Levetiracetam Ratiopharm 250 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levetiracetam ratiopharm 250mg film-coated tablets EFG

Levetiracetam ratiopharm 500mg film-coated tablets EFG

Levetiracetam ratiopharm 750mg film-coated tablets EFG

Levetiracetam ratiopharm 1,000mg film-coated tablets EFG

Levetiracetam

Read the entire leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Levetiracetam ratiopharm is and what it is used for
2. What you need to know before taking Levetiracetam ratiopharm
3. How to take Levetiracetam ratiopharm
4. Possible side effects
5. Storage of Levetiracetam ratiopharm
6. Contents of the pack and other information

1. What Levetiracetam ratiopharm is and what it is used for

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

Levetiracetam ratiopharm is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a type of epilepsy. Epilepsy is a condition in which patients have seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may then spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medicines to treat:
  • partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
  • generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

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

• If you have kidney problems, follow your doctor's instructions. Your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam ratiopharm have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Treatment with Levetiracetam ratiopharm alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Taking Levetiracetam ratiopharm with other medicines

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

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Levetiracetam ratiopharm should not be used during pregnancy unless strictly necessary. A risk of birth defects for the baby cannot be completely ruled out. In animal studies, Levetiracetam ratiopharm has shown adverse effects on reproduction at doses higher than those required to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam ratiopharm may affect your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.

3. How to take Levetiracetam ratiopharm

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

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

Monotherapy

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

Usual dose: between 1,000 mg and 3,000 mg daily.

When you start taking Levetiracetam ratiopharm, your doctor will prescribe a lower dose (500 mg daily) for two weeks before increasing to the lowest usual dose of 1,000 mg.

Concomitant therapy

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

Usual dose: between 1,000 mg and 3,000 mg daily.

For example: if your daily dose is 1,000 mg, you may take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

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

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

Levetiracetam ratiopharm 100 mg/mL oral solution is the most suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) with body weight below 50 kg, especially when tablets do not allow precise dosing.

Method of administration

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

Duration of treatment

• Levetiracetam ratiopharm is used as a chronic treatment. You must continue treatment with Levetiracetam ratiopharm for the duration indicated by your doctor.
• Do not discontinue treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam ratiopharm than you should

Possible adverse effects of an overdose of Levetiracetam ratiopharm include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the best 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 forgotten doses.

If you stop taking Levetiracetam ratiopharm

Discontinuation of Levetiracetam ratiopharm treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam ratiopharm, they will provide instructions for the gradual withdrawal of Levetiracetam ratiopharm.

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

4. Possible adverse effects

Like all medicines, Levetiracetam ratiopharm may cause adverse effects, although not everyone experiences them.

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

• weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and facial rash followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate a sudden decrease in kidney function
• a skin rash that may blister and may appear as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of rash causing skin peeling over 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 (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue, and dizziness. Effects such as drowsiness, feeling weak, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 100 people

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

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

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [serious and severe allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may lead to blisters appearing as small target-like spots (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse 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 stated on the packaging and blister after EXP:. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam ratiopharm

The active substance 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 components are:

Tablet core:

Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Microcrystalline cellulose powder, Magnesium stearate.

Coating:

Levetiracetam ratiopharm 250mg

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Indigo carmine aluminium lake (E132)

Levetiracetam ratiopharm 500mg

Hypromellose (E464), Microcrystalline cellulose (E460), PEG 40 stearate type I, Titanium dioxide, Anatase (E171), Iron oxide yellow (E172)

Levetiracetam ratiopharm 750mg

Hypromellose (E464), Microcrystalline cellulose (E460), PEG 40 stearate type I, Titanium dioxide, Anatase (E171), Iron oxide yellow (E172), Iron oxide red (E172)

Levetiracetam ratiopharm 1,000mg

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

Nature of the product and contents of the pack

Levetiracetam ratiopharm 250mg

The film-coated tablets are blue, oblong and scored on one side. They 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. They 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. They 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. They 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 some 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 medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the last review of this summary: {MM/YYYY}

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