Sodium iodide (123I) capsules GE Healthcare S.R.L.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sodium Iodide ( I) GE Healthcare S.r.l. 3.7 MBq hard capsules

Sodium Iodide ( I) GE Healthcare S.r.l. 7.4 MBq hard capsules
Sodium Iodide ( I) GE Healthcare S.r.l. 18.5 MBq hard capsules
Sodium Iodide ( I)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist in charge of performing the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What Sodium Iodide ( I) GE Healthcare S.r.l. hard capsules is and what it is used for
2. What you need to know before being administered Sodium Iodide ( I) GE Healthcare S.r.l. hard capsules
3. How Sodium Iodide ( I) GE Healthcare S.r.l. hard capsules are used
4. Possible side effects
5. How Sodium Iodide ( I) GE Healthcare S.r.l. hard capsules are stored
6. Contents of the pack and other information

1. What Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules is and what it is used for

This medicinal product is a radiopharmaceutical intended for diagnostic use only. It is used solely to help identify possible diseases.
Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules are administered before a scan and help a special imaging device to visualize the inside of a part of your body.

• It contains an active substance called 'sodium iodide'.
• Once taken, it can be detected from outside your body by the imaging device used for the diagnostic examination.
• The scan can help your doctor to see the thyroid gland and assess how it is functioning.

The nuclear medicine physician will explain to you which part of your body will be examined.
The use of Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist have determined that the clinical benefit of this examination performed with a radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you need to know before you are given Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules

Hard capsules
Do not use Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules:

• If you are allergic (hypersensitive) to sodium iodide ( I) or to any of the excipients of this medicine (listed in section 6).
• If you have difficulty swallowing or have certain stomach or intestinal problems, such as outpouchings in the esophageal wall or a lesion in the walls of the esophagus, stomach, or duodenum.

Do not take Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules if any of the above apply to you. If in doubt, speak with your nuclear medicine physician or nurse.

Warnings and precautions
Exercise particular caution with Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules
Check with your nuclear medicine physician or nurse before being given Sodio Ioduro ( I) hard capsules:

• If you are pregnant or think you might be pregnant.
• If you are on a low-sodium diet.
• If you are under 18 years of age. The capsules are not suitable for patients under 18 years of age, particularly children under 10 years of age.
• If you are breastfeeding.

Before administration of Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules, you must:
Drink plenty of fluids before undergoing the examination, so as to urinate as frequently as possible during the first few hours after the examination.

Children and adolescents
Inform the nuclear medicine specialist if you are under 18 years of age.

Other medicines and Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules
Inform the nuclear medicine specialist or nurse if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal remedies.
This is because some medicines may interfere with Sodio Ioduro ( I) hard capsules.
Before undergoing the examination, inform the nuclear medicine specialist if you are taking any of the following types of medicines, as they may interfere with image interpretation:

• Anti-inflammatory drugs, such as phenylbutazone.
• Antithyroid drugs, such as carbimazole, propylthiouracil, or methimazole.
• Expectorants, such as certain cough medicines.
• Salicylates, such as aspirin.
• Steroids (such as hydrocortisone, prednisolone, or dexamethasone).
• Benzodiazepines (such as diazepam, temazepam, and nitrazepam).
• Medicines used to treat thyroid disorders, such as sodium levothyroxine or sodium liotironine.
• Medicines taken before certain types of scans, such as perchlorate.
• Medicines used to treat infections, such as antiparasitics, penicillins, sulfonamides.
• Amiodarone and antiarrhythmic drugs (used to treat irregular heartbeat).
• Lithium (used in the treatment of certain conditions, such as depression or mental disorders).
• Sodium nitroprusside (used to treat very high blood pressure).
• Sodium sulfobromophthalein (used to test liver function).
• Topical iodides (used to disinfect 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 sugar levels).
• Thiopental (used as a general anesthetic).
• Medicines administered in hospital for X-rays or scans (intravenous contrast agents, with or without iodine).
• Vitamins.

If you are unsure whether any of the above apply to you, inform your nuclear medicine physician or nurse before taking Sodio Ioduro ( I) hard capsules.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your nuclear medicine specialist before being administered this medicine.
You must inform the nuclear medicine specialist before administration of Sodio Ioduro hard capsules if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist performing the examination.

If you are pregnant
The nuclear medicine specialist will administer this medicine during pregnancy only if they determine that the expected benefit outweighs the potential risk.

If you are breastfeeding
Do not breastfeed after being administered Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules.
This is because small amounts of radioactivity may pass into breast milk.
If you are breastfeeding, the nuclear medicine specialist should wait until after the end of breastfeeding before using Sodio Ioduro ( I) hard capsules.
If waiting is not possible, the nuclear medicine specialist will ask you:

• To stop breastfeeding for 1.5–3 days.
• To use infant formula for your baby.
• To express (remove) breast milk and discard it. Your doctor will inform you when you can resume breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

Important information about Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules
When Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules are used, you are exposed to radioactivity.

