Sehcat

Package Leaflet: Information for the Patient

SeHCAT, 370 kBq, Hard Capsules

Tauroselcholic Acid (Se)

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Specialist Doctor in Nuclear Medicine who will Supervise the Examination.
• If the Patient Experiences any Undesirable Effects, Including those not Mentioned in this Leaflet, Inform the Specialist Doctor in Nuclear Medicine. See Section 4.

Table of Contents of the Leaflet

• 1. What is SeHCAT and What is it Used for
• 2. Important Information Before Taking SeHCAT
• 3. How to Take SeHCAT
• 4. Possible Undesirable Effects
• 5. How to Store SeHCAT
• 6. Contents of the Package and Other Information

1. What is SeHCAT and What is it Used for

This Medication is a Radio-pharmaceutical Product Intended Exclusively for Diagnostic Purposes.
It is Used Exclusively to Examine the Patient's Health Status.
Taking this Medication Involves Exposing the Patient to Small Doses of Radioactivity. The Treating Physician and the Specialist Doctor in Nuclear Medicine have Decided that the Clinical Benefits of the Procedure Using the Radio-pharmaceutical Outweigh the Risks Associated with Radiation.
SeHCAT is Administered Before an Examination Performed with a Special Camera, for Imaging the Inside of a Part of the Body.

• It Contains the Active Substance Called "Tauroselcholic Acid (Se)".
• After Swallowing, this Substance can be Seen from the Outside with a Special Camera Used for Scanning.
• The Scan can Help the Doctor Check if the Digestive System is Working Properly. These Examinations Provide Information about the Functioning of the Gastrointestinal Tract, for Example, in People who Suffer from Chronic Diarrhea.

2. Important Information Before Taking SeHCAT

When Not to Take SeHCAT

• If the Patient is Allergic to Tauroselcholic Acid (Se) or any Other Component of this Medication (Listed in Section 6). In Case of Doubts, Consult a Specialist Doctor in Nuclear Medicine or a 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 does not Function Properly or if the Patient has Obstructed Bile Ducts.

Before Administering this Medication

The Patient will be Asked to Drink a Large Amount of Water Before the Examination and to Urinate Frequently in the First Hours After Scanning.

Children and Adolescents

Patients who have not Reached the Age of 18 should Inform the Specialist Doctor in Nuclear Medicine.

SeHCAT and Other Medications

No Interactions with Other Medications that Affect the Action of SeHCAT have been Reported.
However, it is Better to Inform the Doctor or Nurse about the Medications being Taken, Recently Taken, or Planned to be Taken.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Suspects she may be Pregnant, or Plans to Have a Child, she should Consult a Specialist Doctor in Nuclear Medicine Before Taking this Medication.
If the Patient is Pregnant
Before Administering SeHCAT, the Patient must Inform the Specialist Doctor in Nuclear Medicine if there is a Possibility that she is Pregnant, if Menstrual Bleeding is Delayed, or if the Patient is Breastfeeding.
In Case of Doubts, Consult a Specialist Doctor in Nuclear Medicine who will Supervise the Examination.
The Doctor will Only Use this Product if the Benefits Outweigh the Risks.
If the Patient is Breastfeeding
The Patient must Stop Breastfeeding if she has Taken SeHCAT. This is Necessary because Small Amounts of "Radioactivity" can Pass into Breast Milk. If the Patient is Breastfeeding, the Doctor may Wait with the Administration of SeHCAT until Breastfeeding is Stopped. If it is not Possible to Wait, the Doctor will Ask to:

• Pump Breast Milk Before Starting Treatment and Store it,
• Stop Breastfeeding for 3 to 4 Hours, and
• Use Modified Milk for Feeding the Child, and
• Pump (Remove) and Discard Breast Milk for at Least 3 to 4 Hours.

Driving and Operating Machines

It is not Known if this Medication Affects the Ability to Drive or Operate Machines.
In Case of Any Questions, Consult a Specialist Doctor in Nuclear Medicine or a Nurse.

SeHCAT Contains Sodium

The Medication Contains 71 mg of Sodium in each Capsule. This should be Taken into Account in Patients who Control their Sodium Intake.

