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Details for: NAPROXEN

Company: PHARMASCIENCE INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02362430NAPROXENNAPROXEN SODIUM220 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Trust NAPROXEN for providing fast and effective relief of pain such as arthritis pain and pain of inflammation. NAPROXEN relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. NAPROXEN 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 is a pain reliever and fever reducer. NAPROXEN works both at the site of pain and in your central nervous system. NAPROXEN starts to work fast and treats pain where it starts.

When it should not be used

Do not take NAPROXEN 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
  • right before or after heart surgery
What the medicinal ingredient is

Naproxen sodium

What the non-medicinal ingredients are

FD & C blue No. 2 Aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide.

What dosage form it comes in

Caplets: 220 mg

Warnings and precautions

Stomach bleeding warning: This may cause stomach bleeding. Symptoms may include:

  • feeling faint, vomiting blood, bloody or black stools.

The chance of stomach bleeding is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs
  • have 3 or more alcoholic drinks every day while using this product.

Allergy alert: Stop use and get medical help right away if you have ▪ hives ▪swelling of eyes and mouth ▪wheezing ▪shock ▪skin reddening ▪blisters ▪rash

BEFORE you use NAPROXEN 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
  • breastfeeding
  • taking any other drug

When using this product:

  • risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if:

  • fever lasts more than 3 days
  • pain lasts more than 5 days
  • symptoms get worse or new ones appear
Interactions with this medication

Do not use this product if you are taking acetylsalicylic acid (ASA) for preventative therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere with the preventative benefits of ASA.

BEFORE you use NAPROXEN talk to your doctor or pharmacist if you 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 acetylsalicylic acid 81 mg)
  • NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)

Taking NAPROXEN with a meal may slightly delay its absorption.

Proper use of this medication

Usual Dose

Adults (12-65 years): 1 caplet every 8 - 12 hours. Adults over 65 years 1 caplet every 12 hours. Do not take more than 2 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.

Overdose

If you think you have taken too much NAPROXEN, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side effects and what to do about them

Like all medicines, NAPROXEN 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, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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.

How to store

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

Store between 15°C and 30°C.

Reporting side effects

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at, 1-888-550-6060.

This leaflet was prepared by
Pharmascience Inc.
Montréal Québec
H4P 2T4

www.pharmascience.com

Last revised: March 26, 2020

Date modified: