bismuth subsalicylate, metronidazole, and tetracycline

bismuth subsalicylate, metronidazole, and tetracycline

Pronunciation: BIZ muth sub sa LISS i late, MET roe NYE da zole, and tet ra SYE kleen

Brand: Helidac

What is the most important information I should know about bismuth subsalicylate, metronidazole, and tetracycline (Helidac)?

You should not use this medicine if you have severe kidney disease, a blood cell disorder, or if you are allergic to aspirin, bismuth subsalicylate, metronidazole, or tetracycline.

Do not use this medicine if you are pregnant. Tetracycline can cause permanent tooth discoloration and affect growth later in the baby's life.

You should not use this medicine if you drank alcohol in the past 3 days, or if you took Antabuse in the past 14 days. Do not drink alcohol or consume anything that contains propylene glycol while taking Helidac and for at least 3 days after your last dose.

In animal studies, metronidazole caused certain types of cancer. However, it is not known whether these effects would occur in humans.

What is bismuth subsalicylate, metronidazole, and tetracycline (Helidac)?

Bismuth subsalicylate, metronidazole, and tetracycline (Helidac) is a combination antibiotic medicine used to treat peptic ulcer (duodenal ulcer) with H. pylori infection.

Helidac is given together with a stomach acid reducer such as famotidine (Pepcid).

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

What should I discuss with my healthcare provider before taking Helidac?

You should not use this medicine if:

  • you have severe kidney disease;
  • you are pregnant or breastfeeding;
  • you have a blood cell disorder;
  • you drank alcohol in the past 3 days;
  • you have taken disulfiram (Antabuse) in the past 14 days; or
  • you are allergic to aspirin, bismuth subsalicylate (Kaopectate, Pepto-Bismol), metronidazole, or tetracycline.

Do not use Helidac if you are pregnant. Tetracycline can cause permanent tooth discoloration and affect growth later in the baby's life.

You should not breastfeed while using Helidac, and for at least 24 hours after your last dose. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Tetracycline can make birth control pills less effective. To prevent pregnancy while using Helidac, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Tell your doctor if you have ever had:

  • kidney or liver disease;
  • a nervous system disorder such as Alzheimer's disease, multiple sclerosis, or Parkinson's disease;
  • a head injury or brain tumor; or
  • a seizure disorder.

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

In animal studies, metronidazole caused certain types of cancer. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

How should I take Helidac?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Chew and swallow the bismuth subsalicylate tablets.

Do not chew the metronidazole or tetracycline pills. Swallow each pill whole.

To prevent heartburn and damage to the esophagus, be sure to take each dose (especially the bedtime dose) with a full glass of water (8 ounces).

Take all 4 pills four times daily with meals and at bedtime.

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. Helidac will not treat a viral infection such as the flu or a common cold.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Helidac.

If you need surgery, tell the surgeon ahead of time that you are using Helidac.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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 in a row, call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe weakness, confusion, balance problems, nausea, vomiting, diarrhea, high fever, ringing in your ears, numbness or tingling, fast heartbeats, rapid or difficult breathing, seizure, or coma.

What should I avoid while taking Helidac?

Do not drink alcohol while you are taking Helidac and for at least 3 days after your last dose. Drinking alcohol while taking Helidac may cause nausea, vomiting, headache, or flushing (warmth, redness, tingly feeling).

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 Helidac with milk or other dairy products. Also avoid taking the medicine 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.

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

What are the possible side effects of Helidac?

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);
  • numbness, tingling, weakness, problems with balance or muscle movement;
  • pale skin, easy bruising or bleeding;
  • ringing in your ears, vision problems, pain behind your eyes;
  • severe headache, dizziness, confusion, neck stiffness, seizure;
  • fever, sore throat, cough, trouble breathing; or
  • white patches in your mouth, skin rash or itching, vaginal itching and discharge.

Common side effects may include:

  • dark-colored stools;
  • swollen tongue, black or "hairy" tongue;
  • stomach pain, nausea, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 other drugs will affect Helidac?

Tell your doctor about all your other medicines, especially:

  • aspirin;
  • busulfan;
  • cimetidine;
  • lithium;
  • probenecid;
  • birth control pills;
  • any medicine or product that contains propylene glycol;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • diabetes medication; or
  • seizure medicine such as phenytoin or phenobarbital.

This list is not complete. Other drugs may affect Helidac, 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?

Your pharmacist can provide more information about bismuth subsalicylate, metronidazole, and tetracycline (Helidac).

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.

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