Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Risedronate sodium
Viatris UK Healthcare Ltd
M05BA07
Risedronate sodium
35mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5016695003429
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RISEDRONATE SODIUM 35 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. WHAT IS IN THIS LEAFLET : 1. What Risedronate sodium is and what it is used for 2. What you need to know before you take Risedronate sodium 3. How to take Risedronate sodium 4. Possible side effects 5. How to store Risedronate sodium 6. Contents of the pack and other information 1. WHAT RISEDRONATE SODIUM IS AND WHAT IT IS USED FOR WHAT RISEDRONATE SODIUM IS Risedronate sodium 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 and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it. WHAT RISEDRONATE SODIUM IS USED FOR The treatment of osteoporosis • in postmenopausal women, even if osteoporosis is s Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risedronate sodium 35 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium (amorphous), equivalent to 32.48 mg risedronic acid. Excipient with known effect: Each film-coated tablet contains 153.18 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Orange 9.0 mm round, biconvex, film-coated 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 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 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 Risedronate sodium 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 Risedronate sodium is to be taken while in an upright position with a glass of plain water ( ≥ 120 ml). Patients should not lie down for 30 minutes after taking the tablet (see section 4.4). Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. The optimal duration of bisphosphonate treatment for osteoporosis has not been establ Przeczytaj cały dokument