LEVETIRACETAM TARBIS 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam Tarbis

Do not take Levetiracetam Tarbis

• if you are allergic to levetiracetam, to other pyrrolidone derivatives or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Tell your doctor before you start taking this medicine

• if you have kidney problems, your doctor will decide if you need to adjust your dose
• if you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor
• if you notice an increase in seizure severity (e.g. increase in the number of seizures), contact your doctor
• a small number of people being treated with antiepileptics such as Levetiracetam Tarbis have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor

Taking Levetiracetam Tarbis with other medicines

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

Taking Levetiracetam Tarbis with food, drinks and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Levetiracetam Tarbis should not be used during pregnancy unless clearly necessary. The potential risk to the fetus is unknown. In animal studies, levetiracetam has shown adverse effects on reproductive toxicity at doses higher than the therapeutic doses in humans. Breast-feeding is not recommended during treatment with Levetiracetam Tarbis.

Driving and using machines

Levetiracetam Tarbis may cause drowsiness or other adverse effects that could impair your ability to drive or operate machinery. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform such activities is not affected.

3. How to take Levetiracetam Tarbis

Follow exactly the instructions given to you by your doctor for taking Levetiracetam Tarbis. In case of doubt, consult your doctor or pharmacist.

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

Take the number of tablets advised by your doctor.

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 first start taking Levetiracetam Tarbis, your doctor will prescribe you a lower doseduring two weeks before giving you 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 body 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 body weight below 50 kg:

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

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

General dose: between 20 mg per kilogram of body weight and 60 mg per kilogram of body weight each 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 body 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 appropriate formulation for infants under 6 months.

Method of administration:

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

Duration of treatment:

• Levetiracetam Tarbis is used as a chronic treatment. You should continue to take Levetiracetam Tarbis for as long as your doctor has told you.
• Do not stop your treatment without the advice of your doctor, as this may cause your seizures to return. If your doctor decides to stop your treatment with Levetiracetam Tarbis, he/she will tell you how to gradually reduce the dose.

If you take more Levetiracetam Tarbis than you should

In case of overdose or accidental intake, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

Possible side effects of an overdose of Levetiracetam Tarbis are somnolence, 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 Tarbis

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

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam Tarbis

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

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

4. Possible side effects

Like all medicines, Levetiracetam Tarbis can cause side effects, although not everybody gets them.

Some of the side effects like somnolence, fatigue and dizziness are more likely to occur when you first start taking the medicine or when the dose is increased. However, these side effects should decrease over time.

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 (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke's oedema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)

elevated, levels of liver enzymes in blood tests and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)

and

• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles, or hands, as these may be signs of acute kidney injury

a skin rash which may form blisters and may look like the smallpox vaccination (erythema multiforme)

• a widespread rash with blisters and skin peeling, 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)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour or other neurological signs, including involuntary or uncontrolled movements. These may be signs of encephalopathy

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

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 less than 1 in 1,000 people)

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

Very common:

• nasopharyngitis
• somnolence (feeling drowsy), headache

Common:

• loss of appetite (anorexia);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy, tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:

• decrease in the number of platelets, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (lack 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 blood cell types;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• muscle spasms that cannot be controlled, affecting 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 may form blisters and may look like the smallpox vaccination (erythema multiforme), a widespread rash with blisters and skin peeling, 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)
• decrease in blood sodium levels.
• sudden decrease in kidney function
• 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.

If you experience any side effects, talk to your doctor or pharmacist, even if you think the side effects are not serious or are listed in this leaflet.

5. Storing Levetiracetam Tarbis

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Levetiracetam Tarbis

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other ingredients (excipients) are: tablet core: maize starch, povidone, talc, colloidal anhydrous silica, magnesium stearate and purified water. Film coating: Opadry 85F32004 yellow (partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol/PEG 3350, talc and yellow iron oxide (E-172)).

Appearance of Levetiracetam Tarbis and contents of the pack

The film-coated tablets are yellow, oblong, with a central break line on both sides and engraved with “Lev 500” on one side. The tablet can be divided into equal doses.

The packs of Levetiracetam Tarbis 500 mg are PVC/Aluminium blisters and contain 60 and 100 film-coated tablets.

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

• 250 mg tablets: the packs contain 60 film-coated tablets.
• 1,000 mg tablets: the packs contain 30 and 60 film-coated tablets.
• 100 mg/ml oral solution: the packs of oral solution contain 150 ml or 300 ml of levetiracetam 100 mg/ml.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet January 2017.

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/