LEVETIRACETAM TEVA 1000 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 taking 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 suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or a family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

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 reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy
• Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose. If you experience any of these new symptoms while taking Levetiracetam Teva, see a doctor as soon as possible.

Children and adolescents

Monotherapy with Levetiracetam Teva is not indicated in 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 1 hour before and 1 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 can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor.

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam Teva.

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 such activities is not affected.

Levetiracetam Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

Levetiracetam Teva 500 mg contains tartrazine

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

Levetiracetam Teva 750 mg 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

Follow exactly the administration instructions given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets that your doctor has prescribed.

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

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (from 12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1000 mg and 3000 mg each day.

When you first start taking Levetiracetam Teva, your doctor will prescribe you a lower dosefor 2 weeks before giving you the lowest daily dose of 1000 mg.

For example: for a daily dose of 1000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose should be gradually increased to 1000 mg per day after 2 weeks of treatment.

• Adolescents (from 12 to 17 years) weighing 50 kg or less:

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

• Dose in infants (from 1 month to 23 months) and children (from 2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to your weight and dose.

An oral solution is a more appropriate formulation for infants and children under 6 years of age and for children and adolescents (from 6 to 17 years) weighing less than 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 can take Levetiracetam Teva with or without food. After oral administration of levetiracetam, a bitter taste may be experienced.

Duration of treatment

• Levetiracetam Teva is used as a chronic treatment. You should continue with the treatment with Levetiracetam Teva for as long as your doctor has told you.
• Do not stop your treatment without your doctor's advice, as your seizures may get worse.

If you take more Levetiracetam Teva than you should

Possible side effects of an overdose of Levetiracetam Teva are drowsiness, 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 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 casualty 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 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, tiredness, 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of rash 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, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered coordination of movements), paresthesia (tingling), attention disturbances (loss of concentration). 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; seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn, and acid), 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 disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered coordination of movements), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/liver enzyme values in 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;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of the symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• 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 peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing 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;
• limping or difficulty walking;
• a combination of fever, muscle stiffness, unstable blood pressure, and heart rate, confusion, decreased level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). 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. Storing 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 is 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. Packaging Contents and Additional Information

Composition of Levetiracetam Teva

• The active ingredient is levetiracetam.

Each Levetiracetam Teva 250, 500, 750, 1000 mg film-coated tablet contains 250, 500, 750, 1000 mg of levetiracetam.

• The other ingredients are:

Tablet core: corn 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 indigotine (E 132).

500 mg film-coated tablets: indigotine (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).

Product Appearance and Packaging 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 1000 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 for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Teva is supplied 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

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 authorization holder:

Date of the 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.