Binosto^© (alendronate effervescent) 70 mg. Rx, EF

ATC-code: M05BA04

Therapeutic indication: Treatment of postmenopausal osteoporosis Reduces the risk of vertebral and hip fractures.

Dosing: One 70 mg effervescent once weekly. 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. To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation /adverse experiences: 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 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. (For further information see www.fass.se)

Contraindications: Hypersensitivity to alendronate or to any of the excipients. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypocalcaemia.

Warnings and precautions (for complete information see www.fass.se): Alendronate can cause local irritation of the upper gastro-intestinal mucosa. In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis. The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of 5 II/015 [0039] oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient. Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with poor dental status. While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain or swelling. Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating. The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping. bisphosphonate. Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. Causes of osteoporosis other than oestrogen deficiency and ageing or glucocorticoid use should be considered. Hypocalcaemia must be corrected before initiating therapy with Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting Binosot treatment. Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids. This medicinal product contains 603 mg sodium per dose equivalent to 30 % of the WHO recommended maximum daily intake for sodium. Binosto is considered high in sodium. This should be particularly taken into account for those patients on a low sodium diet. (for full information see www.fass.se)

Storage: Binosto does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

Pack size: 4 effervescents packaged individually in aluminum foil.

For full information regarding prescription and SPC (June 2021) please see www.fass.se