Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
CLODRONATE SODIUM, ANHYDROUS
Beacon Pharmaceuticals Limited The Bower 4 Roundwood Avenue, Stockley Park, Heathrow, UB11 1AF, United Kingdom
M05BA02
CLODRONATE SODIUM, ANHYDROUS
FILM-COATED TABLET
CLODRONATE SODIUM, ANHYDROUS 800 milligram(s)
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Authorised
2011-09-09
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER CLASTEON 800MG FILM-COATED TABLETS (SODIUM CLODRONATE) Please read this leaflet carefully before taking Clasteon tablets. Keep the leaflet in case you need to refer to it again. If you want to know more about Clasteon tablets or have any questions, you should ask your doctor or pharmacist. What is in this leaflet 1. What Clasteon tablets are used for 2. What you need to know before taking Clasteon tablets 3. How to take Clasteon tablets 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT CLASTEON TABLETS ARE USED FOR Clasteon tablets contain sodium clodronate, which is one of a group of medicines known as bisphosphonates. These medicines help prevent loss of calcium from bones. Clasteon tablets are used to manage bone diseases, particularly those associated with cancer. They also help to maintain normal levels of calcium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE TAKING CLASTEON TABLETS YOU MUST NOT TAKE CLASTEON TABLETS AND SHOULD TALK TO YOUR DOCTOR IF: ● you are allergic to sodium clodronate, similar medicines or any of the ingredients (listed in section 6) ● you have very poor kidney function ● you are pregnant or breast feeding ● you are already taking a similar medicine (containing bisphosphonates). TELL YOUR DOCTOR IF: ● you have ever had/have pain, numbness or swelling of your jaw or a heavy jaw feeling or loosening of a tooth ● you are having dental treatment or will undergo dental surgery, tell your dentist that you are being treated with a bisphosphonate (Sodium clodronate). Certain types of dental treatment are not recommended while taking bisphosphonates ● you have problems with your kidneys. OTHER MEDICINES AND CLASTEON Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including those obtained without a prescription. This is particularly important if you are taking any of the following: ● antibiotics ● non-steroidal anti Aqra d-dokument sħiħ
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CLASTEON ® 800mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1000mg of disodium clodronate tetrahydrate, equivalent to 800mg of anhydrous sodium clodronate. Each tablet contains 128.24 mg sodium. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. White, oval, convex tablet with breakline. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sodium clodronate 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. Sodium clodronate 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_ : The recommended daily dose is 2 tablets (1600mg sodium clodronate) taken as a single dose. If clinically necessary, the dose may be increased, but is not recommended to exceed 3200 mg daily. Intravenous clodronate is recommended for the treatment of hypercalcaemia due to malignancy. However, if oral therapy is used, a high starting dose of 2400 or 3200 mg daily should be used and, depending on the individual response, this can be reduced gradually to 1600 mg daily in order to maintain normocalcaemia. 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 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), and taking any other oral drugs for one hour. Page 2 of 12 When twice daily dosing is used, the first dose s Aqra d-dokument sħiħ