Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM
B & S Healthcare
M05BA07
RISEDRONATE SODIUM
35 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2007-08-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTONEL ® ONCE A WEEK 35MG FILM-COATED TABLET S (risedronate sodium) 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 Once a Week 35mg film- coated tablets but will be referred to as Actonel Once a Week throughout this leaflet. WHAT IS IN THIS LEAFLET 1. What Actonel Once a Week is and what it is used for 2. What you need to know before you take Actonel Once a Week 3. How to take Actonel Once a Week 4. Possible side effects 5. How to store Actonel Once a Week 6. Contents of the pack and other information 1. WHAT ACTONEL ONCE A WEEK IS AND WHAT IT IS USED FOR WHAT ACTONEL ONCE A WEEK IS Actonel Once a Week belongs to a group of non-hormonal medicines called bisphosphonates which 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 menop Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Once a Week 35mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). Excipients: Lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Italy:_ Oval light-orange film-coated tablet with ‘RSN’ on one side and ‘35 mg’ on the other. 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). Treatment of osteoporosis in men at high risk of fractures (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week. Method of administration The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Actonel Once a Week 35 mg: • Before breakfast: at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Patients should be instructed that if a dose is missed, one Actonel Once a Week 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day. The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel Once a Week 35 mg is to be taken while in an upright position with a glass of Preberite celoten dokument