Tau-Kit soluble tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TAU-KIT® 100 mg effervescent tablets
13C-Urea
Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What TAU-KIT® is and what it is used for
- What you need to know before taking TAU-KIT®
- How to take TAU-KIT®
- Possible side effects
- How to store TAU-KIT®
- Contents of the pack and other information
1. What TAU-KIT® is and what it is used for
TAU-KIT**®** belongs to a group of medicines called other diagnostic agents. TAU-KIT**®** is a breath test indicated to determine the presence in your stomach of a bacterium called Helicobacter pylori, which may be responsible for the symptoms you are experiencing.
This medicine is for diagnostic use only.
2. What you need to know before using TAU-KIT®
Do not take TAU-KIT®
If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
If you have a genetic disorder called phenylketonuria.
Warnings and precautions
Consult your doctor before starting to take TAU-KIT®
- A single positive test result alone does not constitute an absolute indication for eradication treatment.
Diagnosis using other methods (e.g. endoscopy) may be indicated to investigate the presence of other complications such as peptic ulcer, autoimmune gastritis, or malignant tumours.
- Inform your doctor if you have undergone partial removal of your stomach (gastrectomy) or if you are under 5 years of age, as there are insufficient data to recommend use in these cases.
- If you suffer from a type of gastritis called atrophic gastritis, the breath test may yield false-positive results; therefore, additional tests may be necessary to confirm the infection.
- If you vomit during the test, it must be repeated, no sooner than the following day and after an overnight fast.
Other medicines and TAU-KIT®
If you are being treated with antibiotics for Helicobacter pylori infection, you must wait at least 4 weeks after stopping treatment before undergoing the TAU-KIT® diagnostic test, as earlier testing could lead to a false-negative result.
If you are taking an antacid (a medicine to relieve heartburn, such as omeprazole, etc.) or an anti-ulcer drug (bismuth salts, etc.), you must wait at least 2 weeks after stopping treatment before performing the diagnostic test.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Use of TAU-KIT® with food and drink
As directed by your doctor, prior to taking the test you must fast for at least 6 hours—preferably since the previous night—and you must drink 200 ml of a citric acid-rich beverage (Citral Pylori®) at the start of the test (for adults), or 100 ml (for children over 5 years of age).
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported at the recommended dose.
Important information about some components of Citral Pylori®
The performance of the 13C-urea breath test requires prior administration of citric acid (European Protocol). The TAU-KIT package includes one sachet of Citral Pylori® (containing 4.2 g of anhydrous citric acid). Each sachet of Citral Pylori® also contains aspartame (E-951) and sunset yellow FCF (E-110).
Each sachet contains 120 mg of aspartame, equivalent to 60 mg/100 ml.
Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to metabolize it properly.
This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.
3. How to use TAU-KIT®
Follow exactly the administration instructions for this medicine as provided by your doctor. If in doubt, please consult your doctor or pharmacist again.
TAU-KIT**®** is a 13C-urea breath test used to perform a diagnostic test, which must be carried out in the presence of qualified personnel who will guide you through each step.
To correctly perform the test, which lasts approximately 40 minutes and should preferably be conducted in the morning, you must remain fasting for 6 hours, avoid smoking, and stay at rest. The test begins with ingestion of the contents of the Citral Pylori® sachet.
The normal dose is:
Adults over 18 years: one tablet (100 mg of 13C-urea) dissolved in 125 ml of water.
Use in children over 5 years and adolescents:
There are insufficient data to recommend use in patients under five years of age.
Children over 5 years: half a tablet (50 mg of 13C-urea) dissolved in 50 ml of water.
Method of administration:
The medicine is administered orally.
If you experience vomiting during the test, a second test should be performed, but not sooner than 24 hours later.
Follow these instructions unless your doctor has given you different ones.
If you take more TAU-KIT® than you should
Since the package contains only one tablet of 100 mg of 13C-urea, overdose is unlikely. However, if you have taken more TAU-KIT® than prescribed, contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to take TAU-KIT®
Since the product consists of a single tablet used at a specific time determined by your doctor, forgetting to take the medicine is unlikely.
Do not take a double dose to make up for missed doses.
If you stop using TAU-KIT®
The treatment is considered to consist of taking the single tablet containing 100 mg of 13C-urea included in the package; therefore, interruption of treatment is not expected.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, TAU-KIT® may cause adverse effects, although not everyone will experience them.
No adverse effects have been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 TAU-KIT®
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine if you notice any signs of deterioration in the packaging.
Expiry date
Do not use this medicine after the expiry date stated on the packaging, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of TAU-KIT®
- 1 effervescent tablet: the active substance is: 13C Urea 100 mg
The other components of the tablet are: microcrystalline cellulose, povidone K90, colloidal silica, magnesium stearate and sodium croscarmellose.
- 1 sachet of Citral Pylori: anhydrous citric acid, aspartame (E-951), lemon flavour powder and orange-yellow colouring S (E-110).
Presentation of the product and contents of the pack
TAU-KIT® is supplied in packs containing one effervescent tablet containing 100 mg of 13C urea and one sachet of Citral Pylori®. It also includes 1 sample collection tube for pre-dose (BASAL), 1 sample collection tube for post-dose (POST), two flexible tubes and adhesive identification labels for the samples, one of which must be placed in the designated space in the carton.
The pack size of 50 kits consists of 50 kits, each containing 2 air sample collection tubes, 1 tablet of 13C urea and 1 sachet of Citral Pylori®.
Only certain pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder and Manufacturer:
ISOMED PHARMA, S.L.
c/París, nº4, Parque Empresarial Európolis
28232, Las Rozas Madrid
Spain
The last revision of this leaflet was in March 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es
This information is intended exclusively for healthcare professionals.
It is important to follow these instructions precisely to ensure diagnostic reliability.
Specific instructions:
- The test must be performed in the presence of a qualified person.
- It is recommended to perform the test while the patient is at rest.
- The test begins with the intake of 1 sachet of Citral Pylori® dissolved in 200 ml of water for adults, or administration of only 100 ml of the solution for children over 5 years of age. The time of ingestion must be recorded.
- Ten minutes later, collection of samples for determination of the basal value is carried out:
- Take the flexible tube and the pre-dose sample collection tube provided with a label marked “BASAL”.
- Remove the cap from the sample tube and unwrap the flexible tube without bending it, then insert it into the sample collection tube.
- Hold your breath for a few seconds (approximately 30 seconds) to maximize the concentration of 13CO2 in the exhaled breath; immediately afterwards, gently exhale through the flexible tube until the inner surface of the sample collection tube is covered with condensed vapour.
- Continue exhaling while removing the plastic tube and immediately close the sample tube with its cap. To close the tube, screw the cap until it no longer turns easily, then carefully turn it an additional quarter turn. If the container remains open for more than 30 seconds, the test may yield a false result.
- Prepare the test solution: dissolve the tablet in 125 ml of water for adults, or half a tablet in 50 ml of water for children over 5 years of age.
- The patient must drink this test solution immediately, and the time of ingestion must be recorded.
- Thirty minutes after administration of the test solution, collect another breath sample into the sample collection tube labelled “POST”, following the procedure described in point 4.
- The sample collection tubes must be sent in the original box for analysis to a qualified laboratory. The sample identification label must be placed on the box in the designated location.
