Levetiracetam Tarbis 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levetiracetam Tarbis 1,000 mg film-coated tablets EFG

Levetiracetam

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What Levetiracetam Tarbis is and what it is used for
2. What you need to know before taking Levetiracetam Tarbis
3. How to take Levetiracetam Tarbis
4. Possible side effects
5. How to store Levetiracetam Tarbis
6. Contents of the pack and other information

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

Levetiracetam Tarbis 1,000 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Tarbis is used:

• as monotherapy (without the need for another antiepileptic medicine) in adults and adolescents 16 years of age and older with newly diagnosed epilepsy to treat partial-onset seizures with or without secondary generalization.
• in combination with other antiepileptic medicines 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 12 years of age and older with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures in adults and adolescents 12 years of age and older 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 medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take this medicine

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected pubertal development, contact your doctor.
• If you notice an increase in the severity of seizures (e.g., increased frequency), contact your doctor.
• A small number of people treated with antiepileptic medicines such as Levetiracetam Tarbis have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking Levetiracetam Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Levetiracetam Tarbis with food, drinks, and alcohol

You may take Levetiracetam Tarbis with or without food. As a precaution, do not take Levetiracetam Tarbis with alcohol.

Pregnancy and breastfeeding

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

Levetiracetam Tarbis should not be used during pregnancy unless strictly necessary. The potential risk to the unborn baby is unknown. Animal studies have shown that levetiracetam has adverse effects on reproduction at doses higher than those required 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 may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.

3. How to take Levetiracetam Tarbis

Follow exactly the instructions for using Levetiracetam Tarbis provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

Take the number of tablets prescribed by your doctor.

Monotherapy

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

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

When you first start taking Levetiracetam Tarbis, your doctor will prescribe a lower dose for two weeks before increasing to the lowest standard 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

Dosage in adults and adolescents (12 to 17 years of age) weighing 50 kg or more:

Standard 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.

Dosage in infants (6 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and required dose.

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

Standard dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

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

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

Levetiracetam Tarbis 100 mg/ml oral solution is a more appropriate formulation for infants under 6 months of age.

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 a long-term treatment. You must continue treatment with Levetiracetam Tarbis for the duration indicated by your doctor.
• Do not stop your treatment without consulting your doctor, as your seizures may increase. If your doctor decides to discontinue treatment with Levetiracetam Tarbis, they will provide instructions for gradually withdrawing the medication.

If you take more Levetiracetam Tarbis than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Possible adverse effects of a Levetiracetam Tarbis overdose include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate 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 forgotten doses.

If you stop treatment with Levetiracetam Tarbis:

As with other antiepileptic medicines, discontinuation of Levetiracetam Tarbis treatment should be done gradually to avoid an increase in seizures.

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

4. Possible adverse effects

Like all medicines, Levetiracetam Tarbis can cause adverse effects, although not everyone experiences them.

Some adverse effects such as drowsiness, weakness, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Inform your doctor immediately, or go to the nearest hospital emergency department if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema);
• flu-like symptoms and facial rash followed by a prolonged rash with fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS));
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may indicate sudden decrease in kidney function;
• a skin rash that may blister and may appear as small 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 affecting 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 (lethargy), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrollable movements. These may be signs of encephalopathy.

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

Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect fewer than 1 in 1,000 people)
Frequency not known (cannot be estimated from available data)

Very common:

• nasopharyngitis
• somnolence (drowsiness), headache

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorder, dizziness (feeling of unsteadiness), lethargy, tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, heartburn, and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior,
• hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination of movement), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• 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);
• uncontrollable muscle spasms affecting the head, trunk, and limbs,
• difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash, which may lead to blisters appearing as small 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 affecting more than 30% of the body surface (toxic epidermal necrolysis);
• decreased concentration of sodium in blood;
• sudden decrease in kidney function;
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

5. Storage of Levetiracetam Tarbis

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

Do not use this medicine after the expiry date stated on the packaging and/or blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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: maize starch, povidone, talc, colloidal silicon dioxide, magnesium stearate, and purified water. Film coating: Opadry 85F18422 white (partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG 3350, and talc).

Appearance of Levetiracetam Tarbis and contents of the pack

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

Levetiracetam Tarbis 1,000 mg packs are PVC/aluminum blisters containing 30 and 60 film-coated tablets.

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

• 250 mg tablets: packs contain 60 film-coated tablets.
• 500 mg tablets: packs contain 60 and 100 film-coated tablets.
• Oral solution 100 mg/ml: oral solution packs contain 150 ml or 300 ml of levetiracetam 100 mg/ml.

Only certain 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 most recent revision of this leaflet: January 2017.

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