Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Alendronic acid; Vitamin D3
Rowex Ltd
M05BB; M05BB03
Alendronic acid; Vitamin D3
70 mg/5600 international unit(s)
Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates, combinations; alendronic acid and colecalciferol
Marketed
2016-09-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALENDRONATE / COLECALCIFEROL ROWEX 70MG / 5600 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. How to take Alendronate / Colecalciferol Rowex”, before taking this medicine. WHAT IS IN THIS LEAFLET 1. What Alendronate / Colecalciferol Rowex is and what it is used for 2. What you need to know before you take Alendronate / Colecalciferol Rowex 3. How to take Alendronate / Colecalciferol Rowex 4. Possible side effects 5 How to store Alendronate / Colecalciferol Rowex 6. Contents of the pack and other information 1. WHAT ALENDRONATE / COLECALCIFEROL ROWEX IS AND WHAT IT IS USED FOR WHAT IS ALENDRONATE / COLECALCIFEROL ROWEX? Alendronate / Colecalciferol Rowex 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 Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 10 October 2019 CRN00911Z Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronate/Colecalciferol Rowex 70 mg/5600 IU tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg of alendronic acid (as sodium alendronate trihydrate) and 140 micrograms colecalciferol (equivalent to 5600 IU vitamin D3). Excipient with known effect: Each tablet contains 9.8 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _ _ White to almost white, oval, debossed with 714 on one side. Approximately 12.6mm x 6.6mm x 5.2mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendronate / Colecalciferol Rowex 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 / Colecalciferol Rowex 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 / Colecalciferol Rowex 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 / Colecalciferol Rowex 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 / Colecalciferol Rowex on an individual patient basis, particularly after 5 or more years of use. Patients should receive supplemental calcium, if intake from diet is inadequate (see section 4.4). The equivalence of intake of 5,600 IU of vitamin D 3 weekly in Alendronate / Colecalciferol Rowex to daily dosing of vitamin D 800 IU h Lesen Sie das vollständige Dokument