BINOSTO Effervescent tablet Ref.[50814] Active ingredients: Alendronic acid

Posology

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

Patients should be instructed that if they miss a dose of 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 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 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.

Method of administration

To permit adequate absorption of alendronate:

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).

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

• 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).
• 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 after their first food of the day.
• Binosto 70 mg should not be taken at bedtime or before arising for the day.
• 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).

Binosto 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.

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.

The expiry date of the product is indicated on the packaging materials.

Store below 30°C. Store in the original package in order to protect from moisture.

The effervescent tablets are provided in strips of composite foil (paper/polyethylene/aluminium/Znionomer), with 2 effervescent tablets packed in individual units per strip.

Packs with 4, 12 or 24 effervescent tablets.

Not all pack sizes may be marketed.

The appearance of the product after dissolution is a clear to slightly cloudy solution.

No special requirements for disposal.