Pantoprazole

WHY is this medicine prescribed?

Pantoprazole is used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older. Pantoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Pantoprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Pantoprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) tablet and as delayed-release granules to take by mouth. The packets of delayed-release granules must be mixed with applesauce or apple juice and taken by mouth or given through a feeding tube. For the treatment and maintenance of GERD, pantoprazole is usually taken once a day. For the treatment of conditions where the stomach produces too much acid, pantoprazole is usually taken twice a day. The delayed-release tablets are usually taken with or without food, and the granules are usually taken 30 minutes before a meal. Take pantoprazole at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pantoprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them. If your doctor has prescribed the 40 mg tablet and it is too big for you to swallow, ask your doctor to prescribe two of the 20 mg tablets instead.

To take the granules, open the packet and either sprinkle the granules onto one teaspoonful of applesauce or into a cup containing one teaspoonful of apple juice. Do not mix the granules with water, other liquids, or other foods. Use all of the granules in the packet; do not divide the granules into smaller doses. If you sprinkle the granules into apple juice, stir the mixture for 5 seconds. Swallow the mixture of applesauce or apple juice and medication right away (within 10 minutes) without chewing or crushing the granules. If you sprinkled the granules on applesauce, take several sips of water to wash the granules down to your stomach. If you sprinkled the granules into apple juice, rinse the cup once or twice with apple juice and drink the apple juice right away to be sure you swallow any leftover granules.

Pantoprazole granules mixed with apple juice may be given through a feeding tube. If you have a feeding tube, ask your doctor how you should take pantoprazole.

Continue to take pantoprazole even if you feel well. Do not stop taking pantoprazole without talking to your doctor. If your condition does not improve or gets worse, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking pantoprazole,

• tell your doctor and pharmacist if you are allergic to pantoprazole, dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, in Talicia, in Zegerid), rabeprazole (AcipHex), any other medications, or any of the ingredients in pantoprazole tablets or granules. Ask your pharmacist for a list of the ingredients.

• Some medications should not be taken with pantoprazole. Other medications may cause dosing changes or extra monitoring when taken with pantoprazole. Make sure you have discussed any medications you are currently taking or plan to take before starting pantoprazole with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking pantoprazole, please get the advice of your doctor or pharmacist.

• The following nonprescription or herbal products may interact with pantoprazole: iron supplements. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking pantoprazole. Do not start any of these medications while taking pantoprazole without discussing with your healthcare provider.

• tell your doctor if you have or have ever had a low level of magnesium, calcium, or potassium in your blood; hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]); low levels of vitamin B12 in your body; osteoporosis (a condition in which the bones become thin and weak and break easily); or an autoimmune disease (condition in which the body attacks its own organs causing swelling and loss of function) such as systemic lupus erythematosus.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking pantoprazole, call your doctor.

• talk to your doctor about the risks and benefits of taking pantoprazole if you are 70 years of age or older. Do not take this medication for a longer period of time than recommended by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Pantoprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• vomiting
• gas
• joint pain
• diarrhea
• dizziness
• in men, difficulty achieving or maintaining an erection

Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately, or get emergency medical help:

• blistering, peeling, or bleeding skin; sores on the lips, nose, mouth, or genitals; swollen glands; shortness of breath; fever; or flu-like symptoms
• rash hives; itching; swelling of the eyes, face, lips, mouth, throat, or tongue; difficulty breathing or swallowing; or hoarseness
• irregular, fast, or pounding heartbeat muscle spasms; uncontrollable shaking of a part of the body; excessive tiredness; lightheadedness; dizziness; or seizures
• severe diarrhea with watery stools, stomach pain, or fever that does not go away
• new or worsening joint pain; rash on cheeks or arms that is sensitive to sunlight
• increased or decreased urination, blood in urine, fatigue, nausea, loss of appetite, fever, rash, or joint pain

Pantoprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

People who take proton pump inhibitors such as pantoprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. People who take proton pump inhibitors may also develop fundic gland polyps (a type of growth on the stomach lining). These risks are highest in people who take high doses of one of these medications or take them for one year or longer. Talk to your doctor about the risks of taking pantoprazole.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatmen.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking pantoprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.