TAGAMET PREVENT

1 Dosing Considerations • Because cimetidine is excreted by the kidney, a reduced dosage should normally be administered to patients with impaired renal function (see 7 WARNINGS AND PRECAUTIONS). When liver impairment is also present, further reductions in dosage may be necessary.

• Hemodialysis reduces the level of circulating cimetidine. Greater than 80% of a 300 mg intravenous dose is cleared in a single 4 hour period of hemodialysis. It is completely cleared in an 8 hour period. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose is administered after dialysis treatment.

• Peritoneal Dialysis: Peritoneal dialysis does not appear to remove cimetidine to any appreciable extent. 2 Recommended Dose and Dosage Adjustment • Relief and/or Prevention of Stomach Discomfort o For relief of episodic heartburn, acid indigestion, sour stomach and upset stomach and the symptoms that accompany these conditions: Take one tablet (200 mg cimetidine) with water as symptoms occur, or as directed by a physician.

o For prevention of nighttime heartburn and acid indigestion: take one tablet (200 mg cimetidine) with water 60 minutes before bedtime. o For prevention of meal related heartburn and acid indigestion: take one tablet (200 mg cimetidine) with water 30 minutes prior to consumer a symptom provoking meal.

o Do not take more than two tablets in a 24-hour period. Do not use continuously for more than two weeks except under the advice and supervision of a physician. Pediatrics Health Canada has not authorized an indication for pediatric use.

1 PEDIATRICS.

Geriatrics Geriatrics (>65 years of age):

Health Canada has not authorized an indication for geriatric use. 2 GERIATRICS. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.

1 Adverse Reaction Overview Mild and transient diarrhea, tiredness, and dizziness have been reported in a small number of patients during treatment with cimetidine. Skin rashes, sometimes severe, including Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis and generalized exfoliative erythroderma have been reported with H2-receptor antagonists.

Reversible alopecia has also been reported. Page 8 of 24 There have been reports that a few patients have developed reversible non-progressive gynecomastia during prolonged treatment. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing cimetidine treatment.

No effect of cimetidine (in recommended doses) on spermatogenesis, sperm count, motility or morphology has been found in double blind controlled studies. Fertilizing capacity has not been affected in vitro. Blood levels of androgen and gonadotropin were unchanged.

Reversible impotence has been reported in rare instances. H2 antagonist administration has been associated with the occurrence of leukopenia (including agranulocytosis), thrombocytopenia, pancytopenia, and aplastic anemia, as well as extremely rare reports of immune hemolytic anemia.

A few cases of reversible confusional states have been reported, usually in elderly and/or severely ill patients, such as those with renal insufficiency or organic brain syndrome. These confusional states generally cleared within a few days of drug withdrawal.

Small increases of plasma creatine have been reported. These did not progress with continued therapy and disappeared at the end of therapy. Some increases in serum transaminase and rare cases of hepatitis, fever, hypersensitivity vasculitis, interstitial nephritis, urinary retention and pancreatitis, which cleared on withdrawal of the drug, have been reported.

). • Pregnant or lactating patients or women of child-bearing potential should consult a health professional before use (see 7 WARNINGS AND PRECAUTIONS). • Patients taking Theophylline, Warfarin, Phenytoin or any other medications should consult their physician or pharmacists before taking TAGAMET® PREVENT (See 9 DRUG INTERACTIONS).

1 Dosing Considerations • Because cimetidine is excreted by the kidney, a reduced dosage should normally be administered to patients with impaired renal function (see 7 WARNINGS AND PRECAUTIONS). When liver impairment is also present, further reductions in dosage may be necessary.

• Hemodialysis reduces the level of circulating cimetidine. Greater than 80% of a 300 mg intravenous dose is cleared in a single 4 hour period of hemodialysis. It is completely cleared in an 8 hour period. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose is administered after dialysis treatment.

• Peritoneal Dialysis: Peritoneal dialysis does not appear to remove cimetidine to any appreciable extent. 2 Recommended Dose and Dosage Adjustment • Relief and/or Prevention of Stomach Discomfort o For relief of episodic heartburn, acid indigestion, sour stomach and upset stomach and the symptoms that accompany these conditions: Take one tablet (200 mg cimetidine) with water as symptoms occur, or as directed by a physician.

o For prevention of nighttime heartburn and acid indigestion: take one tablet (200 mg cimetidine) with water 60 minutes before bedtime. o For prevention of meal related heartburn and acid indigestion: take one tablet (200 mg cimetidine) with water 30 minutes prior to consumer a symptom provoking meal.

o Do not take more than two tablets in a 24-hour period. Do not use continuously for more than two weeks except under the advice and supervision of a physician. Pediatrics Health Canada has not authorized an indication for pediatric use.

• TAGAMET® PREVENT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.