Consumer Drug Information

Helidac Therapy Pack


Generic Name: Bismuth Subsalicylate/Metronidazole/Tetracycline Therapy Pack (BIZ-muth sub-sa-LIS-a-late/MET-roe-NYE-da-zole/TE-tra-SYE-kleen)
Brand Name: Helidac

Helidac Therapy Pack should only be used to treat ulcers of the small intestine (duodenal ulcers) associated with H. pylori infection.


Helidac Therapy Pack is used for:

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Treating H. pylori infection associated with ulcers. It is used with an H2 blocker (eg, ranitidine).

Helidac Therapy Pack is an antimicrobial combination. It works by killing sensitive bacteria.

Do NOT use Helidac Therapy Pack if:

  • you are allergic to any ingredient in Helidac Therapy Pack or to salicylates (eg, aspirin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)
  • you are pregnant or breastfeeding
  • if you are a child or teenager and have a viral infection (eg, flu, chickenpox, shingles)
  • you have kidney problems, liver problems, or bleeding or blood clotting problems (eg, hemophilia, von Willebrand disease)
  • you are taking acitretin, busulfan, ergot alkaloids (eg, ergotamine), an HIV protease oral solution (eg, amprenavir), isotretinoin, methoxyflurane, a penicillin antibiotic (eg, amoxicillin), ranolazine, or disulfiram, or if you have taken disulfiram within the past 14 days

Before using Helidac Therapy Pack:

Some medical conditions may interact with Helidac Therapy Pack. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of blood problems (eg, anemia, low white blood cells, unusual bleeding or bruising)
  • if you have a seizure disorder (eg, epilepsy), other central nervous system problems, a viral infection (eg, flu, shingles), inflammation of the stomach, peptic ulcers, Crohn disease, dehydration problems, or lupus

Some MEDICINES MAY INTERACT with Helidac Therapy Pack. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Acitretin or isotretinoin because the risk of high pressure in the brain may be increased
  • Methoxyflurane because serious, even fatal kidney problems may occur
  • Amiodarone, busulfan, disulfiram , or an HIV protease oral solution (eg, amprenavir) because irregular heartbeat; serious liver, lung, or bladder problems; severe mood or mental problems; or stomach cramps, nausea, vomiting, headaches, and flushing may occur
  • Barbiturates (eg, phenobarbital), cimetidine, hydantoins (eg, phenytoin), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Helidac Therapy Pack's effectiveness
  • Anticoagulants (eg, warfarin), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), lithium, macrolide immunosuppressants (eg, sirolimus), medicines for diabetes (eg, glipizide), methotrexate, ranolazine, salicylates (eg, aspirin), or valproic acid because the risk of their side effects may be increased by Helidac Therapy Pack
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), atovaquone, hormonal contraceptives (eg, birth control pills, patches), penicillin antibiotics (eg, amoxicillin), or sulfinpyrazone because their effectiveness may be decreased by Helidac Therapy Pack

This may not be a complete list of all interactions that may occur. Ask your health care provider if Helidac Therapy Pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.



How to use Helidac Therapy Pack:

Use Helidac Therapy Pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Helidac Therapy Pack. Talk to your pharmacist if you have questions about this information.
  • Each dose of Helidac Therapy Pack is made up of 2 pink chewable tablets, one white tablet, and one orange and white capsule. Each blister card contains 4 doses (enough doses for 1 day).
  • Take a dose of Helidac Therapy Pack 4 times a day, at mealtimes and at bedtime, unless your doctor tells you otherwise.
  • To take a dose of Helidac Therapy Pack, thoroughly chew 2 pink tablets and swallow. Afterward, take 1 white tablet and 1 orange and white capsule with a full glass of water (8 oz/240 mL). Swallow the tablet and capsule whole. Do not break, crush, or chew before swallowing.
  • Drinking extra fluids while you are taking Helidac Therapy Pack is recommended. Be sure to do this especially with the bedtime dose. Check with your doctor for instructions.
  • Do not take an antacid that has aluminum, calcium, or magnesium in it, or a product that has iron or zinc in it within 2 hours of Helidac Therapy Pack.
  • Do not eat or drink dairy products within 2 hours of Helidac Therapy Pack.
  • To clear up your infection completely, take Helidac Therapy Pack for the full course of treatment. Keep taking it even if you feel better in a few days.
  • If you miss a dose of Helidac Therapy Pack, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 4 doses of Helidac Therapy Pack, contact your doctor.

