Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Carbimazole
Renata Pharmaceuticals (Ireland) Limited
H03BB01
Carbimazole
Tablet
carbimazole
Marketed
2022-11-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CARBIMAZOLE 5 MG TABLETS CARBIMAZOLE 20 MG 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 only. 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. WHAT IS 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 or 20 mg Tablets (this will be referred to as Carbimazole throughout this leaflet). Carbimazole contains the active substance 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 to carbimazole or any of the ingredients of this medicine (listed in section 6). • If you are allergic to other anti-thyroid medications such as thiamazole, methimazole or propylthiouracil. • If you have a serious blood disorder. • If you have a severe liver disorder. • If you had inflammation of the pancreas (acute pancreatitis) afte Izlasiet visu dokumentu
Health Products Regulatory Authority 30 May 2023 CRN00DJ4T Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbimazole 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Carbimazole 20 mg Tablet contains carbimazole 20 mg. Excipients with known effect: Lactose, anhydrous (211.6 mg/tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 8.5 mm, white, circular-shaped, biconvex uncoated tablets debossed with "20" on one side and "C" on other side. 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 Posology Carbimazole should only be administered if hyperthyroidism has been confirmed by laboratory tests. _ _ 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. Therapy should be continued for at least six months and up to eighteen months. Serial thyroid function monitoring is recommended, together with appropriate dosage modification in order to maintain a euthyroid state. _Blocking-replacement regimen_: Dosage is maintained at the initial level, i.e., 20 mg to 60 mg per day, and supplemental L-thyroxine, 50 mcg to 150 mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should be continued for at least six months and up to eighteen months. Where a single dosage of less than 20 mg is recommended, it i Izlasiet visu dokumentu