Omep: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OMEP 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.

OMEP 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:

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

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

Although OMEP 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 capsules 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 OMEP 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.

What the non-medicinal ingredients are:

Each 20 mg capsule contains the non-medicinal ingredients: carrageenan, croscarmellose sodium, dibutyl sebacate, hypromellose, hypromellose phthalate, iron oxide red, lactose anhydrous, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 80, potassium chloride, povidone, talc, titanium dioxide, water.

What dosage forms it comes in:

OMEP is available in capsules containing 20 mg of omeprazole.

WARNINGS AND PRECAUTIONS

BEFORE you use OMEP, 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

INTERACTION WITH THIS MEDICATION

Drugs that may interact with OMEP 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 capsule with a glass of water, before eating in the morning.
• Do NOT chew or crush capsules. This decreases how well OMEP works.
• Do NOT take more than 1 capsule 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 OMEP 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 OMEP 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 capsule. Just take your next dose on time.

SIDE EFFECT AND WHAT TO DO ABOUT THEM

OMEP may cause side effects in some people. Side effects are usually mild and go away a short time after starting OMEP. 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 OMEP, check with your doctor or pharmacist right away.

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

HOW TO STORE IT

OMEP (omeprazole) 20 mg capsules are two-piece hard gelatin capsules with a dark pink cap, pink body, each imprinted with “OME 20”.

Store blister packs at room temperature 15 - 30ºC. Protect from moisture.

Keep OMEP out of reach of children.

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

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

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 0701E

    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.

MORE INFORMATION

This document, plus the full product monograph prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

Or

by written request at:

145, Jules-Léger

Boucherville, (Québec), Canada

J4B 7K8

Or by e-mail at:

medinfo@sandoz.com

Last revised: September 18, 2015