CONSENSI- amlodipine besylate and celecoxib tablet 
Burke Therapeutics, LLC

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Medication Guide
CONSENSI ® (con-sen-see)
(amlodipine and celecoxib)
tablets
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:
  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • with longer use of NSAIDs
Do not take CONSENSI right before or after a heart surgery called a "coronary artery bypass graft" (CABG).
Avoid taking CONSENSI after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death
The risk of getting an ulcer or bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "selective serotonin reuptake inhibitors (SSRIs)", or "serotonin norepinephrine reuptake inhibitors (SNRIs)"
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
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.
CONSENSI should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What is CONSENSI?
CONSENSI is a prescription medicine used in adults who need treatment:
  • with amlodipine for high blood pressure (hypertension), to lower blood pressure, and
  • with celecoxib for the management of the signs and symptoms of osteoarthritis.
It is not known if CONSENSI is safe and effective in children.
Who should not take CONSENSI?
Do not take CONSENSI:
  • if you are allergic to amlodipine, celecoxib or any of the inactive ingredients in CONSENSI. See the end of this Medication Guide for a complete list of ingredients in CONSENSI.
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you have had an allergic reaction to sulfonamides.
Before taking CONSENSI, tell your healthcare provider about all your medical conditions, including if you:
  • have heart problems.
  • have liver or kidney problems.
  • have asthma.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking CONSENSI during pregnancy. You should not take CONSENSI after 29 weeks of pregnancy.
  • are breastfeeding or plan to breastfeed. CONSENSI can pass into your breast milk. It is not known if CONSENSI will harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take CONSENSI.
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.
How should I take CONSENSI?
  • Take CONSENSI exactly as your healthcare provider tells you to.
  • Take 1 CONSENSI tablet orally each day.
  • If your pain stops, do not stop taking CONSENSI until your healthcare provider prescribes a different medicine to treat your blood pressure. Your healthcare provider will monitor your blood pressure when changing to the new medicine.
  • If you take too much CONSENSI, call your healthcare provider or get medical help right away.
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?".
  • liver problems, including liver failure
  • worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease
  • heart failure
  • swelling of your arms, legs, hands and feet (peripheral edema) is common with CONSENSI but can sometimes be serious.
  • kidney problems, including kidney failure
  • increased potassium levels (hyperkalemia)
  • life-threatening allergic reactions
  • life-threatening skin reactions
  • low red blood cells (anemia)
Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment with CONSENSI.
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.
The most common side effects of CONSENSI include:
  • swelling of the arms, legs, hands, and feet
  • joint swelling
  • dizziness
  • stomach pain
  • diarrhea
  • heartburn
  • headache
  • frequent urination
  • hot or warm feeling in your face (flushing)
  • gas
  • tiredness
  • extreme sleepiness
Get emergency help right away if you get any of the following symptoms:
  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat
Stop taking CONSENSI and call your healthcare provider right away if you get any of the following symptoms:
  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • your skin or eyes look yellow
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet
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?
  • Store CONSENSI at room temperature between 68° and 77°F (20°C to 25°C).
Keep CONSENSI and all medicines out of the reach of children.
Other information about NSAIDs
  • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
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.
Revision Date May 2020
Revised: 5/2020
Document Id: a5f236c4-2f35-73f1-e053-2a95a90a7394
Set id: 322f926c-99ac-49f8-9cc5-584594f2891f
Version: 2
Effective Time: 20200518
Burke Therapeutics, LLC