LEVETIRACETAM RATIOPHARM 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam ratiopharm

Do not take Levetiracetam ratiopharm

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

Warnings and precautions

Talk to your doctor before you take Levetiracetam ratiopharm

• if you have kidney problems, follow your doctor’s instructions. He/she will decide if you need to adjust the dose.
• if you notice any decrease in your child’s growth or an unexpected delay in puberty, contact your doctor.
• a small number of people taking antiepileptics such as Levetiracetam ratiopharm have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Monotherapy with Levetiracetam ratiopharm (single treatment) is not indicated for children and adolescents under 16 years.

Use ofLevetiracetam ratiopharmwith other medicines

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

Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam ratiopharm should not be used during pregnancy unless clearly necessary. It cannot be excluded that the risk of malformations in the baby is higher than for other antiepileptic medicines. In animal studies, levetiracetam has shown adverse effects on the reproductive system and on the developing foetus at doses higher than those that you may need to control your seizures.

Breast-feeding is not recommended during treatment with Levetiracetam ratiopharm.

Driving and using machines

Levetiracetam ratiopharm may impair your ability to drive or operate tools or machinery, as it may cause somnolence. This is more likely at the beginning of treatment or when the dose is increased. 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 Levetiracetam ratiopharm

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 tablets that your doctor has prescribed for you.

Levetiracetam ratiopharm should be taken twice a day, once in the morning and once in the evening, approximately at the same time each day.

Monotherapy

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

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

When you first start taking Levetiracetam ratiopharm, your doctor will prescribe you a lower dose(500mg per day)for two weeks before giving you the lowest general dose of 1,000 mg.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17years) with a body weight of 50kg or more:

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

For example, if your daily dose is 1,000mg, you can take 2 tablets of 250mgin the morning and 2tabletsof 250mgin the evening.

Dose in infants (from 1month to 23months), children (from 2 to 11years) and adolescents (from 12 to 17years) with a body weight below 50kg:

Your doctor will prescribe the most appropriate formulation of Levetiracetam ratiopharm according to the age, weight and dose.

Levetiracetam ratiopharm 100 mg/ml oral solution is the most appropriate formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) with a body weight below 50 kg and when tablets do not allow accurate dosing.

Method of administration

Swallow Levetiracetam ratiopharm film-coated tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam ratiopharm with or without food.

Duration of treatment

• Levetiracetam ratiopharm is used as a chronic treatment. You should continue to take Levetiracetam ratiopharm for as long as your doctor has prescribed it for you.
• Do not stop your treatment without the advice of your doctor, as this may increase your seizures.

If you take more Levetiracetam ratiopharm than you should

Possible side effects of an overdose of Levetiracetam ratiopharm are somnolence, agitation, aggression, decreased alertness, respiratory depression and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible treatment for the overdose.

If you forget to take Levetiracetam ratiopharm

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 Levetiracetam ratiopharm

The withdrawal of Levetiracetam ratiopharm should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam ratiopharm, he/she will tell you how to gradually reduce the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke’s oedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling of feet, ankles or hands, as these may be signs of sudden kidney failure
• a rash that may form blisters and may look like small targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention changes (loss of concentration); these may be signs of encephalopathy

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness may be more frequent at the beginning of treatment or when the dose is increased. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling drowsy), headache.

Common:may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid regurgitation), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people

• decreased number of platelets, decreased number of white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention changes (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in liver function tests;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:may affect up to 1 in 1,000 people

• infection;
• decrease in all blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction [severe, important and life-threatening allergic reaction], Quincke’s oedema [swelling of face, lips, tongue and throat]);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• uncontrolled muscle spasms affecting the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden kidney failure;
• skin rash, which may form blisters and may look like small targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam ratiopharm

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP:. The expiry date refers to the last day of that month.

This medicine 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. Package Contents and Additional Information

Composition of Levetiracetam ratiopharm

The active ingredient is levetiracetam.

One film-coated tablet of Levetiracetam ratiopharm 250 mg contains 250 mg of levetiracetam.

One film-coated tablet of Levetiracetam ratiopharm 500 mg contains 500 mg of levetiracetam.

One film-coated tablet of Levetiracetam ratiopharm 750 mg contains 750 mg of levetiracetam.

One film-coated tablet of Levetiracetam ratiopharm 1,000 mg contains 1,000 mg of levetiracetam.

The other ingredients are:

Tablet core:

Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Powdered cellulose, Magnesium stearate.

Coating:

Levetiracetam ratiopharm 250mg

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Aluminum lake with indigo carmine (E132)

Levetiracetam ratiopharm 500mg

Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide, Anatase (E171), Yellow iron oxide (E172)

Levetiracetam ratiopharm 750mg

Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide, Anatase (E171), Yellow iron oxide (E172), Red iron oxide (E172)

Levetiracetam ratiopharm 1,000mg

Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide (E171)

Appearance and Packaging of the Product

Levetiracetam ratiopharm 250mg

The film-coated tablets are blue, oblong, and scored on one side, and are supplied in packs of 20, 30, 50, 60, or 100 film-coated tablets, or in multipacks of 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 500mg

The film-coated tablets are yellow, oval, and scored on one side, and are supplied in packs of 10, 20, 30, 50, 60, or 100 film-coated tablets, or in multipacks of 120 (2 packs of 60) or 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 750mg

The film-coated tablets are light red, oblong, and scored on both sides, and are supplied in packs of 20, 30, 50, 60, 80, or 100 film-coated tablets, or in multipacks of 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 1,000mg

The film-coated tablets are white, oblong, and scored on both sides, and are supplied in packs of 10, 20, 30, 50, 60, or 100 film-coated tablets, or in multipacks of 200 (2 packs of 100) film-coated tablets.

The tablets can be divided into equal parts.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Email: [email protected]

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/YYYY}

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.