LEVETIRACETAM SUN 1000 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

LEVETIRACETAM SUN 1,000 mg FILM-COATED TABLETS EFG

(Levetiracetam)

Read the entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

Levetiracetam SUN is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where patients have seizures (fits). Levetiracetam is used to treat the form of epilepsy where the seizures initially affect only one side of the brain but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.

(partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.

• in combination with other antiepileptic medicines to treat:
• partial onset seizures with or without secondary generalisation in adults, adolescents, children, and infants from 1 month of age
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause)

2. What you need to know before you take Levetiracetam SUN

Do not takeLevetiracetam SUN

• 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

Talk to your doctor before taking Levetiracetam SUN

• If you have kidney problems, follow the instructions of your doctor, who will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam SUN have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a history of heart rhythm problems (visible on an electrocardiogram) or if you have a disease and/or take a treatment that makes you prone to cardiac arrhythmias or electrolyte disturbances.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

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

In rare cases, 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 (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills, you may notice that seizures continue or worsen during treatment.

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

Children and adolescents

• Monotherapy with Levetiracetam SUN is not indicated in children and adolescents under 16 years.

Using Levetiracetam SUN with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use other medicines.

If you are being treated with methotrexate and levetiracetam at the same time, the serum concentrations of these medicines should be carefully monitored.

Do not take macrogol (a medicine used as a laxative) for 1 hour before and 1 hour after taking levetiracetam, as it may lose its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam SUN should only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor.

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam SUN.

Driving and using machines

Levetiracetam SUN may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

3. How to take Levetiracetam SUN

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Take the number of tablets that your doctor has prescribed for you.

Levetiracetam SUN should be taken twice a day, once in the morning and once in the evening, approximately at the same time every day.

Concomitant therapy and monotherapy (from 16 years of age)Adults(≥18 years) and adolescents(from 12 to 17 years) weighing 50 kg or more:

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

When you start taking Levetiracetam SUN, your doctor will prescribe a lower dosefor two weeks before giving you the lowest daily dose.

• For example:for a 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 1,000 mg per day after 2 weeks of treatment.

Adolescents (from 12 to 17 years) weighing 50 kg or less:Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam SUN according to your weight and dose.

Dose in infants (from 1 month to 23 months) and children (from 2 to 11 years) weighing less than 50 kg:

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

Levetiracetam 10 mg/ml oral solution is a more suitable formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) weighing less than 50 kg, and when tablets do not allow for precise dosing.

Method of administration:

Swallow Levetiracetam SUN tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Levetiracetam SUN with or without food. After oral administration of levetiracetam, a bitter taste may be perceived.

Duration of treatment:

• Levetiracetam SUN is used as a chronic treatment. You should continue treatment with Levetiracetam SUN for as long as your doctor has told you.

• Do not stop your treatment without your doctor's advice, as your seizures may increase.

If you take moreLevetiracetam SUNthan you should:

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

Possible side effects of an overdose of Levetiracetam SUN are drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible treatment for the overdose.

If you forget to takeLevetiracetam SUN:

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 takingLevetiracetam SUN:

Stopping treatment with Levetiracetam SUN should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam SUN, he/she will give you instructions for gradual withdrawal of Levetiracetam SUN.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
• swelling of the face, lips, tongue, or throat (Quincke's oedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may look like small targets (central dark spot 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 over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling drowsy), headache.

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered coordination of movements), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/liver enzyme abnormalities 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, Quincke's oedema);
• decrease in sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• epileptic seizures may worsen or occur more frequently;
• delirium;
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms);
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may lead to blisters that may look like small targets (central dark spot 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 over more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients. • limping or difficulty walking.

• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased level of consciousness (may be signs of a condition 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

• Unwanted thoughts or feelings repeated or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam SUN

Keep 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 is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Levetiracetam SUN

The active ingredient is levetiracetam. Each tablet contains 1,000 mg of levetiracetam.

The other components are: Corn starch, Povidone (K30), Microcrystalline cellulose, Anhydrous colloidal silica, Crospovidone (Type B), Talc, Magnesium stearate, White Opadry, (Hypromellose 5cP, Titanium dioxide (E171), Macrogol 400, Talc).

Appearance of the Product and Packaging Content

The film-coated tablets are white, oval, 19.1 x 10.2 mm, with "LT" and "4" engraved on each side of the score line on one face and smooth on the other face. The tablets can be divided into equal doses.

The packages contain 30, 50, 60, 100, and 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.:+34 93 342 78 90

This medicinal product is authorized in the following Member States with the following names:

Date of the last revision of this leaflet: September 2023

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