LEVETIRACETAM ACTAVIS 250 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 medicines that may affect the heart rhythm, or if you have a condition or are taking a medicine that may lead to heart rhythm problems, consult 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 change in your mood or behaviour;
• worsening of epilepsy;

In rare cases, epilepsy may become worse or more frequent, mainly during the first month after starting treatment or when the dose is increased. If you experience any of these new symptoms while taking Levetiracetam Actavis, contact your doctor as soon as possible.

Children and adolescents

Monotherapy with Levetiracetam Actavis (i.e., taking only Levetiracetam Actavis) is not indicated in 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 laxative medicine) for one hour before and one hour after taking levetiracetam as it may reduce the effect of levetiracetam.

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 consulting your doctor.

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

It is not recommended to breast-feed while taking Levetiracetam Actavis.

Driving and using machines

Levetiracetam Actavis 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 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 told you to take.

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 1000 mg and 3000 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 1000 mg, your initial reduced 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 (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 month to 23 months) and children (2 to 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 accurate dosing.

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 to.
• Do not stop your treatment without consulting your doctor, as this may cause your seizures to return.

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 action to take.

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 should be discontinued gradually. If your doctor decides to stop your treatment with Levetiracetam Actavis, he/she will tell you how to gradually reduce 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.

Seek immediate medical attention 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 an extended 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 low urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles or hands, as these may be signs of acute kidney injury;
• a rash that may form blisters and may look like targets (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 significant mental changes or if someone around you notices significant changes in your mood or behaviour, such as 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 symptoms 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, heartburn and acid regurgitation), 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 (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention deficit/hyperactivity disorder (disorders of attention and activity);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver enzymes in blood tests;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decrease in all blood cell types;
• 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 section “Seek immediate medical attention” for a detailed description of the symptoms);
• seizures may become worse or 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 decrease in kidney function;
• skin rash that may lead to blistering, which may look like targets (central dark spots surrounded by a paler area, with a dark ring around 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 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 heart rate, confusion, decreased consciousness (these 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. Storage of 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 to 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).

Product Appearance 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.

Pre-cut unit-dose 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.

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

Date of 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.