10 % Capsules

123 I - CAPSULES are radiopharmaceuticals suitable for the diagnostic examination of your thyroid and the diagnosis of thyroid cancer.

123 I - CAPSULES should not be administered to you :

• if you are hypersensitive (allergic) to iodine or any of the other ingredients of 123 I - CAPSULES (listed in section 6).

Warnings and precautions

123 I - CAPSULES are radioactive and should only be handled and administered by legally authorised personnel. Tell your doctor or health care provider before being given 123 I - CAPSULES:

• if you are pregnant, as 123 I - CAPSULES are not recommended for pregnant patients.
• If you are breast feeding your baby since the iodine - 123 in the capsules is excreted in human milk. You will have to substitute breastfeeding with formula feeding.

Other medicines and 123 I - CAPSULES

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Pregnancy and breastfeeding

The safety of 123 I - CAPSULES in pregnant women has not been established. Since the iodine - 123 in 123 I - CAPSULES is excreted in breast milk, you should substitute breastfeeding with formula feeding if you are breastfeeding your baby.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being given this medicine.

Driving and using machines

It is not always possible to predict to what extent 123 I - CAPSULES may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which 123 I - CAPSULES affects them.

You will not be expected to give yourself 123 I - CAPSULES. It will be given to you by a person who is qualified to do so. You will be given one capsules orally before your diagnostic examination.

If you take more 123 I - CAPSULES than you should

Since a health care provider will administer 123 I - CAPSULES, he or she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take 123 I - CAPSULES

Since a health care provider will administer 123 I - CAPSULES, it is unlikely that the dose will be missed.

No side - effects are known. However, should your general health worsen or if you experience any untoward effects while being given 123 I - CAPSULES, please inform your doctor or health care provider.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of 123 I - CAPSULES.

You will not be expected to store 123 I - CAPSULES yourself. It will be stored by a person who is qualified to do so.