This is a summary of the most important information about Helidac. For details, talk to your healthcare professional.

Prescribing HELIDAC Therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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Bismuth Subsalicylate

Bismuth subsalicylate may cause a temporary and harmless darkening of the tongue and/or black stool. Stool darkening should not be confused with melena.

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Metronidazole

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of, or history of, blood dyscrasia. A mild leukopenia has been observed; however, no persistent hematologic abnormalities attributable to metronidazole have been observed.

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with a candicidal agent.

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Tetracycline

As with other antibiotics, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, tetracycline should be discontinued and appropriate therapy should be instituted. Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. While this condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.

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Information for Patients: Each dose includes 4 pills: 2 pink round chewable tablets (bismuth subsalicylate), 1 white round tablet (metronidazole), and 1 orange and white capsule (tetracycline hydrochloride). Each dose (all 4 pills) should be taken 4 times a day, at mealtimes and bedtime. Patients should be instructed to chew and swallow the pink round tablets (bismuth subsalicylate tablets) and to swallow the white round tablet (metronidazole tablet) and the pale orange and white capsule (tetracycline hydrochloride capsule) whole with a full glass of water (8 ounces). Concomitantly prescribed H2 antagonist therapy should be taken as directed. Administration of adequate amounts of fluid, particularly with the bedtime dose of tetracycline hydrochloride, is recommended to reduce the risk of esophageal irritation and ulceration.

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Missed doses can be made up by continuing the normal dosing schedule until the medication is gone.

Patients should not take double doses. (If more than 4 doses are missed, the prescriber should be contacted.)

This treatment regimen includes salicylates. If taken with aspirin and ringing in the ears occurs, the prescriber should be consulted concerning discontinuation of the aspirin therapy until the HELIDAC Therapy is completed.

Concurrent use of tetracyclines may render oral contraceptives less effective. Patients should be advised to use a different or additional form of contraception. Breakthrough bleeding has been reported. Women who become pregnant while taking components of the HELIDAC Therapy should be advised to notify their prescriber immediately.

Alcoholic beverages should be avoided while taking metronidazole and for at least 1 day afterward.

Patients taking tetracycline hydrochloride should be cautioned to avoid exposure to sun or sun lamps.

Bismuth subsalicylate may cause temporary and harmless darkening of the tongue and/or black stool.

Stool darkening should not be confused with melena (blood in the stool).

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Patients should be counseled that antibacterial drugs, including HELIDAC Therapy, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When HELIDAC Therapy is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by HELIDAC Therapy or other antibacterial drugs in the future.

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Drug Interactions: Individual components of the HELIDAC Therapy have a potential interaction with anticoagulants. Tetracycline has been shown to depress plasma prothrombin activity. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Salicylates may cause an increased risk of bleeding when administered with anticoagulant therapy. Therefore, monitoring anticoagulant therapy with appropriate adjustment of the anticoagulant dosage may be warranted if - concurrent therapy is instituted. Caution is advised in the administration of bismuth subsalicylate to patients taking medication for diabetes (possible enhanced hypoglycemic effect when given with salicylates) or patients taking aspirin, probenecid, or sulfinpyrazone. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium; preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products. There is an anticipated reduction in tetracycline systemic absorption due to an interaction with bismuth and/or calcium carbonate, an excipient of bismuth subsalicylate tablets. The clinical significance of this is unknown as the relative contribution of systemic versus local antimicrobial activity against H. pylori for these agents has not been established. Since bacteriostatic drugs, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of penicillin, it is not advisable to administer these drugs concomitantly. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline may render oral contraceptives less effective. Patients should be advised to use a different or additional form of contraception. Breakthrough bleeding has been reported. Women who become pregnant while on the HELIDAC Therapy should be advised to notify their prescriber immediately.

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The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication. Alcoholic beverages should not be consumed during metronidazole therapy and for at least 1 day afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiramwithin the last 2 weeks.

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