Leaflet: information for the user

Levetiracetam Tarbis 250 mg film-coated tablets EFG

Levetiracetam

Read 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 questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

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

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. Storage of Levetiracetam Tarbis

6. Contents of the pack and additional information

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

Levetiracetam Tarbis is used:

•alone (without the need for another antiepileptic medication) in adults and adolescents aged 16 years or older with recently 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 generalization in adults, adolescents, children, and infants from 1 month of age

-myoclonic seizures in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy.

-primary generalized tonic-clonic seizures in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy.

Do not take Levetiracetam Tarbis

•If you are allergic to the active ingredient 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 your dose.

•If you notice any decrease in your child's growth or an unexpected development of puberty, contact your doctor.

•If you notice an increase in the severity of seizures (e.g. an increase in frequency), contact your doctor.

•A small number of people taking antiepileptic medications 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

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

Taking Levetiracetam Tarbis with food, drinks, and alcohol

You can take Levetiracetam Tarbis with or without meals. 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Levetiracetam Tarbis 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 machinery until it has been confirmed that your ability to perform these activities is not affected.

Follow exactly the administration instructions of Levetiracetam Tarbis as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Take the number of tablets prescribed by your doctor.

Monotherapy

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

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

When starting to take Levetiracetam Tarbis, your doctor will prescribe alower dosefor two weeks before administering the general lowest dosage.

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

Concomitant therapy

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

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

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

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

Your doctor will prescribe the most appropriate levetiracetam formulation according to age, weight, and dosage.

Levetiracetam oral solution is the most appropriate presentation for infants and children under 6 years old.

General dosage: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

For example: for a general dosage of 20 mg per kg of body weight per day, you should give the child weighing 25 kg 1 tablet in the morning and 1 tablet at night.

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

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

Administration form:

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

Treatment duration:

•Levetiracetam Tarbis is used as a chronic treatment. Continue treatment with Levetiracetam Tarbis for the time indicated by your doctor.

•Do not stop treatment without your doctor's recommendation, as this may increase your seizures. If your doctor decides to stop your treatment with Levetiracetam Tarbis, they will give you instructions for the 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The possible adverse effects of a Levetiracetam Tarbis 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 Tarbis:

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

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

If you interrupt treatment with Levetiracetam Tarbis:

Like with other antiepileptic medications, the discontinuation of 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.

Like all medications, Levetiracetam Tarbis may cause side effects, although not everyone will experience them.

Some 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.

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

- weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic).

- swelling of the face, lips, tongue, or throat (Quincke's edema)

- symptoms of flu and rash on the face followed by a prolonged rash with fever

and elevated liver enzyme levels in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Medication Hypersensitivity 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 it may be a sign of sudden renal function decline

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

- a generalized rash with blisters and skin peeling, 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, somnolence (drowsiness), amnesia (memory loss), memory deterioration (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 fewer than 1 in 1,000 patients)

Frequency not known (cannot be estimated from available data)

Very common:

• nasopharyngitis
• drowsiness (drowsiness), headache

Common:

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

Uncommon:

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), 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);
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• hepatic insufficiency, hepatitis (inflammation of the liver);
• skin rash that may form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, 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).
• decrease in sodium concentration in blood.
• decrease in renal function
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. 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 side effects that do not appear in this prospectus.

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 blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Tarbis

• The active ingredient is levetiracetam. Each tablet contains 250 mg of levetiracetam.
• The other components (excipients) are:Tablet core:cornstarch, povidone, talc, colloidal silicon dioxide, magnesium stearate, and purified water.Pellicular coating: Opadry85F20694 blue (apartially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG 3350, talc, and carmine (E-132)).

Appearance of Levetiracetam Tarbis and content of the container

The film-coated tablets are blue, oblong, with a central notch on both sides, and engraved with “Lev250”on one side.The tablet can be divided into equal doses.

The containers of Levetiracetam Tarbis 250 mg are PVC/Aluminum blistersand contain 60 film-coated tablets.

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

• Tablets of 500 mg: the containers contain 60 and 100 film-coated tablets.
• Tablets of 1,000 mg: the containers contain 30 and 60 film-coated tablets.
• Oral solution 100 mg/ml: the containers of oral solution contain150 ml or 300 ml of levetiracetam 100 mg/ml.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Bluepharma Indústria Farmacêutica, S.A.

Cimo de Fala – S. Martinho do Bispo

3045-016 Coimbra

Portugal

Date of the last review of this leaflet January 2017.

The detailed and updated information on this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/