BISMUTH SUBSALICYLATE

Do NOT use bismuth subsalicylate if:

• you are allergic to any ingredient in bismuth subsalicylate
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
• you have bleeding problems (eg, hemophilia), active bleeding ulcer, black or bloody stools, or Von Willebrand disease
• you are taking another salicylate medicine (eg, aspirin)

Contact your doctor or health care provider right away if any of these apply to you.

This medication should be used under a doctor’s direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers.

Side effects from this medication are rare. The most common side effects are darkening of the stools and/or tongue. These effects are harmless and will disappear when you stop the medication.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness

Tell your doctor right away if any of these unlikely but serious side effects occur: ringing ears, hearing loss.

This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, stop taking this medication and consult your doctor or pharmacist right away: vomit that looks like coffee grounds, black/tarry/bloody stools, persistent stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before taking bismuth subsalicylate, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to aspirin, to salicylates (such as salsalate), or to NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding problems (such as hemophilia), bloody/black/tarry stools.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication gout.

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug contains an aspirin-like product (salicylate). Children and teenagers should not take this product if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin or aspirin-like products increases the risk of Reye’s syndrome, a rare but serious illness.

During the first 6 months of pregnancy, this medication should be used only when clearly needed because of the salicylate. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: valproic acid, carbonic anhydrase inhibitors (such as acetazolamide), corticosteroids (such as prednisone), methotrexate.

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, “blood thinners” such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that are similar to this drug and, if taken together, may increase your risk for side effects. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details.

This medication may interfere with certain radiology exams (x-rays of the intestines using contrast dye), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Symptoms of overdose may include: ringing ears, hearing loss. If overdose is suspected, bring the victim to the nearest hospital right away.