Mylan-Esomeprazole (Mylan Pharmaceuticals, Capsule (Delayed-Release)): Uses, Side Effects and Dosage

What is Mylan-Esomeprazole used for?

Mylan-Esomeprazole is used in adults to treat problems caused by too much acid in the stomach such as:

• reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the food tube).
• symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).

• symptoms of nonerosive reflux disease (NERD), not related to tissue damage of the food pipe such as:

  • a burning feeling that moves up the food pipe (heartburn).
  • a sour or bitter taste moving up to the mouth.
• a rare condition where the stomach produces too much acid (Zollinger-Ellison syndrome).
• ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints).

Mylan-Esomeprazole is used in children 12-17 years old to treat:

• reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the food tube).
• symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).

• symptoms of nonerosive reflux disease (NERD), not related to tissue damage of the food pipe such as:

  • a burning feeling that moves up the food pipe (heartburn).
  • a sour or bitter taste moving up to the mouth.

How does Mylan-Esomeprazole work?

Mylan-Esomeprazole is a medicine called a proton pump inhibitor (PPI). Mylan-Esomeprazole works by causing less acid to be made in your stomach.

What are the ingredients in Mylan-Esomeprazole?

Medicinal ingredients: esomeprazole magnesium

Non-medicinal ingredients:

Crospovidone, Glycerol Monostearate, hydroxypropyl cellulose-LF, mannitol, polysorbate 80, sugar spheres, talc, and triethyl citrate.

Mylan-Esomeprazole comes in the following dosage form:

Capsules

Do not use Mylan-Esomeprazole if:

• you are allergic to the active ingredient esomeprazole, substituted benzimidazoles or any of the other ingredients of Mylan-Esomeprazole (see What are the ingredients in Mylan-Esomeprazole?). If you think you may be allergic, ask your doctor for advice.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mylan-Esomeprazole. Talk about any health conditions or problems you may have, including if you:

• have had any health problems in the past.

• have symptoms that may be a sign of a more serious problem in your stomach or intestine such as:

  • trouble swallowing.
  • unplanned weight loss.
  • vomiting blood or food.
  • black (blood-stained) stools.

• are pregnant or trying to become pregnant.

• are breastfeeding or planning to breastfeed.

Other warnings you should know about:

Mylan-Esomeprazole is not recommended for use in patients under 1 year of age.

This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

Treatment in combination with antibiotics:

If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by a bacterial infection (Clostridium difficile). If this happens, stop taking the drug combination and call your healthcare professional immediately.

Long-term use of PPIs may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor about this risk.

Long-term use of PPIs may lead to low blood magnesium in some people. When blood magnesium is lower than normal, it may also lead to low blood calcium and low blood potassium.

Using PPIs for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Mylan-Esomeprazole:

• drugs used to prevent blood clotting (warfarin or coumarin derivatives, clopidogrel). Speak to your doctor or pharmacist if you are taking any of these drugs. Use of Mylan-Esomeprazole with clopidogrel should be avoided.
• medication for HIV: Mylan-Esomeprazole may decrease the effectiveness of some drugs used for HIV treatment; atazanavir and nelfinavir should not be used with Mylan-Esomeprazole.
• a high dose of methotrexate (a drug used in high doses to treat cancer): Mylan-Esomeprazole may need to be temporarily withdrawn.
• Blood levels of some drugs may be influenced if Mylan-Esomeprazole is taken at the same time as drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), drugs to speed up stomach emptying (cisapride*), transplant rejection (tacrolimus), poor circulation in the legs (cilostazol*), heart problems (digoxin), treatment for tuberculosis (rifampin), St John’s Wort (Hypericum perforatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class). However, none of these interactions have been shown to change the effectiveness of esomeprazole magnesium or the other drug.

Drug interactions can be different if you take Mylan-Esomeprazole for short periods of time than if you take it every day.

* not marketed in Canada

How to take Mylan-Esomeprazole:

Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.

• Take all doses of Mylan-Esomeprazole that your doctor prescribes even when you or your child feel well. In some cases, doses every day are needed to control pain and symptoms, to correct acid problems and to help damaged areas heal.
• Take Mylan-Esomeprazole until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if Mylan-Esomeprazole is stopped too soon. Mylan-Esomeprazole needs to be taken for the full treatment duration to help correct acid problems.

• Mylan-Esomeprazole may be taken with food or on an empty stomach.

Capsules:

The capsules should be swallowed whole with sufficient water.

Usual dose:

Adults

Your doctor may tell you to take Mylan-Esomeprazole:

• 20 to 40 mg once a day for 2 to 8 weeks.
• Continue taking Mylan-Esomeprazole 20 mg each day. This is to keep your symptoms from coming back.

Maintenance Treatment of NERD (on-demand) dose

After first treatment of NERD, your doctor may suggest that you take Mylan-Esomeprazole 20 mg once daily, as needed, if symptoms of heartburn and regurgitation return once in a while. Contact your doctor if your symptoms get worse, won’t go away, or if new symptoms arise.

Children (12 –17 years of age)

The suggested dose for treating acute disease is 20 or 40 mg once a day for 2 to 8 weeks.

Overdose:

Missed Dose:

If you/your child miss a dose of Mylan-Esomeprazole, and remember within 12 hours, take the tablet/sachet as soon as possible. Then go back to the regular schedule. If more than 12 hours have passed, do not take the missed dose. Do not double the dose. Just take the next dose on time.

What are possible side effects from using Mylan-Esomeprazole?

Like all medicines, Mylan-Esomeprazole may cause side effects in some people. Side effects are usually mild. They usually go away a short time after starting Mylan-Esomeprazole.

These are not all the possible side effects you may feel when taking Mylan-Esomeprazole. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. These side effects may not be caused by Mylan-Esomeprazole in your case, but only a doctor can assess this.

If these side effects become bothersome (or last longer than 1-2 days), discuss with your doctor:

Common:

• Nausea.
• Stomach upset.
• Diarrhea.
• Headache.

Uncommon:

• Dry mouth.
• Dizziness.
• Insomnia.
• Feeling of burning/prickliness/numbing.
• Swelling of extremities.
• Feeling sleepy.
• Feeling like you or your surroundings are moving (vertigo).

Rare:

• Taste disorders.
• Nervousness.
• Hair loss.
• Increased sweating.

Stopping your PPI therapy after taking it for a long time may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when stopping Mylan-Esomeprazole.

Serious side effects and what to do about them

^θThese would only be seen if a blood test was taken.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep Mylan-Esomeprazole in a dry place at controlled room temperature (15-30°C), and protect from moisture.
• Do not keep Mylan-Esomeprazole in the bathroom medicine cabinet or other warm, moist places.
• Do not use Mylan-Esomeprazole after the expiry date marked on the pack.

Keep out of sight and reach of children.

If you want more information about Mylan-Esomeprazole:

• Talk to your healthcare professional
• This document can be found at: www.mylan.ca.
• The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Revised on: June 03, 2016

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca