Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Zonisamide
Actavis Group PTC ehf
N03AX; N03AX15
Zonisamide
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Other antiepileptics; zonisamide
Not marketed
2016-04-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ZONISAMIDE ACCORD 25 MG HARD CAPSULES ZONISAMIDE ACCORD 50 MG HARD CAPSULES ZONISAMIDE ACCORD 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 question, ask your doctor or 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 Zonisamide Accord is and what it is used for 2. What you need to know before you take Zonisamide Accord 3. How to take Zonisamide Accord 4. Possible side effects 5. How to store Zonisamide Accord 6. Contents of the pack and other information 1. WHAT ZONISAMIDE ACCORD IS AND WHAT IT IS USED FOR Zonisamide Accord contains the active substance zonisamide, and is used as an antiepileptic medicine. Zonisamide Accord 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). Zonisamide Accord 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 ZONISAMIDE ACCORD DO NOT TAKE ZONISAMIDE ACCORD: - 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. WARNINGS AND PRECAUTIONS Zonisamide Accord belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 25 January 2019 CRN008RR7 Page 1 of 27 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zonisamide Accord 100 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of zonisamide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. White to off-white granular powder in hard capsules, size 1 (19.4 mm x 6.91 mm), with a white to off‑white capsule body and a white to off‑white capsule cap. The cap is imprinted with “A740” 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_ _ _ _Dosageescalation 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_ Health Products Regulatory Authority 25 January 2019 CRN008RR7 Page 2 of 27 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: inc সম্পূর্ণ নথি পড়ুন