UBTEST 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

UBTest 100mg film-coated tablets

Urea (13C)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the package leaflet:

1. What is UBTest and what is it used for
2. What you need to know before you take UBTest
3. How to take UBTest
4. Possible side effects
5. Storage of UBTest
6. Contents of the pack and further information

1. What is UBTest and what is it used for

This medicinal product is for diagnostic use only.

UBTest is a tablet for a breath test. It is used to find out if the bacterium Helicobacter pylori (H. pylori)is present in your stomach. Bacteria of this type can cause stomach problems. If this bacterium is present in your stomach, it will be detected by analyzing your breath samples.

2. What you need to know BEFORE you take UBTest

You must have fasted (not eaten or drunk) for at least eight hours before taking the test. Before taking it, you should rest for 10 minutes.

Do not take UBTest

• If you are allergic (hypersensitive) to 13C-urea or any of the other ingredients of UBTest.

Be cautious with UBTest

• A positive breath test result with UBTest alone is not the only basis for treating H. pylorieradication. Depending on factors such as your age, medical history, and symptoms, your doctor will decide if further tests are needed to rule out possible complications.
• If you have a type of gastritis (called atrophic gastritis), because the breath test with UBTest may give a false positive result and further tests may be needed to confirm the presence of H. pylori.
• If the test needs to be repeated, for example, in case of vomiting during the test, because it cannot be repeated until the next day.
• If you have had a partial gastrectomy (surgical removal of part of the stomach), because the breath test with UBTest is not recommended.

Children

There is not enough information about the breath test with UBTest in children under 18 years of age. Therefore, it is not recommended for use in children and adolescents.

Using other medicines

To avoid false negative results, the breath test with UBTest should not be used until four weeks after taking antibiotics and two weeks after the last dose of antacids (a type of medication used to relieve heartburn). This is especially important if you have received antibiotic treatment for H. pyloriinfection before.

If you are taking antibiotics or antacids, inform your doctor before the breath test with UBTest.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

UBTest is not recommended if you are pregnant, possibly pregnant, or breastfeeding, as there is not enough data on the use of this product.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There are no known effects on the ability to drive and use machines.

Important information about some of the ingredients of UBTest

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to TAKE UBTest

Follow the administration instructions of UBTest exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The test takes approximately 30 minutes. The breath test should be performed in the presence of a medically qualified person or under the supervision of a doctor.

Special instructions for the breath test with UBTest

• The test procedure begins with the labeling of the containers for the samples and a breath sample will be taken to compare with the results after the test.
• Then, you will take a tablet with 100 ml of water. The tablet should be swallowed quickly (within 5 seconds) whole; do not crush or chew it.
• You will be asked to lie on your left side for 5 minutes and then remain seated and calm for the rest of the test.
• After 20 minutes, a breath sample will be taken in a properly labeled container.

If you take more UBTest than you should

Urea (13C) is a substance that is naturally present in food. Even if you take a higher dose than recommended, no effects are expected from this overdose.

4. Possible side effects

Like all medicines, UBTest can cause side effects, although not everybody gets them.

These symptoms (difficulty breathing, swelling of the face, hives, skin rash, and flushing) could indicate a seriousallergic reaction and you should immediatelyconsult a doctor.

Uncommon side effects(may affect up to 1 in 100 people)

• Abdominal swelling
• Diarrhea
• Increased potassium levels in the blood.

Rare side effects(may affect up to 1 in 1,000 people)

• Stomach pain

Frequency not known (cannot be estimated from the available data)

• Difficulty breathing
• Swelling of the face
• Hives (urticaria)
• Skin rash
• Flushing
• Nausea
• Vomiting

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of UBTest

Keep out of the reach and sight of children.

Do not use UBTest after the expiry date stated on the individual sachets and on the outer packaging after “EXP”.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and FURTHER INFORMATION

Composition of UBTest

The active substance is urea (13C). One UBTest tablet contains 100 mg of urea (13C).

The other ingredients are:

• In the tablet core: lactose monohydrate, microcrystalline cellulose (E460), corn starch, magnesium stearate.
• In the film coating: hypromellose (E464), macrogol 8000, talc, titanium dioxide (E171).

Appearance of UBTest and contents of the pack

UBTest is a white, film-coated tablet with “OG 73” engraved on one side. UBTest is available in packs containing 1, 10, 20, or 100 sachets, each containing one tablet. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Under licence from Otsuka Pharmaceutical Co., Ltd.