Ask your health care provider any questions you may have about the proper use of Helidac Therapy Pack.

Important safety information:

  • Helidac Therapy Pack may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Helidac Therapy Pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Helidac Therapy Pack and for at least 1 day after you have stopped taking Helidac Therapy Pack. Stomach cramps, nausea, vomiting, headaches, and flushing may occur.
  • Helidac Therapy Pack combination should only be used to treat H. Pylori infection associated with ulcers. It is not effective for treating viral infections (eg, the common cold).
  • Be sure to use Helidac Therapy Pack for the full course of treatment. If you do not, the medicine may not clear up your infection completely. This could cause your ulcer to recur.
  • Long-term or repeated use of Helidac Therapy Pack may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Helidac Therapy Pack may have an aspirin-like medicine in it. Aspirin has been linked to a serious illness called Reye syndrome. Do not use Helidac Therapy Pack to treat nausea or vomiting in a child or teenager who has recently had chickenpox or flu. Nausea or vomiting may be a sign of Reye syndrome. Contact your doctor with any questions or concerns.
  • If you are taking aspirin for some other condition and you develop ringing in the ear, contact your doctor.
  • Do not receive a live vaccine (eg, typhoid) while you are taking Helidac Therapy Pack. Talk with your doctor before you receive any vaccine.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Helidac Therapy Pack. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Helidac Therapy Pack may temporarily discolor or darken the tongue or stools. This is normal and not a cause for concern.
  • Helidac Therapy Pack may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Helidac Therapy Pack. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Helidac Therapy Pack may interfere with certain lab tests, including x-ray, blood, liver function, and triglyceride tests. Be sure your doctor and lab personnel know you are taking Helidac Therapy Pack.
  • Helidac Therapy Pack should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Use of tetracycline in CHILDREN younger than 8 years old may cause serious tooth problems, including softening of the tooth enamel and permanent yellow, gray, or brown discoloration of the teeth.
  • PREGNANCY and BREAST-FEEDING: Do not use Helidac Therapy Pack if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while taking Helidac Therapy Pack. If you think you may be pregnant, contact your doctor right away. Helidac Therapy Pack is found in breast milk. Do not breast-feed while taking Helidac Therapy Pack.

Possible side effects of Helidac Therapy Pack:

Every medicine can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkening of the tongue or stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision; black, hairy tongue or sore tongue; dark urine; depression; loss of coordination; numbness or tingling in the hands or feet; pale stools; red or blistered skin; seizures; severe or persistent headache or stomach pain; signs of infection (eg, fever, chills, or persistent sore throat); sore mouth; unusual bruising or bleeding; vaginal odor or discharge; white patches in the mouth or on the tongue; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; fast heartbeat; high fever; rapid breathing; ringing in the ears; severe or persistent diarrhea, nausea, or vomiting; unusual tiredness or fatigue.

Proper storage of Helidac Therapy Pack:

Store Helidac Therapy Pack at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Helidac Therapy Pack out of the reach of children and away from pets.

General information:

  • If you have any questions about Helidac Therapy Pack, please talk with your doctor, pharmacist, or other health care provider.
  • Helidac Therapy Pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Helidac Therapy Pack. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 4, 2009
Database Edition 09.4.1.002
Copyright © 2009 Wolters Kluwer Health, Inc.

More Helidac Therapy Pack resources

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