Patient Medication Information: uses, side effects, how to take - Omeprazole Magnesium Delayed Release Tablets (Sanis Health)
What is OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS used for?
OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is used to treat problems caused by too much acid in the stomach such as:
- stomach ulcers (sores).
- duodenal ulcers (sores on the first part of the intestine).
- stomach and duodenal ulcers caused by a bacterium, Helicobacter pylori.
- reflux esophagitis (tissue damage caused by stomach acid and juices moving up the food tube).
- symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat).
- ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints).
- dyspepsia, a group of symptoms which may include stomach pain / discomfort, heartburn and backup of stomach contents to the throat. Dyspepsia can be caused by the other conditions in this list.
- a rare condition where the stomach produces too much acid (Zollinger-Ellison syndrome).
How does OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS work?
OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is a medicine called a proton pump inhibitor (PPI). OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS works by reducing the amount of acid made in your stomach.
What are the ingredients in OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS?
Medicinal ingredients: omeprazole magnesium
Non-medicinal ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl methylcellulose, talc, sodium stearyl fumarate, methacrylic acid copolymer, polyethylene glycol, titanium dioxide, iron oxide (red & yellow),
The imprinting ink consists of: shellac, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide.
OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS comes in the following dosage forms:
Tablets of omeprazole 20 mg.
Do not use OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS if:
you are allergic to omeprazole, substituted benzimidazoles or any of the other ingredients in OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS (see “What are the ingredients in
- ?”).
- you are taking rilpivirine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS. Talk about any health conditions or problems you may have, including if you:
- have had any health problems in the past.
- have severe liver problems now or have had in the past.
are pregnant or plan to become pregnant.
- are breastfeeding or planning to breastfeed, as omeprazole is excreted in breast milk.
- take any other medications, including ones you can buy without a prescription.
- are due to have a specific blood test (Chromogranin A).
Other warnings you should know about:
OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is not recommended for use in patients under 18 years 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.
Tell your doctor or pharmacist about 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.
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 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS for a long period of time may cause a growth in your stomach (polyp), especially after one year.
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 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS:
- medication for HIV: OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS may decrease the effectiveness of some drugs used for HIV treatment; atazanavir, nelfinavir and saquinavir should not be used with OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS.
- a high-dose of methotrexate (a drug used in high doses to treat cancer). OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS may need to be temporarily withdrawn.
- clopidogrel, which is used for the prevention of blood clots. OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS may interact with this drug, therefore, use with clopidogrel should be avoided.
drug effects may be influenced if OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is taken at the same time as some drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), blood clotting (warfarin or other vitamin K blockers), 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).
* not marketed in Canada
How to take OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS that your doctor prescribes, even when you feel well. Doses every day are needed to help damaged areas heal.
- If you take OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS with antibiotic drugs, it is important that you take all medications at the right time of day for the whole treatment period. 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 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is stopped too soon. OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS needs to be taken for the full treatment to help correct acid problems.
OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS may be taken with food or on an empty stomach.
- Do not chew or crush your OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS. Swallow the OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS whole with half a glass of water.
Usual dose:
Your doctor may tell you to take OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS:
- 10*-40 mg once a day for 2-8 weeks to heal damaged areas.
10*-40 mg to control symptoms of reflux disease or to stop reflux esophagitis from coming back.
Serious Drug Interactions
- Do not take OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS if you are taking rilpivirine (a drug used for HIV).
- 20 mg to stop ulcers from returning while you take your medicine for pain and joint problems.
- 60 mg once a day to treat Zollinger-Ellison syndrome
In combination with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori.
- as Omeprazole, Amoxicillin and Clarithromycin Triple Therapy: The recommended dose for eradication of H. pylori is OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS 20 mg, amoxicillin 1,000 mg and clarithromycin 500 mg, all twice daily for seven days.
- or as Omeprazole, Metronidazole and Clarithromycin Triple Therapy: The recommended dose for eradication of H. pylori is OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS 20 mg, metronidazole 500 mg and clarithromycin 250 mg, all twice daily for seven days.
- If your ulcer is bothering you, your doctor may recommend further treatment with OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS to make sure that your ulcer is healed.
*OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS is NOT available in 10 mg strength
Overdose:
Missed Dose:
If you miss a dose of OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS and remember within 12 hours, take it as soon as possible. Then go back to your regular schedule. However, if more than 12 hours have passed when you remember, do not take the missed tablet. Do not double the dose. Just take your next dose on time.
What are possible side effects from using OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS?
Like all medicines, OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS may cause side effects in some people. Side effects are usually mild and go away a short time after starting OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS.
These are not all the possible side effects you may have when taking OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS. If you experience any side effects not listed here, tell your healthcare professional.
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. Common side effects that may occur (≥ 1 in 100 patients):
- Headache.
- Diarrhea.
- Constipation.
- Abdominal pain.
- Nausea/ vomiting.
If you think you, or a person you are caring for, have taken too much OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- Excess gas in stomach (flatulence).
Uncommon side effects that may occur (≥ 1 in 1,000 patients, but less than 1 in 100 patients):
- Dizziness.
- Feeling like you or your surroundings are moving (vertigo).
- Difficulty sleeping.
- Feeling sleepy.
- Sensation of burning / prickling / numbness.
Rare side effects that may occur (less than 1 in 1,000 patients):
- Dry mouth.
- Hair loss.
- Increased sweating.
- Taste disorders.
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 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Skin reactions (such as skin rash, dermatitis, itchy skin and / or hives) | X | ||
| RARE | |||
| Inflammation in the mouth | X | ||
| Gastrointestinal fungal infection | X | ||
| Inflammation of the kidney | X | ||
| Liver problems, i.e., inflammation of the liver with or without jaundice, impaired liver function | X | ||
| Blood disorders (reduced number of cells in the blood, low blood sodium) | X | ||
| Sore joints and muscles | X | ||
| Muscular weakness | X | ||
| Development of breasts in males | X | ||
| Sensitivity to sunlight | X | ||
| Severe skin reactions | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Hypersensitive (allergic) reactions (such as swelling of tissues, fever, discomfort / tightness in chest and anaphylactic shock) | X | ||
| Blurred vision | X | ||
| If you already have severe liver disease, you may experience disorientation / aggression / confusion / decreased consciousness | X | ||
| If you are very ill, you may feel confused, nervous, depressed or hallucinate | X | ||
| VERY RARE | |||
Low blood magnesiumθ (which may result in low blood calcium and / or low blood potassium) | X | ||
| UNCOMMON | |||
Microscopic colitis (inflammation of the gut)
The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. | X | ||
| Acute generalized exanthematous pustulosis (AGEP) (severe skin rash): small bumps surrounded by red skin, itching, fever, skin pain | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect more than one or more organs): fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinate less often | ||
| X | ||
θ These 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, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
|---|
Storage:
Keep all OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS in the original container until it is time for a dose. If you do not, moisture from the air may damage the OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS.
Store at room temperature (15-30 °C). Do not keep OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS in the bathroom medicine cabinet or other warm, moist places.
Do not use OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS after the expiry date marked on the pack.
Keep out of reach and sight of children.
If you want more information about OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this
- (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://www.sanis.com/products/, or by calling 1-866-236-4076.
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
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