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Pantoprazole (pan toe’ pra zole) Sodium Delayed-Release Tablets, USP

What is the most important information I should know about Pantoprazole?
You should take Pantoprazole exactly as prescribed, at the lowest dose possible and for the shortest time needed.

Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Pantoprazole can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Pantoprazole, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Pantoprazole. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• Diarrhea caused by an infection ( Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
• Bone fractures (hip, wrist or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Pantoprazole, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
• Low magnesium and other mineral levels in your body can happen in people who have taken Pantoprazole for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

Talk to your doctor about your risk of these serious side effects.

Pantoprazole can have other serious side effects. See "What are the possible side effects of Pantoprazole?"

What is Pantoprazole?
A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

In adults, Pantoprazole is used for:

• up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of Pantoprazole in patients whose EE does not heal.
• maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if Pantoprazole is safe and effective when used longer than 12 months for this purpose.
• the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

In children 5 years of age and older, Pantoprazole is used for:

• up to 8 weeks for the healing and symptom relief of EE.
  It is not known if Pantoprazole is safe if used longer than 8 weeks in children.

Pantoprazole is not for use in children under 5 years of age.
It is not known if Pantoprazole is safe and effective in children for treatment other than EE.

Do not take Pantoprazole if you are:

• allergic to pantoprazole sodium, any of the other PPI medicine, or any of the ingredients in Pantoprazole. See the end of this Medication Guide for a complete list of ingredients in Pantoprazole.
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking Pantoprazole, tell your doctor about all of your medical conditions, including if you:

• have low magnesium levels in your blood.
• are pregnant or plan to become pregnant. Pantoprazole may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with Pantoprazole.
• are breastfeeding or plan to breastfeed. Pantoprazole can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take Pantoprazole.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

How should I take Pantoprazole?

• Take Pantoprazole exactly as prescribed by your doctor.
  Pantoprazole delayed-release tablets (Pantoprazole tablets):
  • Do not split, chew, or crush Pantoprazole tablets.
  • Swallow Pantoprazole tablets whole, with or without food.
  • Tell your doctor if you are not able to swallow your Pantoprazole tablet.
  • You may use antacids while taking Pantoprazole tablets.
• If you miss a dose of Pantoprazole, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much Pantoprazole, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

What are the possible side effects of Pantoprazole?
Pantoprazole can cause serious side effects, including:

• See “What is the most important information I should know about Pantoprazole?”
• Low vitamin B-12 levels in your body can happen in people who have taken Pantoprazole for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
• Severe skin reactions. Pantoprazole can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

    Stop taking Pantoprazole and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects of Pantoprazole in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.

The most common side effects of Pantoprazole in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.

These are not all the possible side effects of Pantoprazole. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Pantoprazole?
Store Pantoprazole at room temperature between 59° to 86°F (15° to 30°C).
Keep Pantoprazole and all medicines out of the reach of children.

General information about the safe and effective use of Pantoprazole
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole for a condition for which it was not prescribed. Do not give Pantoprazole to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Pantoprazole that is written for healthcare professionals.

What are the ingredients in Pantoprazole?
Active ingredient: pantoprazole sodium sesquihydrate
Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablets also contains black iron oxide, isopropyl alcohol, and propylene glycol.

For more information about the drug product, go to www.lannett.com or call 1-844-834-0530.
For more information about the packaging or labeling, call American Health Packaging at 1‐800‐707‐4621.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This product's label may have been updated. For the most recent prescribing information, call American Health Packaging at 1-800-707-4621.

All brand names are the trademarks of their respective owners.

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American Health Packaging
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8264301/0722