PMS-Naproxen EC: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your health care provider has prescribed pms-NAPROXEN EC 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:

pms-NAPROXEN EC, as a nonsteroidal anti-inflammatory drug

(NSAID), can reduce the chemicals produced by your body which

cause pain and swelling.

pms-NAPROXEN EC, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. pms-NAPROXEN EC can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used:

NOT TAKE pms-NAPROXEN EC 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 pms-NAPROXEN EC 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.

pms-NAPROXEN EC 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 important nonmedicinal ingredients are:

pms-NAPROXEN EC Tablets contain croscarmellose sodium, magnesium stearate and povidone, as inactive ingredients. The coating suspension consists of methacrylic acid copolymer, polyethylene glycol, simethicone emulsion, sodium hydroxide, talc, and titanium dioxide. The black ink for printing pms-NAPROXEN EC (375 mg and 500 mg) contains alcohol, ammonium hydroxide, ethanol, iron oxide black, propylene glycol and shellac.

What dosage forms it comes in:

Enteric-coated tablets: 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 pms-NAPROXEN EC:

• 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
• 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 is not

  recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping 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

• 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. 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 and ASA than if you took naproxen alone.

PROPER USE OF THIS MEDICATION

pms-NAPROXEN EC 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:

Take pms-NAPROXEN EC 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 pms-NAPROXEN EC 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 pms-NAPROXEN EC 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.

pms-NAPROXEN EC is NOT recommended for use in patients under 2 years of age since safety and effectiveness have NOT been established.

pms-NAPROXEN EC tablets have not been studied in subjects under the age of 18.

pms-NAPROXEN EC tablets should be swallowed with food or milk. pms-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 pms-NAPROXEN EC 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:

If you take more than the prescribed dose, contact your health care provider immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

pms-NAPROXEN EC 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.

pms-NAPROXEN EC 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 naproxen, do NOT drive or operate machinery.

pms-NAPROXEN EC 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.

This is NOT a complete list of side effects. If you develop any other symptoms while taking pms-NAPROXEN EC, see you health care provider.

HOW TO STORE IT

Store between 15°C and 30°C, protect from moisture and light.

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 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, 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.

IMPORTANT: PLEASE READ

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montreal, Canada

H4P 2T4

Last revised: September 10, 2012