Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMIBANDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; IBANDRONINEZUUR
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
M05BA06
NATRIUMIBANDRONAAT 1-WATER COMPOSITION corresponding to ; IBANDRONINEZUUR
Filmomhulde tablet
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
Common Technical Document Ibandronate 150 mg (as sodium monohydrate) Film-coated tablets Module 1 - Section 3.5 Core SmPC, Labelling and PIL page 1/10 1.3.1 Core Patient Information Leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER IBANDRONINEZUUR POLPHARMA 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. 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 Ibandronic acid 150 mg is and what it is used for 2. What you need to know before you take Ibandronic acid 150 mg 3. How to take Ibandronic acid 150 mg 4. Possible side effects 5. How to store Ibandronic acid 150 mg 6. Contents of the pack and other information 1 WHAT IBANDRONIC ACID 150 MG IS AND WHAT IT IS USED FOR Ibandronic acid 150 mg 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. IBANDRONIC ACID IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE AN INCREASED RISK OF FRACTURES. Common Technical Document Ibandronate 150 mg (as sodium monohydrate) Film-coated tablets Module 1 - Section 3.5 Core SmPC, Labelling and PIL page 2/10 Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopa Lugege kogu dokumenti
Common Technical Document Ibandronate 150 mg (as sodium monohydrate) Film-coated tablets Module 1 - Section 3.5 Core SmPC, Labelling and PIL page 1/21 1.3.5 Core Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Ibandroninezuur Polpharma 150 mg, filmomhulde tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate). _ _ Excipient with known effect _: _ lactose monohydrate. Each film-coated tablet contains 163 mg lactose monohydrate. For a 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 Common Technical Document Ibandronate 150 mg (as sodium monohydrate) Film-coated tablets Module 1 - Section 3.5 Core SmPC, Labelling and PIL page 2/21 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 Lugege kogu dokumenti