Інструкція із застосування ELIDIAG
Зміст інструкції
Helidiag 50 mg tablets
C-urea
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, 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 you take 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 is Helidiag and what is it used for
This medicine is for diagnostic use only.
Helidiag is a breath test. After taking the tablet, your breath test will indicate whether you are
affected by the bacterium Helicobacter pyloriin the stomach.
Why perform the Helidiag test? You may have a gastric infection caused by a bacterium
called Helicobacter pylori. Your doctor has prescribed the test for one of the following reasons:
- The doctor wants to confirm whether you are affected by Helicobacter pyloriinfection.
- You have already been diagnosed with a Helicobacter pyloriinfection and have taken a medicine aimed at curing the infection. Therefore, the doctor will check if the treatment was successful.
2. What you need to know before taking Helidiag
Do not takeHelidiag:
- if you are allergic to C-urea or any of the other ingredients of this medicine (listed in section 6);
- if you have or suspect you have an infection in the stomach as it may cause false results;
- if you have inflammation of the stomach wall (atrophic gastritis) as it may cause false results.
Warnings and precautions
Talk to your doctor or pharmacist before taking Helidiag if you have undergone total or
partial removal of the stomach.
Other medicines and Helidiag
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The test should not be performed within at least:
- 4 weeks after taking medicines against a bacterial infection;
- 2 weeks after the last administration of a medicine to reduce gastric acid release.
Both groups of medicines may affect the test results. This is particularly
relevant after therapy against the bacterium Helicobacter pylori.
Pregnancy and breastfeeding
It is not expected that performing the breath test during pregnancy and breastfeeding may have
a harmful effect. Helidiag can be used during pregnancy and breastfeeding.
Driving and operating machinery
Helidiag has no known effects on the ability to drive vehicles or operate machinery.
3. How to take Helidiag
Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
You must be fasting for at least 6 hours before the breath test is performed. You may drink
water until the test is performed.
Some medications may affect the test result. See the section “Other medicines and
Helidiag”.
The test procedure takes about 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 can be performed no earlier than the next day.
This medicine should not be administered to children under 18 years of age due to insufficient
data.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
If you take more Helidiagthan you should
Since only 1 tablet is provided, an overdose is not expected. If you have any concerns, contact your
doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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 these side effects become serious, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at 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.
5. How to store Helidiag
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging after
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 at a temperature above 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Content of the pack and other information
What the medicine containsHelidiag
- The active ingredient 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 Helidiagand content of the pack
Helidiag is a white, round and convex tablet with a diameter of 12 mm.
Pack size:
1 tablet (kit) in aluminum blister (with sample vials and single-use straw).
10 x 1 tablets in aluminum blister (without sample vials and single-use straw).
Breath collection bags are supplied separately.
Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the
following denominations:
Belgium, Luxembourg, Portugal, Spain, Sweden, Netherlands: Espikur 50 mg
| Component | 1 tablet (kit) | 10 x 1 tablets |
| i Blister pack tablet | 1 | 10 |
| l Sample vials for a breath sample at 00 minutes (blue cap) | 2 | |
| a t Sample vials for a breath sample at 10 minutes (red cap) | 2 | |
| I Single-use straw | 1 | |
| Package leaflet | 1 | 1 |
| Additional labels with barcode | 2 |
Italy: Helidiag
More detailed information on this medicine is available on the website of: Italian Medicines Agency.
https://www.aifa.gov.it/
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The following information is intended exclusively for doctors or healthcare professionals:
It is recommended to perform the test with the patient in a resting position.
If the test must be performed in the morning, the patient must remain fasting overnight and must not
have breakfast. If the test must be performed later in the day or if fasting may cause
some problems for the patient, then only a light breakfast is allowed, e.g. tea and toast.
Furthermore, if the patient has consumed a heavy meal, it will be necessary to fast for six hours before
the test.
Breath samples can be collected using vials or breath bags.
Test procedure using sample vials (see figure 1).
4 vials with caps for the samples and 1 straw are used to perform the test.
Keep one of the additional labels with barcode as a reference label for the patient diary.
- 1.The patient must start the procedure with the two sample vials at 00 MINUTES with the blue cap.
- Unscrew the cap.
- Place the straw at the bottom of the sample vial.
- Take a deep breath and exhale gently into the vial.
- Remove the straw from the vial and immediately close the vial with the cap.
- Check that the cap is closed correctly.
- Repeat the test with the second sample vial at 00 MINUTES.
- 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 vials at 10 MINUTES with the red caps in the same way as described above.
After collecting the samples, the vials must be placed back in the box.
Handle the sample vials with care and avoid any damage that could cause
leaks.

Figure 1. How to perform the test using sample vials
Test procedure using breath bags (see figure 2).
2 single breath bags or 1 double bag and 1 mouthpiece are used to perform the test.
- 1. Remove the closing cap from the tube of the breath bag and connect a mouthpiece to the tube. Exhale through the mouthpiece of the breath sample bag (00 MINUTES). Remove the mouthpiece from the breath bag and close it with the closing 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 bag for the breath test sample (10 MINUTES) in the same way as described above. Mark the breath bags for the purpose of identifying the different samples (e.g., “zero test” and “10 min test”).
Handle the sample bags with care and avoid any damage that could cause leaks.
Figure 2. How to perform the test using breath bags

- Країна реєстрації
- Лікарська формаCoated tablet, 50 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до ELIDIAGЛікарська форма: Oral solution, 75MG/10MLДіюча речовина: 13C-мочевинаВиробник: AB ANALITICA S.R.L.Потрібен рецептЛікарська форма: Powder for oral solution, 75 MGДіюча речовина: 13C-мочевинаВиробник: RICHEN EUROPE S.R.L.Рецепт не потрібенЛікарська форма: Soluble tablet, 100 MGДіюча речовина: 13C-мочевинаВиробник: ALFASIGMA S.P.A.Рецепт не потрібен
Аналоги ELIDIAG в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог ELIDIAG у Іспанія
Лікарі онлайн щодо ELIDIAG
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на ELIDIAG онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
ELIDIAG потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
ELIDIAG виробляється компанією LABORATOIRES MAYOLY SPINDLER. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування ELIDIAG з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати ELIDIAG у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають BREATQUALITY-UBT, KITREDIKI UBT KIT, EXPIROBAKTER. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















