Patient Medication Information: uses, side effects, how to take - Naproxen Sodium Tablets (Vita Health Products)
ABOUT THIS MEDICATION
What the medication is used for:
Trust Naproxen Sodium Tablets/Caplets for providing fast and effective relief of pain such as arthritis pain and pain of inflammation. Naproxen Sodium Tablets/Caplets relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness, of rheumatic conditions. Naproxen Sodium Tablets/Caplets 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 Tablets/Caplets is a pain reliever and fever reducer. Naproxen Sodium Tablets/Caplets works both at the site of pain and in your central nervous system. Naproxen Sodium Tablets/Caplets starts to work fast and treats pain where it starts.
When it should not be used:
Do not take Naproxen Sodium Tablets/Caplets 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 important nonmedicinal ingredients are:
FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, talc, and titanium oxide
What dosage forms it comes in:
Naproxen Sodium Tablet, 220 mg
Naproxen Sodium Caplet, 220 mg
Naproxen Sodium Tablets are blue, round, bi-convex tablets, debossed “m12” on one side and plain on the other side.
Naproxen Sodium Caplets are blue, capsule-shaped, bi-convex caplets, debossed “m13” on one side and plain on the other side.
WARNINGS AND PRECAUTIONS
BEFORE you use Naproxen Sodium Tablets/Caplets 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 Tablets/Caplets 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”)
- Cyclosporin
- Glucocorticoids
- Lithium
- Methotrexate
- Low dose ASA for doctor supervised daily preventative therapy (e.g. ASPIRIN® 81 mg)
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)
Taking Naproxen Sodium Tablets/Caplets with a meal may slightly delay its absorption.
IMPORTANT: PLEASE READ
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (12-65 years): 1 caplet or tablet every 8 – 12 hours. Adults over 65 years 1 caplet or tablet every 12 hours. Do not take more than 2 caplets or tablets 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:
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 Tablets/Caplets 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 Tablets/Caplets, 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 IT
- CAUTION: This package contains enough drug to seriously harm a child. Keep out of children’s reach.
Store at 15-30°C (59-86°F)
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.heathcanada.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 MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of the 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:
Regulatory Affairs Department
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, Manitoba
R2J 3W2