LEVETIRACETAM RATIOPHARM 100 mg/ml ORAL SOLUTION

Introduction

Leaflet:information for the patient

Levetiracetam ratiopharm 100mg/ml oral solution 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, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Levetiracetam ratiopharm and what is it 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

1. Package contents and additional information

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

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

Levetiracetam ratiopharm is used:

• alone in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain, but may later spread to larger 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 (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
  • tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age 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, pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use 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 development of puberty, contact your doctor.
• A small number of people being treated with 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 is not indicated in children and adolescents under 16 years of age.

Using Levetiracetam ratiopharm with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Pregnancy and breastfeeding

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

Levetiracetam ratiopharm should not be used during pregnancy unless strictly necessary. The risk of birth defects for the baby cannot be completely excluded. In animal studies, Levetiracetam ratiopharm has shown unwanted effects on reproduction at doses higher than those you may need 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 start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

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 kidney failure or with low-potassium diets should note that this medicine contains 1.2 mmol (or 46.65 mg) of potassium per 15 ml.

3. How to take Levetiracetam ratiopharm

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Take the oral solution as instructed by your doctor.

Monotherapy

Dose in adults and adolescents from 16 years of age:

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

General dose: Levetiracetam ratiopharm is taken twice a day, divided into two equal doses, each of 5 ml (500 mg) and 15 ml (1,500 mg).

When starting Levetiracetam ratiopharm, your doctor will prescribe a lower dosefor two weeks before administering the lowest general dose.

Concomitant therapy

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

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

General dose: Levetiracetam ratiopharm is taken twice a day, divided into two equal doses, each of 5 ml (500 mg) and 15 ml (1,500 mg).

Dose in children from 6months of age onwards:

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

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

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

General dose: Levetiracetam ratiopharm is taken twice a day, divided into two equal doses, each of 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see dose examples in the table below).

Dose in children from 6months of age onwards:

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

For infants from 1month to less than 6months, measure the appropriate dose using the 1mlsyringe included in the package.

General dose: Levetiracetam ratiopharm is taken twice a day, divided into two equal doses, each of 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see dose examples in the table below).

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

Method of administration

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 baby bottle. You can take Levetiracetam ratiopharm with or without food.

Instructions for correct administration:

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

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

?

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

?

• Fill the syringe by pulling the plunger to the graduation mark corresponding to the amount that matches the dose in milliliters (ml) prescribed by your doctor.
• You can read the amount corresponding to the milliliters at the beginning of the thicker part of the plunger (figure ?.

?

• If bubbles appear, press the plunger back into the syringe and fill it again slowly.
• Move the bottle and syringe back to the initial position.
• Remove the filled syringe from the bottle (figure?).

?

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

?

• Close the bottle with the plastic screw cap after each use.
• Drink the entire contents of the glass.
• Wash the syringe after each use with clear water by filling and emptying the syringe repeatedly.

Duration of treatment

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

If you take more Levetiracetam ratiopharm than you should

The possible side effects of an overdose of Levetiracetam ratiopharm are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

Contact your doctor if you have taken more Levetiracetam ratiopharm 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 the missed doses.

If you stop treatment with Levetiracetam ratiopharm

Stopping 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/she will give you instructions for the gradual withdrawal of Levetiracetam ratiopharm.

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

4. Possible Adverse Effects

Like all medicines, Levetiracetam ratiopharm can cause adverse effects, although not all people suffer from them.

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

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Hypersensitivity Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as these may be signs of sudden decreased kidney function
• a skin rash that can form blisters and may appear as small targets (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)
• a more severe form of rash that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (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, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very Common:may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (feeling of sleep), 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 instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

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

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test results;
• 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 [important and severe allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat]);
• decrease in sodium concentration in the blood;
• suicide, personality disorders (behavioral 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 decreased kidney function;
• skin rash, which can 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), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging and on the bottle after CAD.:. The expiration date is the last day of the month indicated.

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

Do not use after 4 months of opening the package.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam ratiopharm

The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: methyl parahydroxybenzoate (E128), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E950), grape flavor

Appearance of the Product and Package Contents

Levetiracetam ratiopharm oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam ratiopharm oral solution (for children 4 years of age and older, adolescents, and adults) is packaged 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 6 months of age and older and children 2 to 4 years of age) is packaged 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 1 month of age and younger than 6 months) is packaged 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: info@ratiopharm.de

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

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

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