LEVETIRACETAM MABO 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Mabo 500mg film-coated tablets EFG

Levetiracetam

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

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

Levetiracetam Mabo 500 mg film-coated tablets 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 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 subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to help reduce the number of seizures
• in combination with other antiepileptic medicines to treat:

• partial onset seizures with or without 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 Mabo

Do not take Levetiracetam Mabo

• if you are allergic (hypersensitive) 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 or pharmacist before starting to take levetiracetam

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

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

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (single treatment) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Mabo

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

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.

Taking Levetiracetam Mabo with food and drinks

You can take levetiracetam with or without food. As a precaution, do not take levetiracetam with alcohol.

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

Levetiracetam Mabo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Levetiracetam Mabo

Follow exactly the instructions of your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

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, your doctor will prescribe a lower dose for 2 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 suitable 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 suitable pharmaceutical form of levetiracetam according to your age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years of age 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 the Levetiracetam Mabo tablets with a sufficient amount of liquid (e.g., a glass of water). You can take levetiracetam with or without food. After oral administration of levetiracetam, a bitter taste may be perceived.

Duration of treatment

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

If you take more Levetiracetam Mabo than 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 ingested.

The 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 possible treatment for the overdose.

If you forget to take Levetiracetam Mabo

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 Mabo

As with other antiepileptic medicines, 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 will give you instructions for the gradual withdrawal of this medicine.

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

4. Possible side effects

Like all medicines, levetiracetam 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 (angioedema).
• 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, fatigue, 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 targets (central dark 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 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 (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

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

Common:may affect up to 1 in 10 people

• anorexia (loss of appetite);
• anxiety, depression, hostility or aggression, insomnia, nervousness or irritability;
• dizziness (feeling unsteady), seizures, tremor (involuntary trembling), balance disorder, lethargy (lack of energy and enthusiasm);
• vertigo (feeling of spinning);
• cough (increase in a pre-existing cough);
• abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting;
• 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 swings, 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, angioedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms);
• epileptic 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 decrease in kidney function;
• skin rash that may form blisters and may look like targets (central dark 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), 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 level of consciousness (may be signs of a disorder 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, pharmacist, or nurse. 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 Mabo

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

No special storage conditions are required.

Do not use Levetiracetam Mabo after the expiry date stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

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 pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal product. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levetiracetam Mabo

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.

Opadry 85F32004 film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, yellow iron oxide (E172).

Levetiracetam Mabo film-coated tablets are packaged in blisters inside cartons.

Appearance of the product and contents of the pack

The film-coated tablets are yellow, oval, and scored on one side. The cartons contain 60 and 100 film-coated tablets.

Other presentations

Levetiracetam Mabo 250 mg film-coated tablets EFG; 60 film-coated tablets.

Levetiracetam Mabo 1,000 mg film-coated tablets EFG; 30 and 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

This leaflet was approved in July 2022

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