Levetiracetam Sandoz 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Sandoz 250 mg film-coated tablets EFG

Levetiracetam Sandoz 500 mg film-coated tablets EFG

Levetiracetam Sandoz 1,000 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Levetiracetam Sandoz is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a specific form of epilepsy. Epilepsy is a condition in which patients experience 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 (brief, shock-like jerks of a muscle or muscle group) 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 (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Sandoz

Do not take Levetiracetam Sandoz

• 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 Sandoz.

• If you have kidney problems, follow your doctor's instructions. Your doctor should decide whether your dose needs to be adjusted.
• If you notice any slowing in your child's growth or unexpected development of puberty, please contact your doctor.
• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts about harming themselves or 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 side effects worsen or last for more than a few days:

• Abnormal thoughts, feeling irritable, or acting more aggressively than normal, 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.

In a very rare form of early-onset epilepsy (SCN8A mutation-related epilepsy) causing multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam Sandoz, see a doctor as soon as possible.

Children and adolescents

Treatment with levetiracetam (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Sandoz

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 medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

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.

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 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 machines until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; essentially "sodium-free".

3. How to take Levetiracetam Sandoz

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

Take the number of tablets prescribed by your doctor.

Levetiracetam Sandoz 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:

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

When you first start taking Levetiracetam Sandoz, your doctor will prescribe a lower dose for two weeks before administering the lowest daily dose.

For example: for a planned daily dose of 1,000 mg, your reduced starting 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 tablets according to weight and dose.

Dosage 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 Sandoz according to age, weight, and dose.

Levetiracetam Sandoz 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, or when tablets do not allow precise dosing.

Method of administration

Swallow the Levetiracetam Sandoz tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Sandoz with or without food.

After oral administration of levetiracetam, a bitter taste may be noticed.

The tablets may be divided into equal doses.

Duration of treatment

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

If you take more Levetiracetam Sandoz than you should

Possible adverse effects of an overdose of Levetiracetam Sandoz include drowsiness, agitation, aggressiveness, decreased level of alertness, respiratory depression, and coma.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Levetiracetam Sandoz

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 Sandoz

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

Contact 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 serious (anaphylactic) allergic 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, and an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)),
• symptoms such as low urine volume, 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 signs of confusion, drowsiness (numbness), 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 (feeling sleepy), headache, fatigue and dizziness. Adverse effects such as feeling sleepy, 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 (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 instability), lethargy (lack of energy and enthusiasm), tremors (involuntary shaking),
• vertigo (sensation of spinning),
• cough,
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea,
• rash,
• asthenia / fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells,
• weight loss, weight gain,
• suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability / mood swings, agitation,
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination / ataxia (impaired movement coordination), paresthesia (tingling), attention disorders (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,
• decreased number of all types of blood cells,
• severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue and throat)),
• decreased concentration of sodium in blood,
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see subsection “Contact your doctor immediately” for a more 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,
• skin rash that may blister and 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, 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. 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, reduced level of consciousness (may be signs of a disorder 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

• unwanted, repeated thoughts or sensations or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any type 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 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 Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP.

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

Store in the original packaging to protect it from moisture.

For bottles, the shelf-life after first opening is 100 days.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused or expired containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Sandoz

• The active substance is levetiracetam.

Levetiracetam Sandoz 250 mg:

• Each film-coated tablet contains 250 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, polyethylene glycol 6000, titanium dioxide (E-171), talc and indigo carmine aluminium lake (E-132).

Levetiracetam Sandoz 500 mg:

• Each film-coated tablet contains 500 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, polyethylene glycol 6000, titanium dioxide (E-171), talc and yellow iron oxide (E-172).

Levetiracetam Sandoz 1,000 mg:

• Each film-coated tablet contains 1,000 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, polyethylene glycol 6000, titanium dioxide (E-171) and talc.

Appearance of the product and contents of the pack

Levetiracetam Sandoz 250 mg are light blue, oval, biconvex, film-coated tablets, scored on both sides and marked with "LVT/250" on one side.

Levetiracetam Sandoz 500 mg are yellow, biconvex, film-coated tablets, scored on both sides and marked with "LVT/500" on one side.

Levetiracetam Sandoz 1,000 mg are white, oval, biconvex, film-coated tablets, scored on both sides and marked with "LVT/1000" on one side.

The tablets are packed in blisters made of OPA/Alu/PVC-Alu or in HDPE bottles with a polypropylene screw cap and a silica gel desiccant capsule, all contained in cardboard packaging.

Pack sizes:

Levetiracetam Sandoz 250 mg:

Blister: 10, 20, 28, 30, 50, 50x1, 60, 100, 120, 200 film-coated tablets.

Bottle: 10, 20, 30, 50, 60, 100, 120, 200 film-coated tablets.

Levetiracetam Sandoz 500 mg and Levetiracetam Sandoz 1,000 mg:

Blister: 10, 28, 30, 50, 50 x 1, 60, 100, 120 and 200 film-coated tablets.

Bottle: 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovškova 57,

1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d

Trimlini 2 D,

9220 Lendava,

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-

540472 Targu-Mures

Romania

Date of the most recent revision of this leaflet: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/