Helicokit

Package leaflet: Information for the user

HelicoKit 75 mg dispersible tablets, 37.5 mg tablets

C-urea
Please read all of this leaflet carefully before you take 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What HelicoKit is and what it is used for

HelicoKit contains the active substance C-urea, which belongs to a group of medicines called diagnostic agents, used for diagnosing diseases.
HelicoKit is a test for the diagnosis of stomach and intestinal infection (gastroduodenal infection) caused by the bacterium Helicobacter pylori.
This medicine is for diagnostic use only.

2. What you need to know before taking HelicoKit

Do not take HelicoKit

• if you are allergic to C-urea or to any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach infection caused by bacteria other than Helicobacter pylori, or if you have or suspect you have inflammation of the stomach (atrophic gastritis). These conditions may interfere with the test and alter its result.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking HelicoKit.
If the test gives a positive result, you may not necessarily need to start treatment to eliminate the bacterium (eradication therapy). Your doctor will first perform specific tests (internal endoscopic methods) to confirm the disease associated with Helicobacter pylori infection and assess the type and severity of stomach inflammation (gastritis). This is because eradication therapy could mask symptoms of serious diseases associated with Helicobacter pylori infection, such as stomach cancer (gastric adenocarcinoma), potentially delaying appropriate treatment—including surgery and anticancer drug therapy (chemotherapy).
Once your doctor considers it appropriate and you are undergoing eradication therapy to eliminate the bacterium, the HelicoKit test may be used to monitor the effectiveness of treatment.
HelicoKit is not recommended if you have undergone surgical removal of part of the stomach (gastrectomy), as there is insufficient data on the reliability of the test in such cases.
If you vomit during the test, you must repeat the analysis no sooner than the following day, preferably on an empty stomach.

Children
HelicoKit 37.5 mg tablets must not be administered to children under 8 years of age, as the pharmaceutical form is not suitable for children in this age group.

Other medicines and HelicoKit
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The result of the HelicoKit test may be altered by the following medicines:

• antibiotics, medicines used to treat infections;
• proton pump inhibitors, medicines used to treat stomach disorders;
• all medicines that interfere with the presence of Helicobacter pylori;
• all medicines that interfere with urease activity, an enzyme that converts urea present in the stomach.

Do not perform the HelicoKit test:

• within 4 weeks after completing treatment with medicines used to treat infections (antibiotic therapy);
• within 2 weeks after taking gastric antisecretory agents, medicines used to treat stomach disorders.

This is particularly important after eradication therapy for the bacterium.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.
It is unlikely that the dose of urea contained in HelicoKit would cause adverse effects during pregnancy or breastfeeding.

Driving and using machines
HelicoKit does not affect the ability to drive vehicles or operate machinery.

HelicoKit 75 mg
This medicine contains:

• 4 mg of sodium benzoate per tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
• less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free.”

HelicoKit 37.5 mg
This medicine contains:

• less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free.”

3. How to take HelicoKit

Take this medicine exactly as directed by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.

HelicoKit 75 mg effervescent tablets
The recommended dose is 1 effervescent tablet.
Dissolve the tablet in 30 ml of water and drink the solution immediately.

HelicoKit 37.5 mg tablets
The recommended dose is 2 tablets.
Swallow the tablets whole with a sip of water, without dissolving them. It is important that the tablets are taken completely intact and not dissolved.

Read the following instructions carefully before performing the test to ensure valid test results:

• If you are to undergo the test in the morning, you must remain fasting and must not eat breakfast.
• If you are to undergo the test during the day or if fasting causes you problems, have only a light breakfast (tea and toast).
• If you have eaten a heavy meal, wait 6 hours before taking the test.
• During the breath test, remain seated.

