Diabact UBT 50 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

13c-urea

Available from:

Laboratoires Mayoly Spindler

ATC code:

V04CX

INN (International Name):

13c-urea

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Other diagnostic agents

Authorization status:

Marketed

Authorization date:

2002-10-11

Patient Information leaflet

0500-04
PACKAGE LEAFLET: INFORMATION FOR THE USER (UK (NI) + IE)
DIABACT UBT 50 MG TABLETS
13
C-UREA
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Diabact UBT is and what it is used for
2.
What you need to know before you take Diabact UBT
3.
How to take Diabact UBT
4.
Possible side effects
5.
How to store Diabact UBT
6.
Contents of the pack and other information
1.
WHAT DIABACT UBT IS AND WHAT IT IS USED FOR
This medicine is for diagnostic use only to determine the presence of
_Helicobacter pylori_
.
Diabact UBT is a breath test that can be used to determine whether or
not you have a primary or
remaining infection in the stomach caused by the bacterium
_Helicobacter pylori._
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIABACT UBT
DO NOT TAKE DIABACT UBT
-
if you are allergic to
13
C-urea or to any of the other ingredients of this medicine (listed in
section 6).
-
if you have an infection in the stomach, as it may cause a false
result.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Diabact UBT if you
have:
-
partial removal of the stomach
CHILDREN AND ADOLESCENTS
This medicine should not be used in children and adolescents younger
than 18 years due to insufficient
data.
OTHER MEDICINES AND DIABACT UBT
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. The risk for obtaining wrong diagnosis is increased if the
test is performed within four (4)
weeks after using antibiotics and within two (2) weeks after the last
dose

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2023
CRN00DFPW
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diabact UBT 50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
13
C Urea 50 mg enriched stable isotope.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
A white, round convex tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
For_ In vivo _diagnosis of gastroduodenal primary or remaining
_Helicobacter pylori_ infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Diabact UBT tablet is for oral administration.
One tablet as a single dose at one test occasion. The patient should
fast for at least six hours preceding the test. An initial
breath test sample is taken after which the tablet is swallowed whole
with a glass of water. A breath sample is taken after ten
minutes.
It is important to follow the instructions for use, described in
section 6.6.
4.3 CONTRAINDICATIONS
The test must not be used in patients with documented or suspected
gastric infection that might interfere with the urea breath
test.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A positive urea breath test alone does not clinically confirm that
eradication therapy is indicated. Alternative diagnosis with
invasive endoscopic methods might be indicated in order to examine the
presence of any other complicating conditions, eg.
gastric ulcer, autoimmune gastritis and malignancies.
The tablet must be swallowed whole. If the patient chews the tablet,
the test must be performed again as the risk of false
positive results increase. A new test may be performed the following
day.
There are insufficient data to recommend the use of Diabact UBT in
patients with partial gastrectomy and in patients younger
than 18 years.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The validity of the te