JAMP ALENDRONATE / VITAMIN D3

, 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): 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 alendronic acid and cholecalciferol tablets. (see 14 CLINICAL TRIALS) Daily requirements of vitamin D3 may be increased in the elderly.

JAMP Alendronate / Vitamin D3 (Alendronic Acid / cholecalciferol) Page 5 of 54 2 CONTRAINDICATIONS JAMP 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 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 sodium tablets 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 sodium tablets 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- JAMP Alendronate / Vitamin D3 (Alendronic Acid / cholecalciferol) Page 13 of 54 related in ≥ 1% of patients treated with either alendronate sodium tablets 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 sodium tablets (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.

, Endocrine and Metabolism). 3 Pharmacokinetics, Renal Insufficiency). 1 Dosing Considerations • All patients must receive supplemental calcium and/or vitamin D, if intake is inadequate. Health Professionals should consider the vitamin D intake from vitamins and dietary supplements.

g. over the age of 70 years, home bound, or chronically ill) should receive JAMP Alendronate / Vitamin D3 (70 mg/5600 IU) and may also need additional vitamin D supplementation. For patients fifty years and over, the recommended dose is at least 800 IU per day.

Those living in high latitudes (including most of Canada) may also need additional supplementation (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). • The optimal duration of bisphosphonate treatment for osteoporosis has not been established.

The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of JAMP Alendronate / Vitamin D3 on an individual patient basis. • Although no specific studies have been conducted on the effects of switching patients on another therapy for osteoporosis to alendronic acid and cholecalciferol tablets, there are no known or theoretical safety concerns related to alendronic acid and cholecalciferol tablets in patients who previously received any other antiosteoporotic therapy.

2 Recommended Dose and Dosage Adjustment The recommended dosage is one tablet of JAMP Alendronate / Vitamin D3 (70 mg/2800 IU) or JAMP Alendronate / Vitamin D3 (70 mg/5600 IU) once weekly. The appropriate dosage of JAMP Alendronate / Vitamin D3 must be determined by the health professional based on the patient's vitamin D requirement.

Geriatrics (≥65 years of age):

No dosage adjustment is necessary for the elderly. 2 Geriatrics. 1 INDICATION, Pediatrics). 58 to 1 mL/s [35 to 60 mL/min]). 58 mL/s [< 35 mL/min]) (see 2 CONTRAINDICATIONS). 4 Administration JAMP Alendronate / Vitamin D3 must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only.

JAMP

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