Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Carbimazole
Essential-Healthcare Ltd.
H03BB; H03BB01
Carbimazole
20 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Sulfur-containing imidazole derivatives; carbimazole
Not marketed
2018-06-14
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBIMAZOLE 5MG TABLETS CARBIMAZOLE 20MG TABLETS ( CARBIMAZOLE ) 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 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. IN THIS LEAFLET: 1. What Carbimazole is and what it is used for 2. What you need to know before you take Carbimazole 3. How to take Carbimazole 4. Possible side effects 5. How to store Carbimazole 6. Contents of the pack and other information 1. WHAT CARBIMAZOLE IS AND WHAT IT IS USED FOR The name of your medicine is Carbimazole 5 mg Tablets or Carbimazole 20 mg Tablets (this will be referred to Carbimazole throughout the leaflet). Carbimazole contains the active ingredient carbimazole. Carbimazole belongs to a group of medicines called anti-thyroid agents. Carbimazole is used to reduce the formation of thyroid hormones in adults and children with an overactive thyroid gland. The condition 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 other ingredients of Carbimazole. If you are allergic (hypersensitive) to other anti-thyroid medicines such as thiamazole, methimazole or propylthiouracil . If you are breast-feeding. If you have a severe liver disorder. If you have a serious blood disorder. If you had inflammation of Lugege kogu dokumenti
Health Products Regulatory Authority 12 January 2021 CRN00C3SF Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbimazole 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains 20 mg carbimazole. _Excipient with known effect: _ Each tablet contains 280 mg of lactose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White coloured, 9.60mm round shaped standard concave, uncoated tablet plain on one side and scoreline on other side. 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 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 the Lugege kogu dokumenti