Pepcid Complete

Pepcid Complete combines an acid reducer (famotidine) with antacids (calcium carbonate and magnesium hydroxide) to relieve heartburn in two different ways: acid reducers decrease the production of new stomach acid, while antacids neutralize acid already present in the stomach. Heartburn is caused by acid moving from the stomach into the esophagus through a valve-like muscle called the lower esophageal sphincter (LES). This occurs when the LES is relaxed and in an open position, and can result in burning pain and discomfort that interferes with everyday activities. Pepcid Complete is available in a chewable tablet form, and is approved for adults and children twelve years of age and older.

In clinical trials, Pepcid Complete was shown to be significantly more effective than placebo in relieving heartburn. Forty-five percent of heartburn episodes were relieved within 30 minutes with Pepcid Complete, and 70% of heartburn episodes were relieved for at least seven hours.

The following adverse reactions have been reported to occur in more than 1% of patients on therapy with Pepcid (famotidine) in controlled clinical trials, and may be causally related to the drug:

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• Headache (4.7%)
• Dizziness (1.3%)
• Constipation (1.2%)
• Diarrhea (1.7%)

The following list includes (but does not contain all) other adverse reactions that have been reported infrequently in clinical trials or since Pepcid (famotidine) was marketed. The relationship to therapy with Pepcid has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:

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• Body as a Whole: fever, fatigue
• Cardiovascular: arrhythmia, heart palpitation
• Gastrointestinal: vomiting, nausea, abdominal discomfort, anorexia, dry mouth
• Musculoskeletal: musculoskeletal pain including muscle cramps
• Nervous System/Psychiatric: psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; insomnia; somnolence

Pepcid Complete should not be used by patients allergic to famotidine or other acid reducers, or by individuals who have trouble swallowing. Use should be discontinued if stomach pain continues or the product needs to be taken for more than 14 days. Additionally, pregnant or breast-feeding women should check with their physician before use.

Famotidine is an H2 (histamine)-receptor antagonist, also known as an H2-blocker. Histamine is a chemical in some cells of the body that causes production of acid in the stomach. H2-blockers inhibit histamine action, and therefore reduce gastric secretion or the amount of acid produced. Magnesium hydroxide and calcium carbonate are both antacids that function by neutralizing excess gastric acid.

According to Pepcid Complete labeling, the following tips can assist with managing heartburn:

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• Do not lie flat or bend over soon after eating.
• Do not eat late at night, or just before bedtime.
• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.
• Eat slowly and do not eat big meals.
• Maintain healthy body weight.
• Do not smoke.
• Raise the head of your bed.
• Wear loose fitting clothing around your stomach.

For additional information on Pepcid products, please visit the web site of Merck & Co., Inc.