VIACORAM

section). 1 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. 2 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). 2 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

1 Adverse Reaction Overview The following adverse reactions were the most frequently reported during clinical trials: cough, dizziness, headache, and oedema. The most serious adverse reactions reported during clinical trials were: hypotension, lip swelling, and renal failure acute.

The adverse drug reactions most frequently resulting in clinical intervention (discontinuation of VIACORAM®) were due to cough, erythema, fatigue, and peripheral oedema. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

9) Product Monograph - VIACORAM® (Perindopril arginine and Amlodipine) Page 16 of 53 Aml: Amlodipine; Per: Perindopril PATH study The most frequent emergent adverse events (EAEs) during the 6-week active controlled PATH study are presented in Table 3.

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data The following were observed in patients treated with perindopril: - Abnormal liver function test - Hyperkalemia - Increases in blood creatinine, BUN, serum cholesterol and plasma glucose.

- Decreases in hematocrit and hemoglobin. 5 Post-Market Adverse Reactions The most commonly reported adverse reactions with perindopril and amlodipine given separately are: abdominal pain, change of bowel habits, dysgeusia, dyspepsia, dyspnea, exanthema, joint swelling (ankle Product Monograph - VIACORAM® (Perindopril arginine and Amlodipine) Page 18 of 53 swelling), palpitations, paraesthesia, prurit, somnolence, tinnitus, vertigo, visual impairment (including diplopia).

, Renal). • Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see 7 WARNINGS AND PRECAUTIONS, Immune). • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception.

(see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant women) • Nursing women (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Breast-feeding). g. aortic stenosis, hypertrophic cardiomyopathy). • Patients with heart failure.

• Combination with sacubitril/valsartan due to an increased risk of angioedema. VIACORAM® must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. 73m2) (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal and 9 DRUG Product Monograph - VIACORAM® (Perindopril arginine and Amlodipine) Page 5 of 53 INTERACTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs).

• Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency as VIACORAM® contains lactose (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance). • Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces (see 9 DRUG INTERACTIONS).

• Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see 7 WARNINGS AND PRECAUTIONS, Renal). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus.

• When pregnancy is detected, VIACORAM® should be discontinued as soon as possible. 5 mg, 7 mg/5 mg, and 14 mg/10 mg. Dosages of the perindopril arginine in VIACORAM® are not marketed individually. Patients cannot be titrated with the individual drugs currently on the market prior to the initiation of VIACORAM®, since dosages of perindopril arginine in VIACORAM® are not equivalent to those marketed individually (perindopril as erbumine or arginine salt).

[10/2022] 7 WARNING AND PRECAUTIONS [10/2022] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

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