Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
SULPIRIDE
RAFA LABORATORIES LTD
N05AL01
TABLETS
SULPIRIDE 200 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
SULPIRIDE
SULPIRIDE
Anti - dopaminergic agent. 1) For use in vertigo and prepsychotic states. 2) At high doses - in psychiatric patients for treatment of depression and apathy.
2022-11-30
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only MODAL CAPSULES MODAL FORTE TABLETS ACTIVE INGREDIENT: Each Modal capsule contains: Sulpiride 50 mg Each Modal Forte tablet contains: Sulpiride 200 mg For the list of inactive ingredients, please see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Modal: an antidopaminergic medicine for treatment of vertigo (dizziness) and prepsychotic states. Modal Forte: an antidopaminergic medicine for treatment of vertigo (dizziness) and prepsychotic states. At high doses, for treatment of depression and apathy in psychiatric patients. THERAPEUTIC GROUP: benzamides 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: Do not use if you are sensitive (allergic) to the active ingredient or to any of the other ingredients the medicine contains (for a list of inactive ingredients, please see section 6). Do not use if you suffer from pheochromocytoma (tumor of the adrenal gland), prolactin-dependent cancerous tumors, e.g, pituitary gland cancer or breast cancer, or porphyria (a rare metabolic disease). Do not use the medicine if you are taking levodopa or ropinirole (or other medicines for treatment of Parkinson's disease). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Patients aged 65 and over may be more sensitive to the effects of the medicine. Be careful not to become overheated during physical exercise, in hot weather and in a hot shower (may cause a heatstroke). If you become overheated, contact your doctor. Leggi il documento completo
Modal-DL-Jun 2023-02 Doctor leaflet 1. NAME OF THE MEDICINAL PRODUCT CAPSULES ® MODAL FORTE TABLETS ® MODAL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Each capsule of Modal contains sulpiride 50 mg. Each tablet of Modal Forte contains sulpiride 200mg. Excipient with known effect: Modal Forte contains approximately 27 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modal: white powder in light-blue (sea blue) capsules. Modal Forte: white tablets with scoreline, imprinted with Modal F. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS : Modal Capsules Anti - dopaminergic agent for use in vertigo and prepsychotic states. : Modal Forte Tablets Anti - dopaminergic agent. 1) For use in vertigo and prepsychotic states. 2) At high doses - in psychiatric patients for treatment of depression and apathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION VERTIGO Average dosage: The treatment is initiated with low dosages in adults, with 50-100mg per day, in divided doses. As a rule, the maintenance dose for adults is 150-300 mg per day, in divided doses. Severe cases: The dosage may be increased. The duration of treatment should not be less than 15 days and should be continued for several weeks if necessary. _ _ PSYCHIATRY Initial dose of 200-400 mg twice daily, increasing if necessary to a maximum of 1200 mg twice daily. Maintenance dose 600-800 mg per day in divided doses. Psychiatry - Elderly: The same dose ranges may be required in the elderly, but, as a general rule with the use of psychotropics in elderly patients, starting doses should be lower and increased gradually, particularly in those with renal impairment. Psychiatry - Children aged above 6 years old: 3-5 mg/kg body weight/day in devided doses 2 Renal Failure_: _ Sulpiride is primarily excreted renally, and dose adjustments have been suggested in renal insufficiency. - creatinine clearance 30 to 60 mL/minute – 50% of normal dose - creatinine clearance 10 to 30 mL/minute – 30% of normal dose - creatinin Leggi il documento completo