Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Zonisamide
Accord Healthcare Ireland Ltd.
N03AX; N03AX15
Zonisamide
25 milligram(s)
Capsule, hard
Other antiepileptics; zonisamide
Not marketed
2016-04-15
Health Products Regulatory Authority 21 June 2019 CRN008KJ7 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zonisamide Accord 25 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of zonisamide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. Zonisamide Actavis 25 mg hard capsules White to off-white granular powder in hard capsules, size 4 (14.3 mm x 5.31 mm), with a white to off‑white capsule body and a white to off-white capsule cap. The cap is imprinted with “A730” in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zonisamide Accord 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_ Zonisamide Accord 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 _Withdrawal_ When Zonisamide Accord treatment is to be discontinued, it should be withdrawn gradually (see section 4.4).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). _ _ _Table 1. Adults – recommended dosage escalation and maintenance regimen_ TREATMENT REGIMEN TITRATIONPHASE USUALMAINTENANCE 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 Health Products Regulatory Read the complete document