Details for: NAPROXEN SODIUM
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02351013 | NAPROXEN SODIUM | NAPROXEN SODIUM | 275 MG | TABLET | ORAL |
| 02351021 | NAPROXEN SODIUM DS | NAPROXEN SODIUM | 550 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your health care provider has prescribed NAPROXEN SODIUM or NAPROXEN SODIUM DS for you for one or more of the following medical conditions:
- For the relief of mild to moderately severe pain, accompanied by inflammation in conditions such as musculo skeletal trauma and postdental extraction.
- For the relief of pain associated with post-partum cramping and dysmenorrhea.
What it does
NAPROXEN SODIUM or NAPROXEN SODIUM DS (naproxen
sodium), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce
the chemicals produced by your body which cause pain and swelling.
NAPROXEN SODIUM or NAPROXEN SODIUM DS, as a
nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your
illness or prevent it from getting worse. NAPROXEN SODIUM or
NAPROXEN SODIUM DS can only relieve pain and reduce swelling
as long as you continue to take it.
When it should not be used
DO NOT TAKE NAPROXEN SODIUM or NAPROXEN SODIUM DS if you have any of the following medical conditions:
- Heart bypass surgery (planning to have or recently had)
- Severe, uncontrolled heart failure
- Bleeding in the brain or other bleeding disorders
- Current pregnancy (after 28 weeks of pregnancy)
- Currently breastfeeding (or planning to breastfeed)
- Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs
- (Nonsteroidal Anti-Inflammatory Drugs)
- Ulcer (active)
- Bleeding from the stomach or gut (active)
- Inflammatory bowel disease (Crohn’s Disease or
- Ulcerative Colitis)
- Liver disease (active or severe)
- Kidney disease (severe or worsening)
- High potassium in the blood
Patients who took a drug in the same class as NAPROXEN
SODIUM or NAPROXEN SODIUM DS after a type of heart
surgery (coronary artery bypass grafting (CABG)) were more likely
to have heart attacks, strokes, blood clots in the leg(s) or lung(s),
and infections or other complications than those who did NOT take
that drug.
NAPROXEN SODIUM or NAPROXEN SODIUM DS should NOT be
used in patients under 18 years of age since the safety and effectiveness
have NOT been established.
What the medicinal ingredient is
Naproxen sodium
What the non-medicinal ingredients are
NAPROXEN SODIUM or NAPROXEN SODIUM DS Tablets contain the following non-medicinal ingredients: Magnesium Stearate, Microcrystalline Cellulose, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Colloidal Silicon Dioxide and Purified Water. The coating suspension for both the 275 mg and 550 mg tablets contain FD&C Blue #2, Hypromellose, Polyethylene Glycol, Polysorbate and Titanium Dioxide.
What dosage form it comes in
NAPROXEN SODIUM or NAPROXEN SODIUM DS are available as: film coated tablets (275 mg and 550 mg).
Warnings and precautions
If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than NAPROXEN SODIUM or NAPROXEN SODIUM DS:
- Heart Attack or Angina
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks)
- Congestive Heart Failure
Before taking this medication, tell your health care provider if you have any of the following:
- High blood pressure
- High cholesterol
- Diabetes mellitus or on a low sugar diet
- Atherosclerosis
- Poor circulation to your extremities
- Smoker or ex-smoker
- Kidney disease or urine problems
- Previous ulcer or bleeding from the stomach or gut (small or large intestine)
- Previous bleeding in the brain
- Bleeding problems
- Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
- Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
Also, before taking this medication, tell your health care provider if you
are planning to get pregnant.
While taking this medication:
- tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
- do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;
- fertility may be decreased. The use of NAPROXEN SODIUM or NAPROXEN SODIUM DS is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping NAPROXEN SODIUM or NAPROXEN SODIUM DS should be considered.
Interactions with this medication
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):
- Acetylsalicylic Acid (ASA) or other NSAIDs
- e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
- Antacids
- Antidepressants
- Selective Serotonin Reuptake Inhibitors (SSRIs)
- e.g. citalopram, fluoxetine, paroxetine, sertraline
- Blood pressure medications
- ACE (angiotensin converting enzyme) inhibitors
- e.g. enalapril, lisinopril, perindopril, ramipril
- ARBs (angiotensin II receptor blockers)
- e.g. candesartan, irbesartan, losartan, valsartan
- Blood thinners
- e.g. warfarin, ASA, clopidogrel
- Corticosteroids (including glucocorticoids)
- e.g. prednisone
- Cyclosporin
- Digoxin
- Diuretics
- e.g. furosemide, hydrochlorothiazide
- Lithium
- Methotrexate
- Oral contraceptives
- Oral hypoglycemics (diabetes medications)
- Tacrolimus
Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking NAPROXEN SODIUM or NAPROXEN SODIUM DS. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both NAPROXEN SODIUM or NAPROXEN SODIUM DS and ASA than if you took NAPROXEN SODIUM or NAPROXEN SODIUM DS alone.
