Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); perindopril arginine, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
amlodipine besilate,perindopril arginine
Tablet
Excipient Ingredients: magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; microcrystalline cellulose
Oral
30
(S4) Prescription Only Medicine
Perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.
Visual Identification: White to off-white coloured, square-shaped biconvex tablets engraved with 'APO' on one side and '5/10' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-01-12
1 AUSTRALIAN PRODUCT INFORMATION APO-PERINDOPRIL ARGININE/AMLODIPINE (PERINDOPRIL ARGININE AND AMLODIPINE (AS BESILATE)) TABLETS 1 NAME OF THE MEDICINE Perindopril arginine and amlodipine besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine and amlodipine (as besilate) combination tablets contains the following amount of perindopril arginine and amlodipine (as besilate 1 ) respectively: 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg & 10 mg/10 mg. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 5 MG/5 MG TABLET White to off-white coloured, oval-shaped biconvex tablets engraved with “APO” on one side and “5/5” on the other side. 5 MG/10 MG TABLET White to off-white coloured, square-shaped biconvex tablets engraved with “APO” on one side and “5/10” on the other side. 10 MG/5 MG TABLET White to off-white coloured, triangular-shaped biconvex tablets engraved with “APO” on one side and “10/5” on the other side. 10 MG/10 MG TABLET White to off-white coloured, round-shaped biconvex tablets engraved with “APO” on one side and “10/10” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril arginine and amlodipine combination tablets are indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination. 4.2 DOSE AND METHOD OF ADMINISTRATION Perindopril Arginine/Amlodipine tablets are intended for oral administration. 1 Amlodipine doses are given as the active base. 2 Perindopril arginine and amlodipine (as besilate) combination tablet is available in strengths of 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg as substitution therapy for patients already controlled with separate doses of perindopril (5 mg or 10 mg) and amlodipine (5 mg or 10 mg), given concurrently at the dose level as indicated in Read the complete document