Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium clodronate
Bayer Plc
M05BA02
Sodium clodronate
400mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5016703008811
BONEFOS ® 400 MG CAPSULES (disodium clodronate) PATIENT INFORMATION LEAFLET 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. Your medicine is available using the above name but will referred to as Bonefos Capsules throughout the following leaflet. WHAT IS IN THIS LEAFLET: 1. What Bonefos Capsules are and what they are used for 2. What you need to know before you take Bonefos Capsules 3. How to take Bonefos Capsules 4. Possible side effects 5. How to store Bonefos Capsules 6. Contents of the pack and other information 1. WHAT BONEFOS CAPSULES ARE AND WHAT THEY ARE USED FOR Bonefos Capsules contain sodium clodronate which belongs to a group of medicines called bisphosphonates.These medicines help prevent the loss of calcium from bones. Bonefos Capsules are used to help manage bone diseases, particularly those associated with cancer. Bonefos Capsules also help maintain normal levels of calcium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONEFOS CAPSULES DO NOT TAKE BONEFOS CAPSULES 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. ➙ 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 capsules. 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 “heavy jaw feeling” or Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bonefos 400 mg capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg sodium clodronate tetrahydrate, equivalent to 400 mg anhydrous sodium clodronate. Excipients with known effect Each capsule contains 41.5mg lactose (as monohydrate) , see section 4.4. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Pale yellow, hard gelatin capsules printed 'BONEFOS' in black for oral use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bonefos capsules are indicated for the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma. Bonefos capsules 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. The single d Přečtěte si celý dokument