Naproxen

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• NAPROXEN DESCRIPTION
• CLINICAL PHARMACOLOGY
• CLINICAL STUDIES
• INDICATIONS & USAGE
• NAPROXEN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• NAPROXEN ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

NAPROXEN DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

INDICATIONS & USAGE

• ●     For the relief of the signs and symptoms of rheumatoid arthritis

• ●     For the relief of the signs and symptoms of osteoarthritis

• ●     For the relief of the signs and symptoms of ankylosing spondylitis

• ●     For the relief of the signs and symptoms of juvenile arthritis

• ●     For relief of the signs and symptoms of tendonitis

• ●     For relief of the signs and symptoms of bursitis

• ●     For relief of the signs and symptoms of acute gout

• ●     For the management of pain

• ●     For the management of primary dysmenorrhea

NAPROXEN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

NAPROXEN ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

SPL MEDGUIDE

• ●with longer use of NSAID medicines

• ●in people who have heart disease

• ●can happen without warning symptoms

• ●may cause death

• ●taking medicines calledcorticosteroidsandanticoagulants

• ●drinking alcohol

• ●longer use

• ●older age

• ●smoking

• ●having poor health

• ●exactly as prescribed

• ●at the lowest dose possible for your treatment

• ●for the shortest time needed

• ●     different types of arthritis

• ●     menstrual cramps and other types of short-term pain

• ●     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

• ●     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.

• ●heart attack

• ●stroke

• ●high blood pressure

• ●heart failure from body swelling (fluid retention)

• ●kidney problems including kidney failure

• ●bleeding and ulcers in the stomach and intestine

• ●low red blood cells (anemia)

• ●life-threatening skin reactions

• ●life-threatening allergic reactions

• ●liver problems including liver failure

• ●asthma attacks in people who have asthma

• ●stomach pain

• ●constipation

• ●diarrhea

• ●gas

• ●heartburn

• ●nausea

• ●vomiting

• ●dizziness

• ●     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

• ●     nausea

• ●     vomit blood

• ●     more tired or weaker than usual

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

• ●     itching

• ●     unusual weight gain

• ●     your skin or eyes look yellow

• ●     skin rash or blisters with fever

• ●     stomach pain

• ●     swelling of the arms and legs, hands and feet

• ●     flu-like symptoms

• ●     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 (overthe-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION