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 medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets.

How to use Gaviscon

Take this product by mouth as directed. For the chewable form, chew the medication well before swallowing. For the liquid form, shake the bottle well before each dose. Follow all directions on the product package. Do not take more than the maximum recommended dose stated on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

Tell your doctor if your condition persists or worsens. Do not take the maximum dose of the medication for more than 2 weeks unless directed by your doctor. If you think you may have a serious medical problem, seek immediate medical attention.

Constipation, gas, and burping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: loss of appetite, nausea/vomiting, unusual weight loss, bone/muscle pain, mental/mood changes (e.g., confusion), headache, increased thirst/urination, unusual weakness/tiredness.

Tell your doctor immediately if any of this rare but very serious side effects occur: change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice 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 calcium carbonate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as milk or dairy products found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high calcium levels (hypercalcemia), stomach/intestinal blockage.

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

Some products may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

Tell your doctor if you are pregnant before using this medication.

This medication 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: digoxin, certain phosphate binders (such as calcium acetate), phosphate supplements (such as potassium phosphate), sodium polystyrene sulfonate.

Calcium carbonate can decrease the absorption of other drugs. Some examples of affected drugs include tetracycline antibiotics (such as doxycycline, minocycline), bisphosphonates (such as alendronate), estramustine, iron, levothyroxine, pazopanib, strontium, quinolone antibiotics (such as ciprofloxacin, levofloxacin), among others. Therefore, separate your doses of these medications as far as possible from your doses of calcium carbonate. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.

Check the labels on all your prescription and nonprescription/herbal products (such as supplements, vitamins) because they may contain calcium. Ask your pharmacist about using those products safely.

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. Symptoms of overdose may include: nausea/vomiting, loss of appetite, mental/mood changes, headache, weakness, dizziness.

Notes

Keep all regular medical and laboratory appointments.

Lifestyle changes such as stress reduction programs, stopping smoking, limiting alcohol, and diet changes (e.g., avoiding caffeine/certain spices) may help to reduce heartburn and other stomach acid problems. 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. See packaging for the exact temperature range. If you have any questions about storage, ask your pharmacist. Do not store in the bathroom. Keep all medicines 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.