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CONTRAINDICATIONS:
NAPRELAN® is contraindicated in patients with known hypersensitivity to naproxen. NAPRELAN® should not be given to patients who have experienced asthma, urticaria, or allergic-type reations after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reations to NSAIDs have been reported in such patients.

Cardiovascular Risk
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
  • Naproxen as NAPRELAN® is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk
  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach on intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

NAPRELAN® is a registered trademark of Elan Corporation plc. IPDAS® is a registed trademark of Elan Corporation International Ltd.

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© 2010 Victory Pharma, Inc.
Victory
www.victorypharma.com

IMPORTANT SAFETY INFORMATION: NAPRELAN® belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAID). 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.

NAPRELAN® may increase the chance of a heart attack or stroke that can lead to death. This chance increases with longer use of NSAID medicines and in people who have heart disease.

NAPRELAN® should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NAPRELAN® can cause ulcers and bleeding in the stomach and intestines at any time during treatment. This can happen without warning symptoms and may cause death. The chance of a person getting an ulcer or bleeding increases with taking medicines called “corticosteroids” and “anti-coagulants”, longer use, smoking, drinking alcohol, older age, and having poor health.

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

NAPRELAN®, as with all NSAIDs, may cause the following side effects: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Do not take NAPRELAN® if you are allergic to naproxen, or have had an asthma attack, hives, or other allergic reactions when taking aspirin or another NSAID medicine. Serious skin reactions, sometimes fatal, can occur without warning and have been reported with NAPRELAN® use.

Before using NAPRELAN®, talk to your doctor about all of your medical conditions and the medications you take, and if you are pregnant or breastfeeding.

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.

Stop taking NAPRELAN® and call your healthcare provider right away if you have:

  • nausea,
  • are more tired or weaker than usual,
  • itching,
  • 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 tar like
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet.

Please see Full Prescribing Information and Medication Guide for NAPRELAN® (naproxen sodium)

You are encouraged to report side effects to the FDA at 1-800-FDA-1088.

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