Test with HelicoKit 75 mg effervescent tablets - 1 tablet + analysis kit

• Drink a suitable beverage to prevent gastric emptying, such as 200 ml of undiluted orange juice, a citric acid solution, or other suitable beverages.
• After 5 minutes, collect 2 samples of exhaled air at normal speed using one of the straws provided. Perform the procedure as follows: Take a test tube with the blue cap and label marked “base”, and insert the straw so that it touches the bottom of the tube. Exhale the air while slowly and completely withdrawing the straw from the test tube, then immediately close the tube. Repeat the procedure with the other test tube with the blue cap and label marked “base”. The baseline measurement (baseline level of C in the carbon dioxide of exhaled air) will be performed on these two air samples.
• After 5 minutes, take the HelicoKit tablet dissolved in water, lie down on each side for 2 minutes to allow the solution to reach all areas of the stomach.
• After 30 minutes, collect 2 further samples of exhaled air as described above, using the other straw and test tubes with the red cap and label marked “post”.
• Write your first and last name on the labels of the test tubes.
• Place the test tubes back into the package.
• Complete the analysis request form included in the package.
• Seal the box with the security label provided in the package and send everything to a laboratory for analysis.

Test with HelicoKit 75 mg effervescent tablets - 18 tablets
Perform all steps as described above, using test tubes or bags supplied by the facility.

Test with HelicoKit 37.5 mg tablets - 2 tablets + analysis kit

• Drink a suitable beverage to prevent gastric emptying, such as 200 ml of undiluted orange juice, a citric acid solution, or other suitable beverages.

• Take the test tube with the blue cap and label marked “base”, and insert the straw so that it touches the bottom of the test tube.
  Exhale the air while slowly and completely withdrawing the straw from the test tube, then immediately close the test tube.
  The baseline measurement (baseline level of C in the carbon dioxide of exhaled air) will be performed on this air sample.

• After 5 minutes, swallow the 2 HelicoKit tablets whole, using a sip of water if needed.

• After 10 minutes, collect another sample of exhaled air as described above, using the straw and the test tube with the red cap and label marked “post”.

• Write your first and last name on the labels of the test tubes.

• Place the test tubes back into the package.

• Complete the analysis request form included in the package.

• Seal the box with the security label provided in the package and send everything to a laboratory for analysis.

Test with HelicoKit 37.5 mg tablets - 40 tablets (20 tests)
Perform all steps as described above, using test tubes or bags supplied by the facility.

If you are positive for Helicobacter pylori, the value (level of C in the carbon dioxide of exhaled air) obtained from the air in the “post” tubes will be higher than the value previously obtained from the air in the “base” tubes.

Use in children under 8 years of age
Since HelicoKit 37.5 mg tablets must be swallowed whole and not dissolved, this formulation is not suitable for administration in children under 8 years of age.

If you take more HelicoKit than you should
It is unlikely that an overdose with HelicoKit will occur.
In case of accidental ingestion/overdose of HelicoKit, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

No side effects have been reported with the use of this medicinal product.
Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the 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 medicinal product.

5. How to store HelicoKit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store below 25 °C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 package and other information

What HelicoKit contains
HelicoKit 75 mg dispersible tablets

• The active substance is C-urea. Each dispersible tablet contains 75 mg of C-urea.
• The other components are: sodium carboxymethylcellulose type A, microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium benzoate.

HelicoKit 37.5 mg tablets

• The active substance is C-urea. Each tablet contains 37.5 mg of C-urea.
• The other components are: anhydrous citric acid, sodium carboxymethylcellulose type A, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, talc.

Description of the appearance of HelicoKit and contents of the pack
HelicoKit 75 mg dispersible tablets
Carton pack containing 1 tablet + 1 test kit consisting of:

• 4 tubes with screw caps;
• 2 straws;
• 1 patient information leaflet;
• 1 test request form;
• 1 security label for resealing the kit.

Carton pack containing 18 tablets.
HelicoKit 37.5 mg tablets
Carton pack containing 2 tablets + 1 test kit consisting of:

• 2 tubes with screw caps;
• 1 straw;
• 1 patient information leaflet;
• 1 test request form;
• 1 security label for resealing the kit.

Carton pack containing 40 tablets (20 tests).
Marketing Authorization Holder
ITC Farma S.r.l. Viale P.L. Nervi, 164, 04100 Latina
Manufacturer
ITC Production S.r.l.
Via Pontina, Km 29
00071 Pomezia (RM)
Italy