Omeprazole

Dexcel Pharma Technologies Ltd.

Omeprazole Delayed Release Tablets, 20 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
• 14 Count Inner Carton Label
• 14 Count Blister Labels

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Omeprazole delayed-release tablet, 20 mg

Purpose

Purpose

Acid reducer

Uses

Use

• treats frequent heartburn (occurs 2 or more days a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
  

Warnings

Allergy alert:  Do not use if you are allergic to omeprazole

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.  These may be signs of a serious condition.  See your doctor.

Ask a doctor before use if you have

• had heartburn over 3 months.  This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
  

Ask a doctor or pharmacist before use if you are taking

• warfarin, clopidogrel or cilostazol (blood-thinning medicines)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus (immune system medicine)
• prescription antiretrovirals (medicines for HIV infection)
  

Stop use and ask a doctor if

• 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 every 4 months
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.  (1-800-222-1222)

Directions

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

• swallow 1 tablet with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 tablet a day
• do not chew or crush the tablets
• do not crush tablets in food
• do not use for more than 14 days unless directed by your doctor

• you may repeat a 14-day course every 4 months
• do not take for more than 14 days or more often than every 4 months unless directed by a doctor

• children under 18 years of age:  ask a doctor.  Heartburn in children may sometimes be caused by a serious condition.
  

Other information

• read the directions, warnings, and package insert before use
• keep the carton and package insert.  They contain important information.
• store at 20-25°C (68-77°F)
• keep product out of high heat and humidity
• protect product from moisture
  

Inactive ingredients carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl cirtrate

Questions or comments?

1-800-719-9260

Omeprazole Delayed Release Tablets 20 mg

Acid Reducer

Please read all of this package insert before taking Omeprazole Delayed Release Tablets 20 mg.  Save this to read , as you need.

How Omeprazole Delayed Release Tablets 20 mg Work For Your Frequent Heartburn

Omeprazole Delayed Release Tablets 20 mg work differently from other heartburn products, such as antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg stop acid production at the source - the acid pump that produces stomach acid.  Omeprazole Delayed Release Tablets 20 mg are to be used once a day (every 24 hours), every day for 14 days.

What to Expect When Using Omeprazole Delayed Release Tablets 20 mg

Omeprazole Delayed Release Tablets 20 mg are a different type of medicine from antacids and other acid reducers.  Omeprazole Delayed Release Tablets 20 mg may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.  Make sure you take the entire 14 days of dosing to treat your frequent heartburn.

Who Should Take Omeprazole Delayed Release Tablets 20 mg

This product is for adults (18 years and older) with frequent heartburn - when you have heartburn 2 or more days a week.

• Children under 18 years of age:  ask a doctor.  Heartburn in children may sometimes be caused by a serious condition.
• Omeprazole Delayed Release Tablets 20 mg are not intended for those who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief of heartburn.

• Swallow 1 tablet with a glass of water before eating in the morning.
• Take every day for 14 days.
• Do not take more than 1 tablet a day.
• Do not chew or crush the tablets.
• Do not crush tablets in food.
• Do not use for more than 14 days unless directed by your doctor.

• had heartburn over 3 months.  This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

• warfarin, clopidogrel or cilostazol (blood-thinning medicines)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus (immune system medicine)
• prescription antiretrovirals (medicines for HIV infection)

• 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 every 4 months

• Do not lie flat or bend over soon after eating.
• Do not eat late at night or just before bedtime.
• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables.
• Eat slowly and do not eat big meals.
• If you are overweight, lose weight.
• If you smoke, quit smoking.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.

14 Count Inner Carton Label

Treats Frequent Heartburn!

Occurring 2 or More Days a Week

Omeprazole

delayed release tablets 20 mg

acid reducer

14 Tablets

14 Count Blister Labels

Omeprazole DR Tablets

20 mg

Acid reducer

Push tablet through foil.

Dexcel Pharma Technologies Ltd.

10 Hakidma Street, Hi-Tech Park,