LEVETIRACETAM MABO 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Mabo 250 mg Film-Coated Tablets EFG

Levetiracetam

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Levetiracetam Mabo and what is it used for
2. What you need to know before taking Levetiracetam Mabo
3. How to take Levetiracetam Mabo
4. Possible side effects
5. Storage of Levetiracetam Mabo
6. Package Contents and Additional Information

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

Levetiracetam Mabo 250 mg film-coated tablets is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam is used:

• as monotherapy in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain but may later spread to larger areas on both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medications to treat:

• partial onset seizures, with or without generalization, in adults, adolescents, children, and infants from 1 month of age
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Mabo

Do not take Levetiracetam Mabo

• if you are allergic (hypersensitive) to levetiracetam, to pyrrolidone derivatives, or to any of the other components of this medication (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 your dose.
• 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 self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (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 worsen or last more than a few days:

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

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or 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 is not indicated in children and adolescents under 16 years of age.

Other Medications and Levetiracetam Mabo

Tell your doctor or pharmacist if you are using or have recently used other medications or may need to use any other medication.

Do not take macrogol (a medication used as a laxative) within one hour before and one 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 safety measure, do not take levetiracetam with alcohol.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Levetiracetam 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 first.

The risk of birth defects for the baby cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and Using Machines

Levetiracetam may affect your ability to drive or operate 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 confirmed that your ability to perform these activities is not affected.

Levetiracetam Mabo contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Levetiracetam Mabo

Follow your doctor's instructions for taking this medication exactly. If in 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 your doctor has prescribed.

Concomitant Therapy and Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 12 to 17 years) with a weight of 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 administering 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) with a weight of 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) with a weight of 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) with a weight of 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

The possible side effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 missed doses.

If you stop treatment with Levetiracetam Mabo

As with other antiepileptic medications, the end of treatment with levetiracetam should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of this medication.

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

4. Possible Side Effects

Like all medications, levetiracetam can cause side effects, although not everyone will experience them.

Tell your doctor immediately, or go to the emergency 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 (angioedema).
• Flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels 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 the legs, arms, or feet, as this may be a sign of sudden decreased kidney function.
• A skin rash that can lead to blisters and may appear as small targets (dark central spots surrounded by a lighter 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 that causes skin peeling on 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 behavior, 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 of sleep), 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 of sleep), 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 of instability), seizures, tremor (involuntary tremors), balance disorder, lethargy (lack of energy and enthusiasm);
• vertigo (feeling of rotation);
• cough (increase in pre-existing cough);
• abdominal pain, nausea, dyspepsia (heavy digestion, heartburn, and acidity), diarrhea, vomiting;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/liver function test abnormalities;
• 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 (severe and important allergic reaction), angioedema (swelling of the face, lips, tongue, and throat));
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioral 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;
• involuntary muscle spasms that affect 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 can lead to blisters and may appear as small targets (dark central spots surrounded by a lighter 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 that causes 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;
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levetiracetam Mabo

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

No special storage conditions are required.

Do not use Levetiracetam Mabo after the expiration date stated on the carton and blister after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam Mabo

The active ingredient is levetiracetam. Each tablet contains 250 mg of levetiracetam.

The other components are:

Tablet core: croscarmellose sodium, anhydrous colloidal silica, magnesium stearate.

Film coating Opadry 85F20694: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, aluminum lake with carmine (E132).

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

Appearance of the Product and Package Contents

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

Other Presentations

Levetiracetam Mabo 500 mg film-coated tablets EFG; 60 and 100 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 Authorization 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 package leaflet was approved in July 2022

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