Manufacturer:

Otsuka Pharmaceutical, S.A.

Avenida Diagonal, 609-615

08028 Barcelona

Spain

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 - Sant Cugat del Vallès (Barcelona)

Spain

Local representative:

Ferrer Farma, S.A.

AVDA. Diagonal, 549 5ª planta

08029 Barcelona, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain UBTest 100 mg film-coated tablets

Date of last revision of this leaflet: October 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

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This information is intended only for healthcare professionals.

The breath test with urea should be performed in the presence of qualified medical personnel, preferably under the supervision of a doctor. Depending on the analytical method used for determination, a suitable container should be selected for the breath samples (tube or bag).

The analytical method will also determine the number of samples to be taken at each sampling time and the sample volume required for determination.

The patient should attend the doctor's visit in the morning. The breath test with urea should be performed with the patient fasting (both liquids and solids) for at least 8 hours, preferably overnight. The patient should rest for 10 minutes before the test.

The patient should be seated while the test is being performed.

1. The test procedure starts with the labeling of the containers for the samples and the collection of the baseline sample.
2. The patient will exhale gently but continuously into the sample container, which will be closed immediately after. If the breath samples are analyzed using infrared spectrophotometry, it is recommended that the patient hold their breath for a few seconds before sampling.
3. Immediately after, the patient will swallow a whole UBTest 100 mg tablet without crushing or chewing with 100 ml of water.
4. The person performing the breath test with urea should record the time of ingestion.
5. The patient will change position to left lateral decubitus for 5 minutes and then remain seated, upright, and calm until the second sampling.
6. Twenty minutes after ingestion of the film-coated tablet, the second breath sample will be collected in the corresponding properly labeled container, as described in point 2.

Analysis of breath samples and analysis specifications

The 13C enrichment of exhaled air is expressed as an absolute difference (Δ13CO2 value [‰]) between the 13C/12C ratio before administration of the tablet (baseline value) and 20 minutes after administration. If the Δ13CO2 value is equal to or greater than 2.5 ‰, it is considered infected with H. pylori.

Two methods (infrared spectrophotometry (IR) and gas chromatography in line with isotope ratio mass spectrometry (GC/IRMS)) have been validated in clinical studies to analyze the breath test with urea.

In a Phase III clinical trial with UBTest 100 mg film-coated tablets, the breath test with urea was performed on 130 patients infected with H. pyloriand 124 patients not infected with H. pylori. The analysis by mass spectrometry of the breath samples taken 20 minutes after administration of the film-coated tablet resulted in a diagnostic sensitivity of 97.7% [95% CI: 93.4 to 99.5%], a specificity of 98.4% [95% CI: 94.3 to 99.8%], and an accuracy of 98.0% [95% CI: 95.5 to 99.4%] with a cutoff for Δ13C of 2.5‰.

It should be ensured that the CO2 concentration and the 13C/12C ratio do not change from the time of exhalation to analysis of the breath samples. This occurs when containers with desiccants are used. Such containers should be avoided.

Specifications for the determination of the 13C/12C ratio

A) Validation of infrared spectrophotometry

CO2 concentration range: 1% - 6%

Linearity: y = 1.01x - 0.20; r2 = 1.000

Sensitivity: 0.5 ‰ (limit of detection of Δ13C)

Reproducibility: SD: ± 0.5 ‰ or less than a CO2 concentration of 3% in exhaled air

Accuracy: Measurement error: ± 0.5‰ or less (in Δ13C: 0 - 50‰) Measurement error: ± 1 ‰ or less (in Δ13C: 100‰)

• Validation of gas chromatography in line with isotope ratio mass spectrometry

CO2 concentration range: 1% - 5% (for a breath sample volume of 10 ml)

Linearity: y = 1.0183x + 0.5686; r2 = 1.000

Sensitivity: 0.2 ‰ (limit of detection of Δ13C)

Reproducibility: SD (δ13C): ± 0.2‰ or less than a CO2 concentration of 3% in exhaled air

Accuracy: SD (δ13C, n = 5): ± 0.3‰ or less than a CO2 concentration between 1% and 5% in exhaled air

The reference gas should be normalized against an appropriate international reference standard to allow comparison of results between laboratories.

Explanation of results:

δ13C: difference in parts per thousand (‰) relative to an accepted international standard. Δ13C, Δ13CO2: difference between the determinations of the samples taken before and after administration of urea (13C). The patient is diagnosed as not infected if the Δ13CO2 value is less than 2.5‰.