Levetiracetam Ratiopharm 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam ratiopharm 100mg/ml oral solution EFG

Levetiracetam

Read all of this leaflet carefully before you or your child starts taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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. How to store 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 specific type of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may subsequently 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 taking 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 use 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 pubertal development, contact your doctor.
• A small number of people being treated with 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 immediately.

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 effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 unborn child cannot be completely ruled out. Animal studies have shown that Levetiracetam ratiopharm causes unwanted effects on reproduction at doses higher than those needed to control seizures.

Breast-feeding 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.

Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and potassium

Levetiracetam ratiopharm oral solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

Patients with renal insufficiency or those on low-potassium diets should be aware that this medicine contains 1.2 mmol (or 46.65 mg) of potassium per 15 ml.

3. How to take Levetiracetam ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Take the oral solution as directed by your doctor.

Monotherapy

Dosage in adults and adolescents from 16 years of age:

Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of age onwards.

Standard dosage: Levetiracetam ratiopharm is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you first start taking Levetiracetam ratiopharm, your doctor will prescribe a lower dose for two weeks before increasing to the lowest standard dose.

Concomitant therapy

Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:

Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of age onwards.

Standard dosage: Levetiracetam ratiopharm is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Dosage in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm based on the child's age, weight, and required dose.

For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided in the package.

For children over 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

Standard dosage: Levetiracetam ratiopharm is taken twice daily, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dosage examples in the table below).

Dosage in children from 6 months of age onwards:

Dosage in infants (from 1 month to less than 6 months):

For children from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe provided in the package.

General dose: Levetiracetam ratiopharm is taken twice daily, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see dosage examples in the table below).

Dosage in infants (from 1 month to less than 6 months):

Administration method

After measuring the correct dose with an appropriate syringe, Levetiracetam ratiopharm can be taken by diluting the oral solution in a glass of water or in a bottle. Levetiracetam ratiopharm may be taken with or without food.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew it counterclockwise.
• Take the syringe and insert it into the opening of the bottle.

For this, the plunger must be completely inside the syringe (Figure?)

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• Hold the bottle and syringe firmly together. Turn the bottle and syringe upside down.

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• Fill the syringe with liquid by pulling the plunger until the graduation mark corresponding to the prescribed dose in millilitres (ml) is reached.
• You can read the amount in millilitres at the front of the thicker part of the plunger (Figure?).

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• If air bubbles appear, push the plunger back into the syringe and then slowly refill the syringe again.
• Return the bottle and syringe to the upright position.
• Remove the filled syringe from the bottle (Figure?).

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• Empty the contents of the syringe into a glass of water by pressing the syringe plunger (Figure?).

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• After each use, close the bottle with the plastic screw cap.
• Drink the entire contents of the glass.
• After each use, wash the syringe with clean water by filling and emptying it repeatedly.

Duration of treatment

• Levetiracetam ratiopharm is used as a chronic treatment. You must continue treatment with Levetiracetam ratiopharm for the length of time indicated by your doctor.
• Do not stop your treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam ratiopharm than you should

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

Contact your doctor if you have taken more Levetiracetam ratiopharm than you should. Your doctor will determine the appropriate management 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 treatment with Levetiracetam ratiopharm

Discontinuation of treatment with Levetiracetam ratiopharm should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam ratiopharm, he or she will provide you with 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 everybody experiences them.

Immediately contact your doctor or go to the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe 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, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden decrease in kidney function
• a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• 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 confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrollable movements. These may be symptoms of encephalopathy.

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

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (drowsiness), 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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, burning sensation 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 behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired coordination of movement), 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 [severe and serious allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
• decreased sodium concentration in blood;
• suicide, personality disorders (behavioural 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 that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and peeling of the skin, 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 listed 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 which is stated on the packaging and on the bottle after EXP:. The expiry date refers to the last day of the month indicated.

Store the bottle in the original packaging to protect it from light.

Do not use more than 4 months after opening the container.

Medicines should 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. Each ml contains 100 mg of levetiracetam.

The other components are: methyl 4-hydroxybenzoate (E128), propyl 4-hydroxybenzoate (E216), citric acid monohydrate, sodium hydroxide, purified water, potassium acesulfame (E950), grape flavour.

Appearance of the medicinal product and contents of the container

Levetiracetam ratiopharm oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam ratiopharm oral solution (for children from 4 years of age and older, adolescents and adults) is packed in a cardboard box containing a 10 ml syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants from 6 months of age and older and children from 2 to 4 years of age) is packed in a cardboard box containing a 3 ml syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle of Levetiracetam ratiopharm oral solution (for infants from 1 month to less than 6 months of age) is packed in a cardboard box containing a 1 ml syringe (graduated every 0.05 ml) and a syringe adapter.

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 the latest review of this leaflet: {MM/YYYY}

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