Document: Diabact UBT tablet ENG PL change

• Diabact UBT tablet PL
• Diabact UBT tablet ENG PL

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PACKAGE LEAFLET

Package leaflet: Information for the user

Diabact UBT 50mg tablets

¹³C-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.

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

6. Contents of the pack and other information

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.

Do not take Diabact UBT

• if you are allergic (hypersensitive) to ¹³C-urea or to any of the other ingredients of Diabact UBT.

• 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. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Diabact UBT with foodand drink and alcohol

Pregnancy andbreast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any 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.

Always take Diabact UBT exactly as your doctor has told you. You should 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

• Remove 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 product, please 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.

Like all medicines Diabact UBT 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 the national reporting system listed in Appendix V*. 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 Diabact UBT 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 to 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 50mg 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)	10 x 1 tablet
Tablet in a blister	1	10
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	1
Extra bar code labels	2

Marketing Authorisation Holder

Kibion AB

Box 303

SE-751 05 Uppsala

Sweden

Phone: +46 18 780 88 00

Manufacturer

Idifarma Desarrollo Farmacéutico, S.L

Polígono Mocholí.

Calle Noáin N^o1

31110 Noáin (Navarra),

Spain

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 2016-02-12.