Patient Medication Information: uses, side effects, how to take - Nx 12 Hour
ABOUT THIS MEDICATION
What the medication is used for:
NX 12 Hour contains Naproxen Sodium. NX 12 Hour provides fast and effective relief of pain such as arthritis pain and pain of inflammation. NX 12 Hour relieves arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. NX 12 Hour 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.
What it does:
NX 12 Hour is a pain reliever and fever reducer. NX 12 Hour works both at the site of pain and in your central nervous system. Naproxen Sodium starts to work fast and treats pain where it starts.
When it should not be used:
Do not take NX 12 Hour 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 non-medicinal ingredients are:
FD&C Blue No. 2, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, povidone, purified water, talc, titanium dioxide.
What dosage forms it comes in:
220 mg Tablets and Caplets
WARNINGS AND PRECAUTIONS
BEFORE you use NX 12 Hour 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 NX 12 Hour 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 preventative therapy (e.g. ASPIRIN® 81mg)
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen).
Taking NX 12 Hour with a meal may slightly delay its absorption.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults (12-65 years): 1 tablet/caplet every 8-12 hours. Adults over 65 years: 1 tablet/caplet every 12 hours. Do not take more than 2 tablets/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.
IMPORTANT: PLEASE READ
NX 12 Hour (naproxen sodium) Product Monograph Page 32 of 32
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, NX 12 Hour 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 NX 12 Hour, 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.
This is not a complete list of side effects. For any unexpected effects while taking NX 12 Hour, contact your doctor or pharmacist.
HOW TO STORE IT
- CAUTION: Keep out of reach of children. This package contains enough drug to seriously harm a child.
Store at controlled room temperature (15-30°C).
Available in Child Resistant and non-Child Resistant package.
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 0701E Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the 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, 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 http://www.hc-sc.gc.ca (Drug Product Database).
Last revised: January 17, 2012
Manufactured by: Perrigo® International
Allegan, Michigan 49010 USA
Imported by: McNeil Consumer Healthcare Markham, Ontario L3R 5L2