Helidac

Helidac

bismuth ssal/metronid/tetracyc

This product contains 3 medications tetracycline, metronidazole, and bismuth subsalicylate. It is used with an acid blocker (for example, an H2 blocker such as ranitidine) to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Tetracycline and metronidazole are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. Bismuth subsalicylate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. This product treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This product is not recommended for use in children.

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About Helidac

This product contains 3 medications tetracycline, metronidazole, and bismuth subsalicylate. It is used with an acid blocker (for example, an H2 blocker such as ranitidine) to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

Tetracycline and metronidazole are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria. Bismuth subsalicylate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria.

This product treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

This product is not recommended for use in children.

Read the Patient Information Booklet if available from your pharmacist before you start taking this product. If you have any questions, ask your doctor or pharmacist.

This product comes as a package with 14 separate dosing cards. Each card contains enough medication for 1 day (4 doses). Each dose contains 4 pills. For the 2 round pink tablets, chew thoroughly and swallow. For the 1 round white tablet and 1 black/yellow capsule, swallow whole with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. For best results, 1 dose (4 pills) must be taken 4 times daily.

Take this product at mealtimes and at bedtime for 14 days. Do not lie down for 10 minutes after taking this medication.

Take this medication 2 to 3 hours before or after taking any products containing magnesium, aluminum, or calcium. These products bind with tetracycline, preventing its full absorption. Some examples include quinapril, didanosine solution, vitamins/minerals, and antacids. Dairy products (such as milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included.

Take this medication regularly to get the most benefit from it. Continue to take this medication and the acid blocker until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection/ulcer.

Tell your doctor if your condition lasts or gets worse.

Nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Your tongue may turn dark in color while you are taking this medication. This is harmless, and the effect will disappear when you stop the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling of arms/legs, discolored teeth, mental/mood changes (such as confusion, anxiety, irritability, depression), difficult/painful swallowing, heartburn, fast/pounding heartbeat, ringing in the ears, frequent/painful urination.

Tell your doctor right away if any of these rare but very serious side effects occur: severe headache, stiff/painful neck, signs of kidney problems (such as change in the amount of urine), signs of infection (such as a sore throat that doesn't go away, or a fever), easy bruising/bleeding, unusual weakness/tiredness, seizures, chest pain, symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).

This product commonly causes dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a serious condition. Tell your doctor right away if you have dark stools.

Tetracycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tetracycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, vision changes (such as blurred/double vision, decreased vision, sudden blindness).

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subsalicylate, metronidazole, or tetracycline; or to tinidazole; or to other tetracyclines (such as doxycycline); or to other bismuth products (such as bismuth subcitrate); or to aspirin, to salicylates (such as salsalate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood disorders, brain/spinal cord disorders (such as seizures), trouble swallowing, esophagus problems (such as hiatal hernia, reflux disease-GERD), a certain rare genetic disorder (Cockayne syndrome).

Antibiotics may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tetracycline may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Avoid alcoholic beverages and products containing propylene glycol while taking this product and for at least 3 days after finishing this product because severe stomach upset/cramps, nausea, vomiting, headache, and flushing may occur.

This product may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This drug contains an aspirin-like product (salicylate). Children and teenagers younger than 18 years should not take this product if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin or aspirin-like products increases the risk of Reye's syndrome, a rare but serious illness.

Children should also not take this product because it contains tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Consult the doctor for more information.

This product must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

This product contains drugs that may pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Taking outdated tetracycline can result in serious illness. Consult your pharmacist or local waste disposal company.

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: alcohol-containing products (such as cough-and-cold syrups, aftershave), atovaquone, dichlorphenamide, digoxin, lithium, lopinavir/ritonavir solution, products containing propylene glycol, retinoid medications (such as acitretin, isotretinoin, tretinoin), strontium.

This product may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to this product and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Do not take this product if you are also taking disulfiram or if you have taken disulfiram within the last 2 weeks.

This product may interfere with certain lab tests, possibly causing false test results. This product may also interfere with X-ray exams of the stomach/intestines. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures.

Missed Doses:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Contact your doctor if you miss more than 4 doses.

Notes:

Do not share this medication with others.

Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

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