Studies indicate that people who take proton pump inhibitor medications (such as Nexium) may be at an increased risk for broken bones. The risk appears to be highest for people who take such medications at high doses or for long periods (over a year). You and your healthcare provider should take this into account when deciding if the benefits of this medication outweigh the risks for your particular situation.

The use of proton pump inhibitors (including this medication) may increase the risk of a potentially serious condition known as Clostridium difficile-associated diarrhea (CDAD). If you develop diarrhea that does not seem to improve (especially if it is watery and accompanied by a fever and abdominal pain), seek immediate medical attention.

The prominent consumer watchdog group Public Citizen has filed a petition with the FDA, indicating that a new black box warning for Nexium, Prilosec and other proton pump inhibitor drugs is necessary to warn consumers and the medical community about the risk of long-term dependence and other dangerous side effects.

According to the petition (PDF) filed with the FDA on Tuesday, Public Citizen indicates that the strongest possible warning label is necessary for the widely used acid reflux drugs, which were prescribed more than 119 million times in 2009 and generated sales in the United States of $13.6 billion.

An estimated one out of every 20 people in the developed world are currently taking a proton pump inhibitor (PPI) to reduce the production of stomach acid in an attempt to alleviate symptoms of gastroesophageal reflux disease (GERD), ulcers and other stomach ailments. In addition to Nexium and Prilosec, other drugs in the same class included Prevacid, Zegerid, Protonix, Dexilant, Aciphex, Vimovo and a number of generic equivalents.

This combination of three medications is used to treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). Famotidine is a drug that blocks acid release in the stomach and can help stop heartburn and acid indigestion from coming back. Calcium carbonate and magnesium hydroxide are antacids that work quickly to lower acid in the stomach and stop heartburn.

How to use Pepcid Complete

Chew one tablet completely and swallow as needed to stop/prevent the symptoms of heartburn and indigestion, or take as directed by your doctor. Do not swallow the tablets whole.

Do not take more than 2 tablets within 24 hours. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

This product contains an antacid which may react with other medications, preventing them from being fully absorbed by your body. Talk with your doctor or pharmacist about how to schedule your medications to prevent this problem.

Stop taking this medication and call your doctor promptly if your symptoms continue after you begin taking it, or if they do not improve after you have been taking this medication for 14 days in a row. Do not take this medicine for more than 14 days in a row without talking with your doctor.

Diarrhea, headache, constipation, or stomach cramps may occur. If any of these effects persist or worsen, notify your doctor.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, fast/slow/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat, cough), mental/mood changes (e.g., restlessness, confusion, depression, hallucinations), seizure.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada.

Before taking this product, tell your doctor or pharmacist if you are allergic to famotidine; or to other acid blockers (e.g., cimetidine, ranitidine); or to other antacids containing calcium/magnesium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: kidney problems, liver problems, other stomach problems (e.g., tumors).

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.

In addition, before you self-treat with this medication, get medical help right away if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain, frequent wheezing (especially with heartburn), nausea/vomiting, stomach pain.

Do not use this medication in children younger than 12 unless directed by the doctor.

Older adults may be more sensitive to the side effects of this drug, especially confusion.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Tell your doctor if you are pregnant before using this medication.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: amphetamines, bisphosphonates (such as alendronate), tetracycline antibiotics (such as doxycycline, minocycline), quinolone antibiotics (such as ciprofloxacin, levofloxacin), thyroid medicine (such as levothyroxine), calcium channel blockers (such as diltiazem, verapamil), quinidine, digoxin, sodium polystyrene sulfonate, phosphate supplements (such as potassium phosphate), raltegravir.

Since famotidine reduces the amount of acid in your stomach, it may also change the absorption of certain medications and affect how they work. Some examples of affected drugs include atazanavir, dasatinib, delavirdine, certain azole antifungals (such as itraconazole, ketoconazole), pazopanib, among others. Ask your doctor or pharmacist if any of the medications you take are affected by famotidine and how to manage this interaction.

Check the labels on all your medicines because they may contain aspirin or aspirin-like NSAIDs (e.g., ibuprofen, naproxen) that can cause stomach irritation/ulcers. Ask your pharmacist about the safe use of those products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

This medication and similar acid blockers (e.g., cimetidine, ranitidine) are available both over-the-counter and by prescription. Do not take them at the same time. Consult your pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lifestyle changes such as stress reduction programs, stopping smoking, limiting alcohol, and diet changes (e.g., avoiding caffeine, certain spices) may increase the effectiveness of this medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.