国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
INDAPAMIDE HEMIHYDRATE
Mercury Pharmaceuticals (Ireland) Ltd
2.5 Milligram
Tablets
1988-02-24
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agelan Tablets 2.5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains indapamide hemihydrate 2.5mg. _For a full list of excipients, see 6.1._ 3 PHARMACEUTICAL FORM Sugar-coated tablets. Pink, circular, sugar coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Agelan tablets are for oral administration, only. _Adults: _2.5mg (1 tablet) daily taken in the morning. This dose should not be exceeded as there is no additional antihypertensive effect. If blood pressure is not controlled, then an antihypertensive agent of another class should be used. _Elderly: _Indapamide may have a more prolonged elimination time. Since the elderly are more susceptible to electrolyte imbalance and fluid loss it is advisable to monitor these patients frequently for evidence of such effects. 4.3 CONTRAINDICATIONS Use in patients with severe impairment of hepatic function, or severe degrees of renal insufficiency. Use in patients with hypokalaemia. Use in patients hypersensitive to the active ingredient. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state to avoid inadequate potassium supplementation or excessive loss of fluid. The preparation should only be used with particular caution in elderly patients or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precarious. The preparation may induce hyperglycaemia particularly in patients with latent diabetes, and may necessitate IRISH MEDICINES BOARD _____________________________________________________________________ 完全なドキュメントを読む