SEHCAT 370 KBQ CAPSULES

Introduction

Package Leaflet: Information for the Patient

SeHCAT 370 kBq capsules

Tauroselcholic acid (75Se)

Read this package leaflet carefully before this medicine is administered to you because it contains important information for you.

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

Contents of the package leaflet:

1. What SeHCAT is and what it is used for
2. What you need to know before using SeHCAT
3. How to use SeHCAT
4. Possible side effects
5. Storage of SeHCAT
6. Package contents and further information

1. What SeHCAT is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

Administration of SeHCAT involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using SeHCAT

SeHCAT must not be used

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

Warnings and precautions

Be careful with SeHCAT

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

Before administration of SeHCAT, you should:

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

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years of age.

Using SeHCAT with other medicines

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicine, as some medicines may interfere with the interpretation of the images.

Using SeHCAT with food and drinks

Please make sure to take at least 15 ml of water before taking the capsule. You should drink a similar amount of water with the capsule and again after taking it to stimulate rapid transit 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 plan to become pregnant, consult your nuclear medicine doctor before this medicine is administered to you.

You must inform your nuclear medicine doctor before administration of SeHCAT if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

• If you are pregnant

You should know that only strictly necessary procedures should be carried out 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) in pregnancy. Procedures with radiopharmaceuticals carried out in pregnant women also involve radiation doses to the fetus. Your nuclear medicine doctor will only administer this medicine during pregnancy if the benefit is expected to outweigh the risk.

• If you are breastfeeding

Your doctor should consider the possibility of reasonably delaying the examination until the mother has stopped breastfeeding and consider 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 discontinued for 3 or 4 hours after administration of this medicine, and the milk expressed during this period should be discarded. The possibility of expressing milk before administration of this product and storing it for later use should be considered. Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

No studies have been performed on the ability to drive and use machines.

SeHCAT contains sodium.

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

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3. How to use SeHCAT

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. SeHCAT will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide 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 amount for administration to an adult is 370 kBq (kiloBecquerel, the unit used to express radioactivity).

Administration of SeHCAT and performance of the procedure

SeHCAT is administered orally.

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

Duration of the procedure

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

After administration of SeHCAT, you should:

• Urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after this medicine is administered to you. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more SeHCAT than you should

Overdose is unlikely because you will receive a precisely controlled single dose of SeHCAT by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any further questions about the use of SeHCAT, ask the nuclear medicine doctor supervising the procedure.

4. Possible side effects

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

The following side effects may occur with this medicine:

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

Reporting of side effects

If you experience any side effects, consult your doctor, even if they are not listed in this package 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 help provide more information on the safety of this medicine.

5. Storage of SeHCAT

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Keep out of the sight and reach of children.

The following information is intended only for the specialist.

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

Do not use SeHCAT after the expiry date and time stated on the label after EXP.

The shelf life of this product is 18 weeks from the date of manufacture.

6. Package contents and further information

Composition of SeHCAT

• The active ingredient is tauroselcholic acid (75Se). One capsule contains 370 kBq at the date and time of calibration.

• The other ingredients are disodium hydrogen phosphate dihydrate, gelatin capsule (the gelatin capsule contains the following ingredients: titanium dioxide, quinoline yellow, erythrosine, gelatin)

Appearance and package contents of the product

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

C/ Gobelas, 35-37, La Florida

28023 Madrid

Manufacturer:

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

D-38110 Braunschweig

Germany

This package leaflet was approved: December 2020

This information is intended only for doctors or healthcare professionals:

The full technical specifications of SeHCAT are included as a separate section at the end of this package leaflet, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.