Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium clodronate
Kent Pharma (UK) Ltd
M05BA02
Sodium clodronate
800mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5060061160964
ABXP225BNG 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. W HAT C LASTEON T ABLETS 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. W HAT 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-inflammatory medicines such as ibuprofen or diclofen Прочитайте повний документ
OBJECT 1 CLASTEON 800MG TABLETS Summary of Product Characteristics Updated 05-Dec-2022 | Beacon Pharmaceuticals / Kent Pharma UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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 acce Прочитайте повний документ