H. pylori? It’s in the bag

Time to get the answers you need

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

Bloating

Bad Breath

Nausea Loss of Appetite

Vomiting

Belching

Bloating Abdominal Pain

Gnawing Pain

Burning

Gas

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

2

If you have stomach issues, it’s important to fi nd out the real cause

You may often have stomach symptoms that you blame on certain foods or stress. Maybe you take over-the-counter medications to get some relief, but it doesn’t last long. Maybe your doctor has already prescribed medication, but you still do not feel better. If you have stomach symptoms that keep returning, it’s time to fi nd out the actual cause to help you get the relief you need.

Figuring out the cause of stomach symptoms may not be easy. Stomach problems such as heartburn, stomach infl ammation (gastriti s), indigestion (dyspepsia), and pepti c ulcer all share similar symptoms, including those shown below, that are common symptoms for H. pylori infection.1-4

You might think it’s just heartburn or indigestion, but the true cause may be something you haven’t considered: infecti on with Helicobacter pylori (pronounced hell-ee-ko-back-ter pie-lore-ee) or H. pylori.

Up to

H. pyloriinfection

Gastric Ulcers

80%

1.1 graphic3

More than

H. pyloriinfection

Duodenal Ulcers

90%

1.1 graphic2

3

Gastric UlcersDuodenal Ulcers

What is H. pylori?

H. pylori is a bacterium that can cause infection in the stomach. Patients infected with H. pylori often do not suffer any symptoms related to the infection.4 However, it can live in the stomach for many years and damage the stomach’s lining (epithelium) and protective mucus.4 This allows gastric acid to harm the stomach’s wall, which can lead to ulcers.

H. pylori infecti on causes4…

H. pylori infection can also cause gastritis and dyspepsia and, without proper treatment, these conditi ons will probably not go away.4,5 Clinical studies have linked H. pylori infection to an increased risk of developing certain stomach cancers.*6

* Occurrence rates are undetermined for dyspepsia, 10-15% for ulcers, and ~1% for gastric cancer.7

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

4

Don’t let stomach symptoms eat away at you. Ask your doctor about a simple test—BreathTek® UBT for H. pylori.

H. pylori is a common chronic infection that:

• Affects nearly 1 in 3 adults and 25% of children in the United States8,9

• Is usually contracted in childhood and may spread within families living in close quarters5,10

Most people with H. pylori do not have symptoms of infection.4 Others may be tested for H. pylori infection because of an existing or past peptic ulcer or if they are thought to be at risk for stomach cancer.4

If symptoms occur—like the examples listed on page 2—they usually come from the conditions that H. pylori causes. As with many other bacterial infections, antibiotics are prescribed to treat H. pylori. Treating the stomach symptoms alone could mask the infection and delay more effective treatment.4

Finding out if you have H. pylori infection is simple

Medical experts agree that people suffering with dyspepsia (indigestion) should be considered for H. pylori testing since there is some evidence that shows curing the infection may help ease their symptoms.3,5

H. pylori infection can last a lifetime unless it is properly treated11

3.0 graphic13.0 graphic13.0 graphic13.0 graphic1

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

Test AgainWait 4 WeeksTreatTest

5

BreathTek UBT® for H. pylori

BreathTek UBT uses your breath samples to identify if you have an active H. pylori infection.

1. Convenient—Can be done in your doctor’s offi ce or at a laboratory12

— You should have no food or drink for at least 1 hour

before the test and be off antibiotics for 2 weeks

before the test

2. Easy—Simple to do in just 4 easy steps and includes no invasive procedures, no messy collection cups, and no painful needles12

— Breath samples collected before and shortly after

drinking a drug solution are used to test for H. pylori

3. Fast—Administered in approximately 20 minutes in your doctor’s offi ce or laboratory12

4. Covered—Most national and regional health plans cover BreathTek UBT

If you are diagnosed with H. pylori infection, you’ll most likely be prescribed antibiotics. Because these medications are often prescribed to cure infection, some bacteria may have developed a resistance to certain antibiotics.1

To feel confi dent that your infecti on is eliminated, your doctor should retest you with BreathTek UBT. The retest should be at least 4 weeks after you completed your treatment.5

False negative and false positive results may occur with this test. Tell your health care practitioner if you continue to have symptoms. You may need to be retested with a new sample or a different method.

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

6

Find out if H. pylori is causing your symptoms—ask your doctor to test with BreathTek UBT

for H. pylori.

Ulcers are less likely to return once H. pylori infection is eliminated1

May be less expensive to eliminate the infection than staying on medicines to treat the symptoms13,14

May reduce the risk of developing stomach cancer4,15

Why is it important to confi rm that H. pylori is eliminated?

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

7

Patient Reminder Card

Schedule your follow-up test

First day of antibiotic treatment

(date)

Last day of antibiotic treatment

(date)

Appointment to confi rm treatment outcome 4 weeks after completion of antibiotic treatment

(date)

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

8

Stomach symptoms?Let your doctor know!

List your stomach symptoms here and share them with your doctor.

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

9

10

Consumer Brief Summary about BreathTek UBT

Intended Use

The BreathTek® UBT for H. pylori Kit is a breath test that detects a common infection of the stomach called Helicobacter pylori (H. pylori). A licensed health care practitioner may prescribe BreathTek UBT to test for H. pylori infection in patients aged 3 years and older. A patient may need to take the test again 4 weeks after completing antibiotic therapy to monitor whether H. pylori has been wiped out.