Proper use of this medication
Usual dose: 18 years of age and older
| Medical Condition | Starting Dose | Maximum Dose (per day) |
|
Two 275 mg tablets or one 550 mg tablet followed by one 275 mg tablet every six to eight hours as required. | Should not exceed 1375 mg. |
Take NAPROXEN SODIUM or NAPROXEN SODIUM DS only as
directed by your health care provider. Do NOT take more of it, do
NOT take it more often and do NOT take it for a longer period of
time than your health care provider recommended. If possible, you
should take the lowest dose of this medication for the shortest time
period. Taking too much NAPROXEN SODIUM or NAPROXEN
SODIUM DS may increase your chances of unwanted and sometimes
dangerous side effects, especially if you are elderly, have other diseases
or take other medications.
If you will be using NAPROXEN SODIUM or NAPROXEN SODIUM
DS for more than 7 days, see your health care provider regularly to
discuss whether this medicine is working for you and if it is causing you
any unwanted effects.
This medication has been prescribed specifically for you. Do NOT
give it to anyone else. It may harm them, even if their symptoms
seem to be similar to yours.
NAPROXEN SODIUM or NAPROXEN SODIUM DS is NOT
recommended for use in patients under 18 years of age since safety
and effectiveness have NOT been established.
Missed Dose
It may be a good idea to ask your doctor or pharmacist ahead of time what to do about missed doses. If you forget to take a dose of NAPROXEN SODIUM or NAPROXEN SODIUM DS take it as soon as possible, then just carry on with the regular times you take your medication. If you remember your missed dose close to the time of your next dose, do not take the missed dose.
Overdose
Side effects and what to do about them
NAPROXEN SODIUM or NAPROXEN SODIUM DS may cause some
side effects, especially when used for a long time or in large doses.
When these side effects occur, you may require medical attention.
Report all symptoms or side effects to your health care provider.
NAPROXEN SODIUM or NAPROXEN SODIUM DS may cause you
to become drowsy or tired. Be careful about driving or participating in
activities that require you to be alert. If you become drowsy, dizzy or
lightheaded after taking NAPROXEN SODIUM or NAPROXEN
SODIUM DS, do NOT drive or operate machinery.
NAPROXEN SODIUM or NAPROXEN SODIUM DS may cause you
to become more sensitive to sunlight. Any exposure to sunlight or
sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or
discolouration, or vision changes. If you have a reaction from the sun,
check with your health care provider.
Check with your health care provider IMMEDIATELY if you develop
chills, fever, muscle aches or pains, or other flu-like symptoms,
especially if they occur before or together with a skin rash. These
symptoms may be the first signs of a SERIOUS ALLERGIC
REACTION to this medication.
| Symptom / effect | STOP taking NAPROXEN SODIUM or NAPROXEN SODIUM DS and get emergency medical attention IMMEDIATELY | Stop taking NAPROXEN SODIUM or NAPROXEN SODIUM DS and talk to your physician or pharmacist |
|---|---|---|
| Bloody or black tarry stools | ✔ | |
| Shortness of breath, wheezing, any trouble breathing or chest tightness | ✔ | |
| Skin rash, hives, swelling or itching | ✔ | |
| Blurred vision, or any visual disturbance | ✔ | |
| Any change in the amount or colour of your urine (red or brown) | ✔ | |
| Any pain or difficulty experienced while urinating | ✔ | |
| Swelling of the feet, lower legs; weight gain | ✔ | |
| Vomiting or persistent indigestion, nausea, stomach pain or diarrhea | ✔ | |
| Yellow discolouration of the skin or eyes, with or without itchy skin | ✔ | |
| Malaise, fatigue, loss of appetite | ✔ | |
| Headaches, stiff neck | ✔ | |
| Mental confusion, depression | ✔ | |
| Dizziness, lightheadedness | ✔ | |
| Hearing problems | ✔ |
This is NOT a complete list of side effects. If you develop any other symptoms while taking NAPROXEN SODIUM or NAPROXEN SODIUM DS, see your health care provider.
How to store
Store at room temperature (15 to 30°C) in a well-closed container.
Protect from light. Store in a dry place.
Do NOT keep outdated medicine or medicine no longer needed.
Any outdated or unused medicine should be returned to your
pharmacist.
Keep out of reach of children.
Reporting 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, Ontario
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, 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 by contacting Sanis Health Inc., at:
Phone: 1-866-236-4076
1-877-777-9117 (French)
Fax: 905-689-1465
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
Dieppe, New Brunswick
Canada, E1A 1P2
Last revised: May 5, 2014