Patient Medication Information: uses, side effects, how to take - Naproxen Sodium Capsules
ABOUT THIS MEDICATION
What the medication is used for:
Trust NAPROXEN SODIUM CAPSULES for providing fast and effective relief of pain such as arthritis pain and pain of inflammation. NAPROXEN SODIUM CAPSULES relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. NAPROXEN SODIUM CAPSULES 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 CAPSULES is a pain reliever and fever reducer.
NAPROXEN SODIUM CAPSULES works both at the site of pain and in your central nervous system. NAPROXEN SODIUM CAPSULES starts to work fast and treats pain where it starts.
When it should not be used:
Do not take NAPROXEN SODIUM CAPSULES 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 220 mg
What the important non-medicinal ingredients are:
ammonium hydroxide, FD&C Blue #1, gelatin, glycerine, high polychains, lactic acid, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan, titanium dioxide
What dosage forms it comes in:
Capsule: 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 CAPSULES 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 CAPSULES 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. acetylsalicylic acid 81 mg)
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)
Taking NAPROXEN SODIUM CAPSULES with a meal will delay its absorption.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (12 to 65 years): 1 capsule every 8 to 12 hours. Adults over 65 years 1 capsule every 12 hours. Do not take more than 2 capsules 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 Capsules 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 CAPSULES 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 CAPSULES, contact your doctor or pharmacist.
| SERIOUS SIDE EFFEC TS 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°C to 25°C, avoid high humidity and excessive heat over 40°C.
REPORTING SUSPECTED 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
If you want more information about Naproxen Sodium Capsules:
- 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 (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.
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