Details for: M-ESOMEPRAZOLE
Company: MANTRA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02520109 | M-ESOMEPRAZOLE | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) | 20 MG | TABLET (DELAYED-RELEASE) | ORAL |
| 02520117 | M-ESOMEPRAZOLE | ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) | 40 MG | TABLET (DELAYED-RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
M-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).
- duodenal ulcers (sores on the first part of the intestine) caused by a bacterium, Helicobacter pylori.
- 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).
M-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.
What it does
M-ESOMEPRAZOLE is a medicine called a proton pump inhibitor (PPI). M- ESOMEPRAZOLE works by causing less acid to be made in your stomach.
When it should not be used
you are allergic to the active ingredient esomeprazole, substituted benzimidazoles or any of the other ingredients of M-ESOMEPRAZOLE (see What are the ingredients in M-ESOMEPRAZOLE? ). If you think you may be allergic, ask your doctor for advice.
you are taking rilpivirine.
What the medicinal ingredient is
Medicinal ingredients: Esomeprazole (as esomeprazole magnesium amorphous)
What the non-medicinal ingredients are
Non-medicinal ingredients: M-ESOMEPRAZOLE tablet: crospovidone, diethyl phthalate, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, iron oxide red, macrogol 400, macrogol 4000, macrogol 6000, microcrystalline cellulose, povidone, sodium stearyl fumarate, sugar spheres (sucrose and maize starch), talc, titanium dioxide.
What dosage form it comes in
M-ESOMEPRAZOLE is available in 20 mg and 40 mg Tablets.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-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.
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
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. Using M-ESOMEPRAZOLE for a long period of time may cause a growth in your stomach (polyp) especially after one year.
Interactions with this medication
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 M-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 M-ESOMEPRAZOLE with clopidogrel should be avoided.
- medication for HIV: M-ESOMEPRAZOLE may decrease the effectiveness of some drugs used for HIV treatment; atazanavir, nelfinavir, and saquinavir should not be used with M-ESOMEPRAZOLE
- a high dose of methotrexate (a drug used in high doses to treat cancer): M-ESOMEPRAZOLE may need to be temporarily withdrawn.
- Blood levels of some drugs may be influenced if M-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 or the other drug.
Drug interactions can be different if you take M-ESOMEPRAZOLE for short periods of time than if you take it every day.
Proper use of this medication
How to take M-ESOMEPRAZOLE:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of M-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.
- If you take M-ESOMEPRAZOLE with antibiotic drugs, it is important that you take all medications twice each day. Take them at the right time each day for one week. Studies have shown that patients who take their medications as prescribed have better ulcer healing rates and greater success getting rid of their H. pylori infection.
- Take M-ESOMEPRAZOLE until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if M-ESOMEPRAZOLE is stopped too soon. M-ESOMEPRAZOLE needs to be taken for the full treatment duration to help correct acid problems.
- M-ESOMEPRAZOLE may be taken with food or on an empty stomach.
Tablets:
The tablet may be swallowed whole with water. It may also be put in half a glass of water where it will break apart. This will make it easier to swallow. Be sure to swallow all the tiny pellets that come out of the tablet without chewing them. Don’t let the pellets sit in water for more than 30 minutes before drinking them. After drinking, rinse the glass with water and drink this as well.
Usual Dose:
Adults
Your doctor may tell you to take M-ESOMEPRAZOLE:
- 20 to 40 mg once a day for 2 to 8 weeks.
- Continue taking M-ESOMEPRAZOLE 20 mg each day. This is to keep your symptoms from coming back.
- In combination with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori. This also helps to reduce the risk of these ulcers from coming back.
- If your prescription says M-ESOMEPRAZOLE, you will takeM-ESOMEPRAZOLE with the antibiotics clarithromycin and amoxicillin.
- Your pharmacist should also give you information on the two antibiotics.
Maintenance Treatment of NERD (on-demand) dose
After first treatment of NERD, your doctor may suggest that you take M-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)
M-ESOMEPRAZOLE (esomeprazole magnesium amorphous) is not recommended for use in children under 12 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 M-ESOMEPRAZOLE, and remember within 12 hours, take the tablet 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.
Side effects and what to do about them
Like all medicines, M-ESOMEPRAZOLE may cause side effects in some people. Side effects are usually mild. They usually go away a short time after starting M-ESOMEPRAZOLE
These are not all the possible side effects you may feel when taking M-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 M-ESOMEPRAZOLE in your case, but only a doctor can assess this.
Tell your doctor right away if you have any of these symptoms:
- New or worsening joint pain.
- Rash on your cheeks or arms that gets worse in the sun.
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 M-ESOMEPRAZOLE.
| Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| RARE | |||
| skin reactions (such as rash, dermatitis, itching and/or hives) | ✔ | ||
| blurred vision | ✔ | ||
| depression | ✔ | ||
| confusion | ✔ | ||
| shortness of breath | ✔ | ||
| inflammation in the mouth | ✔ | ||
| severe allergic reaction (such as swelling or anaphylactic reaction/shock) | ✔ | ||
| muscle pain | ✔ | ||
| blood disorders (reduced number of cells in the blood, low blood sodium) | ✔ | ||
| inflammation of liver (skin and eyes appear yellow) | ✔ | ||
| gastrointestinal fungal infection | ✔ | ||
| photosensitivity | ✔ | ||
| sore joints | ✔ | ||
| feeling ill | ✔ | ||
| VERY RARE | |||
| severe skin disorders (blisters, ulcers and/or lesions) | ✔ | ||
| aggression | ✔ | ||
| hallucinations | ✔ | ||
| severely impaired liver function | ✔ | ||
| decreased consciousness | ✔ | ||
| inflammation of the kidney | ✔ | ||
| muscular weakness | ✔ | ||
| development of breasts in males | ✔ | ||
| low blood magnesium (which may result in low blood calcium and/or low blood potassium) | ✔ | ||
| Inflammation in the gut (leading to diarrhea) | ✔ | ||
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.
How to store
- Keep all tablets sealed in the blister strips until it is time for a dose. If you do not, moisture from the air may damage the drug.
- Keep M-ESOMEPRAZOLE at controlled room temperature (15° C - 30°C)
- Do not keep M-ESOMEPRAZOLE in the bathroom medicine cabinet or other warm, moist places.
- Do not use M-ESOMEPRAZOLE after the expiry date marked on the pack. Keep out of sight and reach of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about M-ESOMEPRAZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or by contacting Mantra Pharma Inc. at: 1-833-248-7326 or medinfo@mantrapharma.ca.
This leaflet was prepared by:
Mantra Pharma Inc.
9150 Leduc boulevard, suite 201
Brossard, Quebec
J4Y 0E3
Date of revision: September 9, 2021