CONSENSI- amlodipine besylate and celecoxib tablet
Burke Therapeutics, LLC
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Medication Guide
CONSENSI ® (con-sen-see) (amlodipine and celecoxib) tablets |
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What is the most important information I should know about CONSENSI? | ||
CONSENSI contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:
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Do not take CONSENSI right before or after a heart surgery called a "coronary artery bypass graft" (CABG). |
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The risk of getting an ulcer or bleeding increases with: | ||
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You should not take other medicines that contain NSAIDs or salicylates during treatment with CONSENSI because of increased risk of stomach problems. Taking other medicines that contain NSAIDs or salicylates during treatment with CONSENSI will not provide increased relief of symptoms of osteoarthritis.
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What is CONSENSI? | ||
CONSENSI is a prescription medicine used in adults who need treatment:
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It is not known if CONSENSI is safe and effective in children. |
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Who should not take CONSENSI? | ||
Do not take CONSENSI:
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Before taking CONSENSI, tell your healthcare provider about all your medical conditions, including if you:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. CONSENSI and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
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How should I take CONSENSI?
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What are the possible side effects of CONSENSI? | ||
CONSENSI can cause serious side effects, including: | ||
See "
What is the most important information I should know about CONSENSI?".
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Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment with CONSENSI. |
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CONSENSI may cause fertility problems in females that is reversible when treatment with CONSENSI is stopped. Talk to your healthcare provider if this is a concern for you. |
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The most common side effects of CONSENSI include: | ||
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Get emergency help right away if you get any of the following symptoms: | ||
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Stop taking CONSENSI and call your healthcare provider right away if you get any of the following symptoms: | ||
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These are not all the possible side effects of CONSENSI. | ||
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 CONSENSI?
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Keep CONSENSI and all medicines out of the reach of children. | ||
Other information about NSAIDs
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General information about the safe and effective use of CONSENSI | ||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CONSENSI for a condition for which it was not prescribed. Do not give CONSENSI to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about CONSENSI ®, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CONSENSI that is written for health professionals. | ||
What are the ingredients in CONSENSI? | ||
Active ingredients: amlodipine and celecoxib | ||
Inactive ingredients: mannitol DC 200, croscarmellose sodium, povidone K-30, sodium lauryl sulfate, magnesium stearate, and colloidal silicon dioxide. | ||
Manufactured by: Dexcel Pharma Technologies, Ltd., Yokneam, Israel | ||
Distributed by: Burke Therapeutics, LLC., Hot Springs, AR 71913 | ||
For more information, go to www.consensi.com or call 1-888-275-1264 | ||
This Medication Guide has been approved by the U.S. Food and Drug Administration. |
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Revision Date Apr 2021 C10041 |