Patient Medication Information: uses, side effects, how to take - Naproxen Capsules 200 mg (Accucaps Industries)
ABOUT THIS MEDICATION
What the medication is used for:
Trust Naproxen Capsules 200 mg to provide fast and effective relief of pain such as arthritis pain and pain of inflammation. Naproxen Capsules 200 mg relieve arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. Naproxen Capsules 200 mg also relieve 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 Capsules 200 mg is a pain reliever and fever reducer. Naproxen Capsules 200 mg work both at the site of pain and in your central nervous system. Naproxen Capsules 200 mg start to work fast and treats pain where it starts.
When it should not be used:
Do not take Naproxen Capsules 200 mg 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 and naproxen sodium equivalent to 200 mg naproxen.
What the important non-medicinal ingredients are:
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, povidone, sorbitan, sorbitol and water.
What dosage forms it comes in:
Soft gelatin capsules, 200 mg
WARNINGS AND PRECAUTIONS
BEFORE you use Naproxen Capsules 200 mg 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 Capsules 200 mg 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. ASPIRIN® 81 mg)
NSAIDs or other pain medications (e.g.
ibuprofen, acetaminophen)
Taking Naproxen Capsules 200 mg with a meal
will delay its absorption.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (12-65 years): 1 capsule every 8 - 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. 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, contact a Poison Control Center or a doctor at once even if there are no symptoms.
Missed Dose:
If a dose is missed, resume dosing on the normal schedule without exceeding the maximum allowed for 24 hours.
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM
Like all medicines, Naproxen Capsules 200 mg 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 Capsules 200 mg, contact your doctor or pharmacist.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
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 between 15 to 30°C (59 to 86oF).
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 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance reporting Form and 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, contact your health professional. The Canada Vigilance Program does not provided medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor below:
Accucaps Industries Limited, Windsor, Canada N9C 3R5
1-800-665-7210