Naproxen

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

NAPROXEN DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

PHARMACOKINETICS

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

• ●Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

• ●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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

NAPROXEN ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

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

• ●     longer use

• ●     smoking

• ●     drinking alcohol

• ●     older age

• ●     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 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.

• ●     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

• ●     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

• ●     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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL