Label:information for the user

UBTest 100mg film-coated tablets

Urea (13C)

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this label, inform your doctor or pharmacist.

This medication is solely for diagnostic use.

UBTest is a breath test tablet. It is used to determine if the bacterium Helicobacter pylori (H. pylori) is present in your stomach.H. pylori)bacteria can cause stomach problems. If this bacterium is present in your stomach, it will be detected through analysis of your breath samples.

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

Do not take UBTest

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

Be especially careful with UBTest

• A positive breath test with UBTest alone is not the sole basis for giving treatment to eradicate H. pylori. 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 falsely positive result and further tests may be needed to confirm the presence of H. pylori.
• If you need to repeat the test, for example, in case of vomiting while the test is being performed, because it cannot be repeated until the next day.
• If you have had a partial gastrectomy (surgical removal of a part of the stomach), because the breath test with UBTest is not recommended.

Children

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

Use of other medications

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 stomach burning). This is especially important if you have received previous antibiotic treatment for H. pylori infection.

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

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

There is no known effect on the ability to drive and operate machinery.

Important information about some of the components of UBTest

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

Follow the administration instructions for 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 must 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 labeling the containers for the samples and taking a breath sample to compare it with the results after the test.
• Next, you must take a tablet with 100 ml of water. The tablet must be swallowed quickly (within 5 seconds) whole; do not crush or chew it.
• You will be instructed to lie on your left side for 5 minutes and, afterwards, you must remain seated and calm for the rest of the test.
• After 20 minutes, a breath sample will be taken in a correctly labeled sample container.

If you take more UBTest than you should

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

Like all medications, UBTest mayproduceadverse effects, although not all people will experience them.

These symptoms (difficulty breathing, facial swelling, hives, skin rash, and flushing) could indicate a severeallergic reactionand you should consultimmediatelya doctor.

Less common effects(may affect up to 1in 100 people)

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

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

• Stomach pain

Unknown frequency (cannot be estimated from available data)

• Difficulty breathing
• Facial swelling
• Hives (urticaria)
• Skin rash
• Flushes
• Nausea
• Vomiting

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use UBTest after the expiration date that appears on individual packets and the packaging after “CAD”.

No special storage conditions are required.

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

Composition of UBTest

The active ingredient is urea (13C). A UBTest tablet contains 100 mg of urea (13C).

The other components are:

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

Appearance of UBTest and packaging contents

UBTest is a coated tablet, white, and on one of its faces, it has engraved in relief “OG 73”. UBTest is presented in packaging that contains 1, 10, 20 or 100 blisters, each containing one tablet. Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Under license from Otsuka Pharmaceutical Co., Ltd.

Responsible for manufacturing:

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 5th floor

08029 Barcelona, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainUBTest 100 mg coated tablets

Last review date of this leaflet: October 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

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This information is intended solely for healthcare professionals.

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

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

The patient should attend the doctor's visit in the morning. The urea breath test 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 performed.

1.The test procedure begins with the labeling of the sample containers and the collection of the basal sample.

2.The patient will exhale gently but continuously into the sample container, which will be closed immediately afterwards. In the case of breath samples being analyzed using infrared spectrophotometry, it is recommended that the patient hold their breath for a few seconds in the moments immediately before sample collection.

3.Immediately afterwards, the patient will swallow a whole UBTest 100 mg tablet without crushing or chewing it with 100 ml of water.

4.The person performing the urea breath test 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 sample collection.

6.Twenty minutes after ingestion of the coated tablet, the second breath sample will be collected in the corresponding container, properly labeled, as described in point 2.

Analysis of breath samples and analysis specifications

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

Two methods have been validated (infrared spectrophotometry (EIR) and gas chromatography in-line with mass spectrometry of isotope ratios (CG/EMIR)) in clinical studies to analyze the urea breath test.

In a phase III clinical trial with UBTest 100 mg coated tablets, the urea breath test was performed on 130 patients infected with H. pylori and 124 patients not infected with H. pylori. The analysis by mass spectrometry of the breath samples taken 20 minutes after administration of the 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 point for Δ13C of 2.5‰.

It must be ensured that the CO2 concentration and the ratio 13C/12C do not vary from the moment of exhalation to the analysis of the breath samples. This occurs when using containers with humidity extractors. Such containers should be avoided.

Specifications for determination of the 13C/12C ratio

A) Validation of infrared spectrophotometry

Range of CO2 concentration: 1% - 6%

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

Sensitivity:0.5 ‰ (detection limit of Δ13C)

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

Accuracy:Error of measurement: ± 0.5‰ or less (in Δ13C: 0 - 50‰)Error of measurement: ± 1‰ or less (in Δ13C: 100‰)

B)Validation of gas chromatography in-line with mass spectrometry of isotope ratios

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

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

Sensitivity:0.2 ‰ (detection limit of Δ13C)

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

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

The reference gas must 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 value of Δ13CO2 is less than 2.5‰.