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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indapamide 1.5 mg SR Tablets, prolonged-release film coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Indapamide 1.5 mg per prolonged-release film-coated tablet.
Excipients:
124.5 mg lactose manohydrate.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White, round film coated-tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed.
At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased.
_Renal failure (see sections 4.3 and 4.4):_
In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.
_Elderly (see section 4.4):_
In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be
treated with INDAPAMIDE SR 1.5 mg when renal function is normal or only minimally impaired.
_Patients with hepatic impairment (see sections 4.3 and 4.4):_
In severe hepatic impairment, treatment is contraindicated.
_Children and adolescents:_
INDAPAMIDE SR 1.5 mg is not recommended for use in children and adolescents due to a lack of data on safety and
efficacy.
4.3 CONTRAINDICATIONS
- Hypersensitivity to indapamide, to other sulfonamides or to any of the excipients.
- Severe renal failure.
- Hepatic encephalopathy or severe impairment of liver function.
- Hypokalaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IRISH MEDICINES BOARD
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