BUFFERED BINOSTO EFFERVESCENT TABLET 70MG

ZUELLIG PHARMA PTE. LTD.

ZUELLIG PHARMA PTE. LTD.

Therapeutic

Prescription Only

TABLET, EFFERVESCENT

**4.2 Posology and method of administration** Posology The recommended dose is one 70 mg effervescent tablet once weekly. Patients should be instructed that if they miss a dose of Alendronate sodium (Buffered Binosto) 70 mg, they should take one effervescent tablet on the morning after they remember. They should not take two effervescent tablets on the same day but should return to taking one effervescent 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 Alendronate sodium (Buffered Binosto) 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 Alendronate sodium (Buffered Binosto) 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 of alendronic acid in paediatric population is described in section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Method of administration _To permit adequate absorption of alendronate:_ Alendronate sodium (Buffered Binosto) 70 mg 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):_ - Alendronate sodium (Buffered Binosto) 70 mg should only be taken upon arising for the day dissolved in half a glass of plain water (not less than 120 ml or 4.2 fl.oz.). Dissolving the tablet in water yields a buffered solution of pH 4.8 – 5.4. The buffered solution should be drunk, once the fizzing has subsided and the effervescent tablet has completely dissolved to give a clear, to slightly cloudy, buffered solution, followed by at least 30 ml (one sixth of a glass) of plain water. Additional plain water may be taken. - **Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation (see sections 4.4 and 4.8** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **).** - If the tablet does not dissolve completely, the buffered solution may be stirred until it is clear to slightly cloudy. - Patients should not lie down for at least 30 minutes after drinking the oral solution and until their first food of the day. - Alendronate sodium (Buffered Binosto) 70 mg should not be taken at bedtime or before arising for the day. - Alendronate sodium (Buffered Binosto) 70 mg can be given to patients who are unable or unwilling to swallow tablets. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Alendronate sodium (Buffered Binosto) 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.