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Details for: NAT-OMEPRAZOLE DR

Company: NATCO PHARMA (CANADA) INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02439549NAT-OMEPRAZOLE DROMEPRAZOLE (OMEPRAZOLE MAGNESIUM)20 MGTABLET (DELAYED-RELEASE)ORAL
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Summary Reports

Summary Safety Review - Proton Pump Inhibitors - Assessing the Potential Risk of Clostridium difficile Infection
Summary Safety Review - Proton Pump Inhibitors (PPIs) - Assessing the risk of a type of skin reaction [Subacute Cutaneous Lupus Erythematosus (SCLE)]

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

NAT-Omeprazole DR tablets 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).
What it does

Pr NAT-Omeprazole DR tablets are proton pump inhibitors (PPIs). Pr NAT-Omeprazole DR tablets work by reducing the amount of acid made in your stomach.

When it should not be used
  • you are allergic to omeprazole, substituted benzimidazoles or any of the other ingredients in NAT-Omeprazole DR tablets (see “What are the ingredients in NAT-Omeprazole DR tablets?”).
  • you are taking rilpivirine.
What the medicinal ingredient is

omeprazole magnesium

What the non-medicinal ingredients are

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

What dosage form it comes in

Tablets of omeprazole 20 mg.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PrNAT-Omeprazole DR 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:
Pr NAT-Omeprazole DR 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.

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

Interactions with this medication
  • medication for HIV: omeprazole magnesium may decrease the effectiveness of some drugs used for HIV treatment; atazanavir, nelfinavir, and saquinavir should not be used withNAT-Omeprazole DR tablets.
  • a high-dose of methotrexate (a drug used in high doses to treat cancer): NAT-Omeprazole DR tablets may need to be temporarily withdrawn.
  • clopidogrel, which is used for the prevention of blood clots: NAT-Omeprazole DR tablets may interact with this drug, therefore use with clopidogrel should be avoided.
  • Drug effects may be influenced if NAT-Omeprazole DR tablets 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

Proper use of this medication

How to take Pr NAT-Omeprazole DR tablets:

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

  • Take all doses of Pr NAT-Omeprazole DR tablets, that your doctor prescribes even when you feel well. Doses every day are needed to help damaged areas heal.
  • If you take Pr NAT-Omeprazole DR 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 Pr NAT-Omeprazole DR tablets until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if Pr NAT-Omeprazole DR tablets are stopped too soon. Pr NAT-Omeprazole DR tablets need to be taken for the full treatment to help correct acid problems.
  • Pr NAT-Omeprazole DR tablets may be taken with food or on an empty stomach.
  • Do not chew or crush your Pr NAT-Omeprazole DR tablets. Swallow the tablet whole with half a glass of water.

Usual dose

Your doctor may tell you to take Pr NAT-Omeprazole DR tablets:

  • 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:
      • NAT-Omeprazole DR tablets, clarithromycin and amoxicillin triple therapy; or
      • NAT-Omeprazole DR tablets, 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 Pr NAT-Omeprazole DR tablets to make sure that your ulcer is healed.

* NAT-Omeprazole DR tablets 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

If you think you have taken too much Pr NAT-Omeprazole DR tablets, 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 NAT-Omeprazole DR 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.

Side effects and what to do about them

Like any medication, Pr NAT-Omeprazole DR tablets may cause side effects in some people. Side effects are usually mild and go away a short time after starting Pr NAT-Omeprazole DR tablets .

These are not all the possible side effects you may feel when taking Pr NAT-Omeprazole DR tablets. 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 Pr NAT-Omeprazole DR tablets 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 Pr NAT-Omeprazole DR tablets.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
UNCOMMON (≥ 1 in 1000 patients, but < 1 in 100 patients)
skin reactions (such as skin rash, dermatitis, itchy skin and/or hives)   ✔  
feeling ill   ✔  
RARE (≥ 1 in 10 000 patients, but < 1 in 1000 patients)
inflammation in the mouth   ✔  
gastrointestinal fungal infection   ✔  
inflammation of the kidney   ✔  
liver problems, ie, inflammation of the liver with or without jaundice, impaired liver function     ✔
blood disorders (reduced number of cells in the blood, low blood sodium)   ✔  
inflammation in the gut (leading to diarrhea)   ✔  
ore joints and muscles   ✔  
muscular weakness   ✔  
development of breasts in males   ✔  
sensitivity to sunlight   ✔  
severe skin reactions     ✔
hypersensitive (allergic) reactions (such as swelling of tissues, fever, discomfort/ tightness in chest and anaphylactic shock)     ✔
blurred vision   ✔  
if you already have severe liver disease, you may experience disorientation/aggression/confusion/decr eased consciousness   ✔  
If you are very ill, you may feel confused, nervous, depressed or hallucinate   ✔  
VERY RARE (< 1 IN 10 000 patients)
Low blood magnesiumθ (which may result in low blood calcium and/or low blood potassium)   ✔  

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 Pr NAT-Omeprazole DR tablets.

How to store

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 NAT-Omeprazole DR tablets at room temperature (15-30°C). Do not keep NAT-Omeprazole DR tablets in the bathroom medicine cabinet or other warm, moist places.

Do not use NAT-Omeprazole DR tablets 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:

REMARQUE : Consultez votre professionnel de la santé si vous avez besoin de renseignements sur le traitement des effets secondaires. Le Programme Canada Vigilance ne donne pas de conseils médicaux.

More information
  • 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Natco Pharma (Canada) Inc. at 1-800-296-9329.

This leaflet was prepared by:

Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7

Last revised: September 24, 2019

Date modified: