LEVETIRACETAM TARBIS 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Tarbis 1,000 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 not listed in this package leaflet.

Contents of the Package Leaflet:

1. What is Levetiracetam Tarbis and what is it used for
2. What you need to know before taking Levetiracetam Tarbis
3. How to take Levetiracetam Tarbis
4. Possible side effects
5. Storage of Levetiracetam Tarbis
6. Package contents and additional information

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

Levetiracetam Tarbis 1,000 mg film-coated tablets is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Tarbis is used:

• as monotherapy (without the need for another antiepileptic medication) in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat partial onset seizures with or without secondary generalization.
• in combination with other antiepileptic medications to treat:
• partial onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age
• myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy

2. What you need to know before taking Levetiracetam Tarbis

Do not take Levetiracetam Tarbis

• If you are allergic to the active substance levetiracetam, to other pyrrolidone derivatives, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take this medication

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust the dose to take.
• If you notice any decrease in your child's growth or unexpected development of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g., increase in number), contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam Tarbis have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking Levetiracetam Tarbis with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Taking Levetiracetam Tarbis with food, drinks, and alcohol

You can take Levetiracetam Tarbis with or without food. As a safety measure, do not take Levetiracetam Tarbis with alcohol.

Pregnancy and breastfeeding

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

Levetiracetam Tarbis should not be used during pregnancy unless it is strictly necessary. The possible risk to the baby during pregnancy is unknown. In animal studies, levetiracetam has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures. Breastfeeding is not recommended during treatment.

Driving and using machines

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

3. How to take Levetiracetam Tarbis

Follow your doctor's instructions for taking Levetiracetam Tarbis exactly. If you are unsure, consult your doctor or pharmacist again.

Levetiracetam Tarbis 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 for you.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) per day.

When you start taking Levetiracetam Tarbis, your doctor will prescribe a lower dosefor two weeks before administering the lowest general dose.

For example: for a daily dose of 1,000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years) with a weight of 50 kg or more:

General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) per day.

For example: for a daily dose of 1,000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.

Dose in infants (from 6 to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) with a weight below 50 kg:

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

Levetiracetam oral solution is the most suitable presentation for infants and children under 6 years of age.

General dose: between 20 mg per kilogram of body weight and 60 mg per kilogram of body weight per day.

For example: for a general dose of 20 mg per kilogram of body weight per day, you should give the child of 25 kg of weight 1 tablet in the morning and 1 tablet in the evening.

Dose in infants (from 1 month to less than 6 months):

Levetiracetam Tarbis 100 mg/ml oral solution is a more suitable presentation for infants under 6 months.

Method of administration:

Swallow the Levetiracetam Tarbis tablets with a sufficient amount of liquid (e.g., a glass of water).

Duration of treatment:

• Levetiracetam Tarbis is used as chronic treatment. You should continue treatment with Levetiracetam Tarbis for the time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase. If your doctor decides to stop your treatment with Levetiracetam Tarbis, they will give you instructions for gradual withdrawal of Levetiracetam Tarbis.

If you take more Levetiracetam Tarbis 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 an overdose of Levetiracetam Tarbis 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 Tarbis:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for the missed doses.

If you stop taking Levetiracetam Tarbis:

As with other antiepileptic medications, stopping treatment with Levetiracetam Tarbis should be done gradually to avoid an increase in seizures.

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

4. Possible side effects

Like all medications, Levetiracetam Tarbis can cause side effects, although not everyone gets them.

Some of the 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.

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 rash on the face followed by a prolonged rash with fever

and 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 it may be a sign of sudden decrease in kidney function

a skin rash that can form blisters and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

• a generalized 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 peeling of the skin 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, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These may be signs of encephalopathy.

The frequency of the possible side effects listed below is defined as follows:

Very common (may affect more than 1 in 10 patients)

Common (may affect up to 1 in 10 patients)

Uncommon (may affect up to 1 in 100 patients)

Rare (may affect up to 1 in 1,000 patients)

Very rare (may affect less than 1 in 1,000 patients)

Frequency not known (cannot be estimated from the available data)

Very common:

• nasopharyngitis
• drowsiness (feeling of sleep), headache

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy, tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in all types of blood cells;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary muscle spasms that affect the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash, which can lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a generalized 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 peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis).
• decrease in blood sodium levels.
• sudden decrease in kidney function
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Levetiracetam Tarbis

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

Do not use this medication after the expiration date that appears on the packaging and/or on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any questions, 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 Tarbis

• The active substance is levetiracetam. Each tablet contains 1,000 mg of levetiracetam.
• The other components (excipients) are: tablet core: cornstarch, povidone, talc, colloidal silicon dioxide, magnesium stearate, and purified water. Film coating: Opadry 85F18422 white (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG 3350, and talc).

Appearance of Levetiracetam Tarbis and package contents

The film-coated tablets are white, oblong, with a central score line on both sides, and engraved with "Lev 1000" on one side. The tablet can be divided into equal doses.

The packaging of Levetiracetam Tarbis 1,000 mg is PVC/Aluminum blisters and contains 30 and 60 film-coated tablets.

Levetiracetam Tarbis is also available in other doses and pharmaceutical forms:

• 250 mg tablets: the packaging contains 60 film-coated tablets.
• 500 mg tablets: the packaging contains 60 and 100 film-coated tablets.
• 100 mg/ml oral solution: the packaging of the oral solution contains 150 ml or 300 ml of levetiracetam 100 mg/ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Bluepharma Indústria Farmacêutica, S.A.

Cimo de Fala – S. Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the last revision of this package leaflet January 2017.

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/