Naproxen (Perrigo International): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Naproxen Sodium provides fast and effective relief of pain such as arthritis pain and pain of inflammation. Naproxen Sodium relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. Naproxen Sodium also relieves joint and body pain, muscular ache, muscle sprains and strains, backache, minor aches, headaches, migraine pain, menstrual cramps, pain of minor surgery, toothaches, pain of dental extractions, pain associated with the common cold and reduces fever. Clinical studies show long lasting relief for up to 12 hours.

What it does:

Naproxen Sodium is a pain reliever and fever reducer. Naproxen Sodium works both at the site of pain and in your central nervous system. Naproxen Sodium starts to work fast and treats pain where it starts.

When it should not be used:

Do not take Naproxen Sodium if you:

• are allergic to naproxen, naproxen

  sodium, or any ingredient in the

  formulation

• are allergic to acetylsalicylic acid (ASA), other

  salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs)

• have an active peptic ulcer, a history of recurrent

  ulceration, or active gastrointestinal bleeding

• have inflammatory bowel disease
• have liver disease (active or severe)
• have kidney disease (severe or worsening)

• are in your third trimester of pregnancy

What the medicinal ingredient is:

Naproxen sodium 220 mg

What the non-medicinal ingredients are:

FD&C Blue No. 2, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide.

What dosage forms it comes in:

220 mg Tablets and Caplets

WARNINGS AND PRECAUTIONS

BEFORE you use Naproxen Sodium talk to your doctor or pharmacist if you have or have had:

• asthma or a similar respiratory illness
• nasal polyps
• itchy skin and hives
• history of gastrointestinal disease
• high blood pressure
• a blood clotting disorder
• heart disease/failure
• any other serious disease

OR if you are:

• trying to conceive
• in your first or second trimester of pregnancy
• are nursing

INTERACTIONS WITH THIS MEDICATION

BEFORE you use Naproxen Sodium talk to your doctor or pharmacist if are taking any other drug especially:

• Anticoagulants (to decrease blood clotting)

• Antihypertensive drugs for your heart

  (including ACE inhibitors and beta-blockers)

• Diuretics ("water pills")
• Cyclosporine
• Glucocorticoids
• Lithium
• Methotrexate
• low dose ASA for doctor supervised daily preventative therapy (e.g. ASPIRIN^® 81mg)
• NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen).

Taking naproxen sodium with a meal may slightly delay its absorption.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults (12-65 years): 1 tablet/caplet every 8-12 hours. Adults over 65 years: 1 tablet/caplet every 12 hours. Do not take more than 2 tablets/caplets in a 24 hour period. Drink a full glass of water with each dose. Do not use in children under 12 years. Consult a doctor if fever lasts more than 3 days or pain lasts longer than 5 days or if your symptoms change.

IMPORTANT: PLEASE READ

Naproxen Sodium Product Monograph Page 31 of 31

Overdose:

In case of overdose, call a Poison Control Centre or a doctor

immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Naproxen Sodium may occasionally produce unwanted side effects. Stop use and contact a doctor or pharmacist if you experience: heartburn, nausea, vomiting, ringing or buzzing in the ears, bloating, diarrhea or constipation.

This is not a complete list of side effects. For any unexpected effects while taking Naproxen Sodium, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

Stop use and get emergency medical attention IMMEDIATELY if you experience: difficulty breathing, facial swelling, hives, rash or itching.

Stop use and contact a doctor or pharmacist if you experience: black stools, severe abdominal pain, any change in vision or fluid retention.

If you become drowsy, dizzy or lightheaded do not drive or operate machinery and contact your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking Naproxen Sodium, contact your doctor or pharmacist.

HOW TO STORE IT

• CAUTION: Keep out of reach of children. This package contains enough drug to seriously harm a child.

Store at controlled room temperature (15-30°C).

Available in Child Resistant and non-Child Resistant package.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, please contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at http://www.hc-sc.gc.ca (Drug Product Database).

Last revised: January 10, 2012

Manufactured by: Perrigo^® International

Allegan, Michigan 49010 USA

Imported by: The Shandex Group

Pickering, Ontario L1W 3C1