Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Risedronate sodium; Calcium carbonate; Colecalciferol
PCO Manufacturing Ltd.
M05BB04
Risedronate sodium; Calcium carbonate; Colecalciferol
35 mg + 1000 mg/800 international unit(s)
Effervescent granules + film-coated tablet
Product subject to prescription which may be renewed (B)
risedronic acid, calcium and colecalciferol, sequential
Authorised
2013-03-08
_ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTONEL ® PLUS CA & D 35 mg film-coated tablets + 1000 mg/880 IU 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Actonel Plus Ca & D is and what it is used for 2. What you need to know before you take Actonel Plus Ca & D 3. How to take Actonel Plus Ca & D 4. Possible side effects 5. How to store Actonel Plus Ca & D 6. Contents of the pack and other information 1. WHAT ACTONEL PLUS CA & D IS AND WHAT IT IS USED FOR WHAT ACTONEL PLUS CA & D IS A combination medicine containing tablets of Actonel and 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 with new bone. Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had i Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 30 August 2022 CRN00D3YQ Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU 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 1000 mg calcium (as 2500 mg calcium carbonate) and 22 micrograms (880 IU) colecalciferol (vitamin D 3 ). Excipients with known effect: Each film-coated tablet contains lactose monohydrate. Each sachet of effervescent granules contains potassium, sucrose, soya-bean oil and sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Product imported from France:_ _Film-coated tablet_ Oval, light-orange, film-coated tablet with RSN on one side and 35 mg on the other. _Effervescent granules_ White effervescent granules. 4 CLINICAL PARTICULARS As per PA22668/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA22668/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Film-coated tablet: Tablet core: Lactose monohydrate, Crospovidone A, Magnesium stearate. Cellulose microcrystalline, Film coating: Hypromellose, Macrogol Hydroxypropylcellulose Silicon dioxide Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Health Products Regulatory Authority 30 August 2022 CRN00D3YQ Page 2 of 3 Effervescent granules: Citric acid anhydrous Malic acid Gluconolactone Maltodextrin Sodium cyclamate Saccharin sodium Sorbitol (E420) Mannitol (E421) Dextrin, Acacia Natural Lemon oils Natural Lime flavour Rice starch, Potassium carbonate All-rac-α-Tocopherol Soya-bean oil, hydrogenated Gelatin Sucrose Maize starch. 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the blister, sachet and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does Lesen Sie das vollständige Dokument