Bismuth subsalicylate, metronidazole, and tetracycline

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 bismuth subsalicylate, metronidazole, and tetracycline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bismuth subsalicylate, metronidazole, and tetracycline 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.

Pediatric

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. bismuth subsalicylate, metronidazole, and tetracycline should not be given to children 8 years of age and younger unless directed by the child's doctor.

Geriatric

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®.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using bismuth subsalicylate, metronidazole, and tetracycline.

Interactions with Medicines

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 bismuth subsalicylate, metronidazole, and tetracycline, 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 bismuth subsalicylate, metronidazole, and tetracycline 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 bismuth subsalicylate, metronidazole, and tetracycline 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
• 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
• 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
• Isotretinoin
• Itraconazole
• Ivabradine
• Ketoconazole
• Ketoprofen
• Lapatinib
• Leuprolide
• Levofloxacin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• 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
• 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
• 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 bismuth subsalicylate, metronidazole, and tetracycline 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

Interactions with Food/Tobacco/Alcohol

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 bismuth subsalicylate, metronidazole, and tetracycline 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 bismuth subsalicylate, metronidazole, and tetracycline 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 bismuth subsalicylate, metronidazole, and tetracycline, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other Medical Problems

The presence of other medical problems may affect the use of bismuth subsalicylate, metronidazole, and tetracycline. 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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• bloody or black, tarry stools
• diarrhea
• nausea

• Burning, prickling, or tingling sensations
• dizziness
• vomiting

• Bloody vomit
• convulsions (seizures)
• fainting
• heart attack
• irritation of the mouth or tongue
• joint pain and swelling
• sensitivity of the skin to sunlight
• skin rash
• trouble with swallowing

Get emergency help immediately if any of the following symptoms of overdose occur:

• Clumsiness or unsteadiness
• confusion
• continuing ringing or buzzing in ears
• fast heartbeat
• fast or deep breathing
• fever
• pain, numbness, or tingling in the arms, legs, hands, or feet
• unusual tiredness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning or itching around the anus
• constipation
• general feeling of discomfort or illness
• loss of appetite
• nervousness
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.

• If you have an allergy to bismuth, metronidazole, salicylates, tetracycline, or any other part of bismuth subsalicylate, metronidazole, and tetracycline.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have kidney disease.
• If you have taken disulfiram within the past 2 weeks.
• If you drink alcohol or take any drugs that have alcohol.
• If you are taking penicillin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bismuth subsalicylate, metronidazole, and tetracycline with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to bismuth subsalicylate / metronidazole / tetracycline: oral kit

General

The most commonly reported side effects included nausea, abdominal pain, and diarrhea.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 12%)
Common (1% to 10%): Abdominal pain, anal discomfort, constipation, diarrhea, duodenal ulcer, dyspepsia, flatulence, gastrointestinal hemorrhage, melena, stool abnormality/darkening/black stools, tongue discoloration/darkening, vomiting
Frequency not reported: Dry mouth, dysphagia, eructation, gastrointestinal monilia, glossitis, intestinal obstruction, rectal hemorrhage, stomatitis, tooth disorder

Metronidazole:
Frequency not reported: Abdominal pain, constipation, candida overgrowth, diarrhea, dry mouth, furry tongue, glossitis, nausea, pancreatitis, stomatitis, vomiting

Tetracycline:
Frequency not reported: Anogenital region inflammatory lesions/inflammatory lesions with Candida overgrowth, black hairy tongue, diarrhea, dysphagia, enterocolitis, esophagitis, esophageal ulceration, glossitis, nausea, vomiting[Ref]

Nervous system

Common (1% to 10%): Dizziness, dysgeusia/taste perversion/metallic taste, headache, paresthesia
Frequency not reported: Cerebral ischemia, somnolence, syncope

Metronidazole:
Frequency not reported: Aseptic meningitis, ataxia, convulsive seizures, dizziness, dysarthria, encephalopathy, headache, incoordination, metallic taste, peripheral neuropathy, syncope, vertigo

Tetracycline:
Frequency not reported: Intracranial hypertension, pseudotumor cerebri[Ref]

Other

Common (1% to 10%): Asthenia, pain
Frequency not reported: Infection, malaise

Metronidazole:
Frequency not reported: Fever, weakness

Tetracycline:
Frequency not reported: Tinnitus[Ref]

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory infection
Frequency not reported: Rhinitis

Metronidazole:
Frequency not reported: Nasal congestion[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Frequency not reported: Nervousness

Metronidazole:
Frequency not reported: Confusion, decreased libido, depression, insomnia, irritability[Ref]

Metabolic

Common (1% to 10%): Anorexia

Metronidazole:
Frequency not reported: Anorexia

Tetracycline:
Frequency not reported: Anorexia[Ref]

Dermatologic

Frequency not reported: Acne, ecchymosis, photosensitivity reaction, pruritus, rash

Metronidazole:
Frequency not reported: Erythematous rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Tetracycline:
Frequency not reported: Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, erythema multiforme, exfoliative dermatitis, Henoch-Schonlein purpura, maculopapular/erythematous rash, nail discoloration, onycholysis, photosensitivity, Stevens-Johnson syndrome, systemic lupus erythematosus exacerbation, toxic epidermal necrolysis, urticaria[Ref]

Cardiovascular

Frequency not reported: Chest pain, hypertension, myocardial infarction

Metronidazole:
Frequency not reported: T-wave flattening, flushing

Tetracycline:
Frequency not reported: Pericarditis[Ref]

Musculoskeletal

Frequency not reported: Arthritis, rheumatoid arthritis, tendonitis

Metronidazole:
Frequency not reported: Joint pain

Tetracycline:
Frequency not reported: Myasthenic syndrome[Ref]

Hepatic

Frequency not reported: ALT increase, AST increase

Tetracycline:
Frequency not reported: Hepatotoxicity, liver failure[Ref]

Genitourinary

Frequency not reported: Urinary tract infection

Metronidazole:
Frequency not reported: Darkened urine, dyspareunia, dysuria, incontinence, proctitis, sense of pelvic pressure, vaginal/vulvar dryness[Ref]

Immunologic

Frequency not reported: Flu syndrome

Tetracycline:
Frequency not reported: Serum sickness-like reaction[Ref]

Ocular

Frequency not reported: Conjunctivitis

Metronidazole:
Frequency not reported: Optic neuropathy[Ref]

Oncologic

Frequency not reported: Neoplasm[Ref]

Hematologic

Metronidazole:
Frequency not reported: Reversible neutropenia/leukopenia, reversible thrombocytopenia

Tetracycline:
Frequency not reported: Eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia, thrombocytopenic purpura

Renal

Metronidazole:
Frequency not reported: Cystitis

Tetracycline:
Frequency not reported: Increased blood urea nitrogen

Hypersensitivity

Tetracycline:
Frequency not reported: Anaphylaxis, angioedema[Ref]

Some side effects of bismuth subsalicylate / metronidazole / tetracycline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.