Naproxen

Northwind Pharmaceuticals
Northwind Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• Patient Medication Guide

FULL PRESCRIBING INFORMATION

NDC: 51655-626-52

MFG: 68462-0190-05

Naproxen tablets 500 MG

30 Tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains 500 mg naproxen USP

Dosage: See medication guide

Store at 59-86 degrees F. Protect from light and moisture.

Store in a tight, light-resistant container (See USP) Keep out of the reach of children.

Mfg By: Glenmark Generic, Ltd Goa 403513 India for Glenmark Generics Inc,

NJ, 07430 USA  Lot#:    Exp Date:

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Patient Medication Guide

NAPROXEN- naproxen tablet
NAPROXEN SODIUM- naproxen sodium tablet
Glenmark Generics Inc., USA

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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 medicinesin 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 symptomsmay cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called “corticosteroids” and “anticoagulants”longer usesmokingdrinking alcohololder agehaving poor health

NSAID medicines should only be used:

exactly as prescribedat the lowest dose possible for your treatmentfor 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 arthritismenstrual 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 medicinefor 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 breathingslurred speechchest painswelling of the face or throatweakness 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:

nauseathere is blood in your bowel movement or it is black and sticky like tarmore tired or weaker than usualitchingyour skin or eyes look yellowunusual weight gainstomach painskin rash or blisters with feverflu-like symptomsswelling of the arms and legs, hands and feetvomit 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 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) 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.

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®, VVicoprofen®**(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®
Piroxicam Feldene®
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 Ltd
Colvale-Bardez, Goa 403 513
India

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

January 2009

Revised: 01/2011

Glenmark Generics Inc., USA