APO-PERINDOPRIL/AMLODIPINE

section). 1 Pediatrics (<18 years of age) APO-PERINDOPRIL/AMLODIPINE 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) APO-PERINDOPRIL/AMLODIPINE 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 APO-PERINDOPRIL/AMLODIPINE (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.

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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 perindopril arginine and amlodipine) 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.

CL2-005 study The most frequent adverse events during the 8-week placebo-controlled study CL2-005 are presented in Table 2. 9) 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 swelling), palpitations, paraesthesia, prurit, somnolence, tinnitus, vertigo, visual impairment (including diplopia).

10/2023 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 .................................................................................................................... 1 Pediatrics (<18 years of age).......................................................................................

2 Geriatrics (> 65 years of age) ...................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 5 4 DOSAGE AND ADMINISTRATION ....................................................................................... 1 Dosing Considerations ................................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ............................................................................................................ 5 Missed Dose ...............................................................................................................

6 5 OVERDOSAGE ................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING....................................... 7 7 WARNINGS AND PRECAUTIONS ........................................................................................

10/2023 7 WARNINGS AND PRECAUTIONS 10/2023 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 .................................................................................................................... 1 Pediatrics (<18 years of age).......................................................................................

2 Geriatrics (> 65 years of age) ...................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................................

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