Patient Medication Information: uses, side effects, how to take - Mylan-Omeprazole
What is MYLAN-OMEPRAZOLE used for?
MYLAN-OMEPRAZOLE 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.
- ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints).
- 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).
- a rare condition where the stomach produces too much acid (Zollinger-Ellison syndrome).
How does MYLAN-OMEPRAZOLE work?
MYLAN-OMEPRAZOLE is a medicine called a proton pump inhibitor (PPI). MYLAN-OMEPRAZOLE works by reducing the amount of acid made in your stomach.
What are the ingredients in MYLAN-OMEPRAZOLE?
Medicinal ingredients: omeprazole
Non-medicinal ingredients (listed in alphabetical order): ammonium hydroxide, dibutyl sebacate, ethyl cellulose, fumed silica, hydroxypropylmethyl cellulose, methacrylic acid copolymer dispersion, oleic acid, sugar spheres, talc, titanium dioxide, and triethyl citrate. Both 10 mg and 20 mg capsule shells contain FDA/E172 red iron oxide, titanium dioxide and gelatine.
MYLAN-OMEPRAZOLE comes in the following dosage forms:
The 10 mg delayed-release capsules are provided in HDPE bottles of 30 and the 20 mg delayed- release capsules are provided in HDPE bottles of 30, 100 and 500.
Do not use MYLAN-OMEPRAZOLE if:
- you are allergic to omeprazole, substituted benzimidazoles or any of the other ingredients in MYLAN-OMEPRAZOLE (see “What are the ingredients in MYLAN-OMEPRAZOLE?”).
- you are taking rilpivirine
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MYLAN-OMEPRAZOLE. 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:
MYLAN-OMEPRAZOLE 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.
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-OMEPRAZOLE:
medication for HIV: MYLAN-OMEPRAZOLE may decrease the effectiveness of some
drugs used for HIV treatment; atazanavir, nelfinavir and saquinavir should not be used with MYLAN-OMEPRAZOLE.
a high-dose of methotrexate (a drug used in high doses to treat cancer): MYLAN-
OMEPRAZOLE may need to be temporarily withdrawn.
- clopidogrel, which is used for the prevention of blood clots: MYLAN-OMEPRAZOLE may interact with this drug, therefore use with clopidogrel should be avoided.
- Drug effects may be influenced if MYLAN-OMEPRAZOLE 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 performatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class).
* not marketed in Canada
How to take MYLAN-OMEPRAZOLE:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of MYLAN-OMEPRAZOLE that your doctor prescribes even when you feel well. Doses every day are needed to help damaged areas heal.
- Take MYLAN-OMEPRAZOLE until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if MYLAN-OMEPRAZOLE is stopped too soon. MYLAN-OMEPRAZOLE needs to be taken for the full treatment to help correct acid problems.
MYLAN-OMEPRAZOLE may be taken with food or on an empty stomach.
- Do not chew or crush your MYLAN-OMEPRAZOLE capsules. Swallow the capsule whole with half a glass of water.
Usual dose:
Your doctor may tell you to take MYLAN-OMEPRAZOLE:
- 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.
- 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.
Overdose:
No severe symptoms have been seen in patients who have taken doses up to 400 mg.
If you think you have taken too much MYLAN-OMEPRAZOLE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose of MYLAN-OMEPRAZOLE 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 dose. Do not double the dose. Just take your next dose on time.
DO NOT OPEN, DIVIDE, CRUSH, OR CHEW THE CAPSULE
What are possible side effects from using MYLAN-OMEPRAZOLE?
Like all medicines, MYLAN-OMEPRAZOLE may cause side effects in some people. Side effects are usually mild and go away a short time after starting MYLAN-OMEPRAZOLE.
These are not all the possible side effects you may feel when taking MYLAN OMEPRAZOLE. 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-OMEPRAZOLE 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.
Common side effects (≥ 1 in 100 patients):
- Headache.
- Diarrhea.
- Constipation.
- Abdominal pain.
- Nausea/ vomiting.
- Excess gas in stomach (flatulence).
Uncommon side effects (≥ 1 in 1000 patients, but < 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 (< 1 in 1000 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 MYLAN-OMEPRAZOLE.
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 (≥ 1 in 1000 patients, but < 1 in 100 patients) | |||
| skin reactions (such as skin rash, dermatitis, itchy skin and/or hives) | X | ||
| feeling ill | X | ||
| RARE (≥ 1 in 10 000 patients, but < 1 in 1000 patients) | |||
| inflammation in the mouth | X | ||
| gastrointestinal fungal infection | X | ||
| inflammation of the kidney | X | ||
| liver problems, ie, 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 | ||
| inflammation in the gut (leading to diarrhea) | X | ||
| sore joints and muscles | X | ||
| muscular weakness | X | ||
| development of breasts in males | X | ||
| sensitivity to sunlight | X | ||
| severe skin reactions | X | ||
| 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 (< 1 in 10 000 patients) | |||
low blood magnesiumθ (which may result in low blood calcium and/or low blood potassium) | 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, talk to your healthcare professional. Other situations may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using MYLAN-OMEPRAZOLE.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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 capsules in their container until it is time for a dose. If you do not, moisture from the air may damage the capsules.
Remember to keep MYLAN-OMEPRAZOLE well out of reach of children. Keep the package at room temperature (15ºC to 25°C). Do not keep MYLAN-OMEPRAZOLE in the bathroom medicine cabinet or other warm, moist places. Protect from light.
Do not use MYLAN-OMEPRAZOLE after the expiry date marked on the pack.
Keep out of reach and sight of children.
If you want more information about MYLAN-OMEPRAZOLE:
- 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 calling 1-800-575-1379
- This document can be found at: www.mylan.ca.
Last Revised: February 2, 2018
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca