Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
METHYLDOPA
Aspen Europe GmbH
500 mg Milligram
Coated Tablets
2011-05-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aldomet Film-coated Tablets 500 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ‘Aldomet’ tablets 500mg, contain methyldopa equivalent to 500mg anhydrous methyldopa. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets Yellow coloured, round, film-coated tablets marked ‘ALDOMET’ on one side and ‘500’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of hypertension (mild, moderate or severe). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Use in adults: initial dosage_: Usually 250 mg two or three times a day, for two days. _Adjustment_: Usually adjusted at intervals of not less than two days, until an adequate response is obtained. The maximum recommended daily dosage is 3 g. Many patients experience sedation for two or three days when therapy with ‘Aldomet ’ is started or when the dose is increased. When increasing the dosage, therefore, it may be desirable to increase the evening dose first. _General considerations_: Methyldopa is largely excreted by the kidney, and patients with impaired renal function may respond to smaller doses. Withdrawal of ‘Aldomet’ is followed by return of hypertension, usually within 48 hours. This is not complicated generally by an overshoot of blood pressure. Therapy with ‘Aldomet’ may be initiated in most patients already on treatment with other antihypertensive agents by terminating these antihypertensive medications gradually if required (see manufacturer’s recommendations on stopping these drugs). Following such previous antihypertensive therapy, ‘Aldomet ’ should be limited to an initial dose of not more than 500 mg daily and increased as required at intervals of not less than two Read the complete document