देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibandronic sodium monohydrate
Atnahs Pharma UK Ltd
M05BA06
Ibandronic sodium monohydrate
50mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5000471006193
1 uk-mt-pil-bondronat-clean-160425-50mg-fct.doc PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BONDRONAT 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 Bondronat is and what it is used for 2. What you need to know before you take Bondronat 3. How to take Bondronat 4. Possible side effects 5 How to store Bondronat 6. Contents of the pack and other information 1. WHAT BONDRONAT IS AND WHAT IT IS USED FOR Bondronat contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Bondronat 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 Bondronat 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 BONDRONAT DO NOT TAKE BONDRONAT: • 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 ever had low calcium in your blood Do not take this medicine if any of the above apply to you. If you are not sure, talk to yo पूरा दस्तावेज़ पढ़ें
BONDRONAT 50MG FILM-COATED TABLETS Summary of Product Characteristics Updated 10-May-2016 | Roche Products Limited 1. Name of the medicinal product Bondronat 50 mg film-coated tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate). Excipients with known effect: Contains 88.1 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets. White to off-white film-coated tablets, of oblong shape engraved L2 on one side and IT on the other side. 4. Clinical particulars 4.1 Therapeutic indications Bondronat 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 Bondronat 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_ _Patients with hepatic impairment_ No dose adjustment is required (see section 5.2). _Patients with 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 Bondronat 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). Method of administration For oral use. Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the f पूरा दस्तावेज़ पढ़ें