Levetiracetam Ratiopharm: detailed information

Package leaflet: Information for the patient

Levetiracetam ratiopharm 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

levetiracetam
Please read this leaflet carefully before you or your child starts taking this
medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam ratiopharm is and what it is used for
What you need to know before taking Levetiracetam ratiopharm
How to take Levetiracetam ratiopharm
Possible side effects
How to store Levetiracetam ratiopharm
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 epileptic seizures).
Levetiracetam ratiopharm is used:

as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated seizures. Levetiracetam is used for the type of epilepsy where the seizure starts in only one part 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.
as an add-on to other antiepileptic medicines to treat:
■ partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants aged one month and older
■ 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
■ primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed 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
Talk to your doctor before taking Levetiracetam ratiopharm

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
If you notice slowed growth or unexpected development of puberty in your child, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam ratiopharm have experienced suicidal thoughts or self-harming thoughts. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (visible on electrocardiogram) or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

Unusual thoughts, feeling irritable or more aggressive than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while taking Levetiracetam ratiopharm, consult a doctor as
soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not take macrogol (a medicine used as a laxative) one hour before or one hour after taking
levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine. Levetiracetam may be used during pregnancy only if,
after careful evaluation, your doctor considers it necessary.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects for the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam ratiopharm may reduce your ability to drive or operate tools or machinery because it
may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You
must not drive or operate machinery until you are certain that your ability to perform these activities is
not affected.

3. How to take Levetiracetam ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam ratiopharm must be taken twice daily, once in the morning and once in the
evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from age 16 onwards)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam ratiopharm, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing 50 kg or less: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm based on weight and required dose.

Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm based on
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, for children and adolescents (6 to 17 years) weighing less than
50 kg, and when tablets do not allow accurate dosing.

Method of administration
Swallow the Levetiracetam ratiopharm film-coated tablets with a sufficient amount of
liquid (e.g. a glass of water). You may take Levetiracetam ratiopharm with or without food. After
oral administration, a bitter taste of levetiracetam may be perceived.

Duration of treatment

Levetiracetam ratiopharm is used as a chronic treatment. Treatment with Levetiracetam ratiopharm should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures.

If you take more Levetiracetam ratiopharm than you should
Possible adverse effects of an overdose of Levetiracetam ratiopharm include drowsiness,
agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor immediately if you have taken more tablets than prescribed. Your doctor will determine the most appropriate management for the overdose.

If you forget to take Levetiracetam ratiopharm
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed dose.

If you stop taking Levetiracetam ratiopharm
If treatment needs to be discontinued, Levetiracetam ratiopharm should be withdrawn
gradually to avoid an increase in seizure frequency. If your doctor decides to stop your
treatment with Levetiracetam ratiopharm, they will provide you with instructions for the gradual
discontinuation of Levetiracetam ratiopharm.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
swelling of the face, lips, tongue, and throat (angioedema or Quincke's edema);
flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased liver enzyme levels observed in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms]);
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as these may indicate sudden kidney dysfunction;
a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
a more severe form of skin rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
signs of severe mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these effects should decrease over time.

Very common: may affect more than 1 in 10 people

nasopharyngitis;
drowsiness, headache.

Common: may affect up to 1 in 10 people

anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
seizure, 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), vomiting, nausea;
rash;
asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

decreased number of platelets in the blood, decreased number of white blood cells in the blood;
weight loss, weight gain;
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paraesthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma.

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

infection;
decreased number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], angioedema [swelling of the face, lips, tongue, and throat]);
decreased concentration of sodium in the blood;
suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the section “Contact your doctor immediately” for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
changes in heart rhythm (electrocardiogram abnormalities);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, particularly 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 levels. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
limping or difficulty walking;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

repetitive unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and blister after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levetiracetam contains
The active substance is called levetiracetam.
Each film-coated tablet of Levetiracetam ratiopharm 250 mg contains 250 mg of levetiracetam.
Each film-coated tablet of Levetiracetam ratiopharm 500 mg contains 500 mg of levetiracetam.
Each film-coated tablet of Levetiracetam ratiopharm 750 mg contains 750 mg of levetiracetam.
Each film-coated tablet of Levetiracetam ratiopharm 1000 mg contains 1000 mg of levetiracetam.

The other components are:
Tablet core:
Macrogol 6000, Anhydrous colloidal silica, Crospovidone, Powdered cellulose, Magnesium stearate.

