Prospecto:information for the patient

Levetiracetam ratiopharm 100mg/ml oral solution EFG

Levetiracetam

Read this prospectus carefully before you or your child starts taking this medication, 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 medication has been prescribed only for you and should not be given 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 adverse effects

5Storage of Levetiracetam ratiopharm

6.Contents of the package 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 and 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 and older
  • myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
  • generalized tonic-clonic seizures (major 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).

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 use 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, 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 impair your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start 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 affected.

Levetiracetam ratiopharm contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, and potassium

Levetiracetam ratiopharm oral solution may cause allergic reactions (possibly delayed) due to the presence of parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

Patients with renal insufficiency or low-potassium diets should note that this medication contains 1.2 mmol (46.65 mg) of potassium per 15 ml.

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.

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

Take the oral solution according to your doctor's instructions.

Monotherapy

Dosage in adults and adolescents from 16 years of age:

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

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

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

Concomitant therapy

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

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

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

Dosage in children from 6 months of age:

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

For children from 6 months to 4 years:

Measure the appropriate dose using the 3 ml syringe included in the package.

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

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

Dosage in children from 6 months of age:

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

For infants from 1 month to less than 6 months:Measure the appropriate dose using the 1 ml syringe included in the package.

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

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

Administration form

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. You can take Levetiracetam ratiopharm with or without food.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands.
• 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. Turn the bottle and syringe

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

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• If bubbles appear, press the plunger inside the syringe again and fill the syringe again slowly.
• Move the bottle and syringe to the initial 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 plunger of the syringe(figure?).

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• 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.

Treatment duration

• Levetiracetam ratiopharm is used as a chronic treatment. You must 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 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 compensate for the missed doses.

If you interrupt treatment with Levetiracetam ratiopharm

The 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 department 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 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);
• vertigo (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 life-threatening allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat]);
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavioral 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 decline 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 doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.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 medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication 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 packaging.

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.

Levetiracetam ratiopharm Composition

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

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

Appearance of the product and contents of the package

Levetiracetam ratiopharm oral solution is a transparent liquid.

The 300 ml glass bottle of Levetiracetam ratiopharm oral solution (for children aged 4 years 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 aged 6 months and older and children aged 2 to 4 years) 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 aged 1 month 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: [email protected]

Responsible Person for Manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/AAAA}

For more detailed information about this medication, please visit the European Medicines Agency website: http://www.ema.europa.eu