Description
Bismuth subsalicylate, metronidazole, and tetracycline combination is used together with other medicines (eg, H2 -blocker) to treat a stomach infection caused by H. pylori bacteria and duodenal ulcer. This bacteria can cause stomach ulcers if it is not treated. This medicine should not be used for any other infection.
This package contains a combination of 3 different antibiotic medicines. The individual medicines contained in this package should not be used alone or for other purposes than to treat a stomach infection caused by H. pylori and duodenal ulcer.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Chewable
- Tablet
- Capsule
Before Using
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:
Allergies
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.
Pediatric
Because of tetracycline's toxicity, use in children 8 years of age and younger is not recommended. Tetracycline may cause permanent discoloration of the teeth and slow down the growth of bones. Safety and efficacy have not been established in this age group.
Geriatric
Although appropriate studies on the relationship of age to the effects of Helidac® 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 this medicine.
Breastfeeding
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.
Drug Interactions
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
- Amprenavir
- Bepridil
- Cisapride
- Disulfiram
- Dronabinol
- Dronedarone
- Levoketoconazole
- 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
- Acenocoumarol
- Adagrasib
- Alfuzosin
- Amiodarone
- Amitriptyline
- Amoxicillin
- Ampicillin
- Amtolmetin Guacil
- Anagrelide
- Apomorphine
- Aripiprazole
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bacampicillin
- Balsalazide
- Bedaquiline
- Bexarotene
- Bromfenac
- Bufexamac
- Buprenorphine
- Bupropion
- Buserelin
- Busulfan
- Capecitabine
- Celecoxib
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine, Live
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cimetidine
- Ciprofloxacin
- Citalopram
- Clarithromycin
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
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Milk Thistle
- Omadacycline
- Probenecid
- Quinine
- Sulfinpyrazone
- Tamarind
Other Interactions
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
Other Medical Problems
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
- Cockayne Syndrome (genetic disorder) or
- Kidney disease, severe—Should not be used in patients with these conditions.
- Blood disorder (eg, leukopenia, neutropenia), or history of or
- Fungal infection (eg, candidiasis)—Use with caution. May make these conditions worse.
- Chickenpox or
- Influenza—Use with caution. May increase risk of Reye's syndrome in children with or recovering from these conditions.
- Intracranial hypertension (high fluid pressure in the brain), history of or
- Obesity—Use with caution. May increase risk of developing intracranial hypertension or pseudotumor cerebri caused by tetracycline.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of metronidazole and tetracycline from the body.
Proper Use
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.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Each day's treatment 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 (8 ounces) of water. Do not chew, crush, or break the metronidazole tablets and tetracycline capsules.
Take this medicine with meals and at bedtime.
Drink extra fluids to help prevent irritation or ulcers in the esophagus.
Your doctor will also prescribe another medicine called an H2 blocker, which will come with its own directions and must be taken along with this medicine.
Avoid taking milk, dairy products, antacids containing aluminum, calcium, or magnesium (eg, Maalox®, Tums®), or supplements containing iron, zinc, or sodium bicarbonate. This may keep tetracycline from working properly.
Do not drink milk or eat dairy products with this medicine.
Keep using this medicine for the full time of treatment, even if you begin to feel better after the first few doses. Your infection may not clear up if you stop using this medicine too soon.
Dosing
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 H. pylori infection and duodenal ulcer (taken with an H2 blocker):
- Adults—One dose (two 262.4 milligrams [mg] of bismuth subsalicylate, one 250 mg of metronidazole, and one 500 mg of tetracycline) 4 times a day, taken with meals and at bedtime, for 14 days.
- Children—Use and dose must be determined by your doctor.
- For H. pylori infection and duodenal ulcer (taken with an H2 blocker):
Missed Dose
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 4 doses of this medicine, call your doctor right away.
Storage
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you are also using methoxyflurane (Penthrane®) or have used disulfiram (Antabuse®) in the last 2 weeks. Do not drink alcohol and other products containing propylene glycol while you are using this medicine and for at least 3 days after your last dose.
If your condition does not improve or if it becomes worse, check with your doctor.
Using this medicine while you are pregnant, especially during the second and later part of a pregnancy, can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use an effective form of birth control (eg, condoms, spermicide) to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
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 medicines unless directed by the child's doctor. If nausea or vomiting occurs after using this medicine, check with the child's doctor right away.
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 your tongue to become a darker color or even black. It may also make your stools (bowel movements) black. This is only temporary and will not hurt you. Your tongue and stools will go back to normal when you stop using this medicine. Ask your doctor about this if you have any concerns.
Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis.
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
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.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, severe acne or skin rash, sore throat, sores or ulcers on the skin, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are using this medicine.
This medicine may cause serious allergic reactions. Check with your doctor right away if you have feeling of warmth, itching, redness of the face, neck, arms and occasionally, upper chest, or redness of the skin.
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 (eg, x-rays).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
Less common
- Black, tarry stools
- body aches or pain
- burning, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning upper stomach pain
- chest tightness
- chills
- cough
- difficulty in breathing
- ear congestion
- fever
- headache
- loss of appetite
- loss of voice
- nausea
- pain or tenderness around the eyes and cheekbones
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
- weight loss
Rare
- Bladder pain
- bleeding from the rectum
- bloody or cloudy urine
- blurred vision
- bruising
- burning, dry, or itching eyes
- chest pain or discomfort
- confusion
- diarrhea
- difficult, burning, or painful urination
- discharge, excessive tearing
- dizziness
- fainting
- frequent urge to urinate
- general feeling of discomfort or illness
- increased sensitivity of the skin to sunlight
- itching, skin rash
- joint pain
- large, flat, blue or purplish patches in the skin
- lower back or side pain
- muscle aches and pains
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pounding in the ears
- redness or other discoloration of the skin
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- redness, swelling, or soreness of the tongue
- severe constipation
- severe numbness, especially on one side of the face or body
- severe sunburn
- shivering
- slow or fast heartbeat
- sore throat
- stomach pain
- sweating
- tooth disorder
- trouble sleeping
- trouble swallowing
- tumor
- white patches in the mouth or on the tongue
Incidence not known
- Blistering, peeling, loosening of the skin
- clumsiness
- decreased vision
- joint or muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- redness or soreness around fingernails or loosening of the fingernails
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blue lips, fingernails, or skin
- burning, numbness, tingling, or painful sensations
- continuing ringing or buzzing or other unexplained noise in the ears
- coughing that sometimes produces a pink frothy sputum
- difficult, noisy, fast, or deep breathing
- hearing loss
- increased sweating
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- pale skin
- seizures
- shakiness and unsteady walk
- slow heartbeat
- swelling in the legs and ankles
- unsteadiness, trembling, or other problems with muscle control or coordination
- weakness in the arms, hands, legs, or feet
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:
Less common
- Belching
- bloating
- burning or itching around the anus
- change in or loss of taste
- darkening of the tongue
- excess air or gas in the stomach or bowels
- feeling of fullness
- heartburn
- indigestion
- lack or loss of strength
- passing gas
- stomach discomfort or upset
Rare
- Blemishes on the skin
- difficulty in moving
- drowsiness
- dry mouth
- joint swelling or stiffness
- pimples
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.
DRG-20061526
