HELICOKIT 75 mg Tabletka Rozpuszczalna
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Treść ulotki
HelicoKit 75 mg soluble tablets, 37.5 mg tablets
C-urea
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even 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 you take 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 is HelicoKit and what is it used for?
HelicoKit contains the active ingredient C-urea, which belongs to a group of medicines called diagnostic agents, used for the diagnosis of diseases.
HelicoKit is a test for the diagnosis of infection of the stomach and intestine (gastroduodenal infection)
caused by the bacterium Helicobacter pylori.
This medicine is only for diagnostic use.
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 pylorior if you have or suspect you have inflammation of the stomach (atrophic gastritis). Because these conditions may interfere with the test and alter the result
Warnings and precautions
Consult your doctor, pharmacist or nurse before taking HelicoKit.
If the test gives a positive result, you will not necessarily have to start treatment to eliminate the
bacterium (eradication therapy) but the doctor will first subject you to specific tests (internal endoscopic methods) to verify the disease associated with the infection by Helicobacter pylori, the type and
severity of inflammation of the stomach (gastritis). This is because the treatment to eliminate the
bacterium (eradication therapy) could mask the symptoms of some important diseases associated
with Helicobacter pyloriinfection, such as stomach cancer (gastric adenocarcinoma) and for
this could delay the application of the appropriate treatment required by the disease and therefore
surgical intervention and treatment with anticancer drugs (chemotherapy).
Once the doctor has deemed it appropriate and you are following eradication therapy to eliminate
the bacterium, the test with HelicoKit can be used to monitor the effectiveness of the treatment.
HelicoKit is not recommended if you have undergone surgery to remove part of
your stomach (gastrectomy) as there is insufficient data on the reliability of the test.
If you vomit during the test, you must repeat the analysis no earlier than the next day, possibly fasting.
Children
HelicoKit 37.5 mg tablets should not be given to children under 8 years of age, as
the pharmaceutical form is not suitable for children in this age group.
Other medicines and HelicoKit
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The result of the test with HelicoKit may be altered by the following medicines
- antibiotics, medicines used for the treatment of infections;
- proton pump inhibitors, medicines used for the treatment of stomach disorders;
- all medicines that interfere with the presence of Helicobacter pylori;
- all medicines that interfere with the activity of urease, a substance (enzyme) that transforms urea present in the stomach.
Do not perform the test with HelicoKit:
- before 4 weeks after the end of treatment with medicines used for the treatment of infections (antibiotic therapy);
- before 2 weeks after taking gastric antisecretory drugs, medicines used for the treatment of stomach disorders.
This is particularly important after eradication therapy.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor, pharmacist or nurse for advice before taking this medicine.
It is unlikely that the dose of urea contained in HelicoKit can cause adverse effects on pregnancy
and breastfeeding.
Driving and operating machinery
HelicoKit does not impair 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 following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, consult your doctor, pharmacist or nurse.
HelicoKit 75 mg soluble tablets
The recommended dose is 1 soluble 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, so that the test result is valid:
- If you need to take the test in the morning, you must remain fasting without having breakfast.
- If you need to take the test during the day or if fasting causes you problems, have only a light breakfast (tea and toast).
- If you have eaten a large meal, wait 6 hours before taking the test.
- During the breath test, remain seated.
Test with HelicoKit 75 mg soluble tablets - 1 tablet + analysis kit
- Drink a suitable beverage to prevent stomach 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 a normal rate using one of the supplied straws. Perform the operation as follows: Take a tube with the blue capand the label with the writing “base”and position the straw so that it touches the bottom of the tube. Exhale the air while slowly and completely removing the straw from the tube, and immediately close the tube. Repeat the operation with the other tube with the blue cap and the label with the writing “base”. These two air samples will be used to measure the baseline value (baseline level of C in exhaled carbon dioxide).
- After 5 minutes, take the HelicoKit tablet dissolved in water, lie on each side for 2 minutes, so that the solution reaches all areas of the stomach.
- After 30 minutes, collect 2 more samples of exhaled air as described above using the other straw and the tubes with the red capand the label with the writing “post”.
- Write your first and last name on the tube labels.
- Reinsert the tubes into the packaging.
