Prescribing Information
Binosto 70 mg effervescent tablets
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Each effervescent tablet contains alendronate sodium trihydrate equivalent to 70 mg alendronic acid.
Indication(s): Treatment of postmenopausal osteoporosis in adults. Reduces the risk of vertebral and hip fractures.
Dosage and Administration: One 70 mg effervescent tablet weekly. If a dose is missed, take one effervescent tablet in the morning after remembering. Do not take two tablets on the same day. Instead, return to taking one tablet per week, as originally scheduled. Periodically re-evaluate the need for continued treatment on an individual patient basis, particularly after 5 or more years of use. No dosage adjustment is necessary for the elderly. For oral use. Dissolve in half a glass of plain water. Ensure complete dissolution before drinking, stir if necessary. Consume solution when in a seated or upright position. Drink a further 30 ml or more of plain water following consumption of the solution. Take immediately after waking, at least 30 minutes before the first food, beverage, or medicinal product of the day. Do not chew or dissolve in the mouth. Do not lie down for at least 30 minutes after taking.
Contraindications: Hypersensitivity to alendronate or other 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: Contains sodium. Not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min. Not recommended for use in children below 18 years. Use caution in conditions affecting the upper GI tract. In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis. Discontinue use in cases of oesophageal reaction and seek medical attention. Use caution in patients with cancer also receiving IV or oral bisphosphates, and patients with a history of dental disease due to increased risk of osteonecrosis of the jaw. Encourage good oral hygiene. Hypocalcaemia must be corrected before initiating therapy with alendronate. Other disorders affecting mineral metabolism should be effectively treated prior to use. Caution is advised when using NSAIDs alongside alendronate.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Fertility, pregnancy, and breastfeeding: Do not use during pregnancy or breastfeeding.
Undesirable effects: Serious side effects: Hypersensitivity reactions. Eye inflammation (uveitis, scleritis, or episcleritis), upper gastrointestinal PUBs (perforation, ulcers, bleeding), rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, Osteonecrosis of the jaw, Osteonecrosis of the external auditory canal. Other very common side effects: musculoskeletal (bone, muscle or joint) pain sometimes severe. Other common side effects: headache, dizziness, vertigo, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation, alopecia, pruritus, joint swelling, asthenia, peripheral oedema. For a full list of side effects, refer to the Summary of Product Characteristics.
Post-authorisation Safety Study: A prospective, non-interventional, single-arm, safety study was conducted in post-menopausal women (n= 1084) treated with Binosto 70 mg effervescent tablets who were followed in routine clinical practice for 12 months (±3 months). The cumulative incidence of all related upper GI adverse events (AEs) was 9.6% (8.0% mild, 1.5% moderate, 0.2% of severe intensity). There have been no reports of oesophagitis, oesophageal or gastric ulcer and duodenitis, nor of upper GI perforation, haemorrhage or stenosis. No serious side effects related to Binosto 70 mg effervescent tablets were observed. The mean time on Binosto was 12.8 months. The mean overall compliance based on the number of tablets missed was 94.8%.
Legal Category: POM
Pack size and price: 4 x 70mg effervescent tablets – £11.60
MA Number: PL40861/0006
MA Holder: Internis Pharmaceuticals Ltd., Linthwaite Laboratories, Linthwaite, Huddersfield, HD7 5QH, UK
Date of preparation: March 2025
Unique ID: UK-BINO-15(1)
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-MULT-130c(3)a | April 2025