SODIUM IODIDE (123 I) CURIUM PHARMA SPAIN 37 MBq/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution

Sodium Iodide (123I)

Contents of the package leaflet:

1. What Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution is and what it is used for.
2. Before you use Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution
3. How to use Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution
4. Possible side effects
5. Storage of Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution
6. Package contents and further information

1. What Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution is and what it is used for

This medicinal product is for diagnostic use only.

It belongs to a group of medicinal products called other radiopharmaceuticals for cardiovascular system diagnosis. When injected, it temporarily accumulates in the thyroid gland. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera, and an image known as a scintigram can be obtained. This scintigram will show the exact location and distribution of the radiopharmaceutical in the organs and tumors where it accumulates, providing the doctor with valuable information about the shape and function of the thyroid glands.

2. Before you use Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution

Before administering this medicine, you must ensure that you are well hydrated.

Do not use Sodium Iodide (123I) Curium Pharma Spain:

• If you are breastfeeding.
• If you are allergic (hypersensitive) to the active substance or any of the other components of Sodium Iodide (123I) Curium Pharma Spain.

Be cautious with Sodium Iodide (123I) Curium Pharma Spain:

Sodium Iodide (123I) Curium Pharma Spain is a radiopharmaceutical and, therefore, its administration involves the administration of relatively high doses of radiation (radioactivity) in most patients (see "POSSIBLE SIDE EFFECTS").

If you have kidney problems, the activity you receive should be adjusted.

If you are under 18 years old because exposure to radiation is proportionally greater than in adults.

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Some medicines may cause Sodium Iodide (123I) Curium Pharma Spain to not work properly:

• Thyroid inhibitors, carbimazole (or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate, and various agents (anticoagulants, antihistamines, antiparasitics, penicillins, sulfonamides, tolbutamide, thiopentone) are usually suspended 1 week before administration of Sodium Iodide (123I) Curium Pharma Spain.
• Phenylbutazone is usually suspended 1-2 weeks before.
• Expectorants and vitamins, 2 weeks before.
• Natural or synthetic thyroid preparations (sodium thyroxine, sodium liotironine, thyroid extract), 2-6 weeks before.
• Amiodarone, benzodiazepines, lithium, 4 weeks before.
• Skin disinfectants containing iodine, 1-9 months before.
• Intravenous contrast agents, oral cholecystographic agents, and contrast media containing iodine, for periods of up to 1 year before treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are a woman of childbearing age (age at which you can become pregnant)you should always rule out pregnancy. If you experience a delay in your menstrual period, you should consider the possibility that you are pregnant until proven otherwise. In case of doubt, it is essential that radiation exposure is minimal and necessary to obtain the desired clinical information. The possibility of using alternative techniques that do not involve ionizing radiation should be considered.

If you are pregnantyou should not receive this medicine unless it is strictly necessary because the fetus will receive a small amount of radiation, or when the benefit to you outweighs the risk to the fetus.

If you are breastfeeding your child:Before administering Sodium Iodide (123I) Curium Pharma Spain to a breastfeeding mother, the possibility of delaying the examination until the mother has stopped breastfeeding should be considered, and it should be determined whether the most suitable radiopharmaceutical has been selected, taking into account the secretion of activity in breast milk. If administration during breastfeeding is unavoidable, breastfeeding should be suspended for 1.5-3 days after administration of this medicine, as it contains iodine-123 and iodine-124 and iodine-125 as contaminants, and the expressed milk should be discarded during this period. The possibility of expressing milk before administration of this product and storing it for later use should be considered. Breastfeeding can be resumed when the level of radioactivity in breast milk does not pose a radiation dose to the child greater than 1 mSv.

Driving and using machines

No effects on the ability to drive or use machines are expected after using this medicine.

Important information about some of the components of Sodium Iodide (123I) Curium Pharma Spain

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution

This medicine should be administered exclusively by authorized personnel who will indicate the instructions to follow at all times.

Your doctor will decide the amount of this medicine that will be administered to you. This will be the minimum amount necessary to obtain a scintigram with the necessary quality to provide the required information.

For detailed instructions on the correct administration/use of Sodium Iodide (123I) Curium Pharma Spain, see section 6.

If you think the action of Sodium Iodide (123I) Curium Pharma Spain is too strong or too weak, tell your doctor or pharmacist.

If you are given more Sodium Iodide (123I) Curium Pharma Spain than you should be

Since this product is administered by a doctor under strict control conditions, any overdose is very unlikely.

However, in the event that you are administered an excessive dose of this medicine, the absorbed radiation dose should be reduced by increasing the elimination of the radiopharmaceutical from the body, for which you will be recommended to frequently empty your bladder and stimulate gastrointestinal transit.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 5620420.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sodium Iodide (123I) can have side effects, although not everyone gets them.

For all patients: exposure to ionizing radiation should be justified based on the expected medical objective, obtained with the minimum possible dose of radiation received by the patient. Exposure to ionizing radiation is associated with the induction of cancer and the possibility of developing hereditary defects. The probability of these reactions occurring is low due to the low doses of radiation received.

Isolated cases of allergic reactions have been reported without more precise information on frequency and details of such reactions.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience side effects, consult your nuclear medicine doctor, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Sodium Iodide (123I) Curium Pharma Spain 37 MBq/ml injectable solution

Keep out of the reach and sight of children.

Before opening the package for the first time, the product should be stored at a temperature between 15°C and 25°C.

Storage should be carried out in accordance with national regulations on radioactive materials.

The storage period of the vial is 20 hours after the calibration date. The expiration date is indicated on the outside of the package.

Do not use Sodium Iodide (123I) Curium Pharma Spain after the expiration date stated on the package label.

After opening the package for the first time, the storage period is 8 hours when stored between 2-8°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Sodium Iodide (123I) Curium Pharma Spain

• The active substance is Sodium Iodide (123I). 1 ml of injectable solution contains 37 MBq of Sodium Iodide (123I) at the calibration date and time
• The other components are sodium chloride, sodium hydrogencarbonate, and water for injections.

Appearance of the product and package contents

This medicine is presented as an injectable solution. It is supplied in 10 ml glass vials, type I, Ph. Eur., sealed with a bromobutyl rubber stopper coated with Teflon and an aluminum overseal.

A vial contains 1, 2, 5, or 10 ml of injectable solution, corresponding to activities of 37 MBq, 74 MBq, 185 MBq, and 370 MBq at the calibration date and time.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa, 29

28100, Alcobendas, Madrid

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Date of last revision of this leaflet: March 2016

This information is intended only for healthcare professionals:

The full technical data sheet of Sodium Iodide (123I) Curium Pharma Spain is included as a section at the end of this leaflet, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/