SeHCAT 370 kBq capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
SeHCAT 370 kBq capsules
Tauroselcholic acid (75Se)
Read all of this leaflet carefully before you are administered 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 physician who is supervising the procedure.
- If you experience any adverse reactions, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.
Contents of this leaflet:
- What SeHCAT is and what it is used for
- What you need to know before using SeHCAT
- How to use SeHCAT
- Possible side effects
- How to store SeHCAT
- Contents of the pack and other information
1. What SeHCAT is and what it is used for
This medicine is a radiopharmaceutical intended for diagnostic use only.
It belongs to the group of medicines known as other radiopharmaceuticals for diagnosis of the liver and reticuloendothelial system. When administered, it temporarily accumulates in the liver and reticuloendothelial system. Because the radiopharmaceutical contains a small amount of radioactivity, it can be detected either in the faeces or from outside the body using a special detector called a gamma camera, allowing an image known as a scintigram to be obtained. This scintigram will show whether there is malabsorption or loss of bile acids, providing the physician with valuable information in the assessment of ileal function, inflammatory bowel disease and chronic diarrhoea, and in the study of enterohepatic circulation.
Administration of SeHCAT involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the radiation risk.
2. What you need to know before using SeHCAT
SeHCAT must not be used
- If you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Exercise special caution with SeHCAT
- If you have severe hepatic insufficiency or biliary tract obstruction, as the radiation dose to the liver increases significantly.
- If you are under 18 years of age, because radiation exposure is proportionally higher than in adults. Furthermore, it will only be used if the nuclear medicine physician considers that no alternative diagnostic methods are available, as experience with use in this population is limited.
Before administration of SeHCAT you should:
- Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of SeHCAT with other medicines
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with the results of the SeHCAT scan.
Your physician may recommend that you stop taking the following medicines before administration of SeHCAT, as they may interfere with the interpretation of the SeHCAT imaging:
Medicines such as bile acid sequestrants, including cholestyramine and colesevelam, commonly used in the treatment of hypercholesterolemia, may interfere with test results, as they can form insoluble complexes with SeHCAT that are excreted in the feces. It is recommended to discontinue cholestyramine and colesevelam at least 7 days before the SeHCAT test and resume after the seventh-day scan.
Pancreatin contains pancreatic enzymes necessary for digestion, i.e., to help break down fats, starches, and proteins. Treatment with pancreatin may alter bile acid absorption and gastrointestinal transit in patients with exocrine pancreatic insufficiency. It is recommended to withhold pancreatin during the last meal before the SeHCAT examination and resume after the seventh-day scan.
If you are unsure whether any of the above applies to you, inform your nuclear medicine physician or nurse before undergoing the SeHCAT scan.
Use of SeHCAT with food and drink
Please ensure you drink at least 15 mL of water before taking the capsule. You should drink a similar amount of water with the capsule and again after swallowing it, to promote rapid transit of the capsule into the stomach and subsequent dispersion of its contents.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before administration of SeHCAT if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult your nuclear medicine physician supervising the procedure.
- If you are pregnant
You should be aware that procedures should only be performed during pregnancy when strictly necessary, or when the benefit to the mother outweighs the risk to the fetus. There is no clinical experience with the use of tauroselcholic acid (75Se) in pregnancy. Procedures involving radiopharmaceuticals in pregnant women also result in radiation exposure to the fetus. The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
- If you are breastfeeding
Your physician should consider the possibility of reasonably delaying the examination until breastfeeding has ceased, and evaluate whether the most appropriate radiopharmaceutical has been selected, taking into account the excretion of radioactivity into breast milk. If administration during breastfeeding is unavoidable, breastfeeding must be interrupted for 3 to 4 hours after administration of this medicine, and milk expressed during this period must be discarded. The possibility of expressing and storing breast milk before administration of this product for later use should be considered. Please consult your nuclear medicine physician regarding when breastfeeding can be resumed.
Driving and use of machines
Studies on the ability to drive and use machines have not been performed.
SeHCAT contains sodium.
This medicine contains 71.04 mg of sodium (the main component of table/cooking salt) per capsule. This corresponds to 3.6% of the maximum daily sodium intake recommended for an adult.
.
3. How to use SeHCAT
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. SeHCAT will be used only in special controlled areas. This product will be handled and administered solely by trained and qualified personnel competent to use it safely. These individuals will take special care in the safe handling of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of SeHCAT to be used in your case. This will be the minimum quantity necessary to obtain the required information. The amount generally recommended for administration to an adult is 370 kBq (kiloBecquerels, 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 required by your physician.
Duration of the procedure
Your nuclear medicine physician 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.
The nuclear medicine physician will inform you if you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.
If you have been administered more SeHCAT than you should have
An overdose is unlikely because you will receive a single, precisely controlled dose of SeHCAT determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.
If you have any further questions about the use of SeHCAT, please ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
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 medicine:
Adverse reactions to tauroselcholic acid (75Se) are of unknown frequency. There have been some reported cases of possible allergic reactions following administration of tauroselcholic acid (75Se), although a clear causal relationship has not been established.
In patients with severe impairment of liver function or obstruction of the biliary tract: increased radiation exposure may occur.
In the paediatric population (under 18 years of age): it should be noted that the radiation dose received is proportionally higher than in adults.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of SeHCAT
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
Keep out of the sight and reach of children.
The following information is intended for specialists only.
The product must 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. Contents of the pack and other information
Composition of SeHCAT
-
The active substance is taurocholic acid (75Se). One capsule contains 370 kBq at the date and time of calibration.
-
The other components are disodium hydrogen phosphate dihydrate, gelatin capsule (the gelatin capsule contains the following components: titanium dioxide, quinoline yellow, erythrosine, gelatin).
Appearance of the medicinal product and contents of the container
This medicine is presented as a capsule. It is supplied in polystyrene containers containing a single hard gelatin capsule.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
C/ Gobelas, 35-37, La Florida
28023 Madrid, Spain
Manufacturer:
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig, Germany
Date of the most recent review of this leaflet: October 2025
This information is intended for healthcare professionals only:
The complete Summary of Product Characteristics (SmPC) for SeHCAT is included as a separate section at the end of this leaflet, to provide healthcare professionals with scientific data and practical information on the administration and use of this radiopharmaceutical.