国: タンザニア
言語: 英語
ソース: Tanzania Medicinces & Medical Devices Authority
Olmesartan, Amlodipine , Hydrochlorothiazide
Macleods Pharmaceuticals Limited, INDIA
Olmesartan, Amlodipine and Hydrochlorothiazide
40 + 12.5 + 5 mg
Tablet, Film-coated
Macleods Pharmaceuticals Limited, INDIA
Physical description: Light Yellow, round, biconvex, film coated tablets having plain surface on both the sides; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)
Registered/Compliant
2019-08-20
Page 1 of 24 Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT TRIOLMESAR FORTE 5 film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TRIOLMESAR FORTE 5 40 mg/5 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Excipients with known effect; NNN For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. TRIOLMESAR FORTE 5 40 mg/5 mg/12.5 mg film-coated tablets: Light yellow, round, biconvex, film coated tablets having plain surface on both the sides 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension. Add-on therapy TRIOLMESAR is indicated in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as dual-component formulation. Substitution therapy TRIOLMESAR is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component formulation (hydrochlorothiazide or amlodipine). 4.2 Posology and method of administration Posology Adults The recommended dose of TRIOLMESAR is 1 tablet per day. Add-on therapy TRIOLMESAR 40 mg/5 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled on olmesartan medoxomil 40 mg and amlodipine 5 mg taken as dual-component combination. A step-wise titration of the dosage of the individual components is recommended before changing to the triple- 完全なドキュメントを読む