Levetiracetam STADA 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Levetiracetam Stada 100 mg/ml oral solution EFG

Read the entire leaflet carefully before you start 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Levetiracetam Stada

3. How to take Levetiracetam Stada

4. Possible side effects

5. How to store Levetiracetam Stada

6. Contents of the pack and other information

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

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

Levetiracetam is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease in which patients have attacks (seizures). Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain, but may then 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 (short, 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 (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Stada

Do not take Levetiracetam Stada:

• 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

Consult your doctor before starting Levetiracetam Stada:

• If you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted.

• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.

• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

• If you have a personal or family history of irregular heartbeat (seen on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

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

• Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (treatment with levetiracetam alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Stada

Inform your doctor or pharmacist if you are currently 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary. Do not stop your treatment without first discussing it with your doctor. A risk of birth defects for the baby cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and use of machines

Levetiracetam 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. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Stada contains methyl parahydroxybenzoate (E218), liquid maltitol (E965), sodium, and benzyl alcohol.

This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

This medicine also contains maltitol. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

This medicine contains 0.0016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Do not use for longer than one week in young children (under 3 years of age), unless otherwise directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Levetiracetam Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Levetiracetam 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 (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 onwards.

General dose: Levetiracetam is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

When starting levetiracetam treatment, your doctor will initially prescribe a lower dose for two weeks before increasing to the lowest general dose.

Concomitant therapy

Dosage in adults and adolescents (12 to 17 years of age):

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

General dose: Levetiracetam is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children from 6 months of age:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on 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.

General dose: Levetiracetam 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:

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

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

Standard dose: Levetiracetam 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 examples of dosing in the table below).

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

Method of administration

After measuring the correct dose with an appropriate syringe, levetiracetam may be taken by diluting the oral solution in a glass of water or in a baby bottle. You may take levetiracetam with or without food. After oral administration of levetiracetam, you may notice a bitter taste.

Instructions for correct administration:

• Open the bottle: press down on the cap and unscrew it counterclockwise (Figure 1).
• Separate the adapter from the syringe (Figure 2). Insert the adapter into the neck of the bottle. Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter. Turn the bottle upside down (Figure 3).
• Fill the syringe with a small amount of solution by first pushing the plunger down (Figure 4a), then pulling it back up to remove any possible air bubbles (Figure 4b). Pull the plunger back until the graduation mark corresponding to the prescribed dose in millilitres (mL) as directed by your doctor (Figure 4c).
• Place the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or into a baby bottle by pushing the plunger to the end of the syringe (Figure 5).
• Drink the entire contents of the glass or bottle.
• Close the bottle with the child-resistant cap.
• Wash the syringe with water only (Figure 6).

Duration of treatment

• Levetiracetam is used as a chronic treatment. You must continue treatment with levetiracetam for the length of 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 Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Possible adverse effects of a levetiracetam overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam Stada

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 taking Levetiracetam Stada

Discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, he/she will provide you with instructions for gradually withdrawing the medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell 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 (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema);
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, increased levels of 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, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, 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);
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or if someone around you notices 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, somnolence (drowsiness), headache, fatigue, and dizziness. Adverse effects such as drowsiness, feeling weak, and dizziness may be more common when treatment is started or 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 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (impaired movement coordination), 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 1,000 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 (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash, which may lead to blisters appearing 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 peeling of the skin, especially 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.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Stada

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 on the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After first opening: Do not store above 25°C.

Do not use more than 7 months after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. 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 Stada

• The active substance is levetiracetam.

Each ml of solution contains 100 mg of levetiracetam.

• The other components are: sodium citrate (to adjust pH), citric acid (to adjust pH), methyl parahydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), liquid maltitol (E965), liquid raspberry flavour (contains benzyl alcohol).

Appearance of the medicinal product and contents of the pack

Levetiracetam Stada 100 mg/ml oral solution is a clear liquid.

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

The 150 ml glass bottle of Levetiracetam Stada (for infants and young children from 6 months to less than 4 years of age) is packed in a cardboard box with a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1

190 Vienna

Austria

or

Galenica Pharmaceutical Industry S.A.

3rd Km Old National Road Chalkida Athens,

Chalcis, 341 00

Greece

Date of the most recent revision of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).