Coating:
Levetiracetam ratiopharm 250 mg
Polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Indigo carmine aluminium lake (E132).
Levetiracetam ratiopharm 500 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase titanium dioxide (E171), Yellow iron oxide (E172).
Levetiracetam ratiopharm 750 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172).
Levetiracetam ratiopharm 1000 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide (E171).

Description of the appearance of Levetiracetam ratiopharm and contents of the pack
Levetiracetam ratiopharm 250 mg
The film-coated tablets are blue, oblong-shaped, with a break line on one side, and are supplied in packs of 20, 30, 50, 60 or 100 film-coated tablets, or in multiple packs containing 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 500 mg
The film-coated tablets are yellow, oval-shaped, with a break line on one side, and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets, or in multiple packs containing 120 (2 packs of 60) or 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 750 mg
The film-coated tablets are light red, oblong-shaped, with a break line on both sides, and are supplied in packs of 20, 30, 50, 60, 80 or 100 film-coated tablets, or in multiple packs containing 200 (2 packs of 100) film-coated tablets.

Levetiracetam ratiopharm 1000 mg
The film-coated tablets are white, oblong-shaped, with a break line on both sides, and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets, or in multiple packs containing 200 (2 packs of 100) film-coated tablets.

The tablets can be divided into two equal parts.
Not all 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tel./Tél.: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel.: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp.z.o.o
Tél: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm, Comércio e Indústria de Produtos
Tél: +33 155917800 Farmacêuticos Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu

Patient information leaflet

Levetiracetam ratiopharm 100 mg/mL oral solution.

levetiracetam
Please read this leaflet carefully before you or your child starts taking this medicine as it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam ratiopharm is and what it is used for
What you need to know before taking Levetiracetam ratiopharm
How to take Levetiracetam ratiopharm
Possible side effects
How to store Levetiracetam ratiopharm
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 epileptic seizures).
Levetiracetam ratiopharm is used:

as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part of the brain but may subsequently spread to wider 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.
as add-on therapy to 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 from 12 years of age with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the 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
Talk to your doctor before taking Levetiracetam ratiopharm

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
If you notice slowed growth or unexpected onset of puberty in your child, contact your doctor.
A small number of people being treated with antiepileptic medicines such as Levetiracetam ratiopharm have experienced self-harming thoughts or suicidal ideation. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (detectable on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple types of seizures and loss of abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while being treated with Levetiracetam
ratiopharm, consult a doctor as soon as possible.
Children and adolescents

Levetiracetam ratiopharm as monotherapy (used alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 the effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor before taking this medicine. Levetiracetam may be used during
pregnancy only if, after careful evaluation, your doctor considers it necessary.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam ratiopharm may reduce your ability to drive or operate tools or
machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must 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,
potassium and sodium
Levetiracetam ratiopharm oral solution contains methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
This medicine contains 1.2 mmol (or 46.65 mg) of potassium in 15 mL. This should be taken into account
in patients with impaired kidney function or in patients on a low-potassium diet.
This medicine contains less than 1 mmol (23 mg) of sodium per 15 mL, i.e. it is essentially ‘sodium-free’.

3. How to take Levetiracetam ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 instructed by your doctor.

Monotherapy (from 16 years of age)
Adults (≥18 years) 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.
Recommended dose: Levetiracetam ratiopharm is taken twice daily in two equally divided 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 2 weeks before increasing to the lowest daily dose.

Adjunctive therapy
Dose for adults and adolescents (12 to 17 years):
Measure the appropriate dose using the 10 mL syringe provided in the package for patients from 4 years of age.
Recommended dose: Levetiracetam ratiopharm is taken twice daily in two equally divided doses, each ranging from 5 mL (500 mg) to 15 mL (1,500 mg).

Dose for children from 6 months of age:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm depending 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 above 4 years of age: Measure the appropriate dose using the 10 mL syringe provided in the package.
Recommended dose: Levetiracetam ratiopharm is taken twice daily in two equally divided doses, each ranging from 0.1 mL (10 mg) to 0.3 mL (30 mg) per kg of the child's body weight (see the following table for dose examples).
Dose for children from 6 months of age

Weight	Initial dose: 0.1 mL/kg twice daily	Maximum dose: 0.3 mL/kg twice daily
6 kg	0.6 mL twice daily	1.8 mL twice daily
8 kg	0.8 mL twice daily	2.4 mL twice daily
10 kg	1 mL twice daily	3 mL twice daily
15 kg	1.5 mL twice daily	4.5 mL twice daily
20 kg	2 mL twice daily	6 mL twice daily
25 kg	2.5 mL twice daily	7.5 mL twice daily
From 50 kg	5 mL twice daily	15 mL twice daily

