LEVETIRACETAM CINFA 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Cinfa 250 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 Package Leaflet

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 patients have 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 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.
• 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 other pyrrolidone derivative or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Levetiracetam Cinfa.

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

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

Children and adolescents

Monotherapy with levetiracetam is not indicated in children and adolescents under 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 medicine used as a laxative) for one hour before and one 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 or pharmacist for advice before taking this medicine.

Levetiracetam can only be used during pregnancy if, after a 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.

Driving and using machines

Levetiracetam 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 machines until it is established that your ability to perform these activities is not affected.

3. How to take Levetiracetam Cinfa

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Levetiracetam should be taken twice a day, once in the morning and once in the evening, at approximately 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 (4 tablets) and 3,000 mg (12 tablets) per day. When you first start taking levetiracetam, your doctor will prescribe you 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 (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam according to your weight and dose.

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

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

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

Method of administration

Swallow 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 of levetiracetam, a bitter taste may be experienced.

Duration of treatment

• Levetiracetamis used as a chronic treatment. You should continue to take Levetiracetamfor as long as your doctor has told you to.
• Do not stop your treatment without your doctor's advice, as your seizures may get worse.

The tablet can be divided into equal doses.

If you take more Levetiracetam Cinfa than you should

In case of overdose or accidental ingestion, contact 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 a levetiracetam overdose 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 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 forgotten doses.

If you stop taking Levetiracetam Cinfa

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

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.

Contact 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 (anaphylaxis)
• 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 a high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as this may be a sign of sudden kidney failure
• a skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)
• a widespread rash with blisters and skin peeling, 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 serious mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration). 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 at the start of treatment or when the dose is increased. 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):

• anorexia (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 platelet count, decreased 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 swings, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated liver enzymes;
• 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);
• 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);
• seizures may worsen or occur more frequently;
• uncontrolled 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 kidney failure;
• skin rash, which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, 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 (muscle tissue breakdown) 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 (may be signs of a condition called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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 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 the month shown.

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 250 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 indigo carmine (E-132).

Appearance of the product and pack contents:

Levetiracetam Cinfa 250 mg are film-coated tablets, oblong, biconvex, blue, scored on one side, and marked with the code “LV3” on the other.

They are packaged in PVC-PVDC/Aluminium blisters and come in packs of 60 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 about 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/75001/P_75001.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75001/P_75001.html