Helidac therapy pack
Generic Name: bismuth subsalicylate/metronidazole/tetracycline (BIZ-muth SUB-sa-LIS-i-late/MET-roe-NYE-da-zole/TET-ra-SYE-kleen)
Brand Name: Helidac
Metronidazole, a component of Helidac therapy pack, has caused cancer in mice and rats. Discuss any questions or concerns with your doctor. Do not use Helidac therapy pack for a condition other than the one for which it was prescribed.
Helidac therapy pack is used for:
Treating Helicobacter 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, to bismuth subcitrate potassium, or to other tetracycline antibiotics (eg, doxycycline)
- you are allergic to any medicines similar to metronidazole (eg, tinidazole)
- the patient is a child or teenager who has or is recovering from a viral infection (eg, flu, chickenpox, shingles)
- you have severe kidney problems
- you consume alcohol or other products that contain propylene glycol
- you are taking acitretin, busulfan, isotretinoin, or a penicillin antibiotic (eg, amoxicillin)
- you are taking disulfiram or have taken it 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, low white blood cell or platelet levels) or liver or kidney problems
- if you have a seizure disorder (eg, epilepsy), nerve or brain problems, stomach or bowel problems (eg, inflammation, Crohn disease), or lupus
- if you have or are recovering from a viral infection (eg, chickenpox, flu, shingles)
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
- Disulfiram because the risk of severe side effects, such as mental or mood changes, may be increased
- Barbiturates (eg, phenobarbital), cimetidine, hydantoins (eg, phenytoin), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Helidac therapy pack's effectiveness
- Amiodarone, anticoagulants (eg, warfarin), busulfan, lithium, medicines for diabetes (eg, glipizide), methotrexate, or valproic acid because the risk of their side effects may be increased by Helidac therapy pack
- Atovaquone, hormonal contraceptives (eg, birth control pills), 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 (bismuth subsalicylate), 1 white tablet (metronidazole), and 1 black and yellow capsule (tetracycline). 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 the 2 pink tablets and swallow. Afterward, take the white tablet and the black and yellow 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.
- If you take an antacid that has aluminum, calcium, or magnesium in it; a product that has iron, zinc, or sodium bicarbonate in it; or a multivitamin; ask your doctor or pharmacist how to take it with Helidac therapy pack.
- Do not eat or drink calcium-rich foods (eg, milk, dairy products, calcium-enriched juices) within 2 hours of taking 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, 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 consume alcohol or other products that contain propylene glycol while you are using Helidac therapy pack and for at least 3 days 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.
- Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Helidac therapy pack for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Helidac therapy pack may have an aspirin-like medicine in it. Aspirin has been linked to a serious illness called Reye syndrome. Do not give Helidac therapy pack to a child or teenager who has or is recovering from a viral infection (eg, the flu, chickenpox, shingles). 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.
- Tell your doctor or dentist that you take Helidac therapy pack before you receive any medical or dental care, emergency care, or surgery.
- Helidac therapy pack may interfere with certain lab tests, including x-rays and blood, liver function, and triglyceride tests. Be sure your doctor and lab personnel know you are taking Helidac therapy pack.
- Use Helidac therapy pack with caution in the ELDERLY; they may be more sensitive to its effects.
- Helidac therapy pack should not be used in CHILDREN younger than 8 years old; permanent yellow, gray, or brown discoloration of the teeth may occur.
- PREGNANCY and BREAST-FEEDING: Helidac therapy pack has been shown to cause harm to the fetus. 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 and for 24 hours after your last dose.
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; darkening of the tongue or stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; mild stomach pain; nausea; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; flushing); black, hairy tongue or sore tongue; black, tarry stools; bloody stools; blurred vision, vision loss, or other vision changes; changes in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; depression; difficult or painful urination; numbness, tingling, or burning of the arms, hands, legs or feet; one-sided weakness; pale stools; red, swollen, peeling, or blistered skin; ringing in the ears; seizures; severe diarrhea; severe or persistent headache, dizziness, or stomach pain or cramps; signs of infection (eg, fever, chills, or persistent sore throat); speech problems; stiff neck; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vaginal odor or discharge; vomit that looks like coffee grounds; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; decreased coordination; fast heartbeat; fever; rapid or difficult breathing; ringing in the ears; seizures; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; sluggishness.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.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Helidac therapy pack or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Helidac therapy pack. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Helidac therapy pack. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Helidac therapy pack.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.