Bismuth Subcitrate Potassium (BIZ-muth sub-SIT-rate poe-TAS-ee-um), Metronidazole (met-roe-NYE-da-zole), Tetracycline Hydrochloride (tet-ra-SYE-kleen hye-droe-KLOR-ide)

Treats H pylori infection and duodenal ulcer.

Brand Name(s):

Pylera

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole with a full glass of water. Do not crush, break, or chew it.
• Drink extra liquids to help prevent irritation or ulcers in your esophagus.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you miss more than 4 doses contact your doctor right away.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using methoxyflurane or have been using disulfiram within the last 2 weeks. Do not drink alcohol while you are using this medicine and for at least 3 days after you stop taking it.
• Some foods and medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Busulfan, cimetidine, isotretinoin, lithium, phenobarbital, phenytoin
  • Antacid containing aluminum, calcium, or magnesium
  • Birth control pills
  • Blood thinner (including warfarin)
  • Medicine that may cause heart rhythm problems
  • Multivitamin supplements containing iron, zinc, or sodium bicarbonate
• Do not have milk or dairy products while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Using this medicine especially during the second and later part of a pregnancy can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use an effective form of birth control (including condoms, spermicide) during treatment with this medicine.
• Your doctor may tell you to stop breastfeeding, and pump and discard your breast milk during treatment for at least 2 days after treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, fungal infections, brain and nerve problems (including encephalopathy), or a history of blood problems or seizures.
• This medicine may cause the following problems:
  • Brain or nerve problems, including seizures, encephalopathy, peripheral neuropathy, meningitis, intracranial hypertension
  • Permanent discoloration of teeth in children
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, difficult or painful urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Seizure, headache, dizziness, blurred vision, problems with muscle control, clumsiness, shakiness, trouble talking
• Stiff neck, drowsiness, painful eye movements, eye sensitivity to light
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Dark or black tongue or stools
• Diarrhea, change in taste
• Yellow-gray-brown tooth discoloration

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088