Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Risedronate sodium
Zaklad Farmaceutyczny Adamed Pharma S.A.
M05BA; M05BA07
Risedronate sodium
35 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates; risedronic acid
Not marketed
2010-11-05
PACKAGE LEAFLET: INFORMATION FOR THE USER RISEDRONATE SODIUM ADAMED PHARMA ONCE A WEEK 35 MG FILM-COATED TABLETS , 35 MG FILM-COATED TABLETS _Risedronate sodium _ _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any 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 • symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets is and what it is used for 2. Before you take Risedronate sodium ADAMED PHARMA Once a week 35 mg film- coated tablets 3. How to take Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets 4. Possible side effects 5. How to store Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets 6. Further information 1. WHAT RISEDRONATE SODIUM ADAMED PHARMA ONCE A WEEK 35 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets 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 this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss an Lire le document complet
Health Products Regulatory Authority 26 March 2021 CRN00C4RH Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate sodium ADAMED PHARMA 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). Excipient with known effect: lactose monohydrate. Each film-coated tablet contains 133.58 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Film-coated, biconvex, pale orange coloured round tablet. 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. The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets: ° 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 Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets 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 Risedronate sodium ADAMED PHARMA Once a week 35 mg film-coated tablets is to be taken while in an upright position with a glass of plain water (>120 ml). Patie Lire le document complet