3. How to Take SeHCAT

There are Strict Regulations Regarding the Use of Radio-pharmaceutical Products, their Handling, and Disposal. SeHCAT will be Administered Only in Specialized, Controlled Places. This Product will be Prepared and Administered Exclusively by Persons with Appropriate Training and Qualifications in the Field of Safety of its Use. These Persons will Ensure that this Product is Used Safely and will Inform the Patient about their Actions.
The Specialist Doctor in Nuclear Medicine Supervising the Examination will Decide on the Appropriate Dose of SeHCAT to be Administered. It will be the Smallest Amount Necessary to Obtain the Desired Information.
Usually, the Recommended Dose for an Adult is one Capsule, and the Maximum Recommended Activity is 370 kBq (Kilobecquerel, a Unit of Measurement Used to Determine Radioactivity).

• SeHCAT is Always Used in a Hospital or Clinic.

The Nuclear Medicine Doctor will Decide what Dose is Best for the Patient.

Administration of SeHCAT and Course of Examination

Usually, the Administered Dose is:

• One Capsule to be Swallowed Whole, with Water, Usually in a Sitting or Standing Position, to Facilitate the Passage of the Capsule into the Stomach.

Duration of Examination

Scans are Performed Approximately Three Hours After Administering the Capsule.
The Specialist Doctor in Nuclear Medicine will Inform the Patient how Long the Examination Usually Takes.
Before the Examination, the Patient should be Properly Hydrated and Encouraged to Empty the Bladder as Much as Possible in the First Hours After the Examination to Reduce Radiation.

After Administering the Medication

• The Patient will be Asked to Urinate Frequently During the First Few Hours, which will Reduce Radiation in the Bladder.

The Specialist Doctor in Nuclear Medicine will Inform the Patient if it is Necessary to Take Special Precautions After Taking the Medication. In Case of Any Questions, Consult the Specialist Doctor in Nuclear Medicine.

Using a Higher Dose of SeHCAT than Recommended

This Medication is Administered in a Hospital or Clinic by a Specially Trained and Qualified Person.
It is Unlikely that the Patient will Receive Too High a Dose. If this Happens, the Specialist Doctor in Nuclear Medicine will Take Appropriate Action.
In Case of Any Further Questions About the Use of this Medication, Consult the Nuclear Medicine Doctor Supervising the Examination or a Nurse.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everyone will Experience them.
Taking SeHCAT Usually does not Lead to Undesirable Effects.
Hypersensitivity has been Noted in an Unknown Number of Cases.
This Radio-pharmaceutical Product Delivers Small Amounts of Ionizing Radiation, which Carries a Very Small Risk of Cancer and Genetic Disorders.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including those not Mentioned in this Leaflet, Inform the Doctor. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of 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 .
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Allow for More Information to be Collected on the Safety of the Medication.

5. How to Store SeHCAT

The Patient does not Need to Store this Medication. The Medication will be Stored Exclusively by Authorized Persons in Appropriate Conditions. It will be Stored in Accordance with National Regulations Regarding Radioactive Materials.
The Following Information is Intended Exclusively for Medical Personnel.
Do not Use this Medication After the Expiration 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 Tauroselcholic Acid (Se). Each SeHCAT Capsule Contains 370 kBq (Kilobecquerel - a Unit of Measurement Used to Determine Radioactivity) of Tauroselcholic Acid (Se) at a Specified Time.
• Other Substances are Disodium 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 What the Package Contains

SeHCAT is Supplied in the Form of one Hard Capsule in a Polystyrene Container with a PE Cap, Held in Place with a Polyethylene Foam Insert.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
38110 Braunschweig
Germany
To Obtain More Detailed Information, Contact the Representative of the Marketing Authorization Holder:
GE Medical Systems Polska Sp. z o.o.
ul. Wołoska 9
02-583 Warsaw
Phone: +48 22 330 83 00

Manufacturer

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

Date of Last Update of the Leaflet:

Information Intended Exclusively for Medical Personnel:
The Full Characteristic of the Medicinal Product is Provided as a Separate Document in the Packaging of the Medicinal Product to Provide Medical Personnel with Additional Scientific and Practical Information on the Administration and Use of this Radio-pharmaceutical.