Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DIHYDROERGOCRYPTINE MESILATE
Polichem S.A.
DIHYDROERGOCRYPTINE MESILATE
5 Milligram
Capsule
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-02-03
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Almirid 5mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 5 mg of -dihydroergocryptine mesylate. For list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard Capsule. A hard pink-red capsule containing a white – ivory white granular powder. 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. 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. The higher dosages can be reached by administering the multiscored 20 mg tablets, also available as Almirid 20. 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 Read the complete document