Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Alendronic acid
Clonmel Healthcare Ltd
M05BA; M05BA04
Alendronic acid
70 milligram(s)
Effervescent tablet
Oral use
Packs with 4, 12 or 24 effervescent tablets
Product subject to prescription which may be renewed (B)
Drugs affecting bone structure and mineralisation, bisphosphonates
Bisphosphonates; alendronic acid
Treatment of postmenopausal osteoporosis. Binosto 70 mg reduces the risk of vertebral and hip fractures
Marketed
2012-03-02
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BINOSTO ONCE WEEKLY 70 MG EFFERVESCENT TABLETS Alendronic acid • READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist or nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • It is particularly important to understand the information in section 3 before taking this medicine. WHAT IS IN THIS LEAFLET 1. What Binosto is and what it is used for 2. What you need to know before you take Binosto 3. How to take Binosto 4. Possible side effects 5. How to store Binosto 6. Contents of the pack and other information 1. WHAT BINOSTO IS AND WHAT IT IS USED FOR Binosto is an effervescent tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Binosto prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures. Your doctor has prescribed Binosto to treat your osteoporosis. Binosto reduces the risk of spine and hip fractures. BINOSTO IS A ONCE WEEKLY TREATMENT. WHAT IS OSTEOPOROSIS? Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can Baca dokumen lengkap
Health Products Regulatory Authority 25 June 2021 CRN00C45Q Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Binosto Once Weekly 70 mg effervescent tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains alendronate sodium trihydrate equivalent to 70 mg alendronic acid. _Excipient(s) with known effect_: The total amount of sodium from both the active ingredient and excipients in each effervescent tablet is 603 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent Tablet White to off-white round effervescent tablets of 25 mm diameter, flat faced with bevelled edges. After dissolution the solution has a pH of 4.8 – 5.4 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Binosto is indicated in adults for the treatment of postmenopausal osteoporosis. It reduces the risk of vertebral and hip fractures. 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 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, d Baca dokumen lengkap