ALMIRID 5MG CAPSULES 5 Milligram Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

DIHYDROERGOCRYPTINE MESILATE

Available from:

Polichem S.A.

INN (International Name):

DIHYDROERGOCRYPTINE MESILATE

Dosage:

5 Milligram

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2010-02-03

Summary of Product characteristics

                                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 
                                
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