Omeprazole (Laboratoire Riva): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OMEPRAZOLE is recommended for Adults (18 years and older) to relieve frequent heartburn – when you have heartburn 2 or more days a week.

Heartburn is a painful burning feeling in the chest which rises up to the throat.

OMEPRAZOLE is not the right medicine for you if you suffer from heartburn once a week or less, or if you want immediate relief.

What it does:

OMEPRAZOLE belongs to a group of medicines called proton pump inhibitors which work by reducing the amount of acid the stomach makes.

OMEPRAZOLE works differently from other non-prescription heartburn products, such as antacids and other acid reducers. OMEPRAZOLE stops acid production at the source, the acid pump inside your stomach that produces acid.

Although OMEPRAZOLE will start to suppress acid within a few hours, it is not intended to give instant relief. You may have to wait 3 to 5 days to feel the full effect of the product on heartburn symptoms, although some people get complete relief of symptoms within 24 hours. Make sure you take the tablets for all 14 days even if you start to feel better.

What else can you do to help avoid your symptoms?

• Avoid or limit foods such as: caffeine, chocolate, spicy or fatty foods, and alcohol.

• Eat smaller, more frequent meals. Avoid eating or drinking late at night or 2-3 hours before bedtime.
• Avoid lying down or bending over soon after eating.
• Try to reduce stress.
• If you are overweight, try to reduce excess weight.
• If you smoke, try to stop smoking or reduce the amount you smoke.

When it should NOT be used:

• You should not take OMEPRAZOLE if you think you might be allergic to omeprazole or any of the ingredients (see “What the nonmedicinal ingredients are”)
• are taking rilpivirine (medicines for HIV infection)
• are taking medicines for HIV (atazanavir, nelfinavir, and saquinavir)
• are taking medicines for heart disease (clopidogrel)
• have trouble or pain when swallowing food
• have bloody black stools or are vomiting with blood
• have chest or shoulder pain with shortness of breath sweating, pain spreading to arms, neck or shoulders

• have heartburn with light-headedness, sweating or dizziness

  These may be signs of serious condition. See your doctor immediately.

What the medicinal ingredient is:

The medicinal ingredient is omeprazole as omeprazole magnesium.

What the non-medicinal ingredients are:

Each 20 mg tablet contains the following non-medicinal ingredients (alphabetically): hydroxypropyl methylcellulose, methacrylic acid copolymer, iron oxide (red & yellow), mannitol, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide.

The imprinting ink consists of shellac, isopropyl alcohol, iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide

What dosage forms it comes in:

Tablets (delayed release) containing 20 mg of omeprazole.

WARNINGS AND PRECAUTIONS

BEFORE you use OMEPRAZOLE, talk to your doctor or pharmacist if you:

• are taking any other medicines to reduce stomach acid
• have frequent wheezing, particularly with heartburnhave unexplained weight loss
• have nausea or vomiting
• have stomach pain

• have jaundice or other liver problems

  now have or in the past have had a gastric ulcer or surgery on your stomach or bowels

• are pregnant, plan to become pregnant, or are breastfeeding.

Tell your doctor before taking this medicine if:

• You are due to have a specific blood test (Chromogranin A)

STOP USE and ask your doctor if:

• you have severe and/or persistent diarrhea
• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment within a 4-month period

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with OMEPRAZOLE include the following. Askyour doctor or pharmacist before use if you are taking:

• Atazanavir, Nelfinavir and Saquinavir (medicines for HIV infection)
• Cilostazol* (a medicine to treat leg pain)
• Clarithromycin, Erythromycin (antibiotics)
• Clopidogrel (a heart medicine)
• Diazepam (an anxiety medicine)
• Digoxin (a heart medicine)
• Erlotinib (a medicine against cancer) or any other anticancer drug from the same class
• Ketoconazole, Itraconazole, Voriconazole (antifungal or anti-yeast medicines)
• Methotrexate (a medicine used against cancer)
• Phenytoin (an epilepsy medicine)
• Rifampin (a medicine to treat tuberculosis)
• St John’s Wort (Hypericum perforatum)
• Tacrolimus (an immune system medicine)
• Warfarin (a blood-thinning medicine)
• any other prescription drug

*not marketed in Canada

PROPER USE OF THIS MEDICATION

Usual dose: Adults (18 years of age and older)

14-Day Course of Treatment

• Take 1 tablet with a glass of water, before eating in the morning.
• Do NOT chew or crush tablets. This decreases how well OMEPRAZOLE works.
• Do NOT take more than 1 tablet every 24 hours.
• Take every day for 14 days.
• Do NOT use for more than 14 days unless directed by your doctor.
• Do NOT repeat a 14-day course of treatment within a period of 4 months unless directed by your doctor.

When to Take OMEPRAZOLE Again:

You should wait at least 4 months before taking another 14-day course of treatment.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of 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. Just take your next dose on time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

OMEPRAZOLE may cause side effects in some people. Side effects are usually mild and go away a short time after starting OMEPRAZOLE.

Common side effects that may occur: cold or flu-like symptoms, diarrhea, excess gas, headache, nausea or vomiting, stomach pain.

Uncommon side effects that may occur: altered liver values, dizziness, feeling of burning/prickliness/numbness of the skin, feeling sleepy, insomnia, itching, skin rash.

Other unwanted effects may occur in rare cases. If you experience any bothersome or unusual effects such as new or worsening joint pain, rash on your cheeks or arms that gets worse in the sun, while using OMEPRAZOLE, check with your doctor or pharmacist right away.

This is not a complete list of side effects. For any unexpected effects while taking OMEPRAZOLE, contact your doctor or pharmacist.

HOW TO STORE IT

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 tablets.

Keep OMEPRAZOLE out of reach of children.

Store the blisters packages between 15 and 30°C. Protect from moisture.

Do not keep OMEPRAZOLE in the bathroom medicine cabinet or other warm, moist places.

Do not use OMEPRAZOLE after the expiry date marked on the pack.

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Laboratoire Riva Inc., at: 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Québec

J7C 3V4

www.labriva.com

Last revised: November 7, 2019