Patient Medication Information: uses, side effects, how to take - NRA-Omeprazole
What are PrNRA-Omeprazole used for?
NRA-Omeprazole are 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 do PrNRA-Omeprazole work?
PrNRA-Omeprazole are proton pump inhibitors (PPIs). PrNRA-Omeprazole work by reducing the amount of acid made in your stomach.
What are the ingredients in PrNRA-Omeprazole?
Medicinal ingredient: omeprazole magnesium
Non-medicinal ingredients (listed in alphabetical order): hydroxypropyl methylcellulose, iron oxide (red & yellow), mannitol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, sodium stearyl fumarate, talc and titanium dioxide. The imprinting ink of tablet is consists of shellac, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide
PrNRA-Omeprazole comes in the following dosage form:
Tablets of omeprazole 20 mg.
Do NOT use PrNRA-Omeprazole if:
- you are allergic to omeprazole, substituted benzimidazoles or any of the other ingredients in NRA-Omeprazole (see “What are the ingredients in PrNRA-Omeprazole ?”).
- you are taking rilpivirine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PrNRA-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:
PrNRA-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.
Using NRA-Omeprazole 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 PrNRA-Omeprazole:
- medication for HIV: omeprazole magnesium may decrease the effectiveness of some drugs used for HIV treatment; atazanavir, nelfinavir, and saquinavir should not be used with NRA-Omeprazole .
- a high-dose of methotrexate (a drug used in high doses to treat cancer): NRA-Omeprazole may need to be temporarily withdrawn.
- clopidogrel, which is used for the prevention of blood clots: NRA-Omeprazole may interact with this drug, therefore use with clopidogrel should be avoided.
- Drug effects may be influenced if NRA-Omeprazole are 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 PrNRA-Omeprazole:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of PrNRA-Omeprazole, that your doctor prescribes even when you feel well. Doses every day are needed to help damaged areas heal.
- If you take PrNRA-Omeprazole 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 PrNRA-Omeprazole Tablets until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if PrNRA-Omeprazole are stopped too soon. PrNRA-Omeprazole need to be taken for the full treatment to help correct acid problems.
PrNRA-Omeprazole may be taken with food or on an empty stomach.
- Do not chew or crush your PrNRA-Omeprazole. Swallow the tablet whole with half a glass of water.
Usual dose:
Your doctor may tell you to take PrNRA-Omeprazole:
- 10mg*-40mg once a day for 2-8 weeks to heal damaged areas.
- 10mg*-40mg 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
In combination with antibiotic drugs for one week to treat ulcers caused by Helicobacter pylori.
Your doctor may prescribe:
- NRA-Omeprazole, clarithromycin and amoxicillin triple therapy; or
- NRA-Omeprazole, clarithromycin and metronidazole triple therapy.
- Take the 3 drugs two times a day for one week.
- If your ulcer is bothering you, your doctor may recommend further treatment with PrNRA-Omeprazole to make sure that your ulcer is healed.
*NRA-Omeprazole are NOT available in 10 mg strength
A Reminder: This medicine has been prescribed only for you or for the person you are caring for. Never give it to anyone else.
Overdose:
Missed Dose:
If you miss a dose of NRA-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 tablet. Do not double the dose. Just take your next dose on time.
What are possible side effects from using PrNRA-Omeprazole?
Like any medication, PrNRA-Omeprazole may cause side effects in some people. Side effects are usually mild and go away a short time after starting PrNRA-Omeprazole .
These are not all the possible side effects you may feel when taking PrNRA-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 PrNRA-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.
If you think you have taken too much PrOmeprazole Magnesium Delayed Release Tablets, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
- 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 PrNRA-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/decr eased 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 | ||
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. 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 PrNRA-Omeprazole.
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 tablets sealed in the bottle until it is time for a dose. If you do not, moisture from the air may damage the tablets.
Keep NRA-Omeprazole at room temperature (15-30°C). Do not keep NRA-Omeprazole in the bathroom medicine cabinet or other warm, moist places.
Do not use NRA-Omeprazole after the expiry date marked on the pack.
KEEP OUT OF SIGHT AND REACH OF CHILDREN.
If you want more information about PrNRA-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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Nora Pharma Inc. at +1-888-270-9874.
Nora Pharma Inc.
40 rue Prince-Arthur, Suite 310
Saint-Lambert, Quebec
J4P 1X2