventa XL after the expiry date which is stated on the package. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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.

6. FURTHER Information

What Alventa XL contains

•    The active substance is venlafaxine.

Alventa XL 37.5 mg: Each prolonged release capsule, hard, contains 37.5 mg venlafaxine (as 42.43 mg venlafaxine hydrochloride). Alventa XL 75 mg: Each prolonged release capsule, hard, contains 75 mg venlafaxine (as 84.85 mg venlafaxine hydrochloride). Alventa XL 150 mg: 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 capsules contain gelatin, titanium dioxide (E171), red iron oxide (E172)

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

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

What Alventa XL looks like and contents of the pack

Alventa XL 37.5 mg prolonged release capsules, hard: opaque capsules, the upper part is brownish-pink, the lower part is white. Alventa XL 75 mg prolonged release capsules, hard: opaque, light pink capsules.

Alventa XL 150 mg prolonged release capsules, hard: opaque, brownish-orange colored 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 authorization holder:

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia Manufacturer:

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

Distributed by:

Consilient Health (UK) Ltd., No. 1 Church Road, Richmond upon Thames, Surrey, TW9 2QE.

P0288


This leaflet was last revised in July 2014