Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
zonisamide
Amdipharm Limited
N03AX15
zonisamide
Antiepileptics,
Epilepsies, Partial
Zonegran is indicated as:monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.
Revision: 36
Authorised
2005-03-10
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE USER ZONEGRAN 25 MG, 50 MG, AND 100 MG HARD CAPSULES zonisamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zonegran is and what it is used for 2. What you need to know before you take Zonegran 3. How to take Zonegran 4. Possible side effects 5. How to store Zonegran 6. Contents of the pack and other information 1. WHAT ZONEGRAN IS AND WHAT IT IS USED FOR Zonegran contains the active substance zonisamide, and is used as an antiepileptic medicine. Zonegran is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation). Zonegran may be used: • On its own to treat seizures in adults. • With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZONEGRAN DO NOT TAKE ZONEGRAN : • if you are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6), • if you are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines, • if you are allergic to peanut or soya, do not use this medicinal product. WARNINGS AND PRECAUTIONS Zonegran belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zonegran 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of zonisamide. Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. A white opaque body and a white opaque cap printed with “ZONEGRAN 25” in black. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zonegran is indicated as: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1); • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology - Adults _ _ _ _ _Dosage escalation and maintenance _ Zonegran may be taken as monotherapy or added to existing therapy in adults. The dose should be titrated on the basis of clinical effect. Recommended escalation and maintenance doses are given in Table 1. Some patients, especially those not taking CYP3A4-inducing agents, may respond to lower doses. _ _ _Withdrawal _ When Zonegran treatment is to be discontinued, it should be withdrawn gradually (see section 4.4). In clinical studies of adult patients, dose reductions of 100 mg at weekly intervals have been used with concurrent adjustment of other antiepileptic medicine doses (where necessary). 3 TABLE 1. ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN TREATMENT REGIMEN TITRATION PHASE USUAL MAINTENANCE DOSE MONOTHERAPY - Newly diagnosed adult patients WEEK 1 + 2 WEEK 3 + 4 WEEK 5 + 6 300 mg per day (once a day). If a higher dose is required: increase at two-weekly intervals in increments of 100 mg up to a maximum of 500 mg. 100 mg/day (once a day) 200 mg /day (once a day) 300 mg / day (once a day) ADJUNCTIVE THERAPY - with CYP3A4- ind Soma hati kamili