Label: information for the patient

Sodium Iodide (123I) GE Healthcare 37 MBq/ml injectable solution.

Sodium Iodide (123I)

Read this label carefully before this medication is administered, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure..
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

Sodium iodide (123I) is used only to help identify diseases.

Sodium iodide (123I) is a “radiopharmaceutical”. It is administered before an examination and with the help of a special camera allows to see inside a part of the body.

•It contains an active ingredient called “sodium iodide”.

•Once injected, it can be detected from the outside of the body by a special camera used in the examination.

•The examination may help the doctor to see the thyroid gland and how it functions.

The administration of Sodium iodide (123I) involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Sodium Iodide (123I) should not be used

• if you are allergic to Sodium Iodide (123I) or any of the other ingredients (listed in section 6).

Warnings and precautions

Be especially careful with Sodium Iodide (123I):

• if you are pregnant or think you may be pregnant.
• if you are breastfeeding.

Before administration ofSodium Iodide (123I)you should:

Drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion.

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old.

Use of Sodium Iodide (123I) with other medicines

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medicine, as some medicines may interfere with image interpretation.

Before the examination, inform your doctor if you are using any of the following medicines.

• Anti-inflammatory medicines such as phenylbutazone.
• Anti-thyroid medicines, such as propylthiouracil or methimazole.
• Expectorants, such as cough medicines (used to remove mucus from the respiratory tract).
• Salicylates such as aspirin (used to treat pain or heart disease).
• Glucocorticoids, such as hydrocortisone, prednisolone, or dexamethasone.
• Benzodiazepines such as diazepam, temazepam, and nitrazepam (used to treat anxiety or sleep disorders).
• Medicines used to treat thyroid disorders such as levothyroxine sodium or liothyronine sodium.
• Medicines taken before some types of examinations such as perchlorate.
• Medicines used to treat infections such as antiparasitic, penicillins, sulfonamides.
• Amiodarone and medicines for irregular heart rhythm.
• Lithium (used to treat certain conditions such as depression or mental health problems).
• Sodium nitroprusside (used to treat high blood pressure).
• Sulfobromophthalein sodium (used to evaluate liver function).
• Topical iodides (used to clean the skin before surgery).
• Anticoagulants (used to thin the blood).
• Antihistamines (used to treat or prevent allergic reactions).
• Tolbutamide (used in people with diabetes to lower blood glucose levels).
• Thiopental (used as a general anesthetic).
• Medicines administered in hospital for X-rays or examinations (intravenous contrast media).
• Vitamins.

If you are unsure if you are in any of the above circumstances, consult your doctor before using Sodium Iodide (123I).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before this medicine is administered.

You must inform your nuclear medicine doctor before the administration of Sodium Iodide (123I) if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant:

The nuclear medicine doctor will only administer this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding:

Do not breastfeed while using Sodium Iodide (123I) as small amounts of "radioactivity" may pass into breast milk. If you are breastfeeding, your doctor may wait until you have finished breastfeeding before using Sodium Iodide (123I). If this is not possible, your doctor may ask you to:

•interrupt natural breastfeeding for 1.5 to 3 days,

•use artificial milk to feed your child; and

•express and discard breast milk.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machinery

Consult your doctor if you can drive or operate machinery after administration of Sodium Iodide (123I).

Sodium Iodide (123I) contains sodium:This medicine contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Sodium Iodide ( 123 I) will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who will use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide on the amount of Sodium Iodide ( 123 I) to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult ranges from 3.7 to 14.8 MBq (MegaBecquerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the dose to be administered will be adjusted according to their body weight.

Administration of Sodium Iodide ( 123 I) and procedure performance

Sodium Iodide ( 123 I) is administered via intravenous injection.

One injection is sufficient to perform the procedure your doctor needs.

The examination is usually done 3 to 6 hours after the injection.

Procedure duration

Your nuclear physician will inform you about the usual duration of the procedure.

After administration of Sodium Iodide ( 123 I), you should:

Urinate frequently to eliminate the product from your body.

Your nuclear physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear physician if you have any doubts.

If you have been administered more Sodium Iodide ( 123 I) than you should

It is unlikely to experience an overdose because you will receive a controlled and precise dose of Sodium Iodide ( 123 I) from the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any doubts about the use of Sodium Iodide ( 123 I) injectable solution, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Allergic Reactions

If you experience an allergic reaction while in the hospital or clinic undergoing the examination, inform your doctor immediately. The signs may be:

•skin rash, itching, flushing

•swelling of the face

•difficulty breathing

If you experience any of the previously mentioned adverse effects after leaving the hospital or clinic, go directly to the emergency department of the nearest hospital.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored. This medication is stored under the responsibility of specialists in appropriate facilities. Radioactive material storage will be carried out in accordance with national regulations.

The following information is intended solely for the specialist.

Do not use sodium iodide (123I) after the expiration date that appears on the label after CAD.

Composition of Sodium Iodide (123I)injectable solution

• The active ingredient is Sodium Iodide (123I) 37 MBq/ml at the date and time of calibration
• The other components are acetic acid, sodium hydroxide, sodium thiosulfate, sodium bicarbonate, sodium chloride, and water for injectable preparations.

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Appearance of the product and contents of the packaging

Sodium Iodide (123I) is supplied in a multi-dose glass vialclosed with a teflon-coated stopper and sealed with an aluminium capsule. Each vial is introduced into a lead container of adequate thickness.

Each vial contains between 0.5 ml and 10 ml of injectable solution. The activity range per vial oscillates between 18.5 MBq and 370 MBq at the date and time of calibration

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

GE Healthcare Bio-Sciences, S.A.U.

C/ Gobelas, 35-37

28023 Madrid

Spain

Manufacturer

GE Healthcare B.V.

De Rondom 8

5612 AP Eindhoven

Netherlands

Last review date of this leaflet: July 2020

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:// www.aemps.gob.es /

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This information is intended solely for doctors or healthcare professionals.

The complete technical data sheet for Sodium Iodide (123I) is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.