FOSAMAX Once Weekly Tablets Ref.[6116] Active ingredients: Alendronic acid

Posology

The recommended dosage is one 70 mg tablet once weekly.

Patients should be instructed that if they miss a dose of FOSAMAX Once Weekly, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.

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 ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use.

Elderly

In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly.

Renal impairment

No dosage adjustment is necessary for patients with creatinine clearance greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.

Paediatric population

The safety and efficacy of FOSAMAX in children less than 18 years of age has not been established. This medicinal product should not be used in children less than 18 years of age. Currently available data for alendronic acid in the paediatric population is described in section 5.1.

Method of administration

Oral use.

To permit adequate absorption of alendronate:

FOSAMAX must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5).

To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see section 4.4):

• FOSAMAX should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
• Patients should only swallow FOSAMAX whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
• Patients should not lie down for at least 30 minutes after taking FOSAMAX and until after the first food of the day.
• FOSAMAX should not be taken at bedtime or before arising for the day.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see section 4.4).

FOSAMAX Once Weekly 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.

Symptoms

Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.

Management

No specific information is available on the treatment of overdose with alendronate. Milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Aluminum/aluminum blisters in cartons containing 2, 4, 8, 12 or 40 tablets.

Not all pack sizes may be marketed.

No special requirements.