MEDICATION GUIDE

Esomeprazole magnesium (es-oh-MEP-ra-zole mag-NEE-zee-um) For Delayed Release Oral Suspension

What is the most important information I should know about Esomeprazole magnesium For Delayed Release Oral Suspension?

Esomeprazole magnesium For Delayed Release Oral Suspension may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium For Delayed Release Oral Suspension can cause serious side effects, including:

• A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole magnesium For Delayed Release Oral Suspension, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole magnesium For Delayed Release Oral Suspension. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• Diarrheacaused 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 and 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 Esomeprazole magnesium For Delayed Release Oral Suspension, 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.

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

Esomeprazole magnesium For Delayed Release Oral Suspension can have other serious side effects. See “What are the possible side effects of Esomeprazole magnesium For Delayed Release Oral Suspension?”

What is Esomeprazole magnesium For Delayed Release Oral Suspension?

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

Esomeprazole magnesium For Delayed Release Oral Suspension is used in adults for:

• 4 to 8 weeks for the healing and symptom relief of acid-related damage to the esophagus (erosive esophagitis or EE). Your doctor may prescribe another 4-8 weeks of esomeprazole magnesium in patients whose EE does not heal.
• maintaining healing of EE.
• 4-8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
• up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• treating patients with a stomach infection (Helicobacter pylori) and a stomach ulcer, along with the antibiotics amoxicillin and clarithromycin.
• the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.

Esomeprazole magnesium is used in children and adolescents 12 to 17 years of age for:

• 4 to 8 weeks to heal EE.
• 4 weeks to treat heartburn and other symptoms that happen with GERD.

Esomeprazole magnesium is used in children 1 to 11 years of age for:

• 8 weeks to heal EE.
• up to 8 weeks to treat heartburn and other symptoms that happen with GERD.

Esomeprazole magnesium is used in children 1 month to less than 1 year of age to treat GERD with EE for up to 6 weeks.

It is not known if Esomeprazole magnesium For Delayed Release Oral Suspension is safe and effective in children under 1 month of age for the treatment of GERD with EE.

It is not known if esomeprazole magnesium is safe and effective in children less than 1 year of age for the treatment of GERD symptoms.

It is not known if esomeprazole magnesium is safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid.

Do not takeEsomeprazole magnesium For Delayed Release Oral Suspension if you are:

• allergic to esomeprazole magnesium, any other PPI medicine, or any of the ingredients in Esomeprazole magnesium For Delayed Release Oral Suspension. See the end of this Medication Guide for a complete list of ingredients in Esomeprazole magnesium For Delayed Release Oral Suspension.

Tell your doctor right away or get emergency medical help if you get any of the following symptoms of an allergic reaction with esomeprazole magnesium:

rash face swelling

throat tightness difficulty breathing

• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking Esomeprazole magnesium For Delayed Release Oral Suspension, tell your doctor about all of your medical conditions, including if you:

• have low magnesium levels, low calcium levels and low potassium levels in your blood.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if Esomeprazole magnesium For Delayed Release Oral Suspension will harm your unborn baby.
• are breastfeeding or planning to breastfeed. Esomeprazole magnesium may pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take Esomeprazole magnesium For Delayed Release Oral Suspension.

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: clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), rilpivirine (EDURANT), St. John’s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).

How should I take Esomeprazole magnesium For Delayed Release Oral Suspension?

 

• Take Esomeprazole magnesium For Delayed Release Oral Suspension exactly as prescribed by your doctor.
• Do not change your dose or stop Esomeprazole magnesium For Delayed Release Oral Suspension without talking to your doctor.
• Take Esomeprazole magnesium For Delayed Release Oral Suspension at least 1 hour before a meal.
• Antacids may be taken with Esomeprazole magnesium.
• If you forget to take a dose of Esomeprazole magnesium For Delayed Release Oral Suspension, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
• If you take too much Esomeprazole magnesium For Delayed Release Oral Suspension, call your doctor or local poison control center right away at 1-800-222-1222, or go to the nearest hospital emergency room.
• See the Instructions for Use at the end of this Medication Guide for instructions how to take Esomeprazole magnesium for delayed release oral suspension, and how to mix and give Esomeprazole magnesium for delayed release oral suspension through a nasogastric tube or gastric tube.

What are the possible side effects of Esomeprazole magnesium For Delayed Release Oral Suspension?

Esomeprazole magnesium For Delayed Release Oral Suspension can cause serious side effects, including:

• See “What is the most important information I should know about Esomeprazole magnesium For Delayed Release Oral Suspension?”
• Low vitamin B-12 levels in your body can happen in people who have taken Esomeprazole magnesium 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, light headedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Low magnesium levels in your body can happen in people who have taken Esomeprazole magnesium for at least 3 months. Tell your doctor right away 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.
• 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. Esomeprazole magnesium 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 esomeprazole magnesium and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects of esomeprazole magnesium include:

Headache Diarrhea Nausea gas

stomach (abdominal) pain constipation dry mouth

These are not all the possible side effects of esomeprazole magnesium.

 

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 Esomeprazole magnesium For Delayed Release Oral Suspension?

• Store Esomeprazole magnesium For Delayed Release Oral Suspension at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Esomeprazole magnesium For Delayed Release Oral Suspension and all medicines out of the reach of children.

General information about the safe and effective use of Esomeprazole magnesium For Delayed Release Oral Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Esomeprazole magnesium For Delayed Release Oral Suspension for a condition for which it was not prescribed. Do not give Esomeprazole magnesium For Delayed Release Oral Suspension to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about Esomeprazole magnesium For Delayed Release Oral Suspension that is written for health professionals.

For more information, call 1-866-604-3268.

What are the ingredients in Esomeprazole magnesium For Delayed Release Oral Suspension?

Active ingredient: esomeprazole magnesium dihydrate

Inactive granules in Esomeprazole magnesium For Delayed Release Oral Suspension: anhydrous citric acid, crospovidone, dextrose, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methyl cellulose E-15, magnesium stearate, methyl acrylic acid and ethyl acrylate copolymer dispersion, plasACRYL® HTP-20, polysorbate 80, purified water, sugar sphere, talc and xanthan gum. The plasticizer plasACRYL® HTP-20 have the following inactive ingredients: glyceryl monostearate, polysorbate 80, triethyl Citrate.

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

Disclaimer: Other brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured by:

Cipla Ltd.

Kurkumbh, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300, Warren

New Jersey - 07059

Revised: 08/2023