Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
TELMISARTAN, HYDROCHLOROTHIAZIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
C09DA07
TELMISARTAN, HYDROCHLOROTHIAZIDE
80/12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2015-01-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telmisartan/Hydrochlorothiazide Mylan 80mg/12.5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each tablet contains 100.0 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Red and white to off-white, oblong shaped, uncoated, biconvex , bilayered tablets, debossed with ‘TH2M’ on the red side and plain on the other side. The white to off white layer may occasionally contain red tinge/specks. The tablet dimensions are approximately 8 mm x 16 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Telmisartan/Hydrochlorothiazide Mylan fixed dose combination (80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Telmisartan/Hydrochlorothiazide Mylan should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Telmisartan/Hydrochlorothiazide Mylan 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg tablets. Telmisartan/Hydrochlorothiazide Mylan 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg tablets. _Special populations_ Patients with renal impairment Periodic monitoring of renal function Olvassa el a teljes dokumentumot