DOPAGEN Tablets 125 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
METHYLDOPA
Available from:
Mercury Pharmaceuticals (Ireland) Ltd
Dosage:
125 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1981-11-04
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dopagen Tablets 125 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Methyldopa equivalent to 125 mg
anhydrous methyldopa.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Yellow, film-coated tablets embossed ‘a’ on
one face and ‘M/125’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Dopagen tablets are for oral administration only.
_Adults:_
The usual dose is 250 - 500mg daily with
subsequent slow increments until optimal control is achieved. Maintenance
dosage is usually 0.5 to 2.0 grams daily in divided
doses. The maximum recommended daily dosage is 3 grams.
_Children: _
The usual initial dosage is 10mg/kg body weight daily in 2 to 4
divided doses with gradual increments until optimal
control is achieved. The usual maintenance dose is 10 to
65mg/kg daily, but a maximum dose of 3g or 65mg/kg,
whichever is less, should not be exceeded.
_Elderly: _
In older patients, syncope may be related to an increased
sensitivity and to atherosclerosis and may be avoided by using
lower doses.
4.3 CONTRAINDICATIONS
1)
Hypersensitivity to methyldopa or to any of the components in
these tablets.
2)
Active liver disease.
3)
Depression.
4)
Concurrent use of monoamine oxidase inhibitors (MAOIs).
5)
Methyldopa is not recommended
for the treatment of phaeochromocytoma.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/02/2006_
_CRN 2020443_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Methyldopa may give rise to haemolytic anaemia,
the occurrence of which necessitates stopping the drug and the
initiation of appropriate therapy. Leucopenia and
thrombocytopenia may
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