Naprelan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your health care provider has prescribed NAPRELAN for you to help in relieving signs and symptoms of rheumatoid arthritis and osteoarthritis.

What it does:

NAPRELAN (naproxen sodium), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.

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

When it should not be used:

DO NOT TAKE NAPRELAN if you have any of the following medical conditions:

$ Heart bypass surgery (planning to have or recently had)

$ Severe, uncontrolled heart failure

$ Past or recent history of 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 NAPRELAN 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.

NAPRELAN 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 nonmedicinal ingredients are:

Each NAPRELAN tablet contains the following inactive ingredients : ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

What dosage forms it comes in:

Each tablet contains either 375 mg or 500 mg of naproxen as naproxen sodium in a controlled release tablet.

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 NAPRELAN:

• 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

• Any other medical problems

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 heath

  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 NAPRELAN is

  not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping NAPRELAN 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
    • Phenytoin
    • Probenecid
    • Cholestyramine
    • Acetaminophen
    • Potassium Supplements
    • Alcohol

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 NAPRELAN. 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 NAPRELAN and ASA than if you took NAPRELAN alone.

PROPER USE OF THIS MEDICATION

Usual dose:

Medical

Condition

Age

Group

Starting Dose

Maximum Dose (per day)

Maximum Duration of

Treatment (days)

Rheumatoid

arthritis and

osteoarthritis

Adults

(≥18

years

of age)

Two 375 mg tablets (750 mg) once daily or two 500 mg tablets (1000 mg) once daily. The usual daily dose of two 500 mg tablets (1000 mg) once daily.

Three 500 mg tablets (1500

mg) once daily.

7 days*

* If you will be using NAPRELAN 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.

If you are prescribed this medication for use over a long period of time, your doctor will check your health during regular visits to assess your progress and to ensure that this medicine is not causing unwanted effects.

During treatment, your doctor may decide to adjust the dosage according to your response to the medication.

Be sure to take NAPRELAN regularly as prescribed. In some types of arthritis, up to two weeks may pass before you feel the full effects of this medicine.

Take NAPRELAN 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 NAPRELAN may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

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.

To lessen stomach upset, take this medicine immediately after a meal or with food or milk. Also, you should remain standing or sitting upright (i.e., do not lie down) for about 15-30 minutes after taking the medicine. This helps to prevent irritation that may lead to trouble swallowing. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor. Do not crush or chew NAPRELAN tablets; swallow tablet whole.

Overdose:

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

Missed Dose:

If you miss a dose, take the next regularly scheduled dose and do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

NAPRELAN 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.

NAPRELAN 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 NAPRELAN, do NOT drive or operate machinery.

NAPRELAN 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 NAPRELAN, see your health care provider.

HOW TO STORE IT

NAPRELAN should be stored at room temperature (15-30°C/59-86°F) in a closed container.

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 0701D

  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 at:

http://www.sunovion.ca or by contacting the distributor, Sunovion Pharmaceuticals Canada Inc., at: 1-866-260-6291

Last revised: 14 March 2016