국가: 몰타
언어: 영어
출처: Medicines Authority
ALENDRONIC ACID, COLECALCIFEROL
1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany
M05BB03
ALENDRONIC ACID 70 mg COLECALCIFEROL 140 µg
TABLET
ALENDRONIC ACID 70 mg COLECALCIFEROL 140 µg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2016-07-13
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL 70 MILLIGRAMS/5600 IU TABLET 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. How to take Alendronate - 1 A Pharma plus Colecalciferol ”, before taking this medicine. WHAT IS IN THIS LEAFLET: 1. What Alendronate - 1 A Pharma plus Colecalciferol is and what it is used for 2. What you need to know before you take Alendronate - 1 A Pharma plus Colecalciferol 3. How to take Alendronate - 1 A Pharma plus Colecalciferol 4. Possible side effects 5 How to store Alendronate - 1 A Pharma plus Colecalciferol 6. Contents of the pack and other information 1. WHAT ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL IS AND WHAT IT IS USED FOR WHAT IS ALENDRONATE - 1 A PHARMA PLUS COLECALCIFEROL ? Alendronate - 1 A Pharma plus Colecalciferol is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3. 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 전체 문서 읽기
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Alendronate - 1 A Pharma plus Colecalciferol 70mg/5600 IU tablet_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg of alendronic acid (as sodium alendronate trihydrate) and 140 microgram colecalciferol (equivalent to 5600 IU vitamin D3) Excipient(s) with known effect: sucrose (9.8 mg) For the full list of excipients, see section 6.1_ _ 3. PHARMACEUTICAL FORM Tablet_ _ White to almost white, oval tablet debossed with 714 on one side Approximately 12.6 x 6.6 x 5.2mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendronate - 1 A Pharma plus Colecalciferol is indicated for the treatment of postmenopausal osteoporosis in women who are not receiving vitamin D supplementation and are at risk of vitamin D insufficiency. Alendronate - 1 A Pharma plus Colecalciferol 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 Alendronate - 1 A Pharma plus Colecalciferol 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, Alendronate - 1 A Pharma plus Colecalciferol is intended for long-term use. 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 Alendronate - 1 A Pharma plus Colecalciferol on an individual patient basis, particularly after 5 or more years of use. Page 2 of 13 Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4). The equivalence of intake of 5600 IU of vitamin D3 weekly in Alendronate - 1 A Pharma plus Colecalciferol to daily dosing of vitamin D 8 전체 문서 읽기