LEVETIRACETAM COMBIX 500 mg FILM-COATED TABLETS

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

Do not takeLevetiracetam Combix

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

Warnings and precautions

Consult your doctor or pharmacist before taking Levetiracetam Combix.

• a small number of people taking antiepileptics such as Levetiracetam have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

• abnormal thoughts, feeling irritable or behaving more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.

Taking Levetiracetam Combix with other medicines

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

Taking Levetiracetam Combix with food, drinks and alcohol

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

Pregnancy and breast-feeding

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or think you may be pregnant, inform your doctor.

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

Breast-feeding is not recommended during treatment with Levetiracetam Combix.

Driving and using machines

Levetiracetam may cause somnolence, dizziness or other adverse reactions that could impair your ability to drive or operate machinery. These effects, as well as your illness, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery or engage in other activities requiring special attention until your doctor assesses your response to this medicine.

3. How to take Levetiracetam Combix

Follow the instructions for administration of Levetiracetam Combix exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Levetiracetam Combix must 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 that your doctor has prescribed for you.

Monotherapy

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

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.

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

For example: for a daily dose of 2,000 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 (2 tablets) and 3,000 mg (6 tablets) per day.

For example, for a daily dose of 1,000 mg, you should take 1 tablet in the morning and 1 tablet 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 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years.

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

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

The oral solution is a more suitable presentation for infants under 6 months.

Method of administration

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

Duration of treatment

• Levetiracetam Combix is used as a chronic treatment. You should continue with the treatment with Levetiracetam Combix for the time indicated by your doctor.
• Do not stop your treatment without your doctor's advice, as this may increase your seizures. If your doctor decides to stop your treatment with Levetiracetam Combix, he/she will give you instructions for gradual withdrawal of Levetiracetam Combix.

If you take more Levetiracetam Combix than you should

Possible side effects of an overdose of Levetiracetam 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levetiracetam Combix

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 taking Levetiracetam Combix

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

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

4. Possible side effects

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

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 rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests and 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, fatigue, nausea, vomiting, confusion and swelling of feet, arms or legs, as this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 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 impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

Some of the side effects such as feeling drowsy, feeling weak and dizzy 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

• nasopharyngitis;
• somnolence (feeling drowsy), headache.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function tests;
• 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;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary muscle contractions 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 targets (central dark spot surrounded by a paler area, with a dark ring on 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 on more than 30% of the body surface (toxic epidermal necrolysis).
• decrease in sodium levels in the blood.
• 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Combix

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

This medicine does not require any special storage conditions.

Do not use Levetiracetam after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 Combix 500 mg film-coated tablets

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other ingredients are pregelatinised maize starch, sodium starch glycolate (type A) potato, povidone K-30, maize starch, colloidal anhydrous silica, magnesium stearate, coating agent Instacoat Universal ICG-U-10276 Yellow (hypromellose-E464-, macrogol, talc-E553b-, titanium dioxide -E171-, yellow iron oxide -E172-).

Appearance of the product and contents of the pack

Levetiracetam Combix 500 mg film-coated tablets are yellow, oval, biconvex, with the number “500” engraved on one face and scored on the other.

OPA/Al/PVC/Al and PVC/PVDC/Al blisters.

Packs containing 60 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet: September 2019.

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