Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM CALCIUM CARBONATE COLECALCIFEROL
B & S Healthcare
RISEDRONATE SODIUM CALCIUM CARBONATE COLECALCIFEROL
35/1000/88 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTONEL PLUS CA & D 35MG FILM-COATED TABLETS + 1000MG/880IU EFFERVESCENT GRANULES (risedronate sodium + calcium/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. The name of your medicine is Actonel Plus Ca & D 35mg film-coated tablets+10000mg/880IU effervescent granules but will be referred to as Actonel Plus throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Actonel Plus is and what it is used for 2. What you need to know before you take Actonel Plus 3. How to take Actonel Plus 4. Possible side effects 5. How to store Actonel Plus 6. Contents of the pack and other information 1. WHAT ACTONEL PLUS IS AND WHAT IT IS USED FOR WHAT ACTONEL PLUS IS A combination medicine packed as weekly units each containing 1 tablet of Actonel and 6 sachets of calcium/vitamin D 3 . O_ Actonel tablets_ Actonel tablets contain risedronate sodium which belongs to a group of non-hormonal medicines called bisphosphonates. These medicines are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Plus Ca & D 35 mg + 1000 mg / 880 IU film-coated tablets + effervescent granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium, (equivalent to 32.5 mg risedronic acid). Each sachet of effervescent granules contains 2500 mg calcium carbonate equivalent to 1000 mg calcium and 22 micrograms (880 IU) colecalciferol (vitamin D 3 ). Excipients: Each film-coated tablet contains lactose. Each sachet of effervescent granules contains potassium (163 mg), sucrose, soya-bean oil and sorbitol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Film-coated tablet_ Oval, light-orange, film-coated tablet with RSN on one side and 35 mg on the other. _Effervescent granules_ Calcium carbonate/colecalciferol, white effervescent granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1). Actonel Plus Ca & D is only intended for use in assessed patients for whom the amount of calcium and vitamin D 3 included is considered to provide adequate supplementation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A weekly unit of Actonel Plus Ca & D consists of 1 Actonel 35 mg film-coated tablet and 6 calcium/vitamin D 3 sachets in a box. Posology The recommended dose in adults is 1 Actonel 35 mg tablet on the first day followed on the next day by 1 calcium/vitamin D 3 sachet daily for 6 days. This 7-day sequence is then repeated each week starting with Actonel 35 mg tablet. Method of administration _Actonel 35 mg (light-orange tablet):_ The Actonel 35 mg tablet should b Прочитајте комплетан документ