Omeprazole (Pharmascience): 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 non-medicinal ingredients are”).

What the medicinal ingredient is:

The medicinal ingredient is omeprazole magnesium.

What the non-medicinal ingredients are:

Each 20 mg tablet contains the following non-medicinal ingredients (alphabetically): Colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, red iron oxide, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate.

What dosage forms it comes in:

OMEPRAZOLE is available in tablets containing 20 mg of omeprazole.

WARNINGS AND PRECAUTIONS

Warnings. Do not use if:

• You have trouble or pain swallowing food, have bloody black stools or are vomiting with blood.
• You have been having frequent heartburn for over 3 months.

These may be signs of a more serious condition. You may need different treatment. See your doctor immediately.

OMEPRAZOLE may decrease the efficacy of some drugs used for HIV treatment (atazanavir and nelfinavir) or heart disease (clopidogrel); these drugs should not be used with OMEPRAZOLE.

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

• are taking any other medicines to reduce stomach acid
• have heartburn with light-headedness, sweating or dizziness

• have chest pain or shoulder pain with shortness of breath;

  sweating; pain spreading to arms, neck or shoulders

• have frequent wheezing, particularly with heartburn
• have 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

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. Ask your doctor or pharmacist before use if you are taking:

• Atazanavir, Nelfinavir (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)
• St John’s Wort (Hypericum perforatum)
• Tacrolimus (an immune system medicine)
• Warfarin (a blood-thinning medicine)

*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 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°C and 25°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 package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pharmascience Inc. At 1-888-550-6060

Pharmascience Inc.

Montréal Québec

H4P 2T4

www.pharmascience.com

Last revised: October 24, 2014.