Package Insert: Information for the User

Helicobacter Test INFAI 75 mg powder for oral solution

13C-urea

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 package insert. See section 4.

Helicobacter Test INFAI is solely for diagnostic use. It is a breath test for adolescents from 12 years old or adults todetermine the presence of a stomach infection caused by the bacteriaHelicobacter pylori.

Why should you take Helicobacter Test INFAI?

You may have a gastric infection caused by the bacteriaHelicobacter pylori. Your doctor has recommended that you undergo a Helicobacter INFAI test for one of the following reasons:

• Your doctor wants to confirm if you have an infection ofHelicobacter pylorito diagnose your condition.

• You have already been determined to have an infection ofHelicobacter pyloriand are being treated to cure it. Now your doctor wants to know if the treatment has been effective.

What does this test consist of?

All foods contain a substance called carbon 13 (13C). This carbon 13 can be detected in the carbon dioxide that is breathed out of the lungs. The actual amount of carbon 13 contained in the breath depends on the type of food that has been ingested.

The test consists of ingesting the “test food”. Then, breath samples are taken. See “Special Instructions for Use”. These samples will be analyzed to measure the actual amount of carbon 13 content in the carbon dioxide of your breath.

Next, you will be asked to drink a solution of carbon 13-urea. Thirty minutes later, more breath samples will be taken, and the carbon 13 content will be measured again as described above. The results obtained will be compared, and if a significant increase in the carbon 13 content is detected in the second group of samples, this will suggest to your doctor the presence of the bacteriaHelicobacter pylori.

Do not take Helicobacter Test INFAI

This inflammation of the stomach lining may generate incorrect positive results from the breath test. Additional explorations may be required to confirm the presence ofHelicobacter pylori.

Warnings and precautions

Consult your doctor or pharmacist before starting Helicobacter Test INFAI if you have any condition that may affect or be affected by the test.

Even if the Helicobacter INFAI test result is positive, other tests may be necessary before starting treatment forHelicobacter pyloriinfection. These are required to check for any other complications, such as:

There are not enough data on the reliability of Helicobacter Test INFAI to recommend its use in patients who have had part of their stomach removed.

If the patient vomits during the test procedure, the test must be repeated. The repeat must be done on an empty stomach and not before the next day.

Use of Helicobacter Test INFAI with other medications

Medications that affect

affect Helicobacter Test INFAI.

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

Pregnancy and breastfeeding

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

The breath test during pregnancy or breastfeeding is not expected to have a harmful effect.

Driving and operating machines

The influence of Helicobacter Test INFAI on the ability to drive and operate machines is negligible or insignificant.

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

The test must be performed in the presence of your doctor or another qualified person.

The recommended dose is

Patients 12 years of age or older should take the contents of 1 vial for each test.

Method of use

The patient must be fasting for at least 6 hours before application, preferably overnight. Consult your doctor if fasting is a problem, for example, in diabetic patients.

The procedure takes approximately 40 minutes.

The test must be performed at least:

Both groups of medications may affect the results of the Helicobacter Test INFAI, especially after treatment to eradicateHelicobacter pylori. It is essential to follow the usage instructions exactly, particularly after Helicobacter eradication therapy, otherwise the result may be questionable.

Essential elements not included in Helicobacter Test INFAI

Before performing the breath test, the patient must ingest the test meal to delay stomach emptying. This test meal is not included in the package. The following are suitable test meals:

• 200 ml of pure orange juice
• 1 g of citric acid dissolved in 200 ml of water

If there is a reason why you cannot take one of these test meals, notify your doctor so they can suggest an alternative. You will need a glass and water to dissolve the 13C-urea powder. If you need to repeat the test, it will not be repeated before the next day.

Special usage instructions(for mass spectrometry)

This medication should only be administered by a medical professional and under adequate medical supervision. Patient data should be documented on the provided data sheet. It is recommended to perform the test in a resting position.

