Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL ERBUMINE
HEALOL PHARMACEUTICALS SDN. BHD.
PERINDOPRIL ERBUMINE
30tablet Tablets; 90 Tablets
Aurobindo Pharma Ltd
NAME OF DRUG PRODUCT : HITEN 2 (Perindopril tert-Butylamine Tablets 2 mg) HITEN 4 (Perindopril tert-Butylamine Tablets 4 mg) HITEN 8 (Perindopril tert-Butylamine Tablets 8 mg) STRENGTH : 2 mg, 4 mg and 8 mg PHARMACEUTICAL DOSAGE FORM: Tablets QUALITATIVE AND QUANTITATIVE COMPOSITIONS: HITEN 2 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 2 MG_): Each un coated Tablet Contains: Perindopril tert-Butylamine Ph.Eur 2 mg HITEN 4 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 4 MG_): Each un coated Tablet Contains: Perindopril tert-Butylamine Ph.Eur 4 mg HITEN 8 (_PERINDOPRIL TERT-BUTYLAMINE TABLETS 8 MG_): Each un coated Tablet Contains: Perindopril tert-Butylamine Ph.Eur 8 mg PHARMACEUTICAL FORM: _PERINDOPRIL TERT-BUTYLAMINE TABLETS 2 MG:_ White to off-white coloured round biconvex, uncoated tablets with debossing “D” on one side and “57”on the other side. _PERINDOPRIL TERT-BUTYLAMINE TABLETS 4 MG:_ White to off-white coloured capsule shaped, uncoated tablets with debossing “D” on one side and “5” & “8” on either side of the break line on another side. _PERINDOPRIL TERT-BUTYLAMINE TABLETS 8 MG:_ White to off-white coloured round biconvex, uncoated tablets with debossing “D” on one side and “5” & “9” on either side of the break line on another side. CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS _HYPERTENSION:_ Treatment of hypertension. _HEART FAILURE [FOR HITEN 2 MG & 4 MG ONLY]:_ Treatment of symptomatic heart failure. _STABLE CORONARY ARTERY DISEASE:_ Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation POSOLOGY AND METHOD OF ADMINISTRATION For oral use. It is recommended that perindopril is taken once daily in the morning before a meal with a sufficient amount of fluid (e.g. water). The dose should be individualized according to the patient profile and blood pressure response. _HYPERTENSION:_ Perindopril may be used in monotherapy or in combination with other classes of antihypertensive therapy. The recommended starting dose is 4 mg given o Læs hele dokumentet