Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
ibandronic acid
Teva Pharma B.V.
M05BA06
ibandronic acid
Drugs for treatment of bone diseases
Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
Ibandronic acid 50mgIbandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.Ibandronic acid 150mgTreatment of osteoporosis in postmenopausal 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: 12
Authorised
2010-09-17
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBANDRONIC ACID TEVA 50 MG FILM-COATED TABLETS 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. What Ibandronic Acid Teva is and what it is used for 2. What you need to know before you take Ibandronic Acid Teva 3. How to take Ibandronic Acid Teva 4. Possible side effects 5. How to store Ibandronic Acid Teva 6. Contents of the pack and other information 1. WHAT IBANDRONIC ACID TEVA IS AND WHAT IT IS USED FOR Ibandronic Acid Teva contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”). • It helps to prevent your bones from breaking (fractures). • It also helps to prevent other bone problems that may need surgery or radiotherapy. Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC ACID TEVA DO NOT TAKE IBANDRONIC ACID TEVA • if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6) • if you have problems with your food pipe/gullet (oesophagus) such as narrowing or difficulty swallowing • if you cannot stand or sit upright for at least one hour (60 minutes) at a time • if you have or ever had low calcium in your blood. Do Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, biconvex, capsule-shaped film-coated tablets, engraved “50” on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibandronic Acid Teva is indicated in adults for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ibandronic Acid Teva therapy should only be initiated by physicians experienced in the treatment of cancer. Posology The recommended dose is one 50 mg film-coated tablet daily. _ _ _Special populations _ _Hepatic impairment _ No dose adjustment is required (see section 5.2). _Renal impairment _ No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min). For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2). For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly. See dosing instructions, above. _Elderly population (> 65 years) _ No dose adjustment is necessary (see section 5.2). _Paediatric population _ The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established. No data are available. (see sections 5.1 and 5.2). Method of administration 3 For oral use. Ibandronic Acid Teva tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. Medicinal products and supplements (including calcium) should similarly be avoided prior to t Lesen Sie das vollständige Dokument