VIACORAM TABLET 14 MG/10 MG

**INDICATIONS AND CLINICAL USE** VIACORAM® (perindopril arginine and amlodipine) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. VIACORAM® START 3.5 mg/2.5 mg is indicated for initial therapy in patients with mild to moderate essential hypertension. VIACORAM® is not indicated for switching therapy from the individual drugs currently on the market (perindopril as erbumine or arginine salt, amlodipine) (see DOSAGE AND ADMINISTRATION section). **Geriatrics (> 65 years of age):** VIACORAM® is not indicated for the initiation of treatment in elderly patients. There is no sufficient clinical experience to justify the use in the elderly (> 65 years). **Pediatrics (< 18 years of age):** VIACORAM® is not indicated in pediatric patients <18 years of age. The efficacy and safety have not been studied in this population.

**CONTRAINDICATIONS** VIACORAM® (perindopril arginine and amlodipine) is contraindicated in: - Patients who are hypersensitive to the active ingredients of this drug, to any ingredient in the formulation or component of the container, to any other angiotensin converting enzyme inhibitor (ACE-inhibitor), or to any other dihydropyridine derivatives. For a complete listing, see DOSAGE FORMS, COMPOSITION and PACKAGING section of the product monograph – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Patients with renal impairment (creatinine clearance < 60 ml/min) (see WARNINGS and PRECAUTIONS, Renal – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see WARNINGS and PRECAUTIONS, Immune – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception. (see WARNINGS and PRECAUTIONS, Special Populations, Pregnant Women – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients with mitral valve stenosis and left ventricular outflow tract obstruction (e.g. aortic stenosis, hypertrophic cardiomyopathy). - Patients with heart failure. - Concomitant use of angiotensin converting enzyme (ACE) inhibitors, including VIACORAM®, with aliskiren-containing drugs in patients with diabetes mellitus (type 1 or 2) or moderate to severe renal impairment (GFR < 60ml/min/1.73m2) (see WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the total lactase deficiency as VIACORAM® contains lactose (see WARNINGS AND PRECAUTIONS, Sensitivity/Resistance – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces. - Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. - Concomitant use with sacubitril/valsartan therapy, Perindopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)

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