Olex: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OLEX 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.

OLEX 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:

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

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

Although OLEX 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 OLEX 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, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, lactose monohydrate, lecithin, methacrylic acid copolymer, microcrystalline cellulose, propylene glycol, red iron oxide, shellac glaze, simethicone, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate.

What dosage forms it comes in:

OLEX is available in tablets containing 20 mg of omeprazole.

WARNINGS AND PRECAUTIONS

BEFORE you use OLEX, 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 OLEX 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 OLEX 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 OLEX Again:

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

Overdose:

Missed Dose:

If you miss a dose of OLEX 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

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

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 OLEX, check with your doctor or pharmacist right away.

This is not a complete list of side effects. For any unexpected effects while taking OLEX, 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 OLEX out of reach of children.

Store the blisters packages between 15°C and 25°C. Protect from moisture.

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

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

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, PENDOPHARM, Division of Pharmascience Inc. at:

1-888-550-6060

PENDOPHARM, Division of Pharmascience Inc.

Last revised: March 27, 2013.