PYLERA^® is a prescription medication.

PYLERA^® capsules, (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) in combination with omeprazole are used to treat patients with an infection caused by a bacteria called Helicobacter pylori infection 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 (the beginning of the small intestine). In some infected patients, H. pylori can cause stomach problems including ulcers which are sores or an erosion of the lining of the stomach. 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

Tooth discoloration has been reported by patients taking tetracycline during tooth development such as women during the last half of pregnancy, infancy, and children less than 8 years old. This is more common in long term use of tetracycline. This has also been seen following several short-term courses of treatment.

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^®, 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^®.

HOW SHOULD I TAKE PYLERA^®?

It is extremely important to take your PYLERA^® plus omeprazole treatment exactly as directed by your doctor:

Each dose of PYLERA^® includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day at the following times: after each meal, 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:

It is important to drink a full glass of water (8 ounces) to swallow PYLERA^® capsules whole. Drinking enough fluids, particularly with the bedtime dose of PYLERA^®, is recommended to decrease the risk of throat irritation and possible wearing down of the lining of the throat, which can be associated with tetracycline hydrochloride. It's very important 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 as directed until you have none left. Do not take a double dose. If you miss more than 4 doses, contact your health-care provider. Antibacterial drugs (antibiotics) including PYLERA^® should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When PYLERA^® is prescribed to treat a bacterial infection, it is common to feel better soon after beginning the medicine. Although you may feel better, it is important that the medication is taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment. This may also increase the chance that the bacteria will not respond to the medications given and will not be treatable by PYLERA^® or other antibiotics in the future.

If you have any questions or concerns about your PYLERA^® therapy, including omeprazole and how to take it, please ask your physician.

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