देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DIHYDROERGOTAMINE MESILATE
Polichem S.A.
20 Milligram
Tablets
2000-02-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Almirid 20mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20 mg of -dihydroergocryptine mesylate. For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablet. A white to off-white multiscored tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced Parkinson’s disease. Almirid is to be administered by specialists with access to monitoring facilities. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage must be adjusted according to the patient’s response. It is suggested that treatment should begin with Almirid 5. The initial recommended dosage is 5 mg twice a day. The maintenance dosage is generally 60 mg/day, and may be increased to 120 mg/day, this dosage can be reached gradually with successive increases of 10 mg/day every two weeks. If Almirid is administered together with levodopa, with or without decarboxylase inhibitor, lower dosage should be sufficient. Reduction in levodopa dosage must be carried out gradually until the optimal therapeutic effect is reached. There are no special dosage requirements for elderly patients IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/09/2008_ _CRN 2038925_ _page number: 1_ 4.3 CONTRAINDICATIONS Documented individual hypersensitivity to the product. Documented or presumed pregnancy and paediatric use. Due to the high rate of liver metabolism, the drug is contraindicated in severe liver failure. With regard to its inhibitory effect on lactation, the use of the drug is contraindicated during breast-feeding 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In parkinsonian patients with galactorrhoea, prolactin dependent amenorrhoea, menstrual disturban पूरा दस्तावेज़ पढ़ें