Country: Малта
Језик: Енглески
Извор: Medicines Authority
RISEDRONATE SODIUM
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
M05BA07
RISEDRONATE SODIUM 30 mg
FILM-COATED TABLET
RISEDRONATE SODIUM 30 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Authorised
2011-07-18
PACKAGE LEAFLET: INFORMATION FOR THE USER RISEDRONATE AUROBINDO 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. 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 Risedronate Aurobindo is and what it is used for 2. What you need to know before you take Risedronate Aurobindo 3. How to take Risedronate Aurobindo 4. Possible side effects 5. How to store Risedronate Aurobindo 6. Contents of the pack and other information 1. WHAT RISEDRONATE AUROBINDO IS AND WHAT IT IS USED FOR WHAT RISEDRONATE AUROBINDO IS Risedronate Aurobindo 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. Risedronate Aurobindo changes the bone remodeling process back to normal, returning the strength to the bone structure. WHAT RISEDRONATE AUROBINDO IS USED FOR Treatment of Paget’s disease of the bone (osteitis deformans). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISEDRONATE AUROBINDO DO NOT TAKE RISEDRONATE AUROBINDO • If you are allergic to risedronate sodium or any of the other ingredients of this medicine ( listed in section 6). • If your doctor has Прочитајте комплетан документ
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Risedronate Aurobindo 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 with known effect: Each film-coated tablet contains lactose monohydrate 147.6 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white colored, circular shaped film coated biconvex tablets debossed with ‘L’ on one side and ‘30’ on the other side. 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. The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium: • 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, risedronate sodium can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure risedronate sodium is taken on an empty stomach: • Between meals: risedronate sodium should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). • In the evening: risedronate sodium should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate sodium should be taken at least 30 minutes before going to bed. If an occasional dose is missed, risedronate sodium can be taken before breakfast, between meals, or in the evening according to Прочитајте комплетан документ