Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
colecalciferol, alendronic acid (as sodium trihydrate)
N.V. Organon
M05BB03
alendronic acid, colecalciferol
Drugs for treatment of bone diseases
Osteoporosis, Postmenopausal
Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.Adrovance reduces the risk of vertebral and hip fractures.
Revision: 25
Authorised
2007-01-04
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER ADROVANCE 70 MG/2,800 IU TABLETS ADROVANCE 70 MG/5,600 IU TABLETS alendronic acid/colecalciferol 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 ADROVANCE is and what it is used for 2. What you need to know before you take ADROVANCE 3. How to take ADROVANCE 4. Possible side effects 5 How to store ADROVANCE 6. Contents of the pack and other information 1. WHAT ADROVANCE IS AND WHAT IT IS USED FOR WHAT IS ADROVANCE? ADROVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D 3 . WHAT IS ALENDRONATE? Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate 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 VITAMIN D? Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. As we get older our skin makes less vitamin D. Too little vitamin D may lead to bone loss and osteoporosis. Severe vitamin D deficiency may cause muscle weakness which can lead to falls and Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ADROVANCE 70 mg/2,800 IU tablets ADROVANCE 70 mg/5,600 IU tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ADROVANCE 70 mg/2,800 IU tablets Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D 3 ). _Excipients with known effect_ Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg sucrose. ADROVANCE 70 mg/5,600 IU tablets Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D 3 ). _Excipients with known effect _ Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet ADROVANCE 70 mg/2,800 IU tablets Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710' on the other. ADROVANCE 70 mg/5,600 IU tablets Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADROVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The recommended dose is one tablet once weekly. Patients should be instructed that if they miss a dose of ADROVANCE 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. Due to the nature of the disease process in osteoporosis, ADROVANCE is intended for long-term use. 3 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 ADROVANC Olvassa el a teljes dokumentumot