Страна: Мальта
мова: англійська
Джерело: Malta Medicines Authority
IBANDRONIC ACID
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
M05BA06
IBANDRONIC ACID 150 mg
FILM-COATED TABLET
IBANDRONIC ACID 150 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2012-11-28
dimensions: pharmacode: date sent: TECHNICAL APPROVAL min pt size: awstudio@actavis.co.uk print proof no: origination date: originated by: revision date: supplier: technically app. date*: * Please note the technical approval is provided by the supplier and is valid on the date indicated. Any technical changes made by the supplier after approval are not the responsibility of the Artwork Studio. Non Printing Colours colours/plates revised by: 1. 2. 3. 4. 5. 6. black 1 9 pt 160x440 mm 30.01.2017 30.01.2017 KM Synthon ES Item No: AAAJ5941 Ibandronic acid 150 mg, Film-coated tablets, PIL, Malta approved for print/date 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 Osbonelle 150 mg is and what it is used for. 2. What you need to know before you take Osbonelle 150 mg. 3. How to take Osbonelle 150 mg. 4. Possible side effects. 5. How to store Osbonelle 150 mg. 6. Contents of the pack and other information. 1 WHAT OSBONELLE 150 MG IS AND WHAT IT IS USED FOR Osbonelle belongs to a group of medicines called BISPHOSPHONATES. It contains the active substance ibandronic acid. Ibandronic acid may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Ibandronic acid may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip. OSBONELLE IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE AN INCREASED RISK OF F Прочитайте повний документ
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Osbonelle 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate). _ _ Excipients with known effect Each film-coated tablet contains 163 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off-white, oblong, biconvex film-coated tablets, 14 mm in length and debossed with “I9BE” on one side and on the other side with “150” 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: The recommended dose is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium). In case a dose is missed, patients should be instructed to take one ibandronic acid 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two tablets within the same week. Page 2 of 16 Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5). The optimal duration of bisphosphonate treatment for osteoporosis has not been established Прочитайте повний документ