Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Alendronate sodium trihydrate; Colecalciferol
Rowex Ltd
M05BB03
Alendronate sodium trihydrate; Colecalciferol
Tablet
alendronic acid and colecalciferol
Not marketed
2023-03-31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALENDRONIC ACID/COLECALCIFEROL ROWEX 70 MG/2800 IU TABLETS ALENDRONIC ACID/COLECALCIFEROL ROWEX 70 MG/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 before taking this medicine. WHAT IS IN THIS LEAFLET 1. What Alendronic acid/Colecalciferol Rowex is and what it is used for 2. What you need to know before you take Alendronic acid/Colecalciferol Rowex 3. How to take Alendronic acid/Colecalciferol Rowex 4. Possible side effects 5. How to store Alendronic acid/Colecalciferol Rowex 6. Contents of the pack and other information 1. WHAT ALENDRONIC ACID/COLECALCIFEROL ROWEX IS AND WHAT IT IS USED FOR WHAT IS ALENDRONIC ACID/COLECALCIFEROL ROWEX? Alendronic acid/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 sunli Izlasiet visu dokumentu
Health Products Regulatory Authority 19 April 2023 CRN00DJ47 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alendronic acid/Colecalciferol Rowex 70 mg/5 600 IU tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 microgram (5600 IU) colecalciferol (vitamin D 3 ). Excipients with known effect: Each tablet contains 59.1 mg lactose and 27.5 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Modified rectangle-shaped, white to off-white tablet, mottled, engraved with '5600' on one side, 11.4 mm in length and 7.2 mm in width. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alendronic acid/Colecalciferol Rowex 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 Alendronic acid/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, Alendronic acid/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 Alendronic acid/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). Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements. The equivalenc Izlasiet visu dokumentu