Patient Medication Information: uses, side effects, how to take - Naproxen Sodium Tablets (Apotex)
ABOUT THIS MEDICATION
What the medication is used for:
Trust Naproxen Sodium Tablets for providing fast and effective relief of pain such as arthritis pain and pain of inflammation. Naproxen Sodium Tablets relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. Naproxen Sodium Tablets 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 is a pain reliever and fever reducer. Naproxen Sodium Tablets works both at the site of pain and in your central nervous system. Naproxen Sodium Tablets starts to work fast and treats pain where it starts.
When it should not be used:
Do not take Naproxen Sodium Tablets 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
- are right before or after heart surgery
What the medicinal ingredient is:
Naproxen sodium
What the important nonmedicinal ingredients are:
colloidal silicon dioxide, dextrates, FD&C Blue No. 2, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide.
What dosage forms it comes in:
Caplet: 220 mg
WARNINGS AND PRECAUTIONS
Stomach bleeding warning: This may cause stomach bleeding. Symptoms may include:
feeling faint, vomiting blood, bloody or black stools.
- 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 Sodium Tablets 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
- nursing
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 preventive therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere with the preventive benefits of ASA.
BEFORE you use Naproxen Sodium Tablets 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 preventive therapy (e.g. ASPIRIN® 81mg)
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)
Taking Naproxen Sodium Tablets 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.
Overdose:
If you think you have taken too much Naproxen Sodium Tablets contact your healthcare 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 Sodium Tablets 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 contact your doctor or pharmacist.
SERIOUS SIDE EFFEC TS, 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 controlled room temperature, 15°C to 30°C. Protect from moisture.
MORE INFORMATION
If you want more information about Naproxen Sodium Tablets:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website
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. |
- (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.