Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity to be administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
There is little evidence of an increased incidence of cancer, leukaemia or mutations in patients after treatment with radioiodine for benign thyroid diseases, despite its extensive use. In the treatment of malignant thyroid diseases, in a study conducted on patients with doses of sodium iodide (131I) higher than 3700 MBq a higher incidence of bladder cancer was reported. Another study reported a slight increase in leukaemia in patients receiving very high doses. Therefore, total cumulative doses greater than 26000 MBq are not recommended.
Gonadal function in males
The use of the sperm bank could be considered to compensate a potential reversible damage of gonadal function in males due to the high therapeutic dose of radioiodine, in the cases of patients with extensive disease.
Patients with renal impairment
Careful consideration of the benefit/risk balance in these patients is required since an increased radiation exposure is possible. In these patients it may be necessary to adjust the posology.
Paediatric population
Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11). When treating children and young adults, account must be taken of the greater sensitivity of child tissue and the greater life expectancy of such patients. The risks should .be weighed against those of other possible treatments (see sections 4.2 and 11).
The radioiodine treatment of benign thyroid diseases of children and adolescents may be performed only in justified cases, especially in relapse after use of antithyroid medicinal products or in case of serious adverse reactions to antithyroid medicinal products. There is no evidence of an increased incidence of cancer, leukemia or mutations in humans with respect to patients treated for benign thyroid disease with radioiodine, despite extensive use.
Persons who have received radiotherapy of the thyroid as children and adolescents, should be re- examined once a year.
Patient preparation
Patients should be encouraged to increase oral fluids and urged to void as often as possible to reduce bladder radiation, especially after high activities e.g. for the treatment of thyroid carcinoma. Patients with bladder voiding problems should be catheterized after administration of high activities of radioiodine.
To reduce colon radiation exposure, mild laxatives (but not stool softeners which do not stimulate the bowel) may be necessary in patients having less than one bowel movement a day.
To avoid sialoadenitis that may occur after high dose radioiodine administration, the patient should be advised to take sweets or drinks containing citric acid (lemon juice, vitamin C) to stimulate saliva excretion before therapy. Other pharmacological protection measures may be used additionally.
Iodide overload from food or medicinal treatment should be investigated before administration of iodide (see section 4.5). A low-iodine diet prior to therapy is recommended to enhance uptake into functioning thyroid tissue.
Thyroid replacement should be stopped prior to radioiodine administration for thyroid carcinoma to ensure adequate uptake. It is recommended to stop triiodothyronine treatment for a period of 14 days and to stop thyroxine treatment for a period of 4 weeks. They should be restarted two days after treatment.
Carbimazole and propylthiouracil should be stopped 1 week prior to treatment of hyperthyroidismand restarted several days after treatment.
Hyponatraemia: Serious manifestations of hyponatraemia have been reported after sodium iodide (131I) therapy in elderly patients who have undergone total thyroidectomy. Risk factors include older age, female sex, use of thiazide diuretics and hyponatraemia at the start of sodium iodide (131I) therapy.
Regular serum electrolytes measurements shall be considered for these patients.
The radioiodine treatment of Graves’ disease should be performed under concomitant treatment of corticosteroids, particularly when endocrine ophthalmopathy is present.
In patients with suspected gastrointestinal disease, great care should be taken when administering sodium iodide (131I) capsules. Concomitant use of H2- antagonists or proton pump inhibitors is advised.
After the procedure
Close contact with infants and pregnant women should be restricted for at least one week after therapeutic doses.
In case of vomiting, the risk of contamination has to be considered.
Patients receiving therapy of the thyroid should be re-examined at appropriate intervals.
Specific warnings
This medicinal product contains 50 mg of sodium per capsule., equivalent to 2.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For precautions with respect to environmental hazard see section 6.6.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive or use machines have been performed.