Страна: Малта
Език: английски
Източник: Medicines Authority
ZONISAMIDE
Doc Generici srl Via Turati, 40-20121, Milano, Italy
N03AX15
ZONISAMIDE 100 mg
HARD CAPSULE
ZONISAMIDE 100 mg
POM
ANTIEPILEPTICS
Authorised
2016-04-07
03/2019: approved var.03 psusa; 02/2021: approved var. 06 – 08/2022: EoP var 08 – Proposed var 09 Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ZONISAMIDE DOC GENERICI 25 MG HARD CAPSULES ZONISAMIDE DOC GENERICI 50 MG HARD CAPSULES ZONISAMIDE DOC GENERICI 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 Zonisamide Doc Generici is and what it is used for 2. What you need to know before you take Zonisamide Doc Generici 3. How to take Zonisamide Doc Generici 4. Possible side effects 5. How to store Zonisamide Doc Generici 6. Contents of the pack and other information 1. WHAT ZONISAMIDE DOC GENERICI IS AND WHAT IT IS USED FOR Zonisamide Doc Generici contains the active substance zonisamide, and is used as an antiepileptic medicine. Zonisamide Doc Generici 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 Doc Generici 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 DOC GENERICI DO NOT TAKE ZONISAMIDE DOC GENERICI : • 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 diuretic Прочетете целия документ
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zonisamide Doc Generici 100 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of zonisamide. Excipient with known effect: Each hard capsule contains less than 1 mmol sodium (23 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White capsule size No 1, 19.3 mm. A white opaque body and a white opaque cap, marked “Z 100” in black. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zonisamide Doc Generici 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 Doc Generici 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 Doc Generici 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). Page 2 of 20 TABLE 1. ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE REGIMEN TREATMENT REGIMENT TITRATION PHASE USUAL MAINTENANCE DOSE MONOTHERAPY Newly diagnoses 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 Прочетете целия документ