BreathTek UBT is always administered by a health care practitioner, as ordered by a licensed health care practitioner.

Warnings and Precautions

• BreathTek UBT is an in vitro diagnostic test requiring you to provide breath samples and drink a drug solution called Pranactin®-Citric

• If you are sensitive to mannitol, citric acid, or Aspartame, avoid drinking the drug solution (Pranactin-Citric)

• Tell your health care practitioner if you are Phenylketonuric (PKU), as this drug contains Phenylalanine (a component of Aspartame). For reference, 12 ounces of a typical diet cola drink contains approximately the same amount of Phenylalanine

• False negative and false positive results may occur with this test

— Tell your health care practitioner if you continue to have symptoms. You may need to be retested with a new sample or a different method

• Inaccurate results may be caused by drugs you are taking within 2 weeks prior to this test. These may include:

— Proton pump inhibitors (PPIs) such as Aciphex® (rabeprazole), Nexium® (esomeprazole), Prevacid® (lansoprazole), Prilosec® (omeprazole), Prilosec OTC® (omeprazole), Protonix® (pantoprazole), Zegerid® (omeprazole/sodium bicarbonate), and Dexilant® (dexlansoprazole)

—Antibiotics

—Bismuth-based drugs (Pepto-Bismol®)

• Inaccurate test results can also occur if:

—The second breath sample is collected too soon

— You were treated for H. pylori with antibiotics, but take your confi rmation test with BreathTek UBT less than 4 weeks after completing your therapy

• Tell your health care practitioner if you have trouble swallowing because of a medical or physical condition

• The safety of using the BreathTek UBT Kit during pregnancy and lactation is not established

• BreathTek UBT is not to be used with children under the age of 3

11

Adverse Events

The following adverse events in adults have been identifi ed: anaphylactic (allergic) reaction, oversensitivity and rash, burning sensation in the stomach, tingling in the skin, vomiting, and diarrhea.

In one study, the following adverse events in children 3 to 17 years old have been identifi ed: throwing up, mouth and throat pain (including irritation, soreness, and burning), unsettled stomach, restlessness, stomach ache/belly pain, and diarrhea. Most of these adverse events were experienced within minutes to hours of ingestion of the drug solution (Pranactin-Citric). In another study, some patients also experienced headache, cough, dry mouth, and acute upper respiratory tract infection.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

January 2016 05US16IBR0002

Please see enclosed Current Package Insert.

References: 1. Ables AZ, Simon I, Melton ER. Update on Helicobacter pylori treatment. Am Fam Physician. 2007;75(3):351-358. 2. Harmon RC, Peura DA. Evaluation and management of dyspepsia. Ther Adv Gastroenterol. 2010;3(2):87-98. 3. Meurer LN, Bower DJ. Management of Helicobacter pylori infection. Am Fam Physician. 2002;65(7):1327-1336. 4. Centers for Disease Control and Prevention. Helicobacter pylori and peptic ulcer disease: the key to cure. http://www.cdc.gov/ulcer/keytocure.htm. Updated September 28, 2006. Accessed February 13, 2017. 5. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017:1-27. doi:10.1038/ajg.2016.563. 6. National Cancer Institute. Helicobacter pylori and cancer. http://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/h-pylori-fact-sheet. Accessed February 13, 2017. 7. Ernst PB, Peura DA, Crowe SE. The translation of Helicobacter pylori basic research to patient care. Gastroenterology. 2006;130(1):188-206. 8. Everhart JE, Kruszon-Moran D, Perez-Perez GI, Tralka TS, McQuillan G. Seroprevalence and ethnic differences in Helicobacter pylori infection among adults in the United States. J Infect Dis. 2000;181(4):1359-1363. 9. Staat MA, Kruszon-Moran D, McQuillan GM, Kaslow RA. A population-based serologic survey of Helicobacter pylori infection in children and adolescents in the United States. J Infect Dis. 1996;174(5):1120-1123. 10. Kivi M, Tindberg Y. Helicobacter pylori occurrence and transmission: a family affair? Scand J Infect Dis. 2006;38(6-7):407-417. 11. Elitsur Y, Tolia V, Gilger MA, et al. Urea breath test in children: the United States prospective multicenter study. Helicobacter. 2009;14(2):134-140. 12. BreathTek UBT [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2016. 13. Boklage S, Mangel AW, Ramamohan V, Mladsi D, Wang T. Cost-effectiveness analysis of universal noninvasive testing for post-treatment confi rmation of Helicobacter pylori eradication and the impact of patient adherence. Pati ent Pref Adherence. 2016;10:1025-1035. 14. Ford AC, Delaney BC, Forman D, Moayyedi P. Eradication therapy in Helicobacter pylori positive peptic ulcer disease: systematic review and economic analysis. Am J Gastroenterol. 2004;99(9):1833-1855. 15. International Agency for Research on Cancer. Helicobacter pylori eradication as a strategy for preventing gastric cancer IARC working group. World Health Organizati on. 2014;8:1-190.

Tell your doctor about your stomach symptoms and ask

about BreathTek® UBT for H. pylori.

Learn more at BreathTek.com

H. pylori? It’s in the bag

Don’t suffer in silence!

Please see BRIEF SUMMARY on pages 10-11 and enclosed Current Package Insert.

©2017 Otsuka America Pharmaceutical, Inc. May 2017 05US17EBC0002