AURO-FAMOTIDINE MINT

1 Dosing Considerations • Antacids may be given concomitantly if needed. 2 Recommended Dose and Dosage Adjustment Adult and children 12 years of age or older: Auro-Famotidine 10 mg, Auro-Famotidine 20 mg, Auro-Famotidine Mint 20 mg, Product Monograph Page 5 of 30 Auro-Famotidine 10 mg (10 mg Famotidine) For symptom relief: one tablet (10 mg), as required.

For prevention of acid-related symptoms associated with the consumption of food and/or beverage: one tablet (10 mg) 10 – 15 minutes before eating food or drinking beverages that cause heartburn. Tablet to be swallowed whole with a glass of water.

Repeat if symptoms return, up to a maximum of 2 tablets (20 mg in total) in a 24-hour period. Therapy should not exceed two weeks of continuous treatment without medical consultation. Auro-Famotidine 20 mg and Auro- Famotidine Mint 20 mg (20 mg Famotidine) For relief of heartburn, acid indigestion and sour or upset stomach: The patient should take one tablet (20 mg).

To prevent these symptoms, one tablet should be taken 10 – 15 minutes before eating food or drinking beverages that cause heartburn. Tablet to be swallowed whole with a glass of water. The patient should not take more than 1 tablet at a time and the patient should not take more than two tablets (40 mg in total) in 24 hours.

Therapy should not exceed two weeks of continuous treatment without medical consultation.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency:

Patients with severe kidney disease should consult a physician before commencing therapy with Famotidine tablets USP. 48m2). In patients with moderate (creatinine clearance 30 – 50 mL/min), the elimination half-life of famotidine is increased.

For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse reactions have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Health Canada has not authorized an indication for pediatric use. 1 Pediatrics above.

1 Adverse Reaction Overview Famotidine has been demonstrated to be generally well tolerated. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Famotidine 10 mg:

Adverse reactions reported in > 1% of patients were headache and dizziness. These occurred with comparable frequency in patients treated with placebo. Adverse Drug Reactions were evaluated in 28 clinical trials with more than 13, 000 patients.

2%). These occurred with comparable frequency across treatment groups and control groups. 3 Less common clinical Trial Adverse Drug Reactions Other reactions reported in patients using famotidine 20 mg in controlled clinical trials at rates <1%.

These observations are listed. 1%: bronchitis, congestion -nasal, cough, dry throat, influenza, sinus disorder, sneezing, wheezing. 1% edema - angioneurotic, infection -skin, laceration, measles. 1%: eustachian tube disorder, hemorrhage- corneal, pain-ear.

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory parameters may be affected during treatment with famotidine 10 mg, but the changes are usually not considered serious.

Among the laboratory changes that were reported during clinical trials were increases in AST, ALT, BUN, and WBC count and serum creatinine, and decreases in hemoglobin and hematocrit. These changes were rarely of clinical significance.

No famotidine-treated patients/subjects had to be discontinued from therapy because of laboratory adverse experiences. 5 Post-Market Adverse Reactions During marketed use of prescription doses of famotidine, the following adverse reactions have been reported: urticaria, liver enzymes abnormalities, cholestatic jaundice, asthenia, fatigue, abdominal discomfort and pain, abdominal pain upper, diarrhea, dry mouth, nausea, vomiting, rash, hypersensitivity, anaphylaxis, angioedema, malaise, and somnolence.

Toxic epidermal necrolysis has been reported very rarely with H2 receptor antagonists. As with other H2-receptor antagonists, cases of Auro-Famotidine 10 mg, Auro-Famotidine 20 mg, Auro-Famotidine Mint 20 mg, Product Monograph Page 11 of 30 bradycardia, A-V block and other arrhythmia have been reported rarely in patients treated with famotidine.

The following adverse reactions have been reported, however, a causal relationship to therapy with famotidine 10 mg has not been established: agitation, confusion, hallucinations, depression, disorientation, mental disorder, insomnia, psychotic disorder, pruritus, alopecia, photosensitivity, Steven Johnson syndrome, hypotrichosis, neutropenia, anaemia, paraesthesia, dysgeusia, convulsions, syncope, grand mal seizures, rare cases of impotence, thrombocytopenia, pancytopenia, leukopenia, bone marrow depression and agranulocytosis.

Gynecomastia has been reported rarely. In most cases that were followed up, it was reversible after discontinuing treatment. Adverse drug reactions (ADRs) identified during Post-marketing experience with famotidine are included in Table 1 below.

