Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Zonisamide
Chanelle Medical
N03AX; N03AX15
Zonisamide
25 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Other antiepileptics; zonisamide
Not marketed
2016-04-15
ID: PL 181-183M (DCP#3475- IE) VERSION: 04 REVISION DATE: 18/06/2017 Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZONISELLE 25 MG HARD CAPSULES ZONISELLE 50 MG HARD CAPSULES ZONISELLE 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 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 is and what it is used for 2. What you need to know before you take Zonisamide 3. How to take Zonisamide 4. Possible side effects 5. How to store Zonisamide 6. Contents of the pack and other information 1. WHAT ZONISAMIDE IS AND WHAT IT IS USED FOR This medicine contains the active substance zonisamide and is used as an antiepileptic medicine. Zonisamide 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 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 DO YOU NEED TO KNOW BEFORE YOU TAKE ZONISAMIDE DO NOT TAKE ZONISAMIDE If you: are allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6). are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetic medicines. WARNINGS AND PRECAUTIONS Zonisamide belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoniselle 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 capsule Approximately 14mm white opaque body and white opaque cap containing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zoniselle 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 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 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 TITRATION PHASE USUAL MAINTENANCE DOSE MONOTHERAPY - Newly Week 1+2 Week 3+4 Week 5+6 300 mg per day (once a day). If a higher dose is required: H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ read_full_document