Levetiracetam Stadafarma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Stadafarma 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you or your child starts 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levetiracetam Stadafarma is and what it is used for
2. What you need to know before taking Levetiracetam Stadafarma
3. How to take Levetiracetam Stadafarma
4. Possible side effects
5. How to store Levetiracetam Stadafarma
6. Contents of the pack and other information

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

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

This medicine is used:

• as monotherapy (without the need for another antiepileptic medicine) in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat one type of epilepsy. Epilepsy is a condition 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 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 aged 12 years and older with juvenile myoclonic epilepsy.

• primary generalized tonic-clonic seizures (also known as grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Levetiracetam Stadafarma

Do NOT take Levetiracetam Stadafarma

• 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 to take levetiracetam.

• If you have kidney problems, follow your doctor's instructions, who will decide whether your dose needs to be adjusted.
  • If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
  • A small number of people being treated with 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 (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that 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 or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these 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 Stadafarma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take macrogol (a laxative medicine) 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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.

The 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 using machines

Levetiracetam may affect your ability to drive or operate tools or machinery, as this medicine 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.

3. How to take Levetiracetam Stadafarma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Levetiracetam is not available in all the pharmaceutical forms described. For dosage recommendations that cannot be achieved with this medicine, other medicines containing levetiracetam should be used.

Take the number of tablets prescribed by your doctor.

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

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Usual dose: between 1,000 mg and 3,000 mg per day.

When starting levetiracetam, your doctor will prescribe a lower dose for 2 weeks before administering the lowest usual dose.

For example: for a daily dose of 1,000 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 should be gradually increased to reach 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) weighing 50 kg or less:

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

• Dose in 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 based on age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, especially when tablets do not allow precise dosing.

Method of administration

This medicine is for oral use.

Swallow the levetiracetam tablets with sufficient liquid (e.g., a glass of water). You may take levetiracetam with or without food. A bitter taste may be noticed after oral administration of levetiracetam.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You must continue treatment with levetiracetam for the duration indicated by your doctor.
• Do not discontinue your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Stadafarma than you should

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

Contact your doctor if you have taken more tablets than you should. Your doctor will determine the best management for the overdose.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone 91-562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Levetiracetam Stadafarma

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for missed doses.

If you stop taking Levetiracetam Stadafarma

As with other antiepileptic medicines, 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 or she will give you instructions for the gradual withdrawal of levetiracetam.

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 will experience 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 rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in 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 be signs of 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 (numbness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrollable movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue and dizziness. Effects such as feeling sleepy, feeling weak and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common (may affect more than 1 in 10 people):

• nasopharyngitis
• somnolence (feeling sleepy), 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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling of weakness)

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

• decreased number of platelets, decreased number of white blood cells
• weight loss, weight gain
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired coordination of movement), 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 concentration of sodium in blood
• suicide, personality disorders (behavioural 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
• uncontrollable muscle spasms affecting the head, torso 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 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 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 it is a possible adverse effect not listed in this leaflet. You can also report them directly 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 Stadafarma

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Stadafarma

The active substance is levetiracetam.

Each film-coated tablet contains 500 mg of levetiracetam.

The other components are:

Tablet core:

Crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate.

Film coating:

Hypromellose, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Levetiracetam Stadafarma 500 mg film-coated tablets EFG are yellow, oval, film-coated tablets with a score line on one side, measuring approximately 16.5 mm x 7.7 mm. The tablet may be divided into equal doses.

Levetiracetam Stadafarma 500 mg film-coated tablets EFG are available in packs containing 10, 20, 30, 50, 60, 100, 120 or 200 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain
[email protected]

Manufacturer

Rontis Hellas Medical and

Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004,

Greece

or

PharOS MT Ltd

HF 62X, Hal-Far Industrial Estate,

Birzebbugia BBG 3000

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

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

Detailed 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/).