ARONATBOSTON

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration:

Should only swallow tablet whole with water at least 30 minutes before the first food, beverage, or other orally administered medicinal product of the day.

To assist delivery to the stomach and thus reduce the risk of irritation locally and in the oesophagus:

- Should administer tablet orally upon arising for the day with a full glass of water.

- Do not lie down for at least 30 minutes after taking tablet and until after the first food of the day.

- Do not chew the tablet or allow the tablet to dissolve gradually in mouth.T

- Should not be taken at bedtime or before arising for the day.

Posology:

The recommended dose is one 70-mg tablet once weekly.

Paediatric population: The study data has not been established; this medicinal product should not be used in children.

Elderly: No dose adjustment is necessary for the elderly or patients with mild to moderate renal impairment (creatinine clearance 35-60 ml/min), not recommended to use alendronate in patients with severe renal impairment. 

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients of this medicine.

Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia. 

Inability to stand or sit upright for at least 30 minutes.

Hypocalcaemia (see precautions).

WARNINGS AND PRECAUTIONS

Be alert to any signs or symptoms signaling a possible oesophageal reaction and discontinue alendronate if dysphagia, odynophagia or retrosternal pain,or new or worsening heartburn occurs. Adverse oesophageal effects, such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture or perforation, have been reported in patients receiving alendronate treatment.

Caution use recommended in patients with upper gastrointestinal disease, such as dysphagia, oesophageal disease, gastritis, duodenitis, peptic ulcer, because alendronate can cause local irritation of the upper gastro-intestinal mucosa and potentially worsen the underlying disease. 

Osteonecrosis of the jaw has also been reported in patients with tooth extraction and/or local infection (rarely) receiving oral bisphosphonates.

If a weekly dose of ARONATBOSTON is missed, take one tablet in the morning after it is remembered. Do not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on patient chosen day.

Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min.

Causes of osteoporosis other than oestrogen deficiency, ageing and taking glucocorticoid should be considered.

Hypocalcaemia and other disorders affecting mineral metabolism should also be effectively treated before initiating therapy with alendronate.

SHELF-LIFE: 24 months from the manufacturing date. Do not use after the expiry date