Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Renal impairment
The therapeutic administration of 131I capsules in patients with significant renal impair- ment, in which an activity adjustment is necessary, requires special attention.

Paediatric population
In the treatment of children and adolescents, the radioiodine treatment of benign thyroid diseases may be performed in justified cases, especially in relapse after use of antithyroid medicinal prod- ucts or when serious adverse reactions to antithyroid medicinal products do occur. There is no evi- dence of an increased incidence of cancer, leukemia or mutations in man with respect to patients treated for benign thyroid disease with radioiodine, despite extensive use. In the treatment of chil- dren and young people however, account must be taken of the greater sensitivity of child tissue and the greater life expectancy of such patients. The risks must also be weighed against those of other possible treatments. See sections 4.2 and 11.

Patient preparation
Patients should be encouraged to increase oral fluids and urged to void as often as possible to re- duce bladder radiation, especially after high activities e.g. for the treatment of thyroid carcinoma.
Patients with bladder voiding problems should be catheterised after administration of high activities of radioiodine.



The capsules should be swallowed whole with sufficient fluid to ensure clear passage into the stomach and upper small intestine. Concomitant use of H2 antagonists or proton pump inhibitors is advised in order to address the possible gastrointestinal reactions.
In case of vomiting, the risk of contamination has to be considered.

General warnings
Radiopharmaceuticals may be received, used and administered only by authorised persons in des- ignated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regula- tions and/or appropriate licences of the local competent official organisation. Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiological and pharmaceutical quality requirements.

This preparation is likely to result in relatively a high radiation dose to most patients (see sections 4.8 and 11). The administration of high dose radioiodine may result in significant environmental hazard. This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered. Suitable precautions should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.

Specific warnings
The radiation exposure of the salivary glands should be reduced by stimulating saliva excretion with acidic substances. Other pharmacological protection measures may be used additionally.

A low iodine diet prior to therapy will enhance uptake into functioning thyroid tissue.

Thyroid replacement should be stopped prior to radioiodine administration for thyroid carcinoma to ensure adequate uptake. A period of 14 days is recommended for triiodothyronine and 4-5 weeks for thyroxine. They should be restarted two days after treatment. Similarly carbimazole and propy- thiouracil should be stopped five days prior to treatment of hyperthyroidism and restarted several days later.

The radioiodine treatment of Graves’ disease should be performed under concomitant treatment of corticosteroids.

Capsule T should not be used for thyroid scanning except in the follow-up of malignant disease or when I-123 or Tc-99m are not available.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Patients receiving therapy of the thyroid should be re-examined at appropriate intervals.

If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable im- mediate action in emergencies, the necessary medicinal products and equipment such as endotra- cheal tube and ventilator must be immediately available

This medicinal product contains 63.5 mg of sodium per dose. To be taken into account by patients on a controlled sodium diet.



Effects on Driving

4.7   Effects on ability to drive and use machines
Sodium Iodide (I131) Capsule T has no or negligible influence on the ability to drive and use ma- chines.