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1. Desitrend 1000 Mg Coated Granules In Sachet
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Format: 190 x 420 mm Code: ohne Schrift: 10 p MOCKUP

Package Leaflet: Information for the patient

Desitrend® 250 mg coated granules in sachet Desitrend® 500 mg coated granules in sachet Desitrend® 1000 mg coated granules in sachet

Levetiracetam

What is in this leaflet

1.    What Desitrend^® is and what it is used for

2.    What you need to know before you take Desitrend^®

3.    How to take Desitrend®

4.    Possible side effects

5.    How to store Desitrend®

6.    Contents of the pack and other information

1.    What Desitrend® is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Desitrend^® is used

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    as an add-on to other antiepileptic medicines to treat:

•    partial onset seizures with or without generalization in adults, adolescents, children and infants from one month of age;

•    myoclonic seizures (short, shock-like jerks of a muscle group or muscles) in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy;

•    primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.    What you need to know before you take Desitrend^®

Do not take Desitrend^®

•    if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Desitrend^®

•    if you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted;

•    If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

•    A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Desitrend^® coated granules are not indicated in children and adolescents below 16 years on its own (monotherapy), and are not recommended in children under the age of 6 years as well as in the initial treatment of children weighing less than 25 kg.

Other medicines and Desitrend^®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking leveti-racetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

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 any medicine.

Desitrend^® should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Desitrend^® may impair your ability to drive or operate any tools or machinery, as Desitrend^® may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

3. How to take Desitrend®

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of sachets following your doctor’s instructions.

Levetiracetam Desitin must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy:

Dose in adults and adolescents (from 16 years of age):

•    General dose: between 1,000 mg and 3,000 mg each day.

•    When you will first start taking Desitrend®, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg.

Add-on therapy:

Dose in adults and adolescents

(12 to 17 years) weighing 50 kg or more

•    General dose: between 1,000 mg and 3,000 mg each day.

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Desitin according to the age, weight and dose.

Levetiracetam oral solution is a presentation more appropriate to infants and children under the age of 6 years an d to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when sachets don’t allow accurate dosage.

Method of administration

1.    Hold sachet above arrow and shake content downwards.

2.    Tear off at incision (arrowhead) or cut off at dotted line.

3.    Pour content directly into the mouth and swallow the granules immediately with a sufficient quantity of liquid (e.g. a glass of water). Do not chew the coated granules, as they may be of bitter taste. You may take Levetiracetam Desitin with or without food.

The coated granules may also be suspended by

shaking for a minimum of 2 minutes in at least 10 ml

of water and administered via a feeding tube that should be rinsed twice with 10 ml of water each immediately after administration. If this method of administration is used, the suspension should be prepared immediately before administration.

Each sachet is for single use only.

Duration of treatment

•    Desitrend® is used as chronic treatment. You should continue Desitrend^® treatment for as long as your doctor has told you.

•    Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Desitrend® than you should

The possible side effects of an overdose of Desi-trend^® are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more sachets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Desitrend^®

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Desitrend^®

If stopping treatment, Levetiracetam Desitin should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Desitin treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Desitin.

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.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

•    nasopharyngitis;

•    somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)

•    vertigo (sensation of rotation);

•    cough;

•    abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;

•    rash;

•    asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1,000 people

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/ mood swings, agitation;

•    amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

•    diplopia (double vision), vision blurred;

•    elevated/abnormal values in a liver function test;

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare: may affect 1 to 10 users in 10,000 people

•    infection;

•    decreased number of all blood cell types;

•    severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);

•    decreased blood sodium concentration;

•    suicide, personality disorders (behavioural problems),

•    thinking abnormal (slow thinking, unable to concentrate);

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesias (hyperactivity);

•    pancreatitis;

•    liver failure, hepatitis;

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-John-son syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

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 via the Yellow Card Scheme: Website: 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 Desitrend®

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

Do not use this medicine after the expiry date stated on the carton box and sachet after EXP:. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

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.

6.    Contents of the pack and other information What Desitrend^® contains

The active substance is levetiracetam. Each sachet contains 250 or 500 or 1000 mg of levetiracetam.

The other ingredients are:

Povidone K30 Cellulose, microcrystalline Silica, colloidal anhydrous Magnesium stearate Poly(vinyl alcohol)

Titanium dioxide (E171)

Macrogol 3350 Talc

What Desitrend^® looks like and contents of the pack

Coated granules in sachets; the coated granules are white or almost white and round (diameter approx. 2 mm).

Desitrend® 250 mg coated granules in sachet Pack size of 20, 30, 50, 60, 100, 200 sachets

Desitrend® 500 mg coated granules in sachet Pack size of 20, 30, 50, 60, 100, 200 sachets

Desitrend® 1000 mg coated granules in sachet Pack size of 20, 30, 50, 60, 100, 200 sachets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Desitin Arzneimittel GmbH

Weg beim Jaeger 214 ■ 22335 Hamburg

Germany

E-mail: medinfo@desitin.co.uk

This leaflet was last revised in 05/2016

05/2016 DesitrendMini-GB