PYLERA^® is a prescription medication.

PYLERA^® capsules, (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

WHO SHOULD NOT TAKE PYLERA^®?

• pregnant* or nursing women
• pediatric patients under the age of 8
• patients with kidney or liver problems
• patients with hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetra-cyclines

* Notify your doctor immediately if you become pregnant while taking PYLERA^®

WHAT SHOULD I BE AWARE OF WHILE TAKING PYLERA^®?

Warnings

• Metronidazole, one of the active ingredients in PYLERA^®, has been shown to cause cancer in mice and rats. Unnecessary use should be avoided.
• Rarely some components of PYLERA^® can affect the nervous system. Symptoms may include numbness or tingling of arms and legs, headache, blurred vision, and convulsive seizures.
  Tell your doctor immediately if you experience any of these symptoms.
• An exaggerated sunburn reaction has been seen in some individuals taking tetracycline. Avoid exposure to sun or tanning beds while taking PYLERA^®.

Precautions

• PYLERA^® may cause a temporary and harmless darkening of the tongue and/or black stool because it contains bismuth. Stool darkening must not be confused with blood in stool.
• Notify your doctor if you have a blood condition or an infection prior to taking PYLERA^® or develop an infection while taking PYLERA^®.
• Use of tetracyclines may render oral contraceptives less effective. A different or additional form of birth control should be used while taking PYLERA^®.

WHAT ARE THE MOST COMMON SIDE EFFECTS OF PYLERA^®?

The most commonly reported adverse events for PYLERA^® include:

• change in the color, shape, consistency of stool
• diarrhea
• indigestion
• abdominal pain
• nausea
• headache

IS THERE ANYTHING I SHOULD AVOID WHILE TAKING PYLERA^®?

Do not drink alcohol while taking this medication and for at least 1 day afterward because abdominal cramps, nausea, vomiting, headaches and flushing may occur.

Before taking PYLERA^®, speak with your physician if you are taking lithium, anticoagulants (blood thinners), cimetidine, phenytoin, phenobarital, methoxyflurane, and penicillin.

HOW SHOULD I TAKE PYLERA^®?

It is extremely important to follow your PYLERA^® treatment regimen exactly as directed:

Each dose of PYLERA^® includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. You should swallow the PYLERA^® capsules whole with a full glass of water (8 ounces). One omeprazole 20 mg capsule should be taken twice a day with PYLERA^® after the morning and evening meal for 10 days.

Daily Dosing Schedule for PYLERA^® and Omeprazole:

Administration of adequate amounts of fluid, particularly with the bedtime dose of PYLERA^®, is recommended to reduce the risk of esophageal irritation and ulceration, which can be associated with tetracycline hydrochloride.

It's essential to finish the medication, even if you start to feel better. Every dose counts toward helping you get rid of H. pylori. If you miss a dose just continue taking the medication until you have none left.

If you have any questions or concerns about your PYLERA^® regimen including omeprazole, please ask your physician.

You are encouraged to report negative side effects of prescription drugs to AXCAN PHARMA US, Inc. or the FDA. Call Axcan Pharma US, Inc. at 1-800-472-2634, visit http://www.fda.gov/medwatch/ or call 1-800-FDA-1088.