KEPPRA 500 mg FILM-COATED TABLETS

do not stop your treatment without consulting your doctor

the risk of birth defects for your baby cannot be completely excluded

breast-feeding is not recommended during treatment with Keppra

Driving and using machines

Keppra may impair your ability to drive or operate tools or machinery, as it may cause somnolence (drowsiness). This is more likely at the beginning of treatment or after a dose increase. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra 750 mg tablets contain the colouring agent sunset yellow FCF (E110)

The colouring agent sunset yellow FCF (E110) may cause allergic reactions.

Keppra contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Keppra

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

Take the number of tablets as prescribed by your doctor.

Keppra must 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 Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest daily dose.

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

Your doctor will prescribe the most appropriate formulation of Keppra according to the 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 formulation of Keppra according to the age, weight and dose.

Keppra 100 mg/ml oral solution is a more 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 Keppra tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Keppra with or without food. After oral administration, the bitter taste of levetiracetam may be experienced.

Duration of treatment

• Keppra is used as chronic treatment. You should continue to take it for as long as your doctor has told you.
• do not stop your treatment without the advice of your doctor, as this may cause your seizures to return

If you take more Keppra than you should

The possible side effects of an overdose of Keppra are somnolence, agitation, aggression, decrease in alertness, inhibition of respiratory function and coma.

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

If you forget to take Keppra

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 Keppra

Stop your treatment with Keppra only as instructed by your doctor. If your doctor decides to stop your treatment with Keppra, 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, Keppra 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)
• symptoms of flu and rash on the face followed by a prolonged rash with high fever, high levels of liver enzymes in the blood tests and an increase in 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 feet, ankles, face, hands or eyes, as these may be signs of acute kidney injury
• a skin rash which may form blisters and may be accompanied by fever, particularly noticeable during the first few months of treatment (these may be signs of more serious conditions that require immediate medical attention, such as Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
• signs of serious mental changes or if someone close to you notices any of these changes, such as confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (difficulty remembering), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be signs of encephalopathy

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects like somnolence, fatigue and dizziness may be more frequent at the beginning 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

• 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), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people

• decrease in the number of platelets or white blood cells;
• weight decrease, weight increase;
• suicidal thoughts and behaviour, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attacks, mood swings, depression, restlessness, aggression;
• amnesia (loss of memory), memory impairment (difficulty remembering), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention changes (lack of concentration);
• diplopia (double vision), blurred vision;
• 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 blood cell types;
• serious allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioural problems), abnormal thoughts (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms);
• seizures may become worse or more frequent;
• uncontrolled muscle spasms affecting the head, torso and limbs, difficulty in 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 which may form blisters and may be accompanied by fever, particularly noticeable during the first few months of treatment (these may be signs of more serious conditions that require immediate medical attention, such as Stevens-Johnson syndrome or 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 malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects