ALMIRID 20MG TABLETS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

DIHYDROERGOTAMINE MESILATE

Available from:

Polichem S.A.

Dosage:

20 Milligram

Pharmaceutical form:

Tablets

Authorization date:

2000-02-04

Summary of Product characteristics

                                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
                                
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