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general information

LEVETIRACETAM
(Keppra)

Manufactured by UCB Pharma

Uses: Partial seizures

Common side effects: Somnolence, fatigue, and behavioural problems

Remarks: Does not interact with other anticonvulsants

Product Info:

The information below has been provided by UCB Pharma "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

Furthermore the information contained in this document is accurate as of 27th of April 2001 and may become out of date over time and thus should be considered current only as of the date stated. This information is not intended to be a substitute for the advice of a health care professional, or a recommendation for any particular treatment plan, and is not intended to supplement, modify or supercede the information provided in the product package insert with respect to the use of the product for medical purposes.

Levetiracetam (Keppra) is available in film-coated tablets in the following dosages: 250mg/500mg/1000mg. The active substance of Keppra is called Levetiracetam. Keppra also contains the following additional ingredients:

Tablet core: maize starch, providone K30, talc, colloidal anhydrous silica, magnesium stearate.

Film-coating: Opadry Y-1-7000 (hypromellose, macrogol 400, titanium dioxide (E171).

1. What Keppra is and what it is used for?

Keppra is indicated in the treatment of partial seizures in patients who are already taking another antiepileptic medicine.

2. Before you take Keppra

Keppra is indicated in adults and adolescents over 16 years of age. It is not recommended for children and adolescents less than 16 years old. You should tell your doctor if you have kidney and/ or liver problems so that he mat decide if your dose should be adjusted.

Do not take Keppra:

If you are hypersensitive (allergic) to levetiracetam or any of the other ingredients of Keppra.

Take special care with Keppra:

When you discontinue Keppra, follow your doctor's instructions concerning the gradual withdrawal of Keppra.

If you suffer from kidney problems, follow your doctor's instructions.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or if you think you may be pregnant, please inform your doctor. keppra should not be used during pregnancy unless clearly necessary. Breast-feeding is not recommended during treatment.

Driving and using machines:

Caution is recommended if you drive or operate any tools or machines since Keppra may make you feel sleepy. This is more likely at the beginnig of treatment or after dose increase.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even those not prescribed.

3. How to take Keppra

Take the number of tablets following your doctor's instructions.

The dose, adjusted to you and your disease, will be generally between 1,000mg and 3,000mg each day.

Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water).

Keppra must be taken twice a day, once in the morning and once in the evening, at about the same time each day. For example, for a daily dose of 2,000mg, you must take one tablet in the morning and one tablet in the evening.

Keppra is indicated as a chronic treatment. Follow strictly your doctor's instructions and do not discontinue your treatment without your doctor's advice.

If you take more Keppra than you should:

Contact your doctor if you took more tablets than you should.

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:

If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase in seizures.

4. Possible side effects

Like all medicnes, Keppra can have side effects.

Tell your doctor if you have any of the following and they worry you. The most frequent side effects reported with Keppra are somnolence (sleepiness) and asthenia (tiredness). The other side effects reported with Keppra are:

Nervous system disorders: dizziness (sensation of unsteadiness), vertigo (sensation of rotation), convulsion, depression, emotional instability, hostility, insomnia, nervousness, ataxia (lack of coordination), tremor (involuntary trembling), amnesia (loss of memory).

General disorders: headache, accidental injury.

Digestive disorders: nausea, dyspesia (indigestion), diarrhoea, anorexia (loss of appetite).

Skin disorders: rash (skin eruption).

Eye disorders: dilopia (double vision).

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dosage increase. If you notice any side effects not mentioned above, please inform your doctor or pharmacist.

5. Storing Keppra

Keep out of reach and sight of children. Do not store above 25C. Do not use after the expiry date stated on the carton box and blister.

FURTHER READING

1. LEVETIRACETAM FOR PARTIAL SEIZURES - RESULTS OF A DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL - J.J Cereghino et al., Neurology, 55:236-242 2000

2. LONG-TERM CONTINUATION OF LEVETIRACETAM IN PATIENTS WITH REFRACTORY EPILEPSY - Karsten Krakow et al., Neurology 2001 56: 1772-1774

3. COMPARATIVE EVIDENCE ON EFFICACY AND SAFETY OF DIFFERENT DOSAGES OF LEVETIRACETAM IN ADD-ON TREATMENT OF PARTIAL EPILEPSY - S.D Shorvon., Epilepsia., 38 (suppl.3):78 1997

4. SINGLE-DOSE PHARMACOKINETICS OF LEVETIRACETAM IN PEDIATRIC PATIENTS WITH PARTIAL SEIZURES - J. Pellock et al., Epilepsia., 40 (suppl.7):124 1999

5. OPEN-LABEL EFFICACY AND SAFETY OF LEVETIRACETAM IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES - T. Glauser et al., 40 (suppl.7):161 1999

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