Keppra ® 250 mg Film-Coated Tablets

KEPPRA is an anti-epileptic medicine (a medicine used to treat seizures in epilepsy). KEPPRA is used alone in the treatment of partial seizures in patients from 16 years of age. KEPPRA is used in patients who are already taking another anti-epileptic medicine.

• In the treatment of partial seizures with or without secondary generalisation in adults and children over 16 years of age with epilepsy.
• In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• In the treatment of primary generalised tonic-clonic seizures in adults and children from 16 years with idiopathic generalised epilepsy.

Do not take KEPPRA:

Before taking this medicine, you should tell your doctor:

• If you are hypersensitive (allergic) to levetiracetam or any of the other ingredients of KEPPRA stated at the beginning of this leaflet.
• If you are pregnant or breastfeeding your baby.

Take special care with KEPPRA:

• If you suffer from kidney problems, follow your doctor’s instructions. They may decide that your dose should be adjusted.
• If your treatment has to be stopped, your doctor will tell you how to withdraw it gradually.
• KEPPRA tablets have not been approved for children below the age of 12 years.

Always take KEPPRA exactly as your doctor has told you. You should check with your doctor, pharmacist or other healthcare professional if you are unsure.

If you think that the effect of KEPPRA is too strong or too weak, talk to your doctor or pharmacist.

The film-coated tablets must be taken orally (by mouth), swallowed with liquid and may be taken with or without food. The daily dose must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

When KEPPRA is used alone:

Adults and adolescent from 16 years of age: The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response as determined by your doctor. The maximum daily dose is 1 500 mg twice daily. The dose specific for you, will be determined by your doctor and you should follow his/her instructions carefully.

When KEPPRA is used in combination with other anti-epileptic medicine:

Your doctor will advise on the correct dose. Your doctor, pharmacist or other healthcare professional may start you on a lower dose of KEPPRA and increase it as your body gets used to the medicine. You should follow their instructions carefully.

Tell your doctor, pharmacist or other healthcare professional if your seizures get worse or if you have any new types of seizures.

Duration of treatment:

• KEPPRA is used as a chronic treatment. You should continue KEPPRA treatment for as long as your doctor told you.

If you take more KEPPRA than you should:

Signs of taking too much KEPPRA are increased sleepiness, anxiety, decreased consciousness and difficulty breathing.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

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 forgotten individual doses.

Effects when treatment with KEPPRA is stopped: Do not stop your treatment without your doctor’s advice as this could increase your seizures. Should your doctor decide to stop your KEPPRA treatment, they will instruct you about the gradual withdrawal of KEPPRA.

KEPPRA can have side effects. Not all side effects reported for KEPPRA are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking KEPPRA, please consult your doctor pharmacist or healthcare professional for advice. Tell your doctor, pharmacist or other healthcare professional if you have any of the following side effects.

Frequent side effects with use of KEPPRA:

• sleepiness
• tiredness
• dizziness, convulsions, headache, hyperactivity, impaired coordinated movement, involuntary trembling, loss of memory, balance disorder, loss of concentration and forgetfulness
• anxiety, depression, mood swings, aggression, sleeping problems, irritability, behavioural problems, slow thinking or unable to concentrate
• diarrhoea, indigestion, abdominal pain, nausea, vomiting
• loss of appetite, weight increase
• vertigo (sensation of rotation)
• double vision, vision blurred
• muscle pain
• accidental injury
• increase of pre-existing cough
• rash, eczema, itching
• decreased number of blood platelets.

Other side effects reported with the use of KEPPRA:

• tingling sensation (‘pins and needles’)
• confusion, hallucination (a false sense of perception), suicide, suicide attempt or suicidal thoughts
• inflammation of the pancreas or liver, liver failure, or abnormal liver test results
• blistering of the skin, mouth, eyes and genital area, skin eruption, hair loss
• decreased number of red blood cells and/or white blood cells.

If any of these side effects get serious, please tell your doctor or pharmacist immediately. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 °C.

Do not use after the expiry date stated on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).