Triolmesar forte 5 Tablet, Film-coated

国: タンザニア

言語: 英語

ソース: Tanzania Medicinces & Medical Devices Authority

ダウンロード 製品の特徴 (SPC)
27-02-2024

有効成分:

Olmesartan, Amlodipine , Hydrochlorothiazide

から入手可能:

Macleods Pharmaceuticals Limited, INDIA

INN(国際名):

Olmesartan, Amlodipine and Hydrochlorothiazide

投薬量:

40 + 12.5 + 5 mg

医薬品形態:

Tablet, Film-coated

製:

Macleods Pharmaceuticals Limited, INDIA

製品概要:

Physical description: Light Yellow, round, biconvex, film coated tablets having plain surface on both the sides; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

認証ステータス:

Registered/Compliant

承認日:

2019-08-20

製品の特徴

                                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-
                                
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