Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM
Pharmathen S.A.
M05BA07
RISEDRONATE SODIUM
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2010-11-26
PACKAGE LEAFLET: INFORMATION FOR THE USER BONAPENYA 5 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 or nurse.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bonapenya is and what it is used for 2. What you need to know before you take Bonapenya 3. How to take Bonapenya 4. Possible side effects 5. How to store Bonapenya 6. Contents of the pack and other information 1. WHAT BONAPENYA IS AND WHAT IT IS USED FOR WHAT BONAPENYA IS Bonapenya 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 is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids. 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 BONAPENYA IS USED FOR The treatment of osteoporosis in POSTMENOPAUSAL WOMEN The prevention of ost সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bonapenya 5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid). Excipient: 0.57 mg lactose in each tablet For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White round biconvex film-coated tablet with diameter of 6.1 mm and 2.6 mm in thickness. 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. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1). To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses 7.5mg/day prednisone or equivalent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended daily dose in adults is one 5 mg tablet orally. METHOD OF ADMINISTRATION The absorption of Risedronate is affected by food, thus to ensure adequate absorption patients should take Risedronate: • 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 can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate is taken on an empty stomach: • Between meals: Risedronate 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 eveni সম্পূর্ণ নথি পড়ুন