Drug Information for Naproxen Tablets USPNaproxen Sodium Tablets USP (Altura Pharmaceuticals, Inc.): Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

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  • (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)?

    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
    • for pain right before or after heart bypass surgery

    Tell your healthcare provider:

    • about all 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.
    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
    • slurred speech
    • chest pain
    • swelling of the face or throat
    • weakness in one part or side of your body

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

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

    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 ccause 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
    Generic Name Tradename
    Celecoxib Celebrex®
    Diclofenac Cataflam®, Voltaren®, Arthrotec™ (combined with misoprostol)
    Diflunisal Dolobid®
    Etodolac Lodine®, Lodine® XL
    Fenoprofen Nalfon®, Nalfon® 200
    Flurbirofen Ansaid®
    Ibuprofen Motrin®, Tab-Profen®, Vicoprofen Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, 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.* (combined with hydrocodone),
    CombunoxTM (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®
    PiroxicamFeldene®
    Sulindac Clinoril®
    Tolmetin Tolectin®, Tolectin DS®, Tolectin® 600

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

    Manufactured by:Glenmark Generics LtdColvale-Bardez, Goa 403 513India

    Manufactured for:

    Glenmark Generics Inc., USAMahwah, NJ 07430

    Questions? 1 (888) 721-7115www.glenmarkgenerics.com

    This Product was Repackaged By:

    Altura Pharmaceuticals, Inc. 12540 McCann Drive Santa Fe Springs, CA 90670 United States

  • Drug Information Provided by National Library of Medicine (NLM).
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