Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium clodronate
Bayer Plc
M05BA02
Sodium clodronate
800mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5016703008842
PACKAGE LEAFLET: INFORMATION FOR THE USER BONEFOS® 800MG TABLETS (sodium clodronate) 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. The name of your medicine is Bonefos 800mg Tablets, but will be referred to as Bonefos tablets throughout the remainder of the leaflet WHAT IS IN THIS LEAFLET 1. What Bonefos tablets are and what they are used for 2. What you need to know before you take Bonefos tablets 3. How to take Bonefos tablets 4. Possible side effects 5. How to store Bonefos tablets 6. Contents of the pack and other information 1. WHAT BONEFOS TABLETS ARE AND WHAT THEY ARE USED FOR Bonefos tablets contain sodium clodronate which belongs to a group of medicines called bisphosphonates. These medicines help prevent the loss of calcium from bones. Bonefos tablets are used to help manage bone diseases, particularly those associated with cancer. Bonefos tablets also help maintain normal levels of calcium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONEFOS TABLETS DO NOT TAKE BONEFOS TABLETS IF: • you have VERY POOR KIDNEY FUNCTION • you are ALLERGIC to sodium clodronate, or to any of the other ingredients of this medicine (listed in section 6). • you are ALREADY TAKING ANOTHER SIMILAR MEDICINE. Î TELL YOUR DOCTOR if any of these apply to you and DO NOT TAKE BONEFOS. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Bonefos tablets. Your doctor will take special care if: • you have PROBLEMS WITH YOUR KIDNEYS • you have (or have had) PAIN, SWELLING OR NUMBNESS OF THE JAW or a Citiți documentul complet
OBJECT 1 BONEFOS TABLETS Summary of Product Characteristics Updated 11-Oct-2017 | Bayer plc 1. Name of the medicinal product Bonefos 800 mg tablets 2. Qualitative and quantitative composition Each tablet contains 1000 mg of disodium clodronate tetrahydrate, equivalent to 800 mg of anhydrous disodium clodronate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Pale white, oval-shaped, film-coated tablets for oral use. 4. Clinical particulars 4.1 Therapeutic indications Bonefos tablets are indicated in the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma. Bonefos tablets are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous bisphosphonate. 4.2 Posology and method of administration Posology Adults A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below. Paediatric population Bonefos has not been evaluated in children. Elderly There are no special dosage recommendations in the elderly. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported. Renal Impairment Clodronate is eliminated mainly via the kidneys. Therefore, it should be used with caution in patients with renal failure; daily doses exceeding 1600mg should not be used continuously. It is recommended that the clodronate dosage be reduced as follows: DEGREE OF RENAL FAILURE CREATININE CLEARANCE, ML/MIN DOSE Mild 50-80 ml/min 1600 mg daily (no dose reduction recommended) Moderate 30- <50 ml/min 1200 mg/daily Severe 10 - <30 ml/min 800 mg/daily Method of administration Adequate fluid intake should be maintained during treatment. A Bonefos 800mg tablet may be divided into two to ease swallowing, but the halves ha Citiți documentul complet