Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM
Warner Chilcott UK Limited
M05BA07
RISEDRONATE SODIUM
30 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2010-04-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACTONEL 30 MG FILM-COATED TABLETS 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Actonel is and what it is used for 2. What you need to know before you take Actonel 3. How to take Actonel 4. Possible side effects 5. How to store Actonel 6. Contents of the pack and other information 1. WHAT ACTONEL IS AND WHAT IT IS USED FOR WHAT ACTONEL IS Actonel 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. Paget’s disease occurs when this process, called remodeling, happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, painful and may fracture. Actonel changes the bone remodeling process back to normal, returning the strength to the bone structure. WHAT ACTONEL IS USED FOR Treatment of Paget’s disease of the bone (osteitis deformans). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTONEL DO NOT TAKE ACTONEL If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6) If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level) If you may be pregnant, are pregnant or planning to become pregnant If Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg risedronate sodium (equivalent to 27.8 mg risedronic acid). Excipients: Each film-coated tablet contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Oval white film-coated tablet with RSN on one side and 30 mg on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Paget’s disease of the bone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended daily dose in adults is one 30 mg tablet orally for 2 months. If re treatment is considered necessary (at least two months post treatment), a new treatment with the same dose and duration of therapy could be given. Special populations Elderly No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. _Renal Impairment_ No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30 ml/min) (see sections 4.3 and 5.2). _Paediatric population_ Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (see section 5.1). Method of administration The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel: - Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instance that before breakfast dosing is not practical, Actonel can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Actonel is taken on an empty stomach: - Between meals: Actonel should be taken at least 2 hours bef Lestu allt skjalið