Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
HYDROCHLOROTHIAZIDE; TELMISARTAN
ALEMBIC PHARMACEUTICALS LIMITED
C09DA07
TELMISARTAN AND DIURETICS
12.5MG; 80MG
TABLET
HYDROCHLOROTHIAZIDE 12.5MG; TELMISARTAN 80MG
ORAL
(10X10)/30/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0244783001; AHFS:
APPROVED
2018-08-09
_Alembic-Telmisartan/HCTZ Product Monograph _ _Page 1 of 57 _ _ _ PRODUCT MONOGRAPH PR ALEMBIC-TELMISARTAN/HCTZ Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/12.5 mg 80 mg/25 mg (telmisartan/hydrochlorothiazide) Angiotensin II AT 1 Receptor Blocker/Diuretic MANUFACTURED BY: Alembic Pharmaceuticals Limited Alembic Road, Vadodara 390003, Gujarat, India IMPORTED AND DISTRIBUTED BY: Alembic Pharmaceuticals Canada Ltd. 225 Gibraltar Road, Unit 5 Vaughan, Ontario L4H 4P9, Canada CONTROL NUMBER: 256615 DATE OF PREPARATION: March 30, 2022 _ _ _Alembic-Telmisartan/HCTZ Product Monograph _ _Page 2 of 57_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................22 DOSAGE AND ADMINISTRATION ..............................................................................28 OVERDOSAGE ................................................................................................................29 ACTION AND CLINICAL PHARMACOLOGY ............................................................30 STORAGE AND STABILITY ..........................................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................36 PART II: SCIENTIFIC INFORMATION ............................................................................... Soma hati kamili