Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
irbesartan, Quantity: 150 mg; hydrochlorothiazide, Quantity: 12.5 mg
Micro Labs Pty Ltd
Hydrochlorothiazide,Irbesartan
Tablet, film coated
Excipient Ingredients: polysorbate 80; sodium starch glycollate type B; colloidal anhydrous silica; mannitol; hypromellose; povidone; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; Carnauba Wax; macrogol 3350
Oral
30 (3x10 in carton)
(S4) Prescription Only Medicine
Indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.
Visual Identification: Peach coloured, capsule shaped, biconvex, film-coated tablets, approx. 14 mm long and 7 mm wide, debossed with 'IH' on one face and plain on other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-03-14
1 AUSTRALIAN PRODUCT INFORMATION IRBESARTAN HCTZ MLABS 150/12.5 MG, 300/12.5 MG, 300/25 MG (IRBESARTAN/HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Irbesartan/Hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Irbesartan HCTZ MLabs 150/12.5 mg tablets contain 150mg of irbesartan and 12.5mg of hydrochlorothiazide. Irbesartan HCTZ MLabs 300/12.5 mg tablets contain 300mg of irbesartan and 12.5mg of hydrochlorothiazide. Irbesartan HCTZ MLabs 300/25 mg tablets contain 300mg of irbesartan and 25mg of hydrochlorothiazide For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM IRBESARTAN HCTZ MLABS 150/12.5MG FILM-COATED TABLETS: Film-coated tablets containing 150mg of irbesartan and 12.5mg of hydrochlorothiazide. Peach coloured, capsule shaped, biconvex, film-coated tablets, approximately 14 mm long and 7 mm wide, debossed with ‘IH’ on one face and plain on other face. IRBESARTAN HCTZ MLABS 300/12.5 MG FILM-COATED TABLETS: Film-coated tablets containing 300mg of irbesartan and 12.5mg of hydrochlorothiazide. Peach coloured, capsule shaped, biconvex, film-coated tablets, approximately 18 mm long and 9 mm wide debossed with ‘IH2’ on one face and plain on other face. IRBESARTAN HCTZ MLABS 300/25 MG FILM-COATED TABLETS: Film-coated tablets containing 300mg of irbesartan and 25mg of hydrochlorothiazide. Brick red coloured, capsule shaped, biconvex, film-coated tablets, approximately 18 mm long and 9 mm wide, debossed with ‘IH1’ on one face and plain on other face. 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan HCTZ MLabs is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination. 4.2 DOSE AND METHOD OF ADMINISTRATION Irbesartan HCTZ MLabs should not be initiated as first-line therapy. The daily dose can be administered with or without food. REPLACEMENT THERAPY The combination may be substituted for the titrated components at the same dose level. DOSE TITRATION BY CLINICAL EFFECT When clini Lue koko asiakirja