APO-AMLODIPINE-ATORVASTATIN

). 1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of amlodipine besylate and atorvastatin calcium tablets in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin calcium tablets) is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.

For a complete listing, see

1 Adverse Reaction Overview Amlodipine The most serious adverse reaction associated with the amlodipine component of amlodipine besylate and atorvastatin calcium tablets is hypotension (including syncope) especially under gross overdose (see 5 OVERDOSAGE).

2 Clinical Trial Adverse Reactions). 5 Post-Market Adverse Reactions). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials 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 is useful for identifying drug-related adverse events and for approximating rates of adverse drug reactions in real-world use. For amlodipine besylate and atorvastatin calcium tablets, itself Amlodipine besylate and atorvastatin calcium tablets has been evaluated for safety in 1,092 APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin calcium tablets) Page 20 of 83 Protected B / Protégé B patients in two double-blind, placebo-controlled studies treated for co-morbid hypertension and dyslipidemia.

In these studies, no unexpected adverse experiences particular to this combination have been observed. Adverse experiences have been limited to those that were reported previously with amlodipine and/or atorvastatin. For the most part, adverse experiences with amlodipine besylate and atorvastatin calcium tablets have been mild or moderate in severity.

0% of patients given placebo. The most common safety-related reasons for discontinuation from these studies in the combination treatment groups were headache and peripheral edema. In a double-blind, controlled clinical trial of all available amlodipine besylate and atorvastatin calcium tablets doses (5/10 mg to 10/80 mg amlodipine besylate and atorvastatin calcium tablets respectively), the incidences of treatment-emergent adverse events (all causalities) that occurred in at least 1% of all combination treatment groups, pooled across all the combination doses, are summarized below.

, Musculoskeletal 11/2025 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 .......................................................................................................................

2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................

4 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ...................................................................................................

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

8 5 OVERDOSAGE ................................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 9 7 WARNINGS AND PRECAUTIONS ...................................................................................

APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin calcium tablets) is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • patients with severe hypotension (less than 90 mmHg systolic) and in patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.

2 Breast- feeding). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions).