DIABACT UBT Tablet Ref.[28028] Active ingredients: Urea ¹³C

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.

The validity of the test result may be affected if the patient is currently being treated with antibiotics or a proton-pump inhibitor or has completed a course of treatment with these drugs. The results may be affected in general by all treatments interfering with H. pylori status or urease activity.

Suppression of H. pylori may lead to false negative results. Therefore, the test must not be used until after at least four (4) weeks after systemic antibacterial therapy and at least two (2) weeks after last dose of acid antisecretory agents. This is especially important after eradication therapy.

Pregnancy and breastfeeding

The endogenous production of urea amounts to 25–35 g/day. It is therefore unlikely that the dose of 50 mg urea should cause any adverse effects on pregnancy and lactation.

The Diabact UBT test is not expected to be harmful during pregnancy or to the health of the foetus/newborn child. Diabact UBT can be used during pregnancy and lactation.

Diabact UBT has no known or negligible influence on the ability to drive or to use machines.

Isolated reports of stomach pain, fatigue and distortion of the sense of smell (parosmia) have been reported in one clinical trial.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions viaHPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: http://www.hpra.ie/; E-mail: medsafety@hpra.ie.

Not applicable.