Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMIBANDRONAAT 1-WATER 168,75 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 150 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
M05BA06
NATRIUMIBANDRONAAT 1-WATER 168,75 mg/stuk SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR 150 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Ibandronic Acid
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2010-12-31
Ibandronic acid, NL/1831/002, 05.09.22 1 rvg 106014 EU PIL IA-020 met NL info-tracked BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER _ _ IBANDRONINEZUUR RATIOPHARM 150 MG, FILMOMHULDE TABLETTEN_ _ Ibandronic acid 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. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you take Διαβάστε το πλήρες έγγραφο3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR belongs to a group of medicines called BISPHOSPHONATES . It contains the active substance 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. may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip. 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:
Ibandronic acid, NL/H/1831/002, 05.09.22 rvg 106014 EU SPC IA-020 met NL info-tracked 1. NAAM VAN HET GENEESMIDDEL Ibandroninezuur Ratiopharm 150 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate). _Excipients with known effect:_ 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. 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 osteopor Διαβάστε το πλήρες έγγραφο