Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbimazole
CST Pharma Ltd
H03BB01
Carbimazole
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200; GTIN: 5055946807348
– You are pregnant, think you may become pregnant or are trying to become pregnant – You have bone marrow depression – You have mild or moderate liver problems – You are receiving radio-iodine (for thyroid problems) – You are of child-bearing potential – You are allergic to thiamazole, methimazole or propylthiouracil (other thyroid medications) – You are lactose intolerant or have any other lactose deficiency. – You are unable to comply with the instructions for use or cannot be monitored regularly. If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Carbimazole. CHILDREN Do not give this medicine to children under the age of two years because it may not be safe or effective. OTHER MEDICINES AND CARBIMAZOLE Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Carbimazole can affect the way some medicines work. Also, some medicines can affect the way Carbimazole works. In particular tell your doctor or pharmacist if you are taking any of the following: – Medicines to thin your blood or to stop clotting – A medicine to help your breathing called 'theophylline’ – Steroids such as prednisolone – An antibiotic called erythromycin – A medicine for heart failure called digitalis – Medicines for high blood pressure called beta-blockers. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Carbimazole. PREGNANCY AND BREAST-FEEDING Carbimazole can cause harm to an unborn baby. If you could get pregnant, use reliable contraception from the time you start treatment and during treatment. If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away. Your treatment with Carbimazole may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbimazole 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of carbimazole. Excipients with known effect: Lactose Anhydrous (140.485 mg per tablet) For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pale pink, uncoated, round, biconvex tablets marked with LINK C5 on one side and a scoreline on the reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbimazole is an anti-thyroid agent. It is indicated in adults and children in all conditions where reduction of thyroid function is required. Such conditions are: 1. Hyperthyroidism. 2. Preparation for thyroidectomy in hyperthyroidism. 3. Therapy prior to and post radio-iodine treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Carbimazole should only be administered if hyperthyroidism has been confirmed by laboratory tests. Posology _ _ _ _ _Older people _ No special dosage regimen is required, but care should be taken to observe the contraindications and warnings as it has been reported that the risk of a fatal outcome to neutrophil dyscrasia may be greater in the elderly (aged 65 or over). _Paediatric population _ Use in children and adolescents (3 to 17 years of age) The usual initial daily dose is 15 mg per day adjusted according to response. Use in children (2 years of age and under) Safety and efficacy of carbimazole in children below 2 years of age have not been evaluated systematically. Use of carbimazole in children below 2 years of age is therefore not recommended. _ _ _Adults _ The initial dose is in the range 20 mg to 60 mg, taken as two to three divided doses. The dose should be titrated against thyroid function until the patient is euthyroid in order to reduce the risk of over-treatment and resultant hypothyroidism. Subsequent therapy may then be administered in one of two ways. Maintenance regimen: Final dosage is usually Perskaitykite visą dokumentą