البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
BOEHRINGER INGELHEIM ISRAEL LTD.
N04BC05
TABLETS EXTENDED RELEASE
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 MG
PER OS
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
PRAMIPEXOLE
PRAMIPEXOLE
Treatment of signs and symptoms of idiopathic Parkinson's disease, as monotherapy or in combination with levodopa.
2015-11-30
Sifrol ER Updated Patient Information Leaflet 0.375,0.75,1.5 mg April 2020 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon physician’s prescription only SIFROL ® ER 0.375 SIFROL ® ER 0.75 SIFROL ® ER 1.5 EXTENDED-RELEASE TABLETS Each tablet of Sifrol ER 0.375 contains pramipexole dihydrochloride monohydrate 0.375 mg Each tablet of Sifrol ER 0.75 contains pramipexole dihydrochloride monohydrate 0.75 mg Each tablet of Sifrol ER 1.5 contains pramipexole dihydrochloride monohydrate 1.5 mg *For the list of inactive ingredients and allergens in the medicine - see section 6, "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is indicated for the treatment of the signs and symptoms of Parkinson's disease (alone or in combination with levodopa). THERAPEUTIC GROUP: medicines that activate the dopamine receptor (dopaminergic medicines). 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients that this medicine contains (for the list of inactive ingredients, see section 6). • You are breastfeeding. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE BEFORE TAKING SIFROL ER, TELL YOUR PHYSICIAN IF you have (had) or if you develop any symptoms or medical conditions, especially any of the following: • Kidney disease. • Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual. • You suffer from dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disease and are taking اقرأ الوثيقة كاملة
Sifrol ER Updated Prescribing Information 0.375,0.75,1.5 mg April 2020 1 PRODUCT INFORMATION SIFROL ER PRAMIPEXOLE EXTENDED-RELEASE TABLETS 1. NAME OF THE MEDICINAL PRODUCT SIFROL ER 0.375 MG EXTENDED-RELEASE TABLETS SIFROL ER 0.75 MG EXTENDED-RELEASE TABLETS SIFROL ER 1.5 MG EXTENDED-RELEASE TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Sifrol ER 0.375 extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole. Each Sifrol ER 0.75 extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.52 mg pramipexole. Each Sifrol ER 1.5 extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole. _Please note: _ Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM EXTENDED-RELEASE TABLETS. The tablets are white to off-white and have a code embossed. STRENGTH (MG SALT) APPEARANCE Sifrol ER 0.375 round, with bevelled edges, code embossed (one side with code P1 and one side with the Boehringer Ingelheim company symbol). Sifrol ER 0.75 round, with bevelled edges, code embossed (one side with code P2 and one side with the Boehringer Ingelheim company symbol). Sifrol ER 1.5 oval, code embossed (one side with code P3 and one side with the Boehringer Ingelheim company symbol). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SIFROL is indicated for treatment of signs and symptoms of idiopathic Parkinson’s disease, as monotherapy or in combination with levodopa. Sifrol ER Updated Prescribing Information 0.375,0.75,1.5 mg April 2020 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY SIFROL extended-release tablets are a once-a-day oral formulation of pramipexole. Initial treatment Doses should be increased gradually from a starting dose of 0.375 mg of salt (0.26 mg of base) اقرأ الوثيقة كاملة