- Complete the analysis request form contained in the packaging.
- Seal the box with the safety label provided in the packaging and send it to a laboratory for analysis.
Test with HelicoKit 75 mg soluble tablets - 18 tablets
Perform all steps as described above using tubes or bags provided by the facility.
Test with HelicoKit 37.5 mg tablets - 2 tablets + analysis kit
- Drink a suitable beverage to prevent stomach emptying, such as 200 ml of undiluted orange juice, a citric acid solution, or other suitable beverages.
- Take the tube with the blue capand the label with the writing “base”and position the straw so that it touches the bottom of the tube.
Exhale the air while slowly and completely removing the straw from the tube and immediately close
the tube.
This air sample will be used to measure the baseline value (baseline level of C
in exhaled carbon dioxide).
- After 5 minutes, swallow the 2 HelicoKit tablets whole with the help of a sip of water.
- After 10 minutes, collect another sample of exhaled air as described above using the straw and the tube with the red capand the label with the writing “post”.
- Write your first and last name on the tube labels.
- Reinsert the tubes into the packaging.
- Complete the analysis request form contained in the packaging.
- Seal the box with the safety label provided in the packaging and send it to a laboratory for analysis.
Test with HelicoKit 37.5 mg tablets - 40 tablets (20 tests)
Perform all steps as described above using tubes or bags provided by the facility.
If you are positive for Helicobacter pylori, the value (level of C in exhaled carbon dioxide) obtained from the air contained in the “post” tubes will be higher than the value previously
obtained from the air contained 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 to children under 8 years of age.
If you take more HelicoKit than you should
An overdose with HelicoKit is unlikely.
In case of accidental ingestion/intake of an excessive dose of HelicoKit, immediately inform
your doctor 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 medicine.
Like all medicines, this medicine can cause side effects although not everyone
will experience them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact
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. Reporting side effects can help provide more information
on the safety of this medicine.
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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature below 25 °C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What HelicoKit contains
HelicoKit 75 mg soluble tablets
- The active ingredient is C-urea. Each soluble tablet contains 75 mg of C-urea.
- The other ingredients are: sodium carboxymethylamide type A, microcrystalline cellulose, anhydrous colloidal silica, sodium benzoate.
HelicoKit 37.5 mg tablets
- The active ingredient is C-urea. Each tablet contains 37.5 mg of C-urea.
- The other ingredients are: anhydrous citric acid, sodium carboxymethylamide type A, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, talc.
Description of the appearance of HelicoKit and contents of the pack
HelicoKit 75 mg soluble tablets
Pack of 1 tablet + 1 analysis kit consisting of:
- 4 vials with screw cap;
- 2 straws;
- 1 patient information leaflet;
- 1 test request form;
- 1 safety label for resealing the kit.
Pack of 18 tablets.
HelicoKit 37.5 mg tablets
Pack of 2 tablets + 1 analysis kit consisting of:
- 2 vials with screw cap;
- 1 straw;
- 1 patient information leaflet;
- 1 test request form;
- 1 safety label for resealing the kit.
Pack of 40 tablets (20 tests).
Marketing Authorisation 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
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- Kraj rejestracji
- Postać farmaceutycznaSoluble tablet, 75 MG
- Kod ATCV04CX05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ELIKOKITPostać farmaceutyczna: Oral solution, 75MG/10MLSubstancja czynna: 13C-ureaProducent: AB ANALITICA S.R.L.Wymaga receptyPostać farmaceutyczna: Powder for oral solution, 75 MGSubstancja czynna: 13C-ureaProducent: RICHEN EUROPE S.R.L.Bez receptyPostać farmaceutyczna: Soluble tablet, 100 MGSubstancja czynna: 13C-ureaProducent: ALFASIGMA S.P.A.Bez recepty
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ELIKOKIT wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ELIKOKIT jest 13C-urea. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ELIKOKIT jest produkowany przez ITC FARMA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ELIKOKIT jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Możesz kupić ELIKOKIT w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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Inne leki zawierające tę samą substancję czynną (13C-urea) to m.in. BREATQUALITY-UBT, KITREDIKI UBT KIT, EXPIROBAKTER. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
