SeHCAT

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SeHCAT 370 kBq hard capsule

tauroselcholic acid (Se)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this 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. How to store SeHCAT
6. Contents of the pack and other information

1. What SeHCAT is and what it is used for

SeHCAT is a ‘radiopharmaceutical’ medicinal product used exclusively for diagnostic purposes.
SeHCAT is used solely to identify a disorder affecting certain parts of the digestive system.
SeHCAT is administered prior to a scan and helps a special camera to visualise the inside of a specific area of your body (e.g. gamma camera or whole-body scanner).

• It contains an active substance called ‘tauroselcholic acid (75Se)’.
• Once ingested, it can be detected from outside your body by a special scanning device.
• The scan can help the doctor assess how well your digestive system is functioning.

The nuclear medicine specialist or nurse will inform you which part of your body will be scanned.
The use of SeHCAT involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist have determined that the clinical benefit of this examination performed with a radiopharmaceutical outweighs the risk associated with exposure to these small radiation doses.

2. What you need to know before using SeHCAT

Do not use SeHCAT:

• If you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or suspect you may be pregnant.
• If you are breastfeeding.

Warnings and precautions
Talk to your nuclear medicine specialist before using SeHCAT:

• If a doctor has told you that your liver is not functioning properly.

Before administration of SeHCAT, you will be asked to drink water and to urinate as frequently as possible.
Children and adolescents

• Speak with your nuclear medicine specialist if you are under 18 years of age.

Other medicines and SeHCAT
Inform your nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as some medicines may interfere with the results of the SeHCAT scan.
Your doctor may advise you to stop taking the following medications before administration of SeHCAT, as they may interfere with the interpretation of the SeHCAT test.
Bile acid sequestrants (BAS), such as colestyramine and colesevelam, commonly used in the treatment of hypercholesterolemia, may interfere with test results, since BAS can form insoluble complexes with SeHCAT that are excreted in the faeces. It is recommended to discontinue colestyramine and colesevelam at least 7 days before the SeHCAT test and to resume them after the day 7 scan.
Pancreatin contains pancreatic enzymes necessary for digestion, i.e. to help break down fats, starches and proteins. In patients with exocrine pancreatic insufficiency (EPI), treatment with pancreatin may affect bile salt absorption, as it may influence gastrointestinal transit. It is recommended to discontinue pancreatin with the last meal before the SeHCAT test and to resume it after the day 7 scan.
If you are unsure whether any of the above situations apply to you, inform your nuclear medicine doctor or nurse before taking SeHCAT.
SeHCAT with food and drinks
You will be asked to drink some water before, during and after swallowing the capsule.
During administration, the patient should be sitting or standing.
Pregnancy, breastfeeding and fertility
You must inform your nuclear medicine specialist before administration of SeHCAT if there is any possibility that 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 specialist.
If you are pregnant
SeHCAT must not be administered if you are pregnant or think you may be pregnant (see section 2, Do not use SeHCAT).
If you are breastfeeding
SeHCAT must not be administered if you are breastfeeding (see section 2, Do not use SeHCAT).
Driving and use of machines
Ask your doctor whether you may drive or operate machinery after administration of SeHCAT.
SeHCAT contains sodium
This medicine contains 71.04 mg of sodium (3.01 mmol) per capsule. This should be taken into account for patients on a low-sodium diet.

3. How to use SeHCAT

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
SeHCAT will only be used in designated controlled areas. This medicine will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. This staff will provide you with all necessary information about the procedure.

Dose
The nuclear medicine specialist responsible for performing the test will determine the dose of SeHCAT to be used in your case. The doctor will choose the smallest amount necessary to obtain the required information.
The usual recommended amount for an adult is one capsule, and the maximum recommended activity is 370 kBq (kilobecquerel, the unit used to express radioactivity).

Use in children and adolescents
The amount administered to a child or adolescent will be the same as that for adults.
Before using this product in children, a careful benefit-risk assessment must be carried out, particularly because the use of a fixed dose results in an increased effective dose in children.
There is no specific dosage recommendation or clinical experience regarding the use of this product in children.

Administration of SeHCAT and performance of the test
SeHCAT is administered orally.
One single capsule is sufficient to perform the test requested by the doctor.
The capsule may be taken while sitting or standing.

Duration of the test
The nuclear medicine specialist will inform you about the duration of the procedure and advise you on any special precautions to follow after administration of the medicine. Please consult the nuclear medicine specialist if you have any doubts or questions.

After administration you must:
avoid close contact with young children and pregnant women for a reasonable period of time, taking into account the biological half-life of the radiopharmaceutical, which is 2.6 days, and the emission energy of the radionuclide (100–400 keV). Please ask your nuclear medicine specialist for further information.

If you have been administered an excessive dose of SeHCAT:
It is unlikely that you will receive an excessive dose of the medicine, as you will receive only one capsule administered carefully and under control by the nuclear medicine specialist. However, in the event of an overdose, appropriate treatment will be given.

If you have any further questions about the use of this medicine, please consult the nuclear medicine specialist.

4. Possible side effects

Like all medicines, SeHCAT may cause side effects, although not everybody gets them.
The following side effects may occur with this medicinal product:

Allergic reactions (Hypersensitivity) Frequency not known.
If you experience an allergic reaction, inform your doctor immediately, as you may require urgent medical treatment. Signs may include:

• rash, itching, redness
• swelling of the face
• difficulty breathing

If any of the side effects listed above occur after you have left the hospital or clinic, go directly to the nearest hospital emergency department.

This radiopharmaceutical will emit low levels of ionising radiation, which are associated with a minimal risk of developing cancer and hereditary abnormalities (transmission of defective genes).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your nuclear medicine specialist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SeHCAT

You should not store this medicinal product. This medicinal product is stored under the responsibility of a specialist and in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist.
SeHCAT must be kept out of the sight and reach of children.
This medicinal product must not be used after the expiry date and time stated on the label after EXP.

6. Package contents and other information

What SeHCAT contains

• The active substance is taurocholic acid ( Se). Each SeHCAT capsule contains 370 kBq (kilobecquerel - the unit of measurement for radioactivity) of taurocholic acid ( Se).
• The other ingredients are disodium hydrogen phosphate dihydrate and a gelatin capsule containing titanium dioxide, quinoline yellow, erythrosine, gelatin, sodium lauryl sulfate and acetic acid.

Appearance of SeHCAT and contents of the pack
SeHCAT is a hard capsule supplied in a polystyrene container.
Marketing Authorization Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano - Italy
Manufacturer
GE Healthcare Buchler GmbH & Co. KG.
Gieselweg 1
38110 Braunschweig - Germany

The following information is intended for healthcare professionals only:

The complete Summary of Product Characteristics (SmPC) for SeHCAT is provided as a separate document in the product packaging. This provides healthcare professionals with additional scientific and practical information relating to the administration and use of this radiopharmaceutical. Refer to the SmPC.