CELECOXIB - celecoxib capsule 
Alembic Pharmaceuticals Limited

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Medication Guide


Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)  
(See the end of this Medication Guide for a list of prescription NSAID medicines.)





What is the most important information I should know about medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
 
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.
This chance increases:
  • with longer use of NSAID medicines
  • in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
  NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
  • can happen without warning symptoms
  • may cause death
The chance of a person getting an ulcer or bleeding increases with:
  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health 
NSAID medicines should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed



What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?



Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
 Do not take an NSAID medicine:

Tell your healthcare provider:


What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?



Serious side effects include:
Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness
 


Get emergency help right away if you have 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 your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:



  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • skin rash or blisters with fever
  • unusual weight gain
  • swelling of the arms and legs, hands and feet

 These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.



Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)


Some of these NSAID medicines 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.
NSAID medicines that need a prescription


Generic Name
Tradename
Celecoxib
Celebrex
Diclofenac
Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal
Dolobid
Etodolac
Lodine, Lodine XL
Fenoprofen
Nalfon, Nalfon 200
Flurbiprofen
Ansaid
Ibuprofen
Motrin,  Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin
Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen
Oruvail
Ketorolac
Toradol
Mefenamic Acid
Ponstel
Meloxicam
Mobic
Nabumetone
Relafen
Naproxen
Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin
Daypro
Piroxicam
Feldene
Sulindac
Clinoril
Tolmetin
Tolectin,TolectinDS, Tolectin 600

  

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
 

Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Panelav 389350, Gujarat, India

Revised: 09/2019 

Revised: 9/2019
Alembic Pharmaceuticals Limited