Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Rx only

(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)?

Increased risk of a heart attack or stroke that can lead to death. The risk may happen early in treatment and may increase:

• with increasing doses of NSAIDs
• with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs 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.

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)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• right before or after heart bypass surgery

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
• are breastfeeding or plan to breast feed.

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant.NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding.Talk to your doctor.
• if you have high blood pressure

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

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

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
• unusual weight gain
• skin rash or blisters with fever
• 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.

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

• Aspirin is an NSAID medicine 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 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

* 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 label warns that long term continuous use may increase the risk of heart attack or stroke.
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#®, Tolectin DS#®, Tolectin 600#®

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

This Medication Guide has been approved by the U.S. Food and Drug Administration.

# Brands mentioned are trademarks of their respective owners.

Manufactured by:

Cadila Healthcare Ltd.

Baddi, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 11/20