PATIENT INFORMATION LEAFLET

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

Sodium Iodide (123I)

This medication is solely for diagnostic use.

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

Before administering this medication, ensure that you are well hydrated.

Do not use Ioduro (123I) de sodio Curium Pharma Spain:

• If you are breastfeeding your child.
• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Ioduro (123I) de sodio Curium Pharma Spain.

Be especially careful with Ioduro (123I) de sodio Curium Pharma Spain:

Ioduro (123I) de sodio Curium Pharma Spain is a medication in the group of radioisotopes and, therefore, its administration involves the administration of relatively high doses of radiation (radioactivity) in most patients (see “POSSIBLE ADVERSE EFFECTS”).

If you have problems with your renal function, the activity you receive should be adjusted.

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

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Some medications may cause Ioduro (123I) de sodio Curium Pharma Spain not to work correctly:

• Antithyroid agents, carbimazole (or other imidazolic derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sulfobromophthalein sodium, perchlorate, and various agents (anticoagulants, antihistamines, antiparasitics, penicillins, sulfonamides, tolbutamide, thiopental), usually suspended for 1 week before administration of Ioduro (123I) de sodio Curium Pharma Spain.
• Phenylbutazone usually suspended for 1-2 weeks before.
• Expectorants and vitamins, for 2 weeks.
• Natural or synthetic thyroid preparations (sodium thyroxine, sodium liothyronine, thyroid extract), for 2-6 weeks.
• Amiodarone, benzodiazepines, lithium, for 4 weeks.
• Topical skin disinfectants containing iodine, for 1-9 months.
• Intravenous contrast agents, oral cholecystographic agents, and iodine-containing contrast media, for periods of up to 1 year before treatment.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are a fertile woman (age at which you can become pregnant)you should always rule out pregnancy. If you experience a delay in menstruation, consider yourself pregnant until otherwise proven. In case of doubt, it is essential that the exposure to radiation be the minimum necessary to obtain the desired clinical information. Consider the possibility of performing alternative techniques that do not involve the use of ionizing radiation.

If you are pregnantdo not receive this medication 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 Ioduro (123I) de sodio Curium Pharma Spain to a mother who is breastfeeding her child, consider the possibility of reasonably delaying the examination until the mother has stopped breastfeeding and consider whether the selected radioisotope is the most appropriate, 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 medication, as it contains iodo-123, iodo-124, and iodo-125 as contaminants, and the milk extracted during that period should be discarded. Consider the possibility of expressing milk before administration of this product and storing it for later use. Breastfeeding can be resumed when the level of radioactivity in breast milk does not represent a radiation dose for the child greater than 1 mSv.

Driving and operating machinery

No effects are expected on the ability to drive or operate machinery after using this medication.

Important information about some of the components of Ioduro (123I) de sodio Curium Pharma Spain

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially “sodium-free”.

This medication must be administered exclusively by authorized personnel who will instruct you at all times on the steps to follow.

Your doctor will decide the amount of this medication that will be administered to you. This will be the minimum amount necessary to obtaina gamma scan with the required quality to provide the necessary information.

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

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

If you are administered more Sodium Iodide (123I) Curium Pharma Spainthan you should

Since this product is administered by a doctor under strict control conditions, it is very difficult for any overdose to occur.

However, in the event of an excessive dose of this medication being administered to you, the dose of radiation absorbed by you must be reduced by causing an increase in the elimination of the radioactive substance 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 Toxicological Information Service. Phone 91 5620420.

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

Like all medications, sodium iodide (123I) may have adverse effects, although not everyone will experience them.

For all patients: exposure to ionizing radiation must 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 linked to 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 described, with no further information available on frequency and details of these reactions.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

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

Keep out of reach and sight of children.

Before opening the container for the first time, the product must be stored at a temperature between15ºCand25ºC.

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

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

The validity period of the capsule is 20 hours after the calibration date. The expiration date is indicated on the exterior of the container.

Do not use Sodium Iodide (123I) Curium Pharma Spain after the expiration date appearing on the label of the container.

After opening the container for the first time, the validity period is8 hoursstored between2-8ºC.

Medicines should not be disposed of in wastewater or trash. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

Composition of Sodium Iodide ( 123 I) from Curium Pharma Spain

• The active ingredient is sodium iodide ( 123 I). 1 ml of injectable solution contains 37 MBq of sodium iodide ( 123 I) at the time and date of calibration
• The other components are sodium chloride, sodium hydrogen carbonate, and water for injectable preparations.

Appearance of the product and contents of the packaging

This medication is presented in the form of an injectable solution. It is supplied in multi-dose glass vials of type I of the Ph. Eur. of 10 ml, sealed with a bromobutyl rubber stopper coated with Teflon and with an aluminum overcap.

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 time and date of calibration

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Last review date of this leaflet: March/2016

This information is intended solely for medical professionals or healthcare professionals:

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

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