Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
ibandronic acid
Roche Registration Ltd.
M05BA06
ibandronic acid
Drugs for treatment of bone diseases
Osteoporosis, Postmenopausal
Treatment of osteoporosis in post-menopausal women at increased risk of fracture.A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established.
Revision: 16
Withdrawn
2004-02-23
B. PACKAGE LEAFLET 38 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER BONDENZA 150 mg film-coated tablets Ibandronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAU SE 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 : PLANNING WHEN TO TAKE BONDENZA WITH PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR 1. What Bondenza is and what it is used for 2. What you need to know before you take Bondenza 3. How to take Bondenza 4. Possible side effects 5. How to store Bondenza 6. Content of the pack and other information 1. WHAT BONDENZA IS AND WHAT IT IS USED FOR Bondenza belongs to a group of medicines called bisphospho nates. It contains the active substance ibandronic acid. Bondenza 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. Bondenza may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip. BONDENZA IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE AN INCREASED RISK OF FRACTURES . Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy. The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include: - not enough calcium and vitamin D in the diet - smoking, or drinkin Læs hele dokumentet
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Bondenza 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandr onic acid (as sodium monohydrate). Excipients with known effect: Contains 162.75 mg lactose monohydrate (equivalent t o 154.6 mg anhydrous lactose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off white film-coated tablets, of oblong shape marked “BNVA” on one side, and “150” on the other side. 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. Bondenza should be taken after an overnight fast (at l east 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 Bondenza 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. Patients should receive supplemental calcium and / or vitam in 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. Læs hele dokumentet