The frequencies are provided according to the following convention based on spontaneous reporting rates: Very common ≥1/10 Common ≥1/100 and <1/10 Uncommon ≥ 1/1000 and < 1/100 Rare ≥1/10,000 and < 1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) Table 1: Adverse Drug Reactions Identified during Post-Marketing Experience with Famotidine for OTC use by Frequency Category Estimated from Clinical Trials SOC Adverse Event Preferred Term Frequency Category Clinical Trials Spontaneous Reporting Rates Nervous System Disorders Dizziness Asthenia, Fatigue Somnolence Uncommon* Uncommon* Rare* Very rare Very rare Very rare Gastrointestinal Disorders Abdominal discomfort and pain Uncommon* Very rare Abdominal pain upper Not known Very rare Diarrhea Uncommon* Very rare Dry mouth Rare* Very rare Nausea Uncommon* Very rare Vomiting Uncommon Very rare Skin and Subcutaneous Tissue Disorders Auro-Famotidine 10 mg, Auro-Famotidine 20 mg, Auro-Famotidine Mint 20 mg, Product Monograph Page 12 of 30 Pruritus Rash Urticaria Rare* Uncommon* Not […]

g. duodenal ulcer, gastric ulcer) did not experience complications; in general, they did not exhibit a clinically significant deterioration in their condition. However, if patients have difficulty swallowing, pain on swallowing, unexpected weight loss, severe vomiting, melaena (black stools), choking, chest pain, or if abdominal discomfort persists, patients should consult a physician to determine the underlying cause.

Symptomatic response to therapy with Famotidine tablets USP does not preclude the presence of gastric malignancy. Patients with severe coexisting illness should consult a physician before commencing therapy with Auro- Famotidine 10 mg, Auro-Famotidine 20 mg and Auro-Famotidine Mint 20 mg.

Patients consuming nonsteroidal anti-inflammatory drugs may have dyspepsia as a side effect of these medicines and should consult a physician or a pharmacist before taking Famotidine tablets USP. Patients over 40 who are experiencing heartburn for the first time and patients who have noticed unintentional weight loss should consult a physician before using the product.

Further medical evaluation is required if therapy exceeds two weeks of continuous treatment, if two 14- day courses of treatment are needed at intervals of less than 6 weeks, or if heartburn is frequent (>3 times per week) and/or severe.

Driving and Operating Machinery In very rare cases, some patients have experienced adverse reactions such as dizziness and somnolence while taking famotidine. Patients should be informed that they should avoid driving vehicles, operating machinery or doing activities which require prompt vigilance if they experience these symptoms.

Gastrointestinal Patients with a previous history of ulcer disease complications, those who are experiencing unintended weight loss in association with dyspeptic symptoms, and those who are middle-aged or older with new or recently changed dyspeptic symptoms should consult a physician before commencing therapy with Famotidine tablets USP.

Auro-Famotidine 10 mg, Auro-Famotidine 20 mg, Auro-Famotidine Mint 20 mg, Product Monograph Page 8 of 30 Renal Patients with severe kidney disease should consult a physician before commencing therapy with Famotidine tablets USP. 48m2).

3 Pharmacokinetics, 4 DOSAGE AND ADMINISTRATION, Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency). 1 Pregnant Women Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively (approximately 2500 and 625 times the maximum recommended prescription human dose [80 mg], respectively), and have revealed no evidence of impaired fertility or harm to the fetus due to famotidine.

There are, however, no adequate or well-controlled studies in pregnant women. Since the safe use of famotidine tablets in pregnant women has not been established, pregnant women should not use Famotidine 10 mg, Auro-Famotidine 20 mg and Auro-Famotidine Mint 20 mg unless directed otherwise by a physician.

This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus. 2 Breast-feeding Famotidine is detectable in human milk. Nursing mothers should either stop this drug or should stop nursing.

3 Pediatrics Safety and effectiveness in children have not been established. Famotidine tablets USP should not be administered to children under 12 years of age. 3 Pharmacokinetics). This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 2 Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency).

Auro-Famotidine 10 mg, Auro-Famotidine 20 mg, Auro-Famotidine Mint 20 mg, Product Monograph Page 9 of 30

• Famotidine 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.

• Cross-sensitivity has been observed between H2-receptor antagonists. Therefore, Famotidine tablets USP should not be taken by individuals with a history of hypersensitivity to other drugs in this class of compounds.