البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ROPINIROLE AS HYDROCHLORIDE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
N04BC04
FILM COATED TABLETS
ROPINIROLE AS HYDROCHLORIDE 2 MG
PER OS
Required
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY
ROPINIROLE
ROPINIROLE
Treatment of idiopathic Parkinson's disease : Ropinirole may be used alone in the treatment of idiopathic Parkinson's disease.Addition of ropinirole to levodopa may be used to control " on - off " fluctuations and permit a reduction in the total daily dose of levodopa.
2015-11-30
_This leaflet format has been determined by the Ministry of Health and the content thereof has been _ _checked and approved on_ October 2016 1. NAME OF THE MEDICINAL PRODUCT ROPINIROLE TEVA ® 0.25 mg ROPINIROLE TEVA ® 2 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet of ROPINIROLE TEVA ® 0.25 mg contains 0.285 mg ropinirole hydrochloride equivalent to 0.25 mg ropinirole. Each film coated tablet of ROPINIROLE TEVA ® 2 mg contains 2.28 mg ropinirole hydrochloride equivalent to 2 mg ropinirole. Excipient(s) with known effect: ROPINIROLE TEVA ® 0.25 mg: lactose monohydrate (110.615 mg) ROPINIROLE TEVA ® 2 mg : lactose monohydrate -108.62 mg, Lecitin (soya) E322 ( 0.1575 mg) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablets ROPINIROLE TEVA 0.25 mg: White, round slightly arched tablet, debossed "R 0.25" on one side and plain on the other. ROPINIROLE TEVA 2 mg : Pink, round slightly arched tablet. Debossed "R 2"on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of idiopathic Parkinson's disease : Ropinirole may be used alone in the treatment of idiopathic Parkinson's disease. Addition of ropinirole to levodopa may be used to control " on - off " fluctuations and permit a reduction in the total daily dose of levodopa. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When switching treatment from another dopamine agonist to ropinirole, the manufacturer's guidance on discontinuation should be followed before initiating ropinirole. Patients should be down-titrated if they experience disabling somnolence at any dose level. For other adverse events, down-titration followed by more gradual up-titration has been shown to be beneficial. POPULATIONS : ADULTS Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken three times a day, preferably with meals to improve gastrointestinal tolerance. _TREATMENT INITIATION: _ _ _ _ _The initial dose should be 0.25 mg three times dail اقرأ الوثيقة كاملة