מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alendronate sodium
Teva UK Ltd
M05BA04
Alendronate sodium
70mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5017007029854
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALENDRONIC ACID 70 MG 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. This medicine has been prescribed for you only. 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. 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 Alendronic Acid 70 mg Tablets is and what it is used for 2. What you need to know before you take Alendronic Acid 70 mg Tablets 3. How to take Alendronic Acid 70 mg Tablets 4. Possible side effects 5. How to store Alendronic Acid 70 mg Tablets 6. Contents of the pack and other information 1. WHAT ALENDRONIC ACID 70 MG TABLETS IS AND WHAT IT IS USED FOR WHAT IS ALENDRONIC ACID 70 MG TABLETS? Alendronic Acid 70 mg is a tablet containing the active substance alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid 70 mg tablets 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. WHAT IS ALENDRONIC ACID 70 MG TABLETS USED FOR? Your doctor has prescribed Alendronic Acid 70 mg tablets to treat your osteoporosis. It reduces the risk of spine and hip fractures. ALENDRONIC ACID 70 MG TABLETS 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 res קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT Alendronic acid 70 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg alendronic acid (as 81.2 mg alendronate sodium monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, flat-faced bevel-edged round tablet, debossed with T on one side, plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendronic acid 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 dosage is one 70 mg tablet once weekly. Patients should be instructed that if they miss a dose of Alendronic acid they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one 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 alendronic acid 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 Alendronic acid 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 for alendronic acid in the paediatric population is described in section 5.1. _ _ Method of administratio קרא את המסמך השלם