Details for: TEVA-NAPROXEN
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00565350 | TEVA-NAPROXEN | NAPROXEN | 250 MG | TABLET | ORAL |
| 00627097 | TEVA-NAPROXEN | NAPROXEN | 375 MG | TABLET | ORAL |
| 00589861 | TEVA-NAPROXEN | NAPROXEN | 500 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 TEVA-NAPROXEN for you for one or more of the following medical conditions
- For the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and juvenile rheumatoid arthritis.
- For the relief of minor aches and pains in muscles, bones and joints, mild to moderate pain accompanied by inflammation in sprains and strains and primary dysmenorrhea.
What it does
TEVA-NAPROXEN (naproxen), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.
TEVA-NAPROXEN, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. TEVA-NAPROXEN can only relieve pain and reduce swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE TEVA-NAPROXEN 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 TEVA-NAPROXEN 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.
TEVA-NAPROXEN should NOT be used in patients under 2 years of age since the safety and effectiveness have NOT been established.
What the medicinal ingredient is
naproxen
What the non-medicinal ingredients are
TEVA-NAPROXEN Tablets contain the following nonmedicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate, sodium starch glycolate, D&C yellow #10 lake 15-20% (HT), FD&C yellow #6 lake 15-18% (HT), FD&C blue #1 lake 11-13% (HT).
TEVA-NAPROXEN EC Tablets contain the following nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium (Ac-Di- Sol), magnesium stearate, povidone, sodium lauryl sulphate, dri klear 042, eudragid L30D, chromateric white deb 5018 WE, purified water.
What dosage form it comes in
TEVA-NAPROXEN is available as: immediate release tablets (250 mg, 375 mg and 500 mg); sustained-release tablet (750 mg); enteric coated tablets (250 mg, 375 mg and 500 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 TEVA-NAPROXEN
- Heart Attack or Angina
- Stroke or Mini-stroke
- Loss of Vision
- Current Pregnancy (less than 28 weeks) Congestive Heart Failure
- 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 TEVA-NAPROXEN is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping TEVA-NAPROXEN 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
- Selective Serotonin Reuptake Inhibitors (SSRIs)
- 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
- ACE (angiotensin converting enzyme) inhibitors
- 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 TEVA-NAPROXEN. 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 TEVA-NAPROXEN and ASA than if you took TEVA-NAPROXEN alone.
Proper use of this medication
TEVA-NAPROXEN is intended for use in patients greater than 2 years of age for the shortest possible duration.
Usual dose: 18 years of age and older
| Medical Condition | Starting Dose | Maximum Dose (per day) |
| Osteoarthritis/Rheumatoid Arthritis/Ankylosing Spondylitis | 250 mg twice daily | 1000 mg (given as 500 mg twice daily) |
| Analgesia/Musculoskeletal Injuries | 250 mg three times daily | 1000 mg (given as 500 mg twice daily) |
| Dysmenorrhea | 500 mg initial dose then 250 mg every 6-8 hours | 1250 mg (given in divided doses) |
Take TEVA-NAPROXEN 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 TEVA-NAPROXEN 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 TEVA-NAPROXEN 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.
TEVA-NAPROXEN is NOT recommended for use in patients under 2 years of age since safety and effectiveness have NOT been established.
TEVA-NAPROXEN tablets should be swallowed with food or milk. TEVA-NAPROXEN tablets, TEVA-NAPROXEN SR and TEVA-NAPROXEN EC tablets should be swallowed whole; do not split, chew, or crush them.
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 TEVA-NAPROXEN 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
TEVA-NAPROXEN tablets 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.
TEVA-NAPROXEN 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 light-headed after taking TEVA-NAPROXEN, do NOT drive or operate machinery.
TEVA-NAPROXEN 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 | STOP taking TEVA-NAPROXEN and get emergency medical attention IMMEDIATELY | Stop taking TEVA-NAPROXEN tablets 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 TEVA-NAPROXEN, see you health care provider.
How to store
TEVA-NAPROXEN tablets, TEVA-NAPROXEN SR tablets and TEVA-NAPROXEN EC tablets: Store at room temperature (15 to 30°C). Store in a dry place. Unit dose strips should be stored between 15 to 25°C and protected from high humidity.
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 help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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
This document plus the full product monograph, prepared for health
professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 5005 (English);
1-877-777-9117 (French)
or druginfo@tevacanada.com
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: March 18, 2016