Prospecto:information for the patient

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 this prospectus carefully before you or your child starts taking this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.See section4.

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

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

3.How to take Levetiracetam ratiopharm

4.Possible side effects

5Storage of Levetiracetam ratiopharm

6.Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication used for the treatment of seizures in epilepsy).

Levetiracetam ratiopharm is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy, to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• Concurrently with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older
  • myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy
  • generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam ratiopharm

• If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Levetiracetam ratiopharm.

• If you have kidney problems, follow your doctor's instructions. They will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications like Levetiracetam ratiopharm have had thoughts of self-harm or 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 old.

Use of Levetiracetam ratiopharm with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) 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, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

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

It is not recommended to breastfeed during treatment.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

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

Monotherapy

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

General dosage: between 1,000 mg and 3,000 mg per day.

When starting to take Levetiracetam ratiopharm, your doctor will prescribe a lower dose (500 mg per day) for two weeks before administering the general lowest dose of 1,000 mg.

Concomitant therapy

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

General dosage: between 1,000 mg and 3,000 mg per day.

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

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

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

Levetiracetam ratiopharm 100 mg/ml oral solution is the most suitable formulation for infants and children under 6 years old and for children and adolescents (6 to 17 years old) with a weight of less than 50 kg and when tablets do not allow for precise dosing.

Method of administration

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

Duration of treatment

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

If you take more Levetiracetam ratiopharm than you should

The possible adverse effects of a Levetiracetam ratiopharm overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 compensate for the missed doses.

If you interrupt 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, they will give you instructions for the gradual withdrawal of Levetiracetam ratiopharm..

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

Like all medicines, Levetiracetam ratiopharm can cause side effects, although not everyone will experience them.

Inform your doctor immediately or go to the nearest hospital emergency service 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 a 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 cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS])
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as it may be a sign of sudden kidney function decline
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized 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 decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (drowsiness), headache, fatigue, and dizziness.The side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10people

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:may affect up to 1 in 100people

• anorexia (loss of appetite);
• depression, hostility or aggressiveness, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• dizziness (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

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

• infection;
• decrease in alltypes of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat]);
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which can lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized 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 elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects

If you experienceany type ofside effect, consult your doctoror pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister after CAD.:.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam ratiopharm

The active ingredient is levetiracetam.

A film-coated tablet ofLevetiracetam ratiopharm 250mgcontains 250mg of levetiracetam.

A film-coated tablet ofLevetiracetam ratiopharm 500mgcontains 500mg of levetiracetam.

A film-coated tablet ofLevetiracetam ratiopharm 750mgcontains 750mg of levetiracetam.

A film-coated tablet ofLevetiracetam ratiopharm 1.000mgcontains 1.000mg of levetiracetam.

The other components are:

Core of the tablet:

Macrogol 6000, Anhydrous colloidal silica, Crospovidone, Powdered cellulose, Magnesium stearate.

Coating:

Levetiracetam ratiopharm 250mg

Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Aluminum lacquer with indigo carmine blue (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 of the product and contents of the package

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 some pack sizes may be marketed.

Marketing Authorization Holder

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Email:[email protected]

Responsible for manufacturing

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:

Last update of this leaflet:{MM/AAAA}

Further information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.