البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ALENDRONIC ACID AS TRIHYDRATE
TZAMAL BIO-PHARMA LTD
M05BA04
TABLETS EFFERVESCENT
ALENDRONIC ACID AS TRIHYDRATE 70 MG
PER OS
Required
SWISS CO SERVICES LTD, SWITZERLAND
ALENDRONIC ACID
For the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures).Treatment to increase bone mass in men with osteoporosis
2022-06-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only BINOSTO EFFERVESCENT TABLETS ACTIVE INGREDIENT AND ITS QUANTITY: Each soluble tablet contains: sodium alendronate trihydrate equivalent to 70 mg alendronic acid Inactive ingredients and allergens: See section 2 “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is not intended for children and adolescents below the age of 18. 1. WHAT IS THIS MEDICINE INTENDED FOR? For treatment of osteoporosis in postmenopausal women to prevent fractures. For treatment to increase bone mass in men with osteoporosis. BINOSTO IS A ONCE WEEKLY TREATMENT. THERAPEUTIC GROUP: bisphosphonates (non-hormonal drug class). WHAT IS OSTEOPOROSIS Osteoporosis is thinning and weakening of the bones. It is common in postmenopausal women. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to maintain the skeleton healthy. As a result, bone loss occurs, and the bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. At the early stages, osteoporosis is usually asymptomatic. However, if left untreated, the condition can result in bone fractures. Although bone fractures in the spine are usually accompanied by pain, they may remain undiagnosed until height loss occurs. Bone fractures can occur during normal everyday activity such as lifting, or from minor injury that would not usually lead to fracture of a healthy bone. Bone fractures usually occur at the hip, spine or wrist, and c اقرأ الوثيقة كاملة
1 BINOSTO Prescribing Information 1. NAME OF THE MEDICINAL PRODUCT Binosto 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains sodium alendronate trihydrate equivalent to 70 mg Alendronic acid. Excipient(s) with known effect: The total amount of sodium from both the active substance and excipients in each effervescent tablet is 603mg. For a 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 Treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis. 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. 2 _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 po اقرأ الوثيقة كاملة