• Your doctor will always assess the potential risks and benefits before administering this medicine. Ask your doctor if you have any questions.

Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules contains sodium
This medicine contains 97.4 mg of sodium per capsule. This should be taken into account if you are on a low-sodium diet.

3. How Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules are used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules will only be used in designated controlled areas.
This product will be handled and administered exclusively by trained and qualified personnel experienced in its safe use.

• Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules will always be used in a hospital or clinic setting.
• The medical staff will ensure the product is used safely and will inform you about the measures taken. The nuclear medicine specialist performing the examination will determine the amount of Sodio Ioduro (I) hard capsules to be used in your case. The minimum necessary dose required to obtain the desired diagnostic information will be administered. The usual administered activity for an adult ranges between 3.7 MBq and 18.5 MBq. (The megabecquerel is the unit of measurement of radioactivity).

Administration of Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules and performance of the procedure:
Sodio Ioduro (I) hard capsule is administered orally.
Usual dose:

• one capsule.

You will be asked to take Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules with water. The capsule must be swallowed whole. Imaging is usually performed between 3 and 6 hours after capsule ingestion.
Duration of the procedure
Your nuclear medicine physician will inform you about the duration of the procedure.
After administration of Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules, you must:

• Avoid close contact with infants and pregnant women.
• Urinate as frequently as possible to eliminate the product from your body.

The nuclear medicine specialist will inform you if any special precautions are necessary after receiving this medicinal product. If you have any questions, please contact the nuclear medicine specialist.
If you have been given more Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules than you should have:
Cases of overdose are unlikely, as you will receive a single, carefully controlled dose of Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules, administered under the supervision of the specialist in charge of the examination. However, in the event of an overdose, appropriate treatment will be provided.
If you have any questions about the use of Sodio Ioduro (I) GE Healthcare S.r.l. hard capsules, please consult the nuclear medicine specialist in charge of the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

If you experience an allergic reaction while you are in hospital or at a clinic undergoing the examination, inform your doctor or nurse immediately.
Signs may include:

• skin rash or itching or hot flushes
• swelling of the face
• difficulty breathing.

Other side effects include
Not known – frequency cannot be estimated from the available data

• nausea, vomiting
• itching, skin rash and urticaria

If any of the above side effects occur after you have left the hospital or clinic, go directly to the nearest hospital emergency department.

This radiopharmaceutical will release a small amount of ionising radiation, with a minimal risk of developing cancer or hereditary abnormalities. If you experience any side effects, contact your nuclear medicine physician. This also applies to any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your nuclear medicine specialist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules are stored

Do not store this medicinal product. This medicinal product is stored under the responsibility of a specialist in suitable premises. Storage must comply with current regulations concerning radioactive materials.
Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules must not be used after the expiry date stated on the packaging.
The following information is intended exclusively for specialists.
Store this medicinal product at a temperature not exceeding 25°C. Do not freeze.
Store in the original lead container.
Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules must not be used after the expiry date indicated on the box following EXP.
Keep Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules out of the reach and sight of children.
The product label includes the correct storage conditions and the batch expiry date.
Hospital staff must ensure that the product is correctly stored and disposed of, and that it is not used after the expiry date stated on the label.

6. Package contents and other information

What Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules contain

• The active substance is Sodium Iodide ( I).
• The other components are: glacial acetic acid, sodium hydroxide, pentahydrate sodium thiosulfate, sodium bicarbonate, sodium chloride, water for injections, anhydrous disodium hydrogen phosphate, hard gelatin capsule.

Description of the appearance of Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules and contents of the pack
Sodio Ioduro ( I) GE Healthcare S.r.l. hard capsules are supplied in a polypropylene vial containing one or more capsules. Each vial is placed inside a lead-shielded container.
Pack sizes
1 capsule or 4 capsules of 3.7 MBq
1 capsule or 3 capsules of 7.4 MBq
1 capsule or 2 capsules of 18.5 MBq
Marketing Authorization Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano
Italy
Manufacturer
GE Healthcare B.V.
De Rondom 8
5612 AP Eindhoven
The Netherlands

The following information is intended exclusively for healthcare professionals:

The complete Summary of Product Characteristics for Sodium Iodide (I) GE Healthcare S.r.l.
hard capsules is provided as a separate document within the package, with the aim of
providing healthcare professionals with additional scientific and practical information
on the administration, dosage, and use of this medicinal product.
Please refer to the SmPC (which must be included in the package).