Package leaflet: Information for the patient

SeHCAT, 370 kBq, hard capsules
Tauroselcholic acid (Se)
Please read carefully all information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult the nuclear medicine specialist who will supervise the examination.
If you experience any adverse reactions, including any not listed in this leaflet, you must inform the nuclear medicine specialist. See section 4.

Table of contents

What SeHCAT is and what it is used for
Important information before taking SeHCAT
How to take SeHCAT
Possible side effects
How to store SeHCAT
Contents of the package and other information

1. What SeHCAT is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic purposes.
It is used exclusively to investigate the patient's health condition.
Use of this medicine involves exposure of the patient to small doses of radioactivity. The attending physician and the nuclear medicine specialist have determined that the clinical benefits obtained from the procedure using this radiopharmaceutical outweigh the risks associated with radiation exposure.
SeHCAT is administered prior to an examination performed using a special camera to image the inside of a body region.

It contains the active substance called "tauroselcholic acid (Se)".
After swallowing, this substance can be externally detected by a special scanning camera.
The scan may help the physician assess whether the digestive system is functioning properly. These tests provide information about gastrointestinal tract function, for example in individuals suffering from chronic diarrhoea.

2. Important information before using SeHCAT

When not to use SeHCAT

if the patient is allergic to tauroselcholic acid (Se) or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a nuclear medicine specialist doctor or nurse.

Warnings and precautions

If the patient is pregnant or suspects she may be pregnant.
If the patient is breastfeeding.
If the patient's liver is not functioning properly or if the patient has obstructed bile ducts.

Before administration of this medicine
The patient will be asked to drink a large amount of water before the examination begins and to urinate frequently during the first hours after scanning.
Children and adolescents
Patients under 18 years of age should inform the nuclear medicine specialist doctor.
SeHCAT and other medicines
Inform the nuclear medicine specialist doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use, because they may interfere with the interpretation of results.
The doctor may recommend discontinuing the use of the following medicines before administering SeHCAT, as they may affect image interpretation:
Medicines such as bile acid sequestrants (BAS), for example cholestyramine and colesevelam, commonly used in the treatment of hypercholesterolemia, may affect test results because BAS can form insoluble complexes with the SeHCAT medicinal product, which are excreted in feces. It is recommended to discontinue cholestyramine and colesevelam for 7 days before the SeHCAT test and resume treatment after the examination performed on day 7.
Pancreatin contains pancreatic enzymes necessary for digestion, which help break down fats, starch, and proteins. Pancreatin treatment may affect bile salt absorption in patients with exocrine pancreatic insufficiency (EPI), potentially affecting gastrointestinal transit. It is recommended to discontinue pancreatin during the last meal before the SeHCAT test and resume after the examination performed on day 7.
If in doubt, consult the nuclear medicine specialist doctor or nurse before taking SeHCAT.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a nuclear medicine specialist doctor before using this medicine.
If the patient is pregnant
Before administering SeHCAT, the patient must inform the nuclear medicine specialist doctor if there is any possibility she is pregnant, if her menstrual period is delayed, or if she is breastfeeding.
If in doubt, consult the nuclear medicine specialist doctor supervising the examination.
The doctor will use this product only if the benefits outweigh the risks.
If the patient is breastfeeding
The patient must stop breastfeeding after taking SeHCAT. This is necessary because small amounts of "radioactivity" may pass into breast milk. If the patient is breastfeeding, the doctor may wait to administer SeHCAT until breastfeeding has ended. If waiting is not possible, the doctor will ask the patient to:

express breast milk before starting treatment and store it,
stop breastfeeding for 3 to 4 hours,
use infant formula to feed the baby, and
express (remove) breast milk during at least 3 to 4 hours and discard it.

Driving and using machines
It is unknown whether this medicine affects the ability to drive or operate machinery.
If you have any questions, consult your nuclear medicine specialist doctor or nurse.
SeHCAT contains sodium
The medicine contains 71 mg of sodium per capsule. This should be taken into account in patients who are controlling sodium intake in their diet.
3. How to use SeHCAT
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. SeHCAT will be administered only in specialized, controlled facilities. This product will be prepared and administered exclusively by personnel with appropriate training and qualifications to ensure its safe use. These personnel will ensure the product is used safely and will inform the patient about their actions.
The nuclear medicine specialist doctor supervising the examination will determine the appropriate dose of SeHCAT. This will be the smallest amount needed to obtain the desired information.
The usual recommended dose for an adult is one capsule, and the maximum recommended activity is 370 kBq (kilobecquerel, a unit of measurement used to indicate radioactivity).

SeHCAT is always administered in a hospital or clinic.

The nuclear medicine doctor will decide which dose is best for the patient.
Administration of SeHCAT and course of the examination
Typically administered dose:

One capsule to be swallowed whole with water, usually while sitting or standing, to facilitate capsule passage into the stomach.

Duration of the examination
Scans are performed approximately three hours after capsule administration.
The nuclear medicine specialist doctor will inform the patient how long the examination usually lasts.
Before starting the examination, the patient should be adequately hydrated and encouraged to empty the bladder as completely as possible during the first hours after the scan to reduce radiation exposure.
After administration of the medicine

The patient will be asked to urinate frequently during the first few hours, which will reduce radiation in the bladder.

The nuclear medicine specialist doctor will inform the patient whether special precautions are necessary after taking the medicine. If you have any questions, contact the nuclear medicine specialist doctor.
Use of a higher than recommended dose of SeHCAT
This medicine is administered in a hospital or clinic by specially trained and qualified personnel. It is unlikely that the patient will receive an overdose. If this occurs, the nuclear medicine specialist doctor will initiate appropriate treatment.
If you have any further questions about the use of this medicine, contact the nuclear medicine doctor supervising the examination or the nurse.

4. Possible adverse reactions

Like any medicine, this medicinal product can cause adverse reactions, although not everyone experiences them.
Administration of SeHCAT usually does not lead to adverse reactions.
Hypersensitivity has been reported in an unknown number of cases.
This radiopharmaceutical product delivers small amounts of ionizing radiation, which carries a very small risk of developing cancer and hereditary defects.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store SeHCAT
The patient does not need to store this medicine. The medicine will be stored exclusively by authorized personnel under appropriate conditions. It will be stored in accordance with national regulations concerning radioactive materials.
The following information is intended solely for medical personnel.
Do not use this medicine after the expiry date stated on the label after "EXP".
The batch number is stated on the label after "Lot".

6. Contents of the package and other information

What SeHCAT contains

The active substance is taurocholic acid (Se). Each SeHCAT capsule contains 370 kBq (kilobecquerel – a unit of measurement used to indicate radioactivity) of taurocholic acid (Se) at a specified reference time.
The other components are disodium hydrogen phosphate dihydrate and the capsule shell (containing titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127) and gelatin).

What SeHCAT looks like and contents of the pack
SeHCAT is supplied as one hard capsule in a polystyrene container with a PE cap, held in place by a polyether foam pad.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunschweig
Germany
For further information, please contact the representative of the Marketing Authorisation Holder:
GE Medical Systems Polska Sp. z o.o.
Wołoska 9 Street
02-583 Warsaw
Tel: +48 22 330 83 00

Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunschweig
Germany

Information intended exclusively for healthcare professionals:
The full Product Characteristic document is supplied as a separate leaflet within the medicinal product package, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.