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1. NAME of the MEDICINAL PRODUCT Carbimazole Orifarm 5

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1. NAME of the MEDICINAL PRODUCT Carbimazole Orifarm 5 1. NAME OF THE MEDICINAL PRODUCT Carbimazole Orifarm 5 mg, 10 mg, 15 mg and 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Carbimazole Orifarm 5 mg Each tablet contains 5 mg carbimazole. Excipient with known effect: Lactose monohydrate 48.6 mg (see section 4.4). Carbimazole Orifarm 10 mg Each tablet contains 10 mg carbimazole. Excipient with known effect: Lactose monohydrate 97.2 mg (see section 4.4). Carbimazole Orifarm 15 mg Each tablet contains 15 mg carbimazole. Excipient with known effect: Lactose monohydrate 145.8 mg (see section 4.4). Carbimazole Orifarm 20 mg Each tablet contains 20 mg carbimazole. Excipient with known effect: Lactose monohydrate 194.4 mg (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Carbimazole Orifarm 5 mg Pink, mottled, round, biconvex uncoated tablets, debossed with "5" on one side and plain on the other side. Diameter 5 mm. Carbimazole Orifarm 10 mg Pink, mottled, round, biconvex uncoated tablets, debossed with "10" on one side and plain on the other side. Diameter 6.5 mm. Carbimazole Orifarm 15 mg Pink, mottled, round, biconvex uncoated tablets, debossed with "15" on one side and plain on the other side. Diameter 7.4 mm. Carbimazole Orifarm 20 mg Pink, mottled, round, biconvex uncoated tablets, debossed with "2 and 0" separated by a score line on one side and plain on the other side. Diameter 8 mm. The 20 mg tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications 1 Long-term treatment of thyrotoxicosis, Basedow's disease (Graves' disease), especially cases with minor, diffuse goitre or without goitre. Therapy prior to radio-iodine treatment or preparation for thyroidectomy. 4.2 Posology and method of administration The dosage is individual and dependent on the severity of the disease. Carbimazole Orifarm should only be administered if hyperthyroidism has been confirmed by laboratory tests. Posology Adults Severe cases: The initial dose is in the range 20-60 mg (depending on the severity of hyperthyroidism), taken as 2-3 divided doses. The patient should be monitored clinically and 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. Mild cases: Initially 20 mg daily. Maintenance regimen: Following normalization of serum thyroxine treatment should be continued, but gradually reduced in steps of 5-20 mg daily, every 10 day until daily dose is 5-20 mg. Therapy should be continued for at least 6 months and up to 18 months with simultaneous control of serum thyroxine. Maintenance dose should be determined according to clinical criteria and laboratory parameters. In some cases, very large doses are required initially, e.g. 120 mg daily. This especially applies to very large goitre and if the patient has received iodine treatment. Serial thyroid function monitoring is recommended, together with appropriate dosage modification in order to maintain an euthyroid state. Blocking-replacement regimen: The treatment is initiated with carbimazole followed by concomitant L-thyroxine administration, in order to prevent hypothyroidism. Therapy should be continued for at least 6 months and up to 18 months. Note that blocking-replacement therapy should not be used during pregnancy (see section 4.6). Special populations Elderly 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 and over). Paediatric population Use in children and adolescents (3-17 years of age) The dose of carbimazole ranges from 0.2-0.5 mg/kg body weight per day divided into 2 doses and is adjusted based on the circulating levels of T4 and T3. For maintenance therapy, the daily dose can be reduced depending on the response of the patient to the treatment. Additional treatment with levothyroxine may be required to avoid hypothyroidism. 2 5 mg tablets: The tablets are not suitable for children with a body weight below 20 kg. For children weighing 20-50 kg, the suitability of the 5 mg tablet depends of the dosage needed. 10 mg, 15 mg and 20 mg tablets: The tablets are not suitable for the small children. The maximum recommended dose of carbimazole is 30 mg/day. 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 not recommended. Patients with mild to moderate hepatic impairment Patients with hepatic impairment, see section 4.4. Method of administration Oral use. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Serious, pre-existing haematological conditions (granulocytopenia). Severe hepatic insufficiency. Breast-feeding (see section 4.6). Patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole. 4.4 Special warnings and precautions for use Treatment with carbimazole is associated with a risk of inhibiting hematopoiesis (leucopenia, granulocytopenia, agranulocytosis, pancytopenia/aplastic anaemia, haemolytic anaemia, thrombocytopenia) and of liver damage. Agranulocytosis or aplastic anaemia may develop within a short period of time, from a few hours to a few days (see section 4.8). Fatalities with carbimazole-induced agranulocytosis have been reported. As early treatment of agranulocytosis is essential, it is important that patients should always be warned about the onset of sore throats, bruising or bleeding, mouth ulcers, fever or malaise and should be instructed to stop the drug and to seek medical advice immediately. In such patients, white blood cell counts should be performed immediately, particularly where there is any clinical evidence of infection. Considering the risk of agranulocytosis, particular following doses of over 40 mg/day and in patients aged over 40 and within the first two months of treatment, the blood picture should be closely monitored before and after initiation of treatment, especially in the case of existing mild granulocytopenia. Following the onset of agranulocytosis, aplastic anaemia (pancytopenia) or severe hepatic impairment, treatment should be discontinued immediately and appropriate treatment initiated if necessary. Patients treated with this medicine should be instructed to seek medical advice as soon as possible if fever, pharyngitis, stomatitis, furunculosis or any other infection occurs. Following the onset of any signs and symptoms of hepatic disorder (pain in the upper abdomen, anorexia, general pruritus) in patients, the drug should be stopped and liver function tests performed immediately. Early withdrawal of the drug will increase the chance of complete recovery. Carbimazole should be used with caution in patients with iodine level imbalance. Carbimazole should be used with caution in patients with mild-moderate hepatic insufficiency. Carbimazole can cause liver disease. If abnormal liver function is discovered, the treatment should be stopped. The half- life may be prolonged due to liver disorder. 3 Carbimazole should be stopped temporarily if radio-iodine is administered. Should the volume of the goitre increase, the dose of carbimazole should not be increased, since growth in volume is more likely to occur following overdosing of the preparation. As carbimazole can cause hypoprothrombinemia and clinical bleeding, thromboplastin time monitoring is recommended during treatment and especially prior to any surgery. Patients unable to comply with the instructions for use or who cannot be monitored regularly should not be treated with carbimazole. Regular full blood count checks should be carried out in patients who may be confused or have a poor memory. Control of serum thyroxine is necessary. Precaution should be taken in patients with intrathoracic goitre, which may worsen during initial treatment with carbimazole. Tracheal obstruction may occur due to intrathoracic goitre. Patients experiencing myalgia after the intake of carbimazole should have their creatine phosphokinase levels monitored. Women of childbearing potential have to use effective contraceptive measures during treatment. The use of carbimazole in pregnant women must be based on the individual benefit/risk assessment. If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered. Close maternal, foetal and neonatal monitoring is warranted (see section 4.6). There is risk of cross-allergy between carbimazole, thiamazole (methimazole) and propylthiouracil. There have been post-marketing reports of acute pancreatitis in patients receiving carbimazole or its active metabolite thiamazole. In case of acute pancreatitis, carbimazole should be discontinued immediately. Carbimazole must not be given to patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole. Re-exposure may result in recurrence of acute pancreatitis, with decreased time to onset. Carbimazole Orifarm contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction The effect of carbimazole is significantly
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