Страна: Израиль
Язык: английский
Источник: Ministry of Health
SULTHIAME
MEGAPHARM LTD
N03AX03
FILM COATED TABLETS
SULTHIAME 200 MG
PER OS
Required
DESITIN ARZNEIMITTEL GMBH, GERMANY
SULTIAME
SULTIAME
Treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of children, when other medication was not adequate.
2014-12-31
2 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by physician’s prescription only OSPOLOT FILM-COATED TABLETS ACTIVE INGREDIENT: Each tablet contains: sulthiame 200 mg Each tablet contains 50 mg lactose monohydrate. Inactive ingredients and allergens in the medicine: see section "Important information about some of this medicine’s ingredients" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, contact the physician or pharmacist. _ _ This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? OSPOLOT is indicated for the treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of children, when other medication was not adequate. THERAPEUTIC GROUP: Carbonic anhydrase inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: - You are sensitive (allergic) to the active ingredient sulthiame, or to medicines from the sulpha group_,_ and/or to any of the other ingredients of this medicine (please see section 6). - You suffer from hyperthyroidism. - You suffer or have previously suffered from congenital or acquired acute porphyria, which affects the production of hemoglobin_ _in your body._ _ - You suffer from high blood pressure._ _ _ _ SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE PRIOR TO COMMENCING TREATMENT WITH OSPOLOT, TELL THE PHYSICIAN IF: you suffer or have previously suffered from impaired renal function you suffer or have previously suffered from psychiatric disorders CONTACT THE ATTENDING PHYSICIAN IMMEDIATELY IF ANY ONE OR MORE OF THE FOLLOWING APPEAR: Fever, sore throat, allergic skin reaction accompanied by lymph node swelling and/or occurrence of flu-like symptoms during treat Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT Ospolot 200 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Ospolot_ _ 200 mg_ 1 film-coated tablet contains 200 mg sulthiame. _EXCIPIENT(S) WITH KNOWN EFFECT: ONE TABLET CONTAINS 50.0 MG LACTOSE MONOHYDRATE _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet _Ospolot_ _ 200 mg _ White, round, slightly domed film-coated tablet with a dividing groove on one side and marked “200” on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of epilepsy in adults and in treatment of the so called focal benign epilepsy of children, when other medication was not adequate . Note: Treatment with _Ospolot_ _®_ should only be conducted by a paediatric neurologist with sufficient experience in treating epilepsy. Efficacy and safety of _Ospolot_ _®_ in the above-mentioned indication have not been investigated in controlled studies. Prior to starting treatment with sulthiame, a thorough differential diagnostic procedure regarding other types of childhood epilepsies is indicated. Rolandic epilepsies demonstrate a high percentage of spontaneous remissions – even without drug treatment – and usually show a favourable course of disease and a good prognosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage must be established and monitored by the doctor on an individual basis. The maintenance dose is about 5 to 10 mg/kg body weight/day. It should be built up step-wise (tapered in) over a one-week period._ Ospolot_ _ _ _200 mg_ film-coated tablets have a dividing groove. Due to the short half-life of sulthiame, the daily dose should as far as possible be spread over three single doses. If the daily dose is spread over the day in this way, constant plasma levels are to be expected after five to six days. Therapeutic plasma concentrations of sulthiame have not yet been determined. _METHOD OF ADMINI Прочитать полный документ