LEVETIRACETAM CINFA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

levetiracetam cinfa 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 get 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 is levetiracetam cinfa and what is it used for
2. What you need to know before you take levetiracetam cinfa
3. How to take levetiracetam cinfa
4. Possible side effects
5. Storage of levetiracetam cinfa
6. Contents of the pack and other information

1. What is levetiracetam cinfa and what is it used for

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

Levetiracetam 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 the patient has fits (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of fits.
• 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 cinfa

Do not take levetiracetam cinfa

• if you are allergic to levetiracetam, to any of the other ingredients of this medicine (listed in section 6), or to other pyrrolidone derivatives.

Warnings and precautions

Consult your doctor or pharmacist before taking levetiracetam cinfa.

• a small number of people being treated with antiepileptics, such as levetiracetam, have had thoughts of harming themselves or ending their lives. If at any time you have these thoughts, contact your doctor.

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

• abnormal thoughts, feeling irritable or more aggressive than usual, or if you or your family and friends notice any significant changes in your mood or behaviour.
• worsening of epilepsy

In rare cases, epilepsy fits may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose. If you experience any of these new symptoms while taking levetiracetam, contact your doctor as soon as possible.

Children and adolescents

Monotherapy (use of levetiracetam on its own) is not indicated in children and adolescents below 16 years.

Other medicines and levetiracetam cinfa

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

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

Pregnancy and breast-feeding

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

Levetiracetam should only be used during pregnancy if clearly necessary.

Do not stop your treatment without consulting your doctor.

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

Breast-feeding is not recommended during treatment with levetiracetam.

Driving and using machines

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

3. How to take levetiracetam cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets as prescribed by your doctor.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at approximately 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 (2 tablets) and 3,000 mg (6 tablets) per day. When you first start taking levetiracetam, your doctor will prescribe you a lower doseduring 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 less than 50 kg:

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

Levetiracetam 100 mg/ml oral solution is a more appropriate 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 a precise dosing.

Method of administration

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

Duration of treatment

• Levetiracetam is used as chronic treatment. You should continue to take levetiracetam for as long as your doctor has told you.
• Do not stop your treatment without your doctor's advice, as this may increase your fits.

The tablet can be divided into equal doses.

If you take more levetiracetam cinfa than you should

In case of overdose or accidental intake, contact your doctor or pharmacist immediately or call the Toxicology Information Service on +34 91 562 04 20, indicating the name of the medicine and the amount taken.

Possible side effects of levetiracetam overdose include somnolence, 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 take levetiracetam cinfa

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

If you stop taking levetiracetam cinfa

Levetiracetam should be withdrawn gradually. If your doctor decides to stop your treatment with levetiracetam, they will tell you how to do this.

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

4. Possible side effects

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

Immediately contact your doctor 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 (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke's oedema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high fever, high levels of liver enzymes in the blood tests and an increased number of a type of white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles, or hands, as these may be signs of acute kidney injury
• a skin rash which may form blisters and may be preceded by fever, flu-like symptoms, headache, cough, and a general feeling of being unwell (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be signs of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness are more frequently reported during the first month of treatment or when the dose is increased. However, these 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;
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• 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):

• decreased number of platelets, decreased number of white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention changes (lack of concentration);
• diplopia (double vision), blurred vision;
• abnormal 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 blood cell types;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see section “Contact your doctor immediately” for a detailed description of the symptoms);
• epilepsy fits may become worse or more frequent;
• involuntary muscle contractions 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 form blisters and may be preceded by fever, flu-like symptoms, headache, cough, and a general feeling of being unwell (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis) 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.
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased consciousness (these may be signs of a condition called Neuroleptic Malignant Syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects

If you get 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of levetiracetam cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of levetiracetam cinfa

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other ingredients are:

Core of the tablet: povidone, hydrogenated ricin oil, anhydrous colloidal silica and magnesium stearate.

Coating: hypromellose, titanium dioxide (E-171), macrogol 400 and yellow iron oxide (E-172).

Appearance of the product and packaging

Levetiracetam cinfa 500 mg are film-coated tablets, oblong, biconvex, yellow, scored on one side and marked with the code “LV2” on the other.

They are packaged in PVC-PVDC/Aluminium blisters and presented in packs of 60, 100 or 500 (Clinical Pack).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:June 2022

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

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75003/P_75003.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75003/P_75003.html