LEVETIRACETAM TEVA 500 mg FILM-COATED TABLETS

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

Do not take Levetiracetam Teva

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

Warnings and precautions

Talk to your doctor before starting to take Levetiracetam Teva

• If you have kidney problems, follow your doctor's instructions. He/she will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam Teva have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

Monotherapy with Levetiracetam Teva is not indicated for children and adolescents under 16 years of age.

Other medicines and Levetiracetam Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam, as it may lose its effect.

Pregnancy and breastfeeding

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

Levetiracetam Teva should not be used during pregnancy unless clearly necessary. It cannot be excluded that the risk of birth defects for the unborn child is higher than for other medicines. In animal studies, Levetiracetam Teva has shown adverse effects on the reproductive system at doses higher than those that you may need to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Teva may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform these activities is not affected.

Levetiracetam Teva 500mg contains tartrazine

Levetiracetam Teva 500 mg contains the colouring agent tartrazine (E 102), which may cause allergic reactions.

Levetiracetam Teva 750mg contains sunset yellow

Levetiracetam Teva 750 mg contains the colouring agent sunset yellow (E 110), which may cause allergic reactions.

3. How to take Levetiracetam Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Take the number of tablets that your doctor has prescribed you.

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

Monotherapy

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

General dose: between 1,000 mg and 3,000 mg each day.

When you first start taking Levetiracetam Teva, your doctor will prescribe you a lower dose(500 mg per day)for two weeks before giving you the lowest general dose of 1,000 mg.

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 and 3,000 mg each day.

For example, if your daily dose is 1,000 mg, you can take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

• Dose in infants (from 1 month 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 weight and dose.

An oral solution is a more appropriate formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) with a body weight below 50 kg and when tablets do not allow for a precise dosing.

Method of administration

Swallow Levetiracetam Teva tablets with a sufficient amount of liquid (e.g., a glass of water). You may take Levetiracetam Teva with or without food.

Duration of treatment

• Levetiracetam Teva is used as a chronic treatment. You should continue to take Levetiracetam Teva for as long as your doctor has prescribed it.
• Do not stop your treatment without your doctor's advice, as this may increase your seizures.

If you take more Levetiracetam Teva than you should

Possible side effects of an overdose of Levetiracetam Teva 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 Teva

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 Teva

Stopping treatment with Levetiracetam Teva should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Teva, he/she will give you the instructions for the gradual withdrawal of Levetiracetam Teva.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 (anaphylactic reaction)
• 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 fever, 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 the legs, ankles, or feet, 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of rash 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 impairment (forgetfulness), abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent at the start of treatment or when the dose is increased. 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; convulsions, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• 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 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 changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), coordination abnormal/ataxia (impaired coordination), paraesthesia (tingling), attention disturbance (lack of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function tests;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:may affect up to 1 in 1,000 people

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behaviour 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);
• sudden decrease in kidney function;
• 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form of rash that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Levetiracetam Teva

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 the month.

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 to protect the environment.

6. Contents of the pack and additional information

Composition of Levetiracetam Teva

• The active substance is levetiracetam.

Each Levetiracetam Teva 250, 500, 750, 1,000 mg film-coated tablet contains 250, 500, 750, 1,000 mg of levetiracetam.

• The other ingredients are:

Core of the tablet: maize starch, povidone, sodium croscarmellose, and magnesium stearate.

Coating: hypromellose 6 cp, titanium dioxide (E 171), macrogol 3350, colorants*.

*The colorants are:

250 mg film-coated tablets: brilliant blue FCF (E 133) and indigo carmine (E 132).

500 mg film-coated tablets: indigo carmine (E 132), tartrazine (E 102), and yellow iron oxide (E 172).

750 mg film-coated tablets: yellow iron oxide (E 172), red iron oxide (E 172), and sunset yellow FCF (E 110).

Appearance of the product and pack contents

Levetiracetam Teva 250 mg film-coated tablets

Blue, oblong, scored film-coated tablets, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7285” on the other side of the tablet.

Levetiracetam Teva 500 mg film-coated tablets

Yellow, oblong, scored film-coated tablets, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7286” on the other side of the tablet.

Levetiracetam Teva 750 mg film-coated tablets

Orange, oblong, scored film-coated tablets, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7287” on the other side of the tablet.

Levetiracetam Teva 1,000 mg film-coated tablets

White, oblong, scored film-coated tablets, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7493” on the other side of the tablet.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Levetiracetam Teva is available in packs of 20, 30, 50, 60, 100, 120, and 200 film-coated tablets and unit dose packs of 50 x 1 film-coated tablets in PVC/PVdC-aluminum perforated.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pagalli út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

United Kingdom

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546

Krakow

Poland

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770

Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.