1. The patient must be fasting for at least 6 hours before application, preferably overnight. If the test is performed later in the day, it is recommended to have only a light meal, perhaps a cup of tea and a toast.
2. The test begins with the collection of samples for baseline value determination.
   • Remove the flexible tube and the two containers with the label: “sampling time: value-minute-00” from the equipment.
   • Remove the cap from one of the containers and place the flexible tube without the wrapper inside the container
   • Now breathe gently through the tube in the sample container.
   • Continue breathing while removing the tube and immediately close the container with its cap. If the sample tube remains open for more than 30 seconds, the result may be inaccurate.
   • Keep the sample container in an upright position and attach the label with the barcode, marked “value-minute-00”, around the container, so that the barcode is horizontal.
3. Now fill the second sample container (labeled: “sampling time: value-minute-00”) by breathing in the same way as described before.
4. The patient must now drink the test meal (200 ml of pure orange juice or 1 g of citric acid in 200 ml of water)
5. Now prepare the test solution as follows:
   • Remove the vial labeled: “13C-urea powder” from the equipment, open it, and fill it to about three-quarters with tap water
   • Close the vial and shake it carefully until all the powder is dissolved
   • Pour the contents into a glass of water, fill the vial again and a third time with water, and add the contents to the same glass until approximately 30 ml of test solution is obtained.
6. The patient must drink this test solution immediately. The moment of ingestion should be noted.
7. 30 minutes after administration of the test solution (point 6), the samples for “value-minute-30” are collected in both containers remaining in the test package (labeled “sampling time: value-minute-30”) as described in points 2 and 3.

Use the labels with barcodes marked “value-minute-30” for these samples.

1. The relevant label with barcode is placed on the patient's data sheet. The four breath sample containers must be returned to the original packaging. This packaging must be sealed with the blue adhesive label.
2. The package must be sent for analysis to a qualified laboratory.

Medical professionals or healthcare workers can find detailed information on breath sample analysis and laboratory testing specifications in section 6.6 of the Technical Data Sheet.

If you take more Helicobacter Test INFAI than you should

Since only 75 mg of 13C-urea is provided, it is not expected to cause an overdose.

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

No adverse effects are known.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist. You can also report them directly through the national notification system included in theAnnex V. 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.

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

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Helicobacter Test INFAI

A bottle contains 75 mg of13C-urea.

Appearance of the product and contents of the package

The Helicobacter INFAI test is a white and crystalline powder for oral solution.

A test kit contains the following parts:

Marketing Authorization Holder

INFAI GmbH

Riehler Str. 36

D-50668 Köln

Germany

Responsible Manufacturer for Lot Release

INFAI GmbH

An der Kohlenbahn 39

D-58135 Hagen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

AT, BE, BG, CZ, DE, DK, EE, ES, FI, IS, IT, LT, LU, LV, MT, NL, NO, RO, SE

INFAI GmbH, Tel / Tél / Te?. / Τηλ / Puh / Sími / Tlf.: +49 221 880 443

Germany / Allemagne / ???????? / Nemecko / Tyskland / Saksamaa / Alemania / Saksa / Þýskaland / Germania / Vokietija / Vacija / Il-Germanja / Duitsland

CY, ELANGELINI PHARMA HELLAS SA, Τηλ: +30 210 626 9200, Greece

FRINFAI FRANCE SARL, Tél: +33 389 2043 82

HRPOLIKLINIKA LABPLUS, Tel: + 385 1 299 3595, E-Mail: [email protected]

IE, UKINFAI UK Ltd., Tel: +44 1904 435 228, United Kingdom

PLDr Piktel Medic@l Systems, Tel: +4885 744 7770

PTSermail Logística Integrada Lda., Tel: +351 21 973 9120

SLPLIVA LJUBLJANA d.o.o., Tel: +386 1 5890 390

HU, SKALLMEDICAL s.r.o, Tel: +421 903 654 103, Slovakia / Slovenská republika

Last review date of this leaflet: {MM/AAAA}.

Further detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.