Prospect: information for the user

TAU-KIT®100 mg soluble tablets

13C-Urea

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is TAU-KIT®and what it is used for

2. What you need to know before starting to use TAU-KIT®

3. How to use TAU-KIT®

4. Possible adverse effects

5. Storage of TAU-KIT®

6. Contents of the package and additional information

TAU-KIT®belongs to the group of medications known as other diagnostic agents. TAU-KIT®is a breath test that is indicated to determine the presence, in your stomach, of a bacterium calledHelicobacter pylori, which may be responsible for the discomfort you are experiencing.

This medication is solely for diagnostic use.

Do not take TAU-KIT®

If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

If you have a genetic disease called Phenylketonuria.

Warnings and precautions

Consult your doctor before starting to take TAU-KIT®

• A positive test result, alone, does not constitute absolute indication for eradication treatment.

The diagnosis may be indicated with other methods (endoscopy), in order to examine the presence of any other complications, for example, ulcer, autoimmune gastritis or malignant tumors.

• If you have undergone a partial stomach removal (gastrectomy) or if you are under 5 years old, inform your doctor, as there are not enough data to recommend its use in these cases.
• If you have a type of gastritis called atrophic, the breath test may have false positive results, so it may be necessary to undergo other studies to confirm the infection.
• If you vomit during the test, it is necessary to repeat it, at least the next day in the fasting state.

Other medications and TAU-KIT®

If you are being treated with antibiotics for Helicobacter pylori infection, you should wait 4 weeks without medication before performing the diagnostic test with TAU-KIT®, as it could lead to a false negative result of the same.

If you are undergoing treatment with an antacid (medication to relieve stomach burning such as omeprazole, etc.) or an antiulcer medication (bismuth salts, etc.), you should wait 2 weeks without medication before performing the diagnostic test.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Use of TAU-KIT®with food and drinks

As your doctor will indicate, before the test, you should be fasting for at least 6 hours, preferably from the night before, and you should take 200 ml of a citric acid-rich beverage (Citral pylori®) at the beginning of the test, in the case of adults, and 100 ml in the case of children over 5 years old.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using this medication.

Driving and operating machines

No effects on the ability to drive or operate machines have been described at the recommended dose.

Important information about some of the components of Citral pylori®.

The breath test with 13C-labeled urea requires prior administration of Citric acid (European Protocol). The Tau-kit package includes a Citral pylori®envelope (4.2 g of anhydrous citric acid). Each envelope of Citral Pylori®also contains aspartame (E-951) and yellow orange S (E-110)

Each envelope contains 120 mg of aspartame equivalent to 60 mg/100 ml.

Aspartame contains a source of phenylalanine that may be harmful in the case of Phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

TAU-KIT®is a breath test with13C urea, which is used for diagnostic testing, which must be performed in the presence of qualified personnel, who will indicate at each moment the instructions to follow.

To perform the test correctly, which lasts approximately 40 minutes, and which should be performed preferably in the morning, it is necessary to remain 6 hours fasting, without smoking, and in a resting position. The test begins with the ingestion of the contents of the Citral pylori®envelope.

The normal dose is:

Adults over 18 years old:one tablet (100 mg of13C-urea) dissolved in 125 ml of water.

Use in children over 5 years and adolescents:

There are not enough data to recommend its use in patients under five years old.

Children over 5 years old: half a tablet (50 mg of13C-urea) dissolved in 50 ml of water.

Administration form:

The medication is administered orally.

If you experience vomiting while performing the test, a second test should be performed, but not before 24 hours.

Follow these instructions unless your doctor has given you different ones.

If you take more TAU-KIT®than you should

Since the package contains a single 100 mg tablet of13C-urea, it is not expected to have an overdose. However, if you have taken more TAU-KIT®than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take TAU-KIT®

Since the product is formed by a single tablet and is used at a specific moment established by your doctor, it is not expected to forget to take the medication.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with TAU-KIT®

The treatment is considered to be the taking of the single tablet with 100 mg of 13C-urea from the package, so it is not expected to interrupt the treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, TAU-KIT®may cause adverse effects, although not all people will experience them.

No adverse effects have been described.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication if you observe any signs of deterioration in the packaging.

Expiration Date

Do not use this medication after the expiration date that appears on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of TAU-KIT®

• 1 soluble tablet: the active ingredient is:13C Urea 100 mg

The other components of the tablet are: microcrystalline cellulose, povidone K90, colloidal silica, magnesium stearate, and sodium croscarmellose.

• 1 Citral pylori packet: Anhydrous citric acid, Aspartame (E-951), Lemon powder flavor, and Yellow-orange S (E-110) colorant.

Appearance of the product and contents of the package

TAU-KIT®is presented in packages with a single soluble tablet containing 100 mg of13C urea and a Citral pylori®packet. It also includes 2 pre-dose sample collection tubes (BASAL), 2 post-dose sample collection tubes (POST), and two flexible tubes, adhesive sample identification labels, one of which is placed in the indicated location in the case.

The 50 kit format is presented as 50 kits with 4 air sample collection tubes in each kit, 113C urea tablet in each kit, and 1 Citral pylori®packet in each kit.

Only some of the package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization and responsible for manufacturing:

ISOMED PHARMA, S.L.

c/París, nº4, Parque Empresarial Európolis

28232, Las Rozas Madrid

Spain

Last review of this leaflet was inOctober 2019

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

This information is intended solely for healthcare professionals.

It is essential to follow these instructions precisely to ensure the reliability of the diagnosis.

Specific instructions:

1. The test must be performed in the presence of a qualified person.
2. It is recommended to perform the test while in a resting position.
3. The test begins with the dissolution of1Citral pylori®packet in 200 ml of water for adults and the administration of only 100 ml of the solution for children over 5 years old.The time of ingestion must be recorded.
4. Ten minutes later, samples are collected for the determination of the basal value:

basal value:

• Take the flexible tube and the two pre-dose sample collection tubes provided with a label that reads “BASAL”.
• Remove the cap from one of the sample collection tubes and unfold the flexible tube, without bending it, and insert it into the sample collection tube.
• Hold your breath for a few seconds (approx. 30 seconds) to ensure that the

concentration of13CO2in the exhaled breath is at its maximum, immediately exhale

gently through the flexible tube until the inner surface of the sample collection tube is covered with condensed vapor.

• Continue exhaling while removing the plastic tube and immediately close the sample collection tube with its cap. To close the tube, proceed as follows:

turn until the cap does not turn easily and then turn an additional quarter of a

turn. If the container remained open for more than 30 seconds, the test may produce a false result.

1. Fill the second sample collection tube, provided with a label that reads “BASAL”, with exhaled breath and follow the same procedure described in point 4.
2. Prepare the test solution: dissolve the tablet in 125 ml of water for adults and half a tablet in 50 ml of water for children over 5 years old.
3. This test solution must be consumed immediately by the patient and the time of ingestion must be recorded.
4. Thirty minutes after administering the test solution, samples of exhaled breath are collected again in the sample collection tubes provided with a label that reads “POST” and the procedure is followed as described in points 4 and 5.
5. The sample collection tubes must be sent in the original packaging for analysis to a qualified laboratory. The sample identification label must be placed in the designated location on the packaging.