Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU UK
Fosamax is indicated for the treatment of osteoporosis in post-menopausal women to prevent fractures.
Fosamax is indicated for the treatment of osteoporosis in men to prevent fractures.
Fosamax is indicated for the treatment of glucocorticoid-induced osteoporosis and prevention of bone loss in post-menopausal women considered at risk of developing the disease.
Risk factors often associated with the development of osteoporosis include thin body build, family history of osteoporosis, early menopause, moderately low bone mass and long-term glucocorticoid therapy, especially with high doses (≥15 mg/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.
Treatment of osteoporosis in post-menopausal women: The recommended dosage is 10 mg once a day.
Treatment of osteoporosis in men: The recommended dosage is 10 mg once a day.
Treatment and prevention of glucocorticoid-induced osteoporosis: For post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen, the recommended dosage is 10 mg once a day.
To permit adequate absorption of Fosamax: Fosamax must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of Fosamax (see 4.5 ‘Interaction with other medicinal products and other forms of interaction’).
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see 4.4 ‘Special warnings and precautions for use’):
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see 4.4 ‘Special warnings and precautions for use’).
Use in the elderly: In clinical studies there was no age-related difference in the efficacy or safety profiles of Fosamax. Therefore no dosage adjustment is necessary for the elderly.
Use in renal impairment: No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. Fosamax is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.
Paediatric patients: Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis (also see section 5.1).
No specific information is available on the treatment of overdosage with Fosamax. Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage. 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.
3 years.
Do not store above 30°C.
Blisters of opaque white PVC lidded with aluminium foil.
Pack size: 28 tablets.
None.
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