Each film coated tablet contains :
Active ingredient : Carbimazole 5 mg.
Inactive ingredients: Dried maize starch, lactose anhydrous, vivacel, polyvinyl pyrrolidone K90, magnesiumstearate,eudragit E 100, talc, titanium dioxide, iron oxide red, puri1ted water.
Therapeutic Indications :
Cartlimazole is an anti-thyroid agent, it is indicated in all conditions where reduction 01. thyroid function is required.
– Preparation for thyroidectomy in hyperthyroidism.
– Therapy prior to and post radio-iodine treatment.
Posology and method of administration :
The initial dose is in the range 20 – 60 mg, taken as two to three divided doses. This is continued until the patient is euthyroid. Subsequent therapy may then be administered in one 01. two ways.
Maintenance regimen: Dosage is gradually reduced SO as to maintain a euthyroid state. Final dosage is usually in the range 5 – 15 mg per day, which may be taken as a Single daily dose. Therapy should be continued for at least six, and up to eighteen months.
blocking-replacement regimen: Dosage is maintained at the initial level, i.e. 20 – 60 mg per day, and supplemental-I thyroxine, 50 -150 mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should.be continued for at least at six months, and up to eighteen months
No special dosage regimen is required, but care should be taken to observe the contraindications and warnings.
The usual initial daily dose is 15 mg per day.
Cartlimazole is contraindicated in patients with a previous history 01. adverse reactions to cartlimazole
Special warnings and special precautions for use :
Palients should be warned about the onset 01. sore throats, mouth ulcers, pyrexia or other symptoms which might suggest the early development 01. bone marrow depression. In such cases it is important that drug treatment is stopped and medical advice sought immediately. In such patients, blood cell counts should be performed, particularly where there is any clinical evidehce of infection. Early withdrawal of the drug will increase the chance of complete recovery. Cartlimazole should be used with caution in patients with liver disorders. Cartlimazole should be stopped temporarily at the time of administration of radio-iodine.
The use of cartlimazole in non-pregnant women of childbearing potential should be based on individual risklbenefit assessment.
Interaction with other medicinal products and other forms of Interaction:
pregnancy & Lactation :
Cartlimazole crosses the placenta but, providedthe ~mothei’s dose
is within the standard range, and her thyroid status is monitored; there is no evidence of neonatal thyroid abnormalities.
Studies have shown that the incidence of congenital malt.ormations is greater in the children of mothers whose hyperthyrOidism has remained untreated than in those to whom treatment with
cartlimazole has been given. However, very rare cases of congenital malformations have been observed following the use of cartlimazole or its active metabolite methimazole during pregnancy. A causal relationship of these malformations, especially choanal atresia and aplasia cutis congenita, to transplacental exposure to cartlimazole and methimazole cannot be excluded. Therefore, the use of cartlimazole in non- pregnant women of childbearing potential should be based on individual risklbenefit assessment.
The dose of cartlimazole must be regulated by the patient’s clinical condition. The lowest dose possible should be used, and this can often be discontinued three to four weeks before term, in order to reduce the risk of neonatal complications. The blocking-replacement regimen should not be used during pregnancy Since very little thyroxine crosses the Placenta in the last trimester.Carbimazole is secreted in breast milk and, if treatment is continued during lactation, the patient should not continue to breastfeed her baby.
Effects on Ability to Drive & Use Machines :
Undesirable Effects :
Adverse reactions usually occur in the first eight weeks of treatment. The most frequently occurrinQ reactions are nausea, headache, arthralgia, mild gastriC distress, skin rashes and pruntus. These reactions are usually self-limiting and may not require withdrawalof the drug.
Blood and lymphatic system disorders :Bone marrow depression has been reported and can lead to agranulocytosis. Rare
cases of pancytopenia/aplastic anaemia and isolated thrombocytopenia have also been reported. Additionally, very rare cases of haemolytic anaemia have been reported. Patients should always be instructed to recognize symptoms which may suggest bone marrow depression, to stop the drug and to seek medical advice immediately. In such patients, blood cell counts should be performed immediately, particularly where there is any clinical evidence of infection.
Nervous system disorders : Headache.
Gastrointestinal system disorders: Nausea, mild gastric distress.
Hepato-biliary system disorders :Hepatic disorders, most commonly jaundice, have been reported; in these cases carbimazole should be withdrawn.
Skin and subcutaneous tissue disorders : Skin rashes, pruritus, urticaria. Hair loss has been occasionally reported.
Musculoskeletal system disorders : Isolated cases of myopathy have been reported. Patients experiencing myalgia after the intake of carbimazole should have their creatine phosphokinase levels monitored.
N.B. : The product contains 0.073 g lactose per unit dose. This should be taken into account in patients with diabetes mellitus.
No symptoms are likely from a single large dose and so no specific treatment is indicated.
Pharmacological Properties :
Pharmacodynam’c properties: Carbimazole is a thyroid reducing agent.
Pharmacokinetic properties: Carbimazole is rapidly metabolised to methimazole. The mean peak plasma concentration
of methimazole is reported to occur one hour after a single dose of carbimazole. The apparent plasma half-life of methimazole is reported as 6.4 hours.
Preclinical safety data : Not relevant.
Incompatibilities : None known.
– Carton box contains 5 ( All PVC) strips each of 10 f.c. tablets and an inner leaflet.
– Carton box contains 100 (N I PVC) strips each of 10 f.c. tablets and an inner leaflet. – Or carton box containing 20 plastic jar, each of 50 f.c. tablets and an inner leaflet (Tender and export pack).
Store at temperature not exceeding 30°C, in dry place.
Produced by :
Chemical Industries Development (CID) – Giza – A.R.E