Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CLODRONATE DISODIUM TETRAHYDRATE
Bayer Limited
M05BA02
CLODRONATE DISODIUM TETRAHYDRATE
800 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Bisphosphonates
Authorised
2007-09-21
Bayer Limited The Atrium Blackthorn Road Dublin 18 Telephone: +353 1 2999313 Fax: +353 1 2061456 Copyright reserved 15260 BONEFOS 800MG FILM-COATED TABLETS SODIUM CLODRONATE PACKAGE LEAFLET – INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have more questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effectsnot listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT BONEFOS TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE BONEFOS TABLETS 3. HOW YOU TAKE BONEFOS TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BONEFOS TABLETS 6. FURTHER 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. BEFORE YOU TAKE BONEFOS TABLETS DO NOT TAKE BONEFOS TABLETS IF: • you are ALLERGIC to the active ingredient (sodium clodronate), or to any of the other ingredients. The ingredients are Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bonefos 800 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sodium clodronate 800 mg (as tetrahydrate). Each tablet contains sodium 128 mg. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, oval, scored, tablets marked ‘L134’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypercalcaemia due to malignancy. Treatment of osteolysis due to malignancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Clodronate is mainly eliminated via the kidneys. Therefore, adequate fluid intake must be maintained during clodronate treatment. • Children Safety and efficacy in paediatric patients have not been established. • Elderly There are no special dosage recommendations for the elderly. Clinical trials have included patients over 65 years and no adverse effects specific to this age group have been reported. A Bonefos 800 mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration. Bonefos tablets should not be crushed or dissolved before intake. A daily dose of 1600 mg may 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. The single daily dose and the first dose of two (in the case of twice daily dosing) should preferably be taken in the morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking (other than plain water), or taking any other oral drugs for one hour. When twice daily dosing is used, the first dose should be taken as recommended above. The second dose s Przeczytaj cały dokument