OMEPRAZOLE- omeprazole capsule, delayed release
Blenheim Pharmacal, Inc.
Omeprazole Delayed-Release Capsules, USP
(oh mep’ ra zole)
Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about omeprazole delayed-release capsules?
Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Omeprazole delayed-release capsules can cause serious side effects, including:
Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
Omeprazole can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Omeprazole delayed-release capsules are used in adults:
GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
For children and adolescents 2 to 17 years of age, omeprazole delayed-release capsules are used:
It is not known if omeprazole delayed-release capsules are safe and effective for the treatment of gastroesophageal reflux disease (GERD) in children under 1 year of age.
Who should not take omeprazole delayed-release capsules?
Do not take omeprazole delayed-release capsules if you:
What should I tell my doctor before taking omeprazole delayed-release capsules?
Before you take omeprazole delayed-release capsules, tell your doctor if you:
Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, anti-cancer drugs, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works.
Especially tell your doctor if you take:
Ask your doctor or pharmacist for a list of these medicines if you are not sure.Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take omeprazole delayed-release capsules?
What are the possible side effects of omeprazole delayed-release capsules?
Omeprazole can cause serious side effects, including:
Tell your doctor right away if you develop any of these symptoms:
Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.
The most common side effects with omeprazole delayed-release capsules in adults and children include:
In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:
Other side effects:
Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole:
Your doctor may stop omeprazole if these symptoms happen.
Tell your doctor if you have any side effect that bothers you or that do not go away. These are not all the possible side effects with omeprazole delayed-release capsules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store omeprazole delayed-release capsules?
Keep omeprazole delayed-release capsules and all medicines out of the reach of children.
General information about omeprazole delayed-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about omeprazole delayed-release capsules.
For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
For more information contact Apotex Corp., Drug Safety at 1-800-706-5575.
Instructions for Use
For instructions on taking omeprazole delayed-release capsules, please see “ How should I take omeprazole delayed-release capsules?”
What are the ingredients in omeprazole delayed-release capsules?
Active ingredient in omeprazole delayed-release capsules: omeprazole
Inactive ingredients in omeprazole delayed-release capsules: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, red iron oxide and titanium dioxide. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.
This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
10 mg, 20 mg and 40 mg
|Manufactured by||Manufactured for|
|Apotex Inc.||Apotex Corp.|
|Toronto, Ontario||Weston, Florida|
|Canada M9L 1T9||USA 33326|