What is Helidac?

Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided .

Bismuth subsalicylate, metronidazole, and tetracycline combination is used together with an H2-receptor antagonist to treat duodenal ulcers caused by H. pylori bacteria.

This package contains a combination of 3 different medicines. The individual medicines contained in this package should not be used alone or for other purposes than to treat duodenal ulcers caused by H. pylori.

This combination of medicines is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Helidac® comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Each day's therapy is packaged in a blister card that contains 8 chewable tablets of bismuth subsalicylate, 4 tablets of metronidazole, and 4 capsules of tetracycline.

Pay attention to how to take each medicine. Completely chew and swallow 2 bismuth tablets. Swallow the metronidazole tablets and tetracycline capsules with a full glass of water. This will help prevent irritation of the esophagus (tube between the throat and stomach). Do not chew, crush, or break the metronidazole tablets and tetracycline capsules.

Your doctor will also prescribe another medicine, a histamine H2 receptor antagonist, which will come with its own directions and must be taken along with this combination of medicines.

Avoid taking milk, dairy products, antacids containing aluminum, calcium, or magnesium (e.g., Maalox®, Tums®), or supplements containing iron, zinc, or sodium bicarbonate. This may keep tetracycline from working properly.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (blister card containing chewable tablets, tablets, and capsules):
  • For treatment of duodenal ulcers caused by H. pylori infection:
    • Adults—One dose (525 milligrams [mg] of bismuth subsalicylate, 250 mg of metronidazole, and 500 mg of tetracycline) four times a day, taken with meals and at bedtime, for 14 days.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss more than four doses of this combination of medicines, check with your doctor.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of Helidac® in the pediatric population. Safety and efficacy have not been established.

Tetracycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger unless directed by the child's doctor.

Although appropriate studies on the relationship of age to the effects of Helidac® therapy have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Helidac®.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin
• Amifampridine
• Amisulpride
• Amprenavir
• Bepridil
• Cisapride
• Disulfiram
• Dronabinol
• Dronedarone
• Mesoridazine
• Methoxyflurane
• Pimozide
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alfuzosin
• Amiodarone
• Amitriptyline
• Amoxicillin
• Ampicillin
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bacampicillin
• Bedaquiline
• Bexarotene
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Busulfan
• Capecitabine
• Celecoxib
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clonixin
• Cloxacillin
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dicloxacillin
• Digoxin
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxifluridine
• Droperidol
• Droxicam
• Ebastine
• Efavirenz
• Encorafenib
• Eribulin
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Etretinate
• Famotidine
• Felbamate
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluorouracil
• Fluoxetine
• Flurbiprofen
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Imipramine
• Indomethacin
• Inotuzumab Ozogamicin
• Isotretinoin
• Itraconazole
• Ivabradine
• Ketoconazole
• Ketoprofen
• Lapatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Mebendazole
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Methadone
• Methicillin
• Mifepristone
• Mizolastine
• Morniflumate
• Moxifloxacin
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nabumetone
• Nafarelin
• Nafcillin
• Naproxen
• Nelfinavir
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osimertinib
• Oxacillin
• Oxaprozin
• Oxyphenbutazone
• Paliperidone
• Panobinostat
• Papaverine Hydrochloride
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin V
• Pentamidine
• Perphenazine
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Pipamperone
• Piperacillin
• Piroxicam
• Pitolisant
• Pivampicillin
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Risperidone
• Ritonavir
• Rofecoxib
• Sertindole
• Sertraline
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulindac
• Sulpiride
• Sultamicillin
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tegafur
• Telaprevir
• Telavancin
• Telithromycin
• Temocillin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Tizanidine
• Tolfenamic Acid
• Tolmetin
• Tolterodine
• Toremifene
• Trazodone
• Tretinoin
• Trimipramine
• Triptorelin
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Warfarin
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Aminolevulinic Acid
• Atovaquone
• Calcium
• Carbamazepine
• Cholestyramine
• Colestipol
• Cyclosporine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Doxycycline
• Iron
• Lithium
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Milk Thistle
• Probenecid
• Quinine
• Sulfinpyrazone
• Tamarind

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aspirin or other salicylates or
• Kidney disease, severe—Should not be used in patients with this condition.

• Blood disorder (e.g., leukopenia, neutropenia), or history of or
• Brain disease or
• Central nervous system disease or—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of metronidazole and tetracycline from the body.

If your condition does not improve or if it becomes worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Your birth control pills may not work as well while you are using this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take this medicine if you are also using disulfiram (Antabuse®) or methoxyflurane (Penthrane®).

Drinking alcoholic beverages while taking metronidazole may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (e.g., elixirs, cough syrups, tonics) may also cause problems. Do not drink alcoholic beverages or take other products containing propylene glycol while you are taking Helidac® and for at least 3 days after stopping it.

Metronidazole may cause some people to become dizzy, clumsy, or trouble seeing clearly.

Children or teenagers who have or who are recovering from chickenpox or influenza should not use this combination of medicines unless directed by the child's doctor. If nausea or vomiting occurs after taking this combination of medicines, check with the child's doctor.

Tetracycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking tetracycline:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

You may still be more sensitive to sunlight or sunlamps for 2 weeks to several months or more after stopping tetracycline. If you have a severe reaction, check with your doctor.

Bismuth subsalicylate may cause dark tongue and/or black stools. This is only temporary and will go away after you stop taking this medicine.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. Avoid people who are sick. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

Before having surgery (including dental surgery) with a general anesthetic, tell the medical doctor or dentist in charge that you are taking tetracycline in this combination of medicines.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.