PYLERA^® capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), in combination with omeprazole, are used to treat patients with an infection caused by bacteria called Helicobacter pylori and duodenal ulcer disease (active or history of within the past 5 years) to kill the H. pylori bacteria.

Helicobacter pylori (H. pylori) is a type of bacteria that lives in the lining of the stomach or duodenum. In some infected patients, H. pylori can cause stomach problems including ulcers. Peptic ulcer disease is a term used to describe these types of ulcers that may occur in the stomach (gastric ulcer) or duodenum (duodenal ulcer).

WHO SHOULD NOT TAKE PYLERA^®?

Patients with severe renal (kidney) or liver impairment
Tell your doctor if you have kidney or liver problems. PYLERA^® may not be right for you.

Patients with hypersensitivity
Patients who are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline should avoid taking PYLERA^®. Tell your doctor immediately if you develop any of the following symptoms: hives, skin irritation or rash, flushing, or fever.

Pregnant or nursing women
Notify your doctor immediately if you become pregnant while taking PYLERA^®. PYLERA^® capsules contain an antibiotic called tetracycline which can cause harm to an unborn child. Tetracycline use during the second or third trimesters of pregnancy can cause permanent discoloration of the baby’s teeth (yellow-gray brown) and may interfere with bone development. Women who are breastfeeding should discontinue feeding or pump and throw away their milk while taking PYLERA^® treatment and for 24 hours after the last dose.

Pediatric patients under the age of 8
PYLERA^® should not be used in children less than 8 years of age. Tetracycline, one of the medicines in PYLERA^®, may cause permanent discoloration of children’s teeth. Problems with building tooth enamel have also been reported.

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

Warnings

• Rarely, some of the medicines in the PYLERA^® capsule can affect the nervous system. Tell your doctor immediately if you experience any of these symptoms: numbness or tingling of arms and legs, headache, blurred vision, or convulsive seizures when taking tetracycline.
• Some individuals can become very sensitive to sunlight and develop bad sunburn, even after a short time in the sun. Avoid exposure to sun, sun lamps or tanning beds while taking PYLERA^®.

Precautions

• PYLERA^® contains bismuth that may cause temporary and harmless dark tongue and/or black stools in some patients. This will go away in a few days after you stop taking PYLERA®. You should not confuse the black stool caused by the bismuth with having blood in the stool while taking PYLERA^®.
• Tell your doctor if you have a blood condition or an infection prior to taking PYLERA® or develop an infection while taking PYLERA^®.
• Use of PYLERA^®, because it contains tetracycline, may make birth control pills less effective, increasing your chances of becoming pregnant. A different or additional form of birth control should be used while taking PYLERA^®.

Tooth Discoloration

The use of tetracycline during tooth development (last half of pregnancy, infancy and children up to the age of 8 years) may result in permanent tooth discoloration. This is more common in long term use of tetracycline. This has also been seen following several short-term courses of treatment.

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^®, tell your doctor if you are taking any prescription or over the counter medications including: methoxyflurane, disulfiram, products containing propylene glycol, birth control pills, anticoagulants (blood thinners), lithium, antacids, multivitamins. Tell your doctor if you are taking dairy products. Also tell your doctor if you are taking any medications while taking PYLERA^®.

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