Leaflet: information for the user

Espikur50mg tablets

13C-Urea

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Espikur is and what it is used for

2.What you need to know before starting to take Espikur

3.How to take Espikur

4.Possible side effects

1. Storage of Espikur
2. Contents of the pack and additional information

This medication is for diagnostic use only.

Espikur is a breath test. After taking the tablet, the breath test will show if your stomach is infected with the bacteriaHelicobacter pylori.

Why do you need to take the Espikur test? You may have a gastric infection caused by a bacteria calledHelicobacter pylori. Your doctor has prescribed the test for one of the following reasons:

• Your doctor wants to confirm if you have an infection caused by Helicobacter pylori.

• You have already been determined to be infected withHelicobacter pyloriand have been taking medication to cure the infection. Your doctor will now check if the treatment has been successful.

Do not takeEspikur:

• if you are allergic to13C-urea or to any of the other components of this medication (listed in section6).
• if you have or suspect you have a stomach infection, as it may cause false results.
• if you have a stomach lining inflammation (gastritis atrófica), as it may cause false results.

Warnings and precautions

Consult your doctor or pharmacist beforestarting totake Espikurif your stomach has been completely or partially removed.

Taking Espikur with other medications

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

The test should not be performed within a period of at least:

• 4weeks after taking antibiotics
• 2weeks after the last administration of a medication to reduce stomach acid release.

Both groups of medications may affect the test results. This is especially important after treatment for the bacteriaHelicobacter pylori.

Pregnancy and breastfeeding

It is not expected that performing the breath test during pregnancy and breastfeeding will have a harmful effect. Espikur can be used during pregnancy and breastfeeding.

Driving and operating machines

Espikurhas no known effects on the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

You must be fasting for at least6hours before performing the breath test. You may drink a small amount of water until the test is performed.

Some medications may affect the test results. See the section “Taking Espikur with other medications”.

The procedure takes10minutes approximately.

The recommended dose is one tablet as a single dose. The tablet should be swallowed whole with a glass of water. If the tablet is chewed, the test must be repeated, as this increases the risk of obtaining a false result.

A new test can be performed as soon as, the next day.

This medication should not be administered to children under18years due to lack of data.

If in doubt, ask your doctor or pharmacist.

If you take more Espikurthan you should

Since only1tablet is provided, an overdose is not expected. If unsure, contact your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rare(may affect up to1in every10000people)

-stomach pain

-fatigue

-alteration of the sense of smell (parosmia)

Inform your doctor or pharmacist if any of the adverse effects become severe.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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.

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

Store in the original packaging to protect it from light.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Espikur

• The active principle is13C-urea. Each tablet contains50mg of13C-urea.
• The other components are: anhydrous citric acid, anhydrous colloidal silica, sodium croscarmellose, microcrystalline cellulose, magnesium stearate, and talc.

Appearance of the product and contents of the package

Espikuris a white, convex, round tablet of12mm in diameter.

Package sizes:

1tablet (kit) in an aluminum blister (with sample tubes and disposable straw).

10x1tablet in an aluminum blister (without sample tubes and disposable straw).

The breath bags are supplied separately.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization :

Laboratoires MAYOLY SPINDLER

6 avenue de l’Europe

78400 Chatou

France

Responsible for manufacturing :

Laboratoires MAYOLY SPINDLER

6 avenue de l’Europe

78400 Chatou

France

This medicinal product has been authorized in the member states of theEuropean Economic Area with the following names:

Belgium, Luxembourg, Portugal, Spain, Sweden, Netherlands:Espikur50mg

Italy:Helidiag 50 mg

Date of the last review of this leaflet: April 2019

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

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This information is intended solely for healthcare professionals:

It is recommended to perform the test with the patient in a resting position.

If the test is to be performed in the morning, the patient should fast overnight and not have breakfast. If the test is carried out later in the day, or if fasting may cause problems for the patient, then only a light breakfast, e.g. tea and toast, is allowed. In addition, if the patient has had a heavy meal, they will need to fast for six hours before the test.

The collection of breath samples can be done using tubes or breath bags.

Procedure for the test using tubes (see figure1).

To perform the test, 4 sample tubes with plugs and 1 straw are used.

Keep one of the additional bar code labels as a reference label for the patient's medical history.

1.The patient should start the procedure with the two sample tubes00-MINUTOS with blue plug.

• Remove the plug.
• Place the straw at the bottom of the sample tube.
• Take a deep breath and exhale slowly into the sample tube.
• Remove the straw from the sample tube and close the sample tube immediately.
• Check that the plug is properly closed.
• Repeat the test with the second sample tube00-MINUTOS

2.Swallow the tablet with a glass of water. Wait10minutes in an upright position (standing or sitting).

3.Exhale into the two sample tubes10-MINUTOS with red plugs in the same way as described above.

After collecting the samples, the 4 sample tubes must be labeled according to the following image, placing a bar code label along each sample tube.

Send the 4 sample tubes labeled for analysis to the local diagnostic laboratory.

Handle the sample tubes with the samples carefully and avoid any damage that may cause leaks.

Figure 1. How to perform the test using sample tubes.

Procedure for the test using breath bags (see figure2).

To perform the test, 2 individual breath bags or 1 double breath bag and 1 mouthpiece are used.

1. Remove the screw cap from the flexible tube of the breath bag and connect the mouthpiece to the flexible tube. Exhale through the mouthpiece to obtain the initial sample (00-MINUTE) from the breath bag. Remove the mouthpiece from the breath bag and close the breath bag with the screw cap.

1. Swallow the tablet with a glass of water. Wait10minutes in an upright position (standing or sitting).

1. Exhale into the unused side of the double breath bag or into another individual breath bag to obtain the sample for the test (10-MINUTE) from the breath bag in the same way as described above.

Mark the breath bags to identify the different samples (e.g. "zero test" and "10-minute test").

Handle the breath bags with the samples carefully and avoid any damage that may cause leaks.