Ülke: Malta
Dil: İngilizce
Kaynak: Malta Medicines Authority
RISEDRONATE SODIUM
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M05BA07
RISEDRONATE SODIUM 35 mg
FILM-COATED TABLET
RISEDRONATE SODIUM 35 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2005-11-21
Risedronic acid 35 mg Film-coated tablets, PIL, Malta item no: AAAJ8151 print proof no: 4 origination date: 22.05.17 originated by: KM revision date: 24.07.2017 revised by: KM dimensions: 190 x 600 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 22.05.17 supplier: Dupnitsa approved: min pt size: 10pt TECHNICAL APPROVAL PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 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 menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. Osteoporosis can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone. The spine, hip and wrist are the most likely bones to break, although Belgenin tamamını okuyun
Page 1 of 17 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Once a Week 35 mg 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 with known effect: Each film-coated tablet contains 126.0 mg lactose monohydrate (equivalent to 119.7 mg lactose). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Oval light-orange 11.7 x 5.8 mm 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. 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. This has also been shown in the very elderly, 75 years old and above postmenopausal population. _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 (also see section 5.1). Page 2 of 17 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 Belgenin tamamını okuyun