APO-ALENDRONATE/VITAMIN D3

4 Administration). Those living in high latitudes (including most of Canada) may also need additional supplementation. An adequate calcium intake is also required. Patients with gastrointestinal malabsorption may not adequately absorb vitamin D3 and will also require further supplementation.

5 nmol/L or 9 ng/mL).

Important limitations of use:

The optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis (see 4 DOSAGE AND ADMINISTRATION). 1 Pediatrics Pediatrics (<18 years of age): APO-ALENDRONATE / VITAMIN D3 (Alendronate Sodium/Cholecalciferol Tablets) Page 5 of 56 No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics Geriatrics (≥65 years of age): In clinical studies, there was no age-related difference in the efficacy or safety profiles of alendronate (see 14 CLINICAL TRIALS) Daily requirements of vitamin D3 may be increased in the elderly.

2 CONTRAINDICATIONS APO-ALENDRONATE / VITAMIN D3 is contraindicated in patients with: • hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see

1 Adverse Reaction Overview APO-ALENDRONATE / VITAMIN D3 (Alendronate Sodium/Cholecalciferol Tablets) Page 13 of 56 The most common drug related adverse reactions include gastrointestinal disorders (abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer, dysphagia, acid regurgitation, melena, nausea and abdominal distention), musculoskeletal (bone, muscle or joint) pain and headache.

It is important to follow the recommended dosing instructions. 4 Administration. Osteonecrosis of the Jaw and atypical bone fractures have been observed under post marketing setting. See 7 WARNINGS AND PRECAUTIONS, Musculoskeletal. 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.

Alendronate Treatment of Osteoporosis Postmenopausal Women:

In two, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational) of virtually identical design, with a total of 994 postmenopausal women, the overall safety profiles of alendronate 10 mg/day and placebo were similar.

0% of 397 patients treated with placebo. Adverse experiences considered by the investigators as possibly, probably, or definitely drug- related in ≥ 1% of patients treated with either alendronate 10 mg/day or placebo are presented in the following table.

0 * Considered possibly, probably, or definitely drug-related as assessed by the investigators. One patient treated with alendronate (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant acetylsalicylic acid (ASA) developed an anastomotic ulcer with mild hemorrhage, which was considered drug-related.

03/2024 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 ........................................................................................................................................... 5 2 CONTRAINDICATIONS .....................................................................................................

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 ...................................................................................... 1 Special Populations ............................................................................................................

APO-ALENDRONATE / VITAMIN D3 is contraindicated in patients with: • hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. • the inability to stand or sit upright for at least 30 minutes. • hypocalcemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).

58 mL/s (< 35 mL/min) (see