LEVETIRACETAM PENSA 500 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Levetiracetam Pensa 500 mg film-coated tablets EFG

Levetiracetam

Read all of this leaflet carefully before you or your child 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 Pensa and what is it used for
2. What you need to know before you take Levetiracetam Pensa
3. How to take Levetiracetam Pensa
4. Possible side effects
5. Storage of Levetiracetam Pensa
6. Contents of the pack and further information

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

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

Levetiracetam Pensa 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 you have attacks (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially affect only one side of the brain but may then spread to other areas on one or 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.
• 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 seizures, 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 Pensa

Do not take Levetiracetam Pensa

Warnings and precautions

Tell your doctor or pharmacist before you start taking Levetiracetam Pensa.

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 more aggressive than usual or if you, your family or friends notice significant changes in your mood or behaviour.
• worsening of epilepsy

Rarely, antiepileptic drugs may increase the risk of seizures in some patients instead of reducing them. If you experience any new seizures while taking levetiracetam, contact your doctor as soon as possible.

Children and adolescents

Monotherapy (use of only one medicine to treat epilepsy) with levetiracetam is not indicated in children and adolescents under 16 years.

Other medicines and Levetiracetam Pensa

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 the effect of levetiracetam.

Pregnancy, breast-feeding and fertility

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 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.

Breast-feeding is not recommended during treatment with levetiracetam.

Driving and using machines

Levetiracetam Pensa 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 such activities is not affected.

This medicine contains less than 23 mg sodium (1 mmol) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Levetiracetam Pensa

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 that your doctor has prescribed for you.

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:

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

When you first start taking levetiracetam, your doctor will prescribe you a lower doseduring the first two weeks before giving you the lowest general 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 your 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 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 age, weight and dose.

An 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 for 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 of levetiracetam, a bitter taste may be noticed.

Duration of treatment:

• Levetiracetam is used as a 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 seizures.

If you take more Levetiracetam Pensa than you should:

Possible side effects of an overdose of levetiracetam are somnolence, agitation, aggression, decreased alertness, respiratory depression and coma. Contact your doctor if you have taken more tablets than you should. Your doctor will decide on the best treatment for the overdose.

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

If you forget to take Levetiracetam Pensa:

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 Pensa:

Levetiracetam must be discontinued gradually. If your doctor decides to stop your treatment with Levetiracetam, he/she will tell you how to do it gradually.

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

4. Possible side effects

Like all medicines, Levetiracetam Pensa 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 (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 high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cell (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 legs, arms or feet, as these may be signs 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 peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (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 somnolence, fatigue 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

• 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 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 (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (lack of concentration);
• double vision, blurred vision;
• elevated liver enzymes in blood tests;
• hair loss, eczema, itching;
• muscle weakness, muscle pain;
• injury.

Rare:may affect up to 1 in 1,000 people

• infection;
• decrease in all blood cell counts;
• 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 “Tell your doctor immediately” for a detailed description of the symptoms);
• seizures may worsen or become more frequent;
• 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 peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling on 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

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 Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Pensa

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

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

This medicine does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and further information

Composition of Levetiracetam Pensa

The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.

The other ingredients are:

Core of the tablet: croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Film coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, yellow iron oxide (E172).

Appearance of the product and pack contents

The film-coated tablets are yellow, oval, film-coated and scored on one side.

The packs contain 60, 100 and 200 film-coated tablets. Not all pack sizes may be marketed.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Marketing authorisation holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Noucor Health, S.A.,

Av. Camí Reial, 51-57,

08184 Palau-solità i Plegamans

(Barcelona-Spain)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Portugal: Levetiracetam Pensa 500 mg film-coated tablets

Spain: Levetiracetam pensa 500 mg film-coated tablets EFG

Italy: Levetiracetam Pensa 500 mg film-coated tablets

Date of last revision of this leaflet:October 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es