Pylera is a combination antimicrobial product that contains bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, intended for oral administration. This medication is provided in capsule form, each containing film-coated tetracycline hydrochloride to prevent contact with bismuth subcitrate potassium. Some of the inactive ingredients in the capsules include colloidal silicon dioxide, gelatin, and titanium dioxide.

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better. Take products with aluminum, calcium, iron, magnesium, or zinc in them at a different time of day than this medication. Talk to your care team if you have questions. Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Dizziness, loss of balance or coordination, confusion or trouble speaking -Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting -Pain, tingling, or numbness in the hands or feet, muscle weakness, trouble walking, loss of balance or coordination -Rash, fever, and swollen lymph nodes -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Seizures -Severe diarrhea, fever -Unusual vaginal discharge, itching, or odor Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Black stools -Change in tooth color -Dark or black tongue -Diarrhea -Metallic taste in mouth -Nausea -Sensitivity to light

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cockayne syndrome -History of blood diseases, such as sickle cell anemia, anemia, leukemia -Frequently drink alcohol -Irregular heartbeat or rhythm -Kidney disease -Liver disease -Low blood counts -Seizures -Tingling of the fingers or toes, or other nerve disorder -An unusual or allergic reaction to bismuth subcitrate potassium, metronidazole, tetracycline, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Acitretin -Alcohol or any product that contains alcohol -Cisapride -Disulfiram -Dronedarone -Pimozide -Thioridazine This medication may also interact with the following: -Antacids, vitamins, or other products that contain aluminum, calcium, iron, magnesium, or zinc -Busulfan -Certain medications that treat or prevent blood clots, such as warfarin -Cimetidine -Estrogen or progestin hormones -Lithium -Other medications that cause heart rhythm changes -Phenobarbital -Phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse. Do not treat diarrhea with over the counter products. Contact your care team if you have diarrhea that lasts more than 2 days or if it is severe and watery. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths. Estrogen and progestin hormones may not work as well while you are taking this medication. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you. Some products may contain alcohol. Ask your care team if this medication contains alcohol. Be sure to tell all care teams you are taking this medication. Certain medications, such as metronidazole and disulfiram, can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours.

What are the most serious risks of this medication?

This medicine was tested in animals. A risk for cancer was found in some animals but not in others. It is not clear if people have an increased risk for cancer with this medicine. This medicine will only be used when it is clearly needed for your condition.