Helidiag

Package leaflet: Information for the user

Helidiag 50 mg tablets

C-urea
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Helidiag is and what it is used for

This medicinal product is for diagnostic use only.
Helidiag is a breath test. After taking the tablet, your breath test will indicate whether you are infected with the bacterium Helicobacter pylori in the stomach.

Why perform the Helidiag test? You may have a gastric infection caused by a bacterium called Helicobacter pylori. Your doctor has prescribed this test for one of the following reasons:

• Your doctor wants to confirm whether you are infected with Helicobacter pylori.
• You have already been diagnosed with a Helicobacter pylori infection and have taken medication to treat the infection. Therefore, your doctor will check whether the treatment has been successful.

2. What you need to know before taking Helidiag

Do not take Helidiag:

• if you are allergic to C-urea or to any of the other ingredients of this medicine (listed in section 6);
• if you have or suspect you have a stomach infection, as this may lead to false results;
• if you have inflammation of the stomach lining (atrophic gastritis), as this may lead to false results.

Warnings and precautions
Consult your doctor or pharmacist before taking Helidiag if you have undergone total or partial removal of the stomach.
Other medicines and Helidiag
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
The test must not be performed within at least:

• 4 weeks after taking antibiotics;
• 2 weeks after the last dose of a medicine used to reduce gastric acid secretion.

Both groups of medicines may affect the test results. This is particularly relevant following treatment against the bacterium Helicobacter pylori.
Pregnancy and breastfeeding
It is not expected that performing the breath test during pregnancy or breastfeeding could have harmful effects. Helidiag may be used during pregnancy and breastfeeding.
Driving and using machines
Helidiag has no known effects on the ability to drive or operate machinery.

3. How to take Helidiag

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must fast for at least 6 hours before the breath test is performed. You may drink water up to the time the test is carried out.
Some medicines may affect the test result. See section “Other medicines and Helidiag”.
The test procedure takes approximately 10 minutes.
The recommended dose is one tablet as a single dose. The tablet must be swallowed whole with a glass of water. If the tablet is chewed, the test must be repeated, as the risk of false results increases.
A new test may be performed no sooner than the following day.
This medicine must not be administered to children under 18 years of age due to insufficient data.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you take more Helidiag than you should
Since only one tablet is provided, overdose is not expected. In case of doubt, contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very rare (may affect up to 1 in 10,000 people)

• stomach pain
• fatigue
• distortion of the sense of smell (parosmia)

If any of the side effects becomes severe, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Helidiag
5.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton, following "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Helidiag contains

• The active substance is C-urea. Each tablet contains 50 mg of C-urea.
• The other ingredients are: anhydrous citric acid, anhydrous colloidal silica, sodium croscarmellose, microcrystalline cellulose, magnesium stearate and talc.

Description of the appearance of Helidiag and package contents
Helidiag is a white, round, convex tablet with a diameter of 12 mm.
Pack sizes:
1 tablet (kit) in aluminum blister (with sample tubes and single-use straw).
10 x 1 tablets in aluminum blisters (without sample tubes and single-use straw).
Breath collection bags are supplied separately.

Marketing Authorization Holder
LABORATOIRES MAYOLY SPINDLER
6, AVENUE DE L’EUROPE
78400 CHATOU
France
Manufacturer
Idifarma Desarrollo Farmacéutico, S.L.
Polígono Mocholí. Calle Noáin Nº1
31110 Noáin (Navarra)
Spain
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Belgium, Luxembourg, Portugal, Spain, Sweden, Netherlands: Espikur 50 mg
Italy: Helidiag
More detailed information on this medicinal product is available on the website of: Italian Medicines Agency.
https://www.aifa.gov.it/

The following information is intended exclusively for physicians or healthcare professionals:
It is recommended that the test be performed while the patient is at rest.
If the test is to be performed in the morning, the patient must remain fasting overnight and must not eat breakfast. If the test is to be performed later in the day, or if fasting may cause some difficulties for the patient, only a light breakfast is allowed, e.g. tea and toast.
Furthermore, if the patient has consumed a heavy meal, a fasting period of six hours is required before the test.
Breath sample collection can be performed using sample tubes or breath bags.

Test procedure using sample tubes (see Figure 1).
To perform the test, 4 sample tubes with caps and 1 straw are used.
Keep one of the additional barcode labels as a reference label for the patient’s record.

1. The patient should begin the procedure with the two 00 MINUTES sample tubes with blue caps.
   • Unscrew the cap.
   • Insert the straw to the bottom of the sample tube.
   • Take a deep breath and gently exhale into the tube.
   • Remove the straw from the tube and immediately close the tube with the cap.
   • Ensure the cap is properly sealed.
   • Repeat the procedure with the second 00 MINUTES sample tube.
2. Swallow the tablet with a glass of water. Wait for 10 minutes in an upright position (standing or sitting).
3. Exhale into the two 10 MINUTES sample tubes with red caps using the same method described above.

After sample collection, the tubes should be placed back into the box.
Handle the sample tubes carefully and avoid any damage that could cause leakage.

Figure 1. How to perform the test using sample tubes

Test procedure using breath bags (see Figure 2).
To perform the test, 2 single breath bags or 1 double breath bag and 1 mouthpiece are used.

1. Remove the closure cap from the breath bag tube and connect a mouthpiece to the tube. Exhale through the mouthpiece into the breath bag for the baseline breath sample (00 MINUTES). Remove the mouthpiece from the breath bag and close it with the closure cap.
2. Swallow the tablet with a glass of water. Wait for 10 minutes in an upright position (standing or sitting).
3. Exhale into the unused side of the double breath bag or into the other single breath bag for the test breath sample (10 MINUTES), using the same method described above. Label the breath bags to identify the different samples (e.g., “zero test” and “10 min test”).

Handle the sample bags carefully and avoid any damage that could cause leakage.
Figure 2. How to perform the test using breath bags