מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbimazole
DE Pharmaceuticals
H03BB01
Carbimazole
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200
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 Tablets are and what they are used for 2. What you need to know before you take Carbimazole Tablets 3. How to take Carbimazole Tablets 4. Possible side effects 5. How to store Carbimazole Tablets 6. Contents of the pack and other information 1. WHAT CARBIMAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR Carbimazole belongs to a group of medicines called anti- thyroid agents. It is used in adults and children for the following: • Hyperthyroidism, which is a condition where in the thyroid gland is hyperactive. Carbimazole is used to reduce the formation of thyroid hormones. • Treatment in more serious cases, for example, to restore the normal function of the thyroid before its partial removal by surgery. • It is also used together with other treatments for overactive thyroid. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIMAZOLE TABLETS DO NOT TAKE CARBIMAZOLE TABLETS IF YOU: • are allergic to carbimazole or any of the other ingredients of this medicine (listed in section 6) • have a serious blood disorder • have a severe liver disorder • had inflammation of the pancreas (acute pancreatitis) after administration of carbimazole or thiamazole in the past. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Carbimazole Tablets if you: • have bone marrow depression • have mild or moderate liver problems • are receiving radio-iodine (for thyroid problems) • have swelling in your neck called an ‘i קרא את המסמך השלם
OBJECT 1 CARBIMAZOLE 5MG TABLETS Summary of Product Characteristics Updated 23-Jan-2020 | Accord-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 Carbimazole 5mg Tablets 2. Qualitative and quantitative composition Each tablet contains Carbimazole Ph. Eur. 5mg Excipients with known effect: Each tablet also contains lactose monohydrate. For full list of excipients, see section 6.1 3. Pharmaceutical form Tablet White, round, biconvex, uncoated tablets with a score line on one side and embossed 'F1' on the other 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. 1. Hyperthyroidism. 2. Preparation for thyroidectomy in hyperthyroidism. 3. Preparation for, and as concomitant therapy with, radio-iodine treatment. 4.2 Posology and method of administration Carbimazole should only be administered if hyperthyroidism has been confirmed קרא את המסמך השלם