Pylera Capsules ( Bismuth Subcitrate 140 mg + Metronidazole 125 mg + Tetracycline HCL 125 mg ) 120 capsules

WHAT IS BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE (PYLERA) (PYLERA)?
Bismuth subcitrate potassium is a mineral. Metronidazole and tetracycline are antibiotics that fight bacteria in the body.

Bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera) is a combination medicine used to treat peptic ulcer (duodenal ulcer) with Helicobacter pylori infection. Pylera is usually given together with omeprazole (Prilosec).

Pylera may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF PYLERA (PYLERA)?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
dizziness, problems with speech or coordination;
fever, chills, sore throat, flu symptoms;
neck stiffness, increased sensitivity to light, purple spots on the skin;
numbness or tingling in your arms and legs;
a seizure; or
increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
If you have Cockayne syndrome, stop taking Pylera and call your doctor right away if you have signs of liver problems such as stomach pain, nausea, clay-colored stools, or yellowing of your skin or eyes.

Pylera may cause your tongue to become darker in color. It may also cause your stools to appear black in color. These are harmless and temporary side effects.

Common side effects may include:

diarrhea or other changes in your stools;
nausea; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT THIS MEDICINE (PYLERA)?
You should not use this medicine if you have severe kidney disease, or if you have taken disulfiram (Antabuse) within the past 2 weeks.

Do not use this medicine if you are pregnant or breastfeeding.

Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are taking Pylera and for at least 3 days after you stop taking it.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING PYLERA (PYLERA)?
You should not use Pylera if you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline, or if:

you have severe kidney disease; or
you drink alcohol daily.
Some medicines can cause unwanted or dangerous effects when used with Pylera. Your doctor may change your treatment plan if you also use:

disulfiram (Antabuse), especially if you have taken it in the past 14 days;
methoxyflurane; or
any medicine that contains propylene glycol.
Do not use if you are pregnant. Taking Pylera during pregnancy may affect tooth and bone development in the unborn baby. Taking Pylera during the last half of pregnancy can cause permanent tooth discoloration later in the baby's life.

Tetracycline can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breastfeed within 2 days after using Pylera. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Tell your doctor if you have ever had:

kidney disease;
liver disease;
Cockayne syndrome (a rare genetic disorder);
a blood cell disorder; or
any type of infection.
Metronidazole has caused cancer in animal studies. However, it is not known whether this would occur in humans. Ask your doctor about your risk.

Pylera is not approved for use by anyone younger than 18 years old.

HOW SHOULD I TAKE PYLERA (PYLERA)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take your medicine with a full glass (8 ounces) of water. Swallow the capsule whole.

Pylera is usually taken after meals and at bedtime. If you also take omeprazole (Prilosec), take it after your morning and evening meals.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Pylera will not treat a viral infection such as the flu or a common cold.

You will need frequent blood tests to check your liver function.

Metronidazole can affect the results of certain x-rays or medical tests. Tell any doctor who treats you that you are using Pylera.

Store at room temperature away from moisture and heat. If you use the 10-day Pylera package, keep each capsule in the blister pack until you are ready to take a dose.

WHAT HAPPENS IF I MISS A DOSE (PYLERA)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you miss more than 4 doses, call your doctor for instructions.

WHAT HAPPENS IF I OVERDOSE (PYLERA)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WHAT SHOULD I AVOID WHILE TAKING PYLERA (PYLERA)?
Do not drink alcohol or consume food or medicines that contain propylene glycol while you are taking Pylera. You may have unpleasant side effects such as headaches, stomach cramps, nausea, vomiting, and flushing (warmth, redness, or tingly feeling).

Avoid alcohol or propylene glycol for at least 3 days after you stop taking Pylera. Check the labels of any medicines or food products you use to make sure they do not contain alcohol or propylene glycol.

Avoid exposure to sunlight or tanning beds. Pylera can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Avoid taking Pylera with milk or other dairy products. Also avoid taking Pylera at the same time you take any multivitamins, mineral supplements, or antacids. These products can make it harder for your body to absorb the medicine.

WHAT OTHER DRUGS WILL AFFECT PYLERA (PYLERA)?
Tell your doctor about all your other medicines, especially:

busulfan;
cimetidine;
lithium;
a blood thinner (warfarin, Coumadin, Jantoven); or
seizure medication such as phenobarbital or phenytoin.
This list is not complete. Other drugs may affect Pylera, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

WHERE CAN I GET MORE INFORMATION (PYLERA)?
Your pharmacist can provide more information about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera).

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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