Patient Information Leaflet: SeHCAT 370 kBq capsules

Tauroselcholic acid (75Se)

Read this leaflet carefully before you start using this medicine because it contains important information for you.

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

1. What is SeHCAT and how is it used

2. What you need to know before starting to use SeHCAT

3. How to use SeHCAT

4. Possible side effects

5. Storage of SeHCAT

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

It belongs to the group of medications known as other radiopharmaceuticals for liver and reticuloendothelial system diagnosis. When administered, it temporarily accumulates in the liver and reticuloendothelial system. Due to the radiopharmaceutical containing a small amount of radioactivity, it can be well detected in the feces or from the outside of the body using a special detector called a gamma camera, and an image known as a gamma scan can be obtained. This gamma scan will show if there is malabsorption or loss of bile acids, providing the doctor with valuable information in the study of ileal function, inflammatory intestinal disease, and chronic diarrhea, and in the study of enterohepatic circulation.

The administration of SeHCAT 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.

SeHCAT should not be used

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Be especially careful with SeHCAT

• If you have severe liver failure or bile duct obstruction, as the radiation dose to the liver significantly increases.
• If you are under 18 years of age, as the exposure to radiation is proportionally greater than in adults. Additionally, it will only be used if the doctor considers that there are no alternative diagnostic methods, as the experience of use is limited.

Before the administration of SeHCAT, you must:

• Drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.

Children and adolescents

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

Use of SeHCAT with other medications

Inform your nuclear doctor if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with the interpretation of the images.

Use of SeHCAT with food and drinks

Please make sure to take at least 15 ml of water before taking the capsule. You will need to drink a similar amount of water with the capsule and again after taking it to stimulate a quick passage of the capsule to the stomach and subsequent dispersion of its contents.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your nuclear doctor before this medication is administered.

You must inform your nuclear doctor before the administration of SeHCAT if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult your nuclear doctor who will supervise the procedure in case of doubt.

You should know that only procedures strictly necessary should be performed during pregnancy, or when the benefit to the mother outweighs the risk to the fetus, taking into account that there is no clinical experience with the use of tauroselcholic acid (75Se) during pregnancy. Procedures with radioactive substances performed in pregnant women also involve radiation doses to the fetus. Your nuclear doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

Your doctor should consider the possibility of reasonably delaying the examination until the mother has stopped breastfeeding and consider whether the selected radioactive substance is the most suitable, taking into account the secretion of activity in breast milk. If administration during breastfeeding is unavoidable, breastfeeding should be suspended for 3 or 4 hours after administration of this medication and the milk expressed during that period should be discarded. It should be considered the possibility of expressing milk before administration of this product and storing it for later use. Please consult your nuclear doctor when you can resume breastfeeding.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

SeHCAT contains sodium

This medication contains 71.04 mg of sodium (main component of table salt/for cooking) in each capsule. This is equivalent to 3.6% of the maximum daily sodium intake recommended for an adult.

.

There are strict guidelines for the use, handling, and disposal of radioactive medications. SeHCAT will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. Those 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 SeHCAT 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 is 370 kBq (kiloBecquerel, the unit used to express radioactivity).

Administration of SeHCAT and procedure performance

SeHCAT is administered orally.

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

Procedure duration

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

After SeHCAT administration, you must:

• 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 SeHCAT than you should

A overdose is unlikely because you will receive a single, precisely controlled dose of SeHCAT from the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use of SeHCAT, ask the nuclear physician overseeing the procedure.

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

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

The following adverse effects may occur with this medication:

Adverse reactions to tauroselcholic acid (75Se) are of unknown frequency. Some cases of possible allergic reactions have been reported after administration of tauroselcholic acid (75Se), although the causal relationship has not been clearly established.

In patients with severe liver function impairment or bile duct obstruction:it is possible that they may have increased exposure to radiation.

In pediatric population (less than 18 years of age):it should be taken into account that the dose received is proportionally greater than in adults.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is possible adverse effects that do not appear 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.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Keep out of sight and reach of children.

The following information is intended solely for the specialist.

The product must be kept at a temperature between 15°C and 25°C, and protected from light.

Do not use SeHCAT after the expiration date and time that appears on the label after CAD.

The validity period of this product is 18 weeks from the date of manufacture.

Composition of SeHCAT

Appearance of the product and contents of the packaging

This medication is presented in the form of a capsule. It is supplied in polystyrene containers with a single hard gelatin capsule.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

C/ Gobelas, 35-37, La Florida

28023 Madrid

Manufacturer:

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

D-38110 Braunshweig

Germany

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

The complete technical data sheet for SeHCAT is included as a separate 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.