Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium clodronate
Mawdsley-Brooks & Company Ltd
M05BA02
Sodium clodronate
520mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200
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 Loron is and what it is used for 2. What you need to know before you take Loron 3. How to take Loron 4. Possible side effects 5. How to store Loron 6. Contents of the pack and other information 1. WHAT LORON IS AND WHAT IT IS USED FOR Loron contains a medicine called clodronate disodium. This medicine is a non-amino-bisphosphonate. Loron is used to treat bone problems in people with certain types of cancer. These problems include: • Loss of calcium (a mineral) from the bones and bone pain. • High levels of calcium in the blood caused by loss of calcium from the bones. Loron works by binding to the bones. This helps to stop the bones from losing calcium which helps to keep the bones strong. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORON DO NOT TAKE LORON: • if you are allergic to clodronate disodium or any of the other ingredients of this medicine (listed in section 6). • if you have pain or discomfort in your stomach or bowel that is severe. • if you are pregnant, might become pregnant, or are breast-feeding (see the section on 'Pregnancy and breast-feeding'). • if you have problems with your kidneys (renal failure with creatinine clearance below 10 ml/min). • if you are taking any other bisphos- phonate medicines. These include amongst others alendronate sodium, ibandronic acid and risedronate sodium. For details see the section on 'Other medicines and Loron'. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before t Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loron 520 520 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 649.7 mg clodronate disodium tetrahydrate, equivalent to 520 mg clodronate disodium. Excipients with known effect: lactose monohydrate; sodium (3.6 mmol per film- coated tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet for oral administration. Oblong, white, film-coated tablets, imprinted with “E9” on one side and with a break line on both sides. The film-coated tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loron is 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. Loron is also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous infusion of clodronate disodium 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Clodronate is mainly eliminated via the kidneys. Therefore, adequate fluid intake must be maintained during clodronate treatment. AFTER TAKING LORON THE PATIENT SHOULD NOT LAY DOWN, BUT REMAIN IN AN UPRIGHT POSITION TO PREVENT UPPER ABDOMINAL PAIN. Posology _Adults _ The recommended dose is 2 film-coated tablets (1040 mg clodronate disodium) daily. If necessary, the dosage may be increased but should not exceed a maximum of 4 film-coated tablets (2080 mg clodronate disodium) daily. _Elderly _ No special dosage recommendations. _Children _ Safety and efficacy in children has not been established. _Use in renal impairment _ In patients with renal insufficiency with creatinine clearance between 10 and 30 ml/min, the daily dose should be reduced to one half of the recommended adult dose. Serum creatinine should be monitored during therapy. Clodronate disodium is contra-indicated in patients with creatinine clearan Baca dokumen lengkapnya