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DIABACT UBT 50MG TABLETS

Active substance: UREA C-13

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PACKAGE LEAFLET Diabact UBT 50mg tablets 13C-urea
Information for the user
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 13C-urea or any of the other
ingredients of this medicine.
- if you have an infection in the stomach, as it may
cause a false result.
Other medicines and Diabact UBT
Diabact UBT may be affected by other medicines.
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 of acid reduction treatments.
Diabact UBT with food, drink and alcohol
- You should not eat for at least 6 hours before the
test is performed. You may drink some water up to
the time the test is performed.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine. It is not expected that performing
the breath test during pregnancy and lactation has a
damaging effect.
Driving and using machines
Diabact UBT has no known effects on the ability to
drive or to use machines.
3. How to take Diabact UBT
Always take Diabact UBT exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
You should be fasting for at least 6 hours before the
test is performed. The usual dose is one tablet as
single dose. The tablet should be swallowed as whole
with a glass of water. If the tablet is chewed, the test
must be performed again as the risk of false results
increase. A new test may be performed at the earliest
the following day.
Stepwise description of the test procedure
To perform the test, 4 test tubes with stoppers and a
straw are used.
1. You should begin the procedure with the two
00-MINUTES test tubes with blue stopper.
• Unscrew the stopper
• Place the straw in the bottom of the test tube
• Take a deep breath and blow gently into the tube
• emove the straw from the tube and close the tube
with the stopper.
• Check that the stopper is properly closed.
• Repeat the test with the other 00-MINUTES test tube
2. Swallow the tablet with a glass of water.
3. Wait for 10 minutes in an upright position
(standing or sitting)
4. Blow into the two 10-MINUTES tubes with red
stoppers in the way described above.
After the test has been performed, the tubes should
be placed in the box, if the Diabact UBT kit is used.
The address of the testing laboratory is to be filled in
on the designated place on the underside of the box.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
If you take more Diabact UBT than you should
Because only 1 tablet is provided in each kit, no
overdose is expected. If you are uncertain, please
contact your doctor.

UK

IE

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stomach pain, fatigue and distortion of the sense of
smell (parosmia) have been reported.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard (United
Kingdom) or via IMB Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie (Ireland).
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Diabact UBT
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 carton after EXP.
The expiry date refers to the last day of that month.
Store in the original package in order to protect from
light. Do not store above 25°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Diabact UBT contains
- The active substance is 13C-urea enriched stable
isotope. Each tablet contains 50 mg 13C-urea.
- The other ingredients are anhydrous citric acid,
colloidal anhydrous silica, croscarmellose sodium,
microcrystalline cellulose, magnesium stearate
and talc.
What Diabact UBT looks like and contents of the
pack
Diabact UBT is a white round convex tablet.
Pack sizes:
1 tablet (kit)
10 x 1 tablets (without sample tubes and disposable
straw).

Component

1 tablet
(kit)

Tablet in a blister

1

Sample tubes for 00
minute breath sample
(blue stopper)

2

Sample tubes for 10
minute breath sample
(red stopper)

2

Disposable straw

1

Patient information

1

Extra bar code labels

10 x 1
tablet
10

2

1

Marketing Authorisation Holder
Kibion AB
Box 303
SE-751 05 Uppsala
Sweden
tel: +46 18 780 88 00

Manufacturer
Orifice Medical AB
Aktergatan 2
SE-271 55 Ystad
Sweden
This medicinal product is authorised in the Member States of the EEA under the following names:
Diabact UBT (SE)
Diabact UBT 50 mg Tabletten (AT), (DE)
Diabact UBT 50 mg Tablet (UK), (IE)
Diabact UBT 50 mg (DK), (FI), (NO)
This leaflet was last revised in June 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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