LEVETIRACETAM ACTAVIS 1000 mg FILM-COATED TABLETS

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

Do not take Levetiracetam Actavis:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Levetiracetam Actavis.

• If you have kidney problems, follow your doctor's instructions. He 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 Actavis have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a history of heart rhythm problems or if you are taking any other medicines that may affect the heart, or if you have a condition that may affect the heart, inform 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 more aggressive than usual, or if you or your family and friends notice any significant changes in mood or behaviour.
• worsening of epilepsy

Rarely, antiepileptic medicines may increase the risk of seizures in some patients. If you experience any new seizures while taking Levetiracetam Actavis, contact your doctor immediately.

Children and adolescents

Monotherapy (use of only one medicine to treat epilepsy) with Levetiracetam Actavis is not indicated for children and adolescents under 16 years.

Taking Levetiracetam Actavis with other medicines

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 reduce its effect.

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 for advice before taking this medicine. Levetiracetam should only be used during pregnancy if your doctor considers it essential.

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

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

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

Driving and using machines

Levetiracetam Actavis may affect your ability to drive or use 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 machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Actavis 750 mg tablets contain sunset yellow FCF (E110)

Levetiracetam Actavis contains sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take Levetiracetam Actavis

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets that your doctor has prescribed.

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

Concomitant therapy and monotherapy (from 16 years of age)

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

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

When you first start taking Levetiracetam Actavis, your doctor will prescribe you a lower doseduring 2 weeks before giving you the lowest daily dose.

For example: for a daily dose of 1,000 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 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12-17 years) weighing less than 50 kg:

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

Dose in infants (1-23 months) and children (2-11 years) weighing less than 50 kg:

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

The oral solution is the most appropriate formulation for infants and children under 6 years and for children and adolescents (6-17 years) weighing less than 50 kg and when tablets do not allow for an accurate dosage.

Method of administration

Swallow Levetiracetam Actavis tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Actavis with or without food. After oral administration, the bitter taste of levetiracetam may be experienced.

Duration of treatment

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

If you take more Levetiracetam Actavis than you should

Possible side effects of overdosing with levetiracetam are somnolence, agitation, aggression, decrease in alertness, respiratory depression, and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will decide on the best course of treatment.

If you forget to take Levetiracetam Actavis

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 Actavis

Levetiracetam Actavis must be discontinued gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Actavis, he/she will tell you how to gradually discontinue the dose.

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.

Immediately inform your doctor 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 fever, elevated liver enzymes in blood tests, and an increased number of a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS);
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion, and swelling of the feet, ankles, or hands, as these may be signs of sudden kidney failure;
• a rash that may form blisters and looks like the centre of a target (central red spot surrounded by a paler area, with a red ring around the edge) (erythema multiforme);
• a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• 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 coordination (ataxia), paraesthesia (tingling), or changes in mental status (including decreased consciousness). These may be signs of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as somnolence, fatigue, and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these 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), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people

• decreased platelet count, decreased 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 (difficulty remembering), abnormal coordination/ataxia (difficulty coordinating movements), paraesthesia (tingling), attention changes (difficulty concentrating);
• diplopia (double vision), blurred vision;
• elevated liver enzymes;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decrease in all blood cell counts;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema);
• decreased sodium level in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see section “Contact your doctor immediately” for a detailed description of the symptoms);
• seizures may worsen or become more frequent;
• 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 kidney failure;
• skin rash that may lead to blisters and looks like the centre of a target (central red spot surrounded by a paler area, with a red ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly 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);
• 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 unstable heart rate, confusion, decreased 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 Actavis

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, label, or 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. Package Contents and Additional Information

Composition of Levetiracetam Actavis

The active substance is called levetiracetam.

A Levetiracetam Actavis 250 mg tablet contains 250 mg of levetiracetam.

A Levetiracetam Actavis 500 mg tablet contains 500 mg of levetiracetam.

A Levetiracetam Actavis 750 mg tablet contains 750 mg of levetiracetam.

A Levetiracetam Actavis 1,000 mg tablet contains 1,000 mg of levetiracetam.

The other ingredients are:

Crospovidone, povidone, colloidal anhydrous silica, magnesium stearate, partially hydrolyzed polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E171), colorants*.

• The colorants are:

250 mg tablet: Carmine indigo (E132).

500 mg tablet: Yellow iron oxide (E172), carmine indigo (E132).

750 mg tablet: Carmine indigo (E132), orange yellow S (E110), red iron oxide (E172).

Appearance of the Product and Package Contents

The film-coated Levetiracetam Actavis 250 mg tablets are oval, light blue, 13.6 x 6.4 mm, with an "L" engraved on one side and "250" on the other.

The Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm, with an "L" engraved on one side and "500" on the other.

The Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm, with an "L" engraved on one side and "750" on the other.

The Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm, with an "L" engraved on one side and "1,000" on the other.

Package Sizes

Blister: 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Unit dose precut blister: 60 x 1 film-coated tablets (only available for 250 mg, 500 mg, and 1,000 mg tablets).

Tablet containers: 30, 100, and 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Manufacturers

Specifar S.A.

1, 28 Octovriou str., 123 51 Ag. Varvara, Athens

Greece

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80, 31-546 Krakow, Poland

Tjoapack Netherlands B.V.

Nieuwe Donk 9, ETTEN-LEUR, 4879AC, Netherlands

Actavis Group PTC ehf.

Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland

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

Date of the Last Revision of this Leaflet:{MM/YYYY}.

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