Drugs & Vitamins

Helidac Active Ingredients: Bismuth Subsalicylate, Metronidazole, and Tetracycline Combination Representative Names: Helidac Available Product Images: What are bismuth subsalicylate; metronidazole; tetracycline tablets and capsules? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with Helidac®? What side effects may I notice from taking Helidac®? What should I watch for while taking Helidac®? Where can I keep my medicine? What are bismuth subsalicylate; metronidazole; tetracycline tablets and capsules? (Back to top) BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE (Helidac®) is a combination of medications used to treat stomach and intestinal ulcers associated with Helicobacter pylori, a bacterial infection. The Helidac® kit contains bismuth subsalicylate chewable tablets, metronidazole tablets, and tetracycline capsules packaged together. Generic Helidac® therapy kits are not available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •if you smoke or drink alcoholic beverages •anemia, bleeding problems, or other blood disorders •dental disease •diabetes •disease of the nervous system such as neuropathy •disease of the esophagus, stomach, or bowel (like Crohn's disease) •fungal infection •gout •kidney disease •liver disease •recent vaccination with chickenpox vaccine •recent viral illness, such as the flu or chickenpox •seizures (convulsions) •other chronic illness •an unusual or allergic reaction to aspirin or other salicylates, bismuth compounds, metronidazole, tetracycline antibiotics, or other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Each "dose" of Helidac® contains four pills: two bismuth subsalicylate chewable tablets, one metronidazole tablet, and one tetracycline capsule. Each dose should be taken four times each day, at mealtimes and at bedtime. Follow the directions on the prescription label. The bismuth subsalicylate tablets (pink) should be chewed and swallowed. The metronidazole tablet (white) and the tetracycline capsule (orange/white) should be swallowed whole, with a full glass of water (8 ounces). Take the metronidazole tablets and tetracycline capsules in an upright or sitting position. If possible, take the bedtime dose at least 10 minutes before lying down. Take your doses at regular intervals. Do not take your medicine more often than directed. Finish the full course prescribed by your prescriber or health care professional even if you think your condition is better. Do not stop taking except on your prescriber's advice. You should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking Helidac® and for at least 1 day after stopping it. Alcohol may make you dizzy, feel sick, and flushed; or give you headaches and stomach pains while you are taking metronidazole, a component of Helidac®. Do not take antacids, milk, milk formulas, or other dairy products within 1 to 2 hours of the time you take the tetracycline capsule. These products may keep tetracycline from working properly. Products containing calcium, iron or zinc (including multivitamins), can stop tetracycline from working properly. Take these products at least 2 hours after your last dose of tetracycline, or at least 4 hours before your next dose. What if I miss a dose? (Back to top) If you miss a Helidac® dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Continuing the normal dosing schedule until the medication is gone can make up missed doses. If more than 4 doses are missed, your prescriber should be contacted. What drug(s) may interact with Helidac®? (Back to top) •acetazolamide •alcohol or alcohol-containing beverages or liquid medicines containing alcohol •antacids •aspirin or other salicylate pain relievers (choline salicylate, magnesium salicylate, or Trilisate®) •atovaquone •bismuth subsalicylate (Peptobismol®) •calcium supplements •celecoxib •cholestyramine or colestipol •cimetidine •ciprofloxacin, levofloxacin, ofloxacin, or other similar antibiotics •didanosine, ddI •disulfiram •female hormones, including birth control pills •ferrous sulfate or other iron supplements •lithium •magnesium supplements •medicines for diabetes •medicines to control heart rhythm such as digoxin or dofetilide •medicines that increase your sensitivity to sunlight such as sulfa drugs, tretinoin, or porfimer •methadone •methazolamide •multivitamins with minerals •probenecid •quinapril •ritonavir or Kaletra® •sevelamer •sirolimus or tacrolimus •sodium bicarbonate •soy isoflavones •sucralfate •vitamin A •warfarin •zinc supplements or zinc lozenges Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking Helidac®? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: Rare or uncommon: •clumsiness or unsteadiness •decrease in the amount of urine passed •fever or chills, sore throat •loss of hearing, ringing in the ears •numbness, tingling, pain or weakness in the hands or feet •unusual or persistent skin rash, redness, blistering, peeling or loosening of the skin, including inside the mouth •seizures (convulsions) More common: •dizziness or headache •increased sweating or flushing •itching or burning in the rectal or genital area •nervousness •skin rash, itching •stomach pain or cramps •trouble sleeping •trouble swallowing •unusual tiredness or weakness •vomiting, blood in vomit •watery diarrhea •yellowing of the eyes or skin Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •change in taste •constipation •dark yellow or reddish-brown urine •diarrhea (mild) •discolored tongue (dark or black) •discolored stools (gray-black) •dry mouth, mild irritation of the mouth or throat •increased skin sensitivity to sunlight •joint pain •nausea or loss of appetite •mild stomach pain or cramps What should I watch for while taking Helidac®? (Back to top) It can take several days of therapy with Helidac® before your stomach pains improve. Check with your prescriber or health care professional if your condition does not improve, or if it gets worse. Call your prescriber or health care professional as soon as you can if you get a fever, watery diarrhea, stomach pain, or vomiting. These could be symptoms of a more serious illness. Do not treat yourself. Call your prescriber for advice. Do not take tetracycline just before going to bed. It may not dissolve properly when you are lying down and can cause pain in your throat. Keep out of the sun, or wear protective clothing outdoors and use a sunscreen. Do not use sun lamps or sun tanning beds or booths. Birth control pills (contraceptive pills) may not work properly while you are taking this medicine. Use an extra method of birth control for at least one month. If you become pregnant, contact your prescriber immediately. Helidac® should not be used during pregnancy. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how Helidac® affects you. To reduce the risk of dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Do not smoke cigarettes or drink alcohol; these increase irritation of your stomach. If you are diabetic, you may get a false result for sugar in your urine while you are taking bismuth subsalicylate. Check with your prescriber or health care professional before you change your diet or the dose of your diabetic medicine. In some patients, bismuth subsalicylate in this combination of medicines may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking bismuth subsalicylate. Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. If you are going to have surgery, tell your prescriber or health care professional that you are taking Helidac®. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date. Never use tetracycline if it is past the expiration date; it can make you seriously ill. Last Updated:08/20/2001 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.