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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

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 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.

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 of bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
  • increasing doses of NSAIDs
  • older age
  • longer use of NSAIDs
  • poor health
  • smoking
  • advanced liver disease
  • drinking alcohol
  • bleeding problems

NSAIDs should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are NSAIDs?

NSAIDs 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 NSAIDs?

Do not take NSAIDs:

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.

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. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.

are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs 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.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

new or worse high blood pressure

heart failure

liver problems including liver failure

kidney problems including kidney failure

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

shortness of breath or trouble breathing

slurred speech

chest pain

swelling of the face or throat

weakness in one part or side of your body

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

nausea

vomit blood

more tired or weaker than usual

there is blood in your bowel movement or it is black and sticky like tar

diarrhea

itching

unusual weight gain

your skin or eyes look yellow

skin rash or blisters with fever

indigestion or stomach pain

swelling of the arms, legs, hands and feet

flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

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 NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.


Distributed by: Almatica Pharma, Inc., Morristown, NJ 07960 USA
For more information, call 1-877-447-7979
This Medication Guide has been approved by the U.S. Food and Drug Administration.
PL272-07
PKG02620
Rev. 03/2019

IMPORTANT SAFETY
INFORMATION
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Download Full Prescribing Information including Boxed WARNING and Medication Guide

INDICATIONS

NAPRELAN® may be used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. It may also be used to relieve mild to moderate pain and the treatment of primary dysmenorrhea (menstrual cramps).

IMPORTANT SAFETY INFORMATION

NAPRELAN ® is a non-steroidal anti-inflammatory drug (NSAID). Like all NSAIDS, it can cause an increased risk of a heart attack or stroke that can lead to death. This risk may occur early in treatment and may increase by taking higher doses or with longer use.

NAPRELAN ® should not be taken right before or after a heart surgery called a coronary artery bypass graft (CABG), or after a recent heart attack.

Bleeding, ulcers, and tears of the esophagus, stomach and intestines may occur without warning anytime during use and may cause death. These risks increase in patients taking certain medications, those who smoke or drink alcohol, and the elderly.

You should not take NAPRELAN ® if you have had an asthma attack, hives or other allergic reaction with aspirin or any other NSAIDs.

Tell your doctor if you have liver or kidney problems, high blood pressure, asthma, pregnant or plan to become pregnant or breastfeeding.

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.

NAPRELAN ® can cause new or worse high blood pressure, heart failure, liver problems including liver failure, kidney problems including kidney failure, and low red blood cells (anemia).

Life threatening allergic reactions, including serious skin reactions can occur with NAPRELAN ® .

Get emergency help right away if you have 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.

NAPRELAN ® should be used exactly as prescribed at the lowest dose possible and for the shortest time needed.

These are not all of the side effects associated with NAPRELAN®. Please see full prescribing information for additional safety information on NaprelanUS.com .

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088 .