Country: European Union
Language: English
Source: EMA (European Medicines Agency)
ibandronic acid
Sandoz GmbH
M05BA06
ibandronic acid
Drugs for treatment of bone diseases, Bisphosphonates
Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.,
Revision: 9
Authorised
2011-07-26
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBANDRONIC ACID SANDOZ 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 Sandoz is and what it is used for 2. What you need to know before you take Ibandronic acid Sandoz 3. How to take Ibandronic acid Sandoz 4. Possible side effects 5. How to store Ibandronic acid Sandoz 6. Contents of the pack and other information 1. WHAT IBANDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR Ibandronic acid Sandoz contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Ibandronic acid Sandoz tablets 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 Sandoz 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 SANDOZ DO NOT TAKE IBANDRONIC ACID SANDOZ • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are 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 ev Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ibandronic acid Sandoz 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate). Excipient with known effect Each film-coated tablet contains 0.86 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White round biconvex tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibandronic acid Sandoz 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 Sandoz 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 _ No dose adjustment is necessary (see section 5.2). _Paediatric population_ The safety and efficacy of ibandronic acid in children and adolescents below the age of 18 years have not been established. No data are available (see section 5.1 and 5.2). 3 Method of administration For oral use. Ibandronic acid Sandoz 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 t Read the complete document