Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Perindopril 6.79 mg eqv Perindopril arginine
SERVIER (S) PTE LTD
C09AA04
10 mg
TABLET, ORALLY DISINTEGRATING
Perindopril 6.79 mg eqv Perindopril arginine 10 mg
ORAL
Prescription Only
SERVIER (IRELAND) INDUSTRIES LTD. [ SII]
ACTIVE
2012-07-04
PACKAGE INSERT COVERSYL ORODISPERSIBLE 2.5 MG TABLETS COVERSYL ORODISPERSIBLE 5 MG TABLETS COVERSYL ORODISPERSIBLE 10 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT COVERSYL orodispersible 2.5 mg tablets COVERSYL orodispersible 5 mg tablets COVERSYL orodispersible 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine. COVERSYL orodispersible 2.5 mg tablets One orodispersible tablet contains 1.698 mg perindopril corresponding to 2.5 mg perindopril arginine. Excipients with known effect: 31.365 mg lactose, 0.1 mg aspartame. COVERSYL orodispersible 5 mg tablets One orodispersible tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine. Excipients with known effect: 62.73 mg lactose, 0.2 mg aspartame. COVERSYL orodispersible 10 mg tablets One orodispersible tablet contains 6.790 mg perindopril corresponding to 10 mg perindopril arginine. Excipients with known effect: 125.46 mg lactose, 0.4 mg aspartame. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White, round, tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _COVERSYL orodispersible 2.5 mg, 5 mg and 10 mg tablets_ Hypertension: Treatment of hypertension. Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. _ _ _COVERSYL orodispersible 2.5 mg and 5 mg tablets_ Heart failure: Treatment of symptomatic heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ For oral use. COVERSYL orodispersible tablet is recommended to be taken once daily in the morning before a meal. The tablet should be placed on the tongue for disintegration and swallowed with saliva. Alternatively, patients can disperse the tablet in a glass of water and drink the resulting suspension. Baca dokumen lengkap
PACKAGE INSERT COVERSYL ORODISPERSIBLE 2.5 MG TABLETS COVERSYL ORODISPERSIBLE 5 MG TABLETS COVERSYL ORODISPERSIBLE 10 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT COVERSYL orodispersible 2.5 mg tablets COVERSYL orodispersible 5 mg tablets COVERSYL orodispersible 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine. COVERSYL orodispersible 2.5 mg tablets One orodispersible tablet contains 1.698 mg perindopril corresponding to 2.5 mg perindopril arginine. Excipients with known effect: 31.365 mg lactose, 0.1 mg aspartame. COVERSYL orodispersible 5 mg tablets One orodispersible tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine. Excipients with known effect: 62.73 mg lactose, 0.2 mg aspartame. COVERSYL orodispersible 10 mg tablets One orodispersible tablet contains 6.790 mg perindopril corresponding to 10 mg perindopril arginine. Excipients with known effect: 125.46 mg lactose, 0.4 mg aspartame. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White, round, tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _COVERSYL orodispersible 2.5 mg, 5 mg and 10 mg tablets_ Hypertension: Treatment of hypertension. Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. _ _ _COVERSYL orodispersible 2.5 mg and 5 mg tablets_ Heart failure: Treatment of symptomatic heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ For oral use. COVERSYL orodispersible tablet is recommended to be taken once daily in the morning before a meal. The tablet should be placed on the tongue for disintegration and swallowed with saliva. Alternatively, patients can disperse the tablet in a glass of water and drink the resulting suspension. _ _ _POSOLOGY _ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension COVERSYL orodispersible tablets may be used in mon Baca dokumen lengkap