Land: Malta
Språk: engelsk
Kilde: Medicines Authority
CARBIMAZOLE
Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom
H03BB01
CARBIMAZOLE 10 mg
TABLET
CARBIMAZOLE 10 mg
POM
THYROID THERAPY
Withdrawn
2018-02-14
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER CARBIMAZOLE MACLEODS 5MG, 10MG, 15MG AND 20 MG TABLETS 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. Do not pass it on to others. It may harm them, even if their symptoms 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 Carbimazole Macleods is and what it is used for 2. What you need to know before you take Carbimazole Macleods 3. How to take Carbimazole Macleods 4. Possible side effects 5. How to store Carbimazole Macleods 6. Contents of the pack and other information 1. WHAT CARBIMAZOLE MACLEODS IS AND WHAT IT IS USED FOR The name of your medicine is Carbimazole Macleods 5 mg tablets or Carbimazole Macleods 10 mg tablets or Carbimazole Macleods 15 mg tablets or Carbimazole Macleods 20 mg tablets (it will be referred to as Carbimazole throughout the leaflet). Carbimazole contains the active substance carbimazole. Carbimazole belongs to a group of medicine called anti-thyroid agents. Carbimazole is used to reduce the formation of thyroid hormones in adults and children with an overactive thyroid gland. The conditions is called hyperthyroidism. Carbimazole is also used in more serious cases, for example, to restore the normal function of the thyroid before its partial removal by surgery. It may also be used together with other treatments for hyperthyroidism. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIMAZOLE DO NOT TAKE CARBIMAZOLE: if you are allergic (hypersensitive) to carbimazole or any of the ingredients of Carbimazole. if you are allergic (hypersensitive) to other anti-thyroid medications such as thiamazole, methimazole or propylthiouracil. if you a Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbimazole Macleods 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of carbimazole. Excipient(s) with known effect Lactose monohydrate (97.175mg per tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pink, mottled, round, biconvex uncoated tablets, debossed with "10" on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbimazole Macleods 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 Macleods 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 in the range 5 mg to 15 mg per day, which may be taken as a single daily dose. The Les hele dokumentet