Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Zonisamide
Neuraxpharm Ireland Limited
N03AX15
Zonisamide
Tablet
zonisamide
Not marketed
2022-11-18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZONISAMIDE NEURAXPHARM 25 MG TABLETS ZONISAMIDE NEURAXPHARM 50 MG TABLETS ZONISAMIDE NEURAXPHARM 100 MG TABLETS ZONISAMIDE NEURAXPHARM 200 MG TABLETS ZONISAMIDE NEURAXPHARM 300 MG TABLETS 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 Zonisamide Neuraxpharm is and what it is used for 2. What you need to know before you take Zonisamide Neuraxpharm 3. How to take Zonisamide Neuraxpharm 4. Possible side effects 5. How to store Zonisamide Neuraxpharm 6. Contents of the pack and other information 1. WHAT ZONISAMIDE NEURAXPHARM IS AND WHAT IT IS USED FOR Zonisamide Neuraxpharm contains the active substance zonisamide, and is used as an antiepileptic medicine. Zonisamide Neuraxpharm 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 Neuraxpharm 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 NEURAXPHARM DO NOT TAKE ZONISAMIDE NEURAXPHARM • 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 Baca dokumen lengkap
Health Products Regulatory Authority 20 April 2023 CRN00DHDF Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zonisamide Neuraxpharm 200 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of zonisamide. Excipient with known effect Each tablet contains 67.64 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, oblong biconvex scored tablets, with the inscription "N3" debossed on one side Size: 16 mm x 7 mm The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zonisamide Neuraxpharm 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 Neuraxpharm 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 Neuraxpharm 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 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: Health Products Regulatory Authority 20 April 2023 CRN00DH Baca dokumen lengkap