Dosage for infants (from 1 month up to less than 6 months):
For infants from 1 month up to less than 6 months: measure the appropriate dose using the 1 mL syringe provided in the package.
Recommended dose: Levetiracetam ratiopharm should be taken twice daily in two equally divided doses, each ranging from 0.07 mL (7 mg) to 0.21 mL (21 mg) per kg of the infant's body weight (see the following table for examples of doses).
Dosage for infants (from 1 month up to less than 6 months):

Weight	Initial dose: 0.07 mL/kg twice daily	Maximum dose: 0.21 mL/kg twice daily
4 kg	0.3 mL twice daily	0.85 mL twice daily
5 kg	0.35 mL twice daily	1.05 mL twice daily
6 kg	0.45 mL twice daily	1.25 mL twice daily
7 kg	0.5 mL twice daily	1.5 mL twice daily

Administration method
After measuring the correct dose with an appropriate syringe, Levetiracetam ratiopharm oral solution
may be diluted in a glass of water or in a bottle. Levetiracetam ratiopharm may be taken with or without food.
After oral administration, a bitter taste of levetiracetam may be perceived.
Instructions for use:

Open the bottle: press down on the cap and turn counterclockwise.
Take the syringe and insert it into the opening of the bottle. To do this, the plunger must be fully pushed into the syringe (figure  )

A hand holds a syringe and pushes it downward with an arrow indicating the movement to aspirate liquid from a vial, shown using two hands

Ensure that the bottle and syringe are securely attached. Then turn the bottle and syringe upside down (figure  ).

A hand holds the top part of a syringe while the

Fill the syringe with the liquid by pulling the plunger up to the graduation mark corresponding to the amount in millilitres (mL) prescribed by the doctor.
The millilitres can be read at the beginning of the thicker part of the plunger (figure  ).

Circular close-up of a syringe with gray liquid reaching the 2 ml mark indicated by the label 'Your dose'

If air bubbles appear, push the plunger back into the syringe and refill the syringe more slowly.
Return the bottle and filled syringe to the upright position.
Remove the filled syringe from the bottle (figure ).

A hand vertically lifts a syringe with needle from a medicine vial held with the

Pour the contents of the syringe into a glass of water by pushing the plunger into the syringe (figure  ).

A hand holds a tilted syringe above a liquid container as a drop falls from the tip of the

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

Duration of treatment

Levetiracetam ratiopharm is used as a chronic treatment. Treatment with Levetiracetam ratiopharm should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures. If you take more Levetiracetam ratiopharm than you should
Possible adverse effects of an overdose of Levetiracetam ratiopharm include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma. Contact your doctor if you have taken more Levetiracetam ratiopharm than prescribed. The doctor will determine the most appropriate treatment for overdose.

If you forget to take Levetiracetam ratiopharm
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a missed dose.
If you stop taking Levetiracetam ratiopharm
If treatment needs to be discontinued, Levetiracetam ratiopharm should be gradually withdrawn to avoid an increase in seizures. If your doctor decides to discontinue treatment with Levetiracetam ratiopharm, they will provide you with instructions on how to gradually stop taking it.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
swelling of the face, lips, tongue, and throat (Quincke's oedema)
flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden kidney dysfunction
a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental disturbances or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache,
fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects
such as drowsiness, fatigue, and dizziness may be more common. However, these effects should
decrease over time.
Very common: may affect more than 1 in 10 people

nasopharyngitis;
drowsiness, headache;

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

decreased number of platelets in the blood, decreased number of white blood cells in the blood;
weight loss, weight gain;
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paraesthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma;

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

infection;
decreased number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], Quincke's oedema [swelling of face, lips, tongue, and throat]);
decreased concentration of sodium in the blood;
suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection “Contact your doctor immediately” for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
change in heart rhythm (electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting 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;
limping or difficulty walking;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

repetitive unwanted thoughts or urges to repeatedly perform certain actions (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and on the bottle after
Exp.
The expiry date refers to the last day of that month.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not use after 4 months from the first opening of the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam ratiopharm contains
The active substance is called levetiracetam. Each mL contains 100 mg of levetiracetam.
The other components are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E950), grape flavour.

Description of the appearance of Levetiracetam ratiopharm and contents of the pack
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, adolescents and adults) is packaged in a cardboard box containing a 10 mL oral dosing 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 children from 2 to 4 years) is packaged in a cardboard box containing a 3 mL oral dosing 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 packaged in a cardboard box containing a 1 mL oral dosing syringe (graduated every 0.05 mL) and a syringe adapter.

Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
e-mail: [email protected]

Manufacturer
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder: