Adverse reactions usually occur in the first eight weeks of treatment. The most frequently occurring reactions are nausea, headache, arthralgia, mild gastric distress, skin rashes and pruritus. These reactions are usually self-limiting and may not require withdrawal of the drug.
The undesirable effects are listed below by system organ class and the following frequency convention: Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) Not known (cannot be estimated from the available data). System Organ Class Frequency Adverse events Blood and lymphatic system disorders Rare Very rare Not known Purpura, anaemia, pancytopenia/aplastic anaemia,neutropenia, leucopenia and isolated thrombocytopenia have also been reported.
ageusia, acute salivary gland swelling Hepatobiliary disorders Not known Hepatic disorders, including abnormal liver function tests, hepatitis, cholestatic hepatitis, cholestatic jaundice and most commonly jaundice, have been reported*.
Skin and subcutaneous tissue disorders Very rare Not known Severe cutaneous hypersensitivity reactions in both adult and paediatric patients, including Stevens-Johnsons syndrome**. Skin rash, pruritus, urticaria. Alopecia. Musculoskeletal and connective tissue disorders Not known Patients experiencing myalgia after the intake of Carbamazole should have their creatine phosphokinase levels monitored.
Isolated cases of myopathy have been reported. General disorders and administration site conditions Not known Pyrexia, malaise Injury, poisoning and procedural complications Not known Contusion Patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever and malaise and should be instructed to stop the drug and to seek medical advice immediately.
In such patients, blood cell counts should be performed, particularly where there is any clinical evidence of infection. * in these cases, carbimazole should be withdrawn. ** very rare including isolated reports: severe forms, including generalised dermatitis, have only been described in isolated cases Paediatric population Frequency, type and severity of adverse reactions in children appear to be comparable with those in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.