Naproxen Capsules 200 mg (Apotex): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Trust Naproxen Capsules 200 mg to provide fast and effective relief of pain such as arthritis pain and pain of inflammation. Naproxen Capsules 200 mg relieve arthritic conditions such as stiffness, pain experienced day or night due to arthritis or stiffness of rheumatic conditions. Naproxen Capsules 200 mg also relieve 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. Clinical studies show long-lasting relief for up to 12 hours.

What it does:

Naproxen Capsules 200 mg is a pain reliever and fever reducer. Naproxen Capsules 200 mg work both at the site of pain and in your central nervous system. Naproxen Capsules 200 mg start to work fast and treats pain where it starts.

When it should not be used:

Do not take Naproxen Capsules 200 mg 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

  • Are right before or after heart surgery

What the medicinal ingredient is:

Naproxen and naproxen sodium equivalent to 200 mg naproxen.

What the important non-medicinal ingredients are:

FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan and sorbitol.

What dosage forms it comes in:

Soft gelatin capsules, 200 mg

WARNINGS AND PRECAUTIONS

Stomach bleeding warning: This may cause stomach bleeding.

Symptoms may include:

• Feeling faint, vomiting blood, bloody or black stools.

The chance of stomach bleeding is higher if you:

• Are age 60 or older
• Have had stomach ulcers or bleeding problems

• Take a blood thinning (anticoagulant)

  or steroid drug

• Take with other drugs containing an

  NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs

• Have 3 or more alcoholic drinks every day while using this product.

Allergy alert: Stop use and get medical help right away if you have

• Hives
• Swelling of eyes and mouth
• Wheezing
• Shock
• Skin reddening
• Blisters
• Rash

BEFORE you use Naproxen Capsules 200 mg 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

• Nursing
• Taking any other drug

When using this product:

• Risk of heart attack or stroke may increase

  if you use more than directed or for longer than directed

Stop use and ask a doctor if:

• Fever lasts more than 3 days
• Pain lasts more than 5 days
• Symptoms get worse or new ones appear

INTERACTIONS WITH THIS MEDICATION

Do not use this product if you are taking acetylsalicylic acid (ASA) for preventative therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere

with the preventative benefits of ASA.

BEFORE you use Naproxen Capsules 200 mg talk to your doctor or pharmacist if you 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 preventive therapy (e.g. ASPIRIN® 81 mg)

• NSAIDs or other pain medications (e.g.

  ibuprofen, acetaminophen)

Taking Naproxen Capsules 200 mg with a meal will delay its absorption.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults (12-65 years): 1 capsule every 8 - 12 hours. Adults over 65 years: 1 capsule every 12 hours. Do not take more than 2 capsules 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.

Overdose:

• In case of drug overdose, contact a healthcare practitioner (or doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Naproxen Capsules 200 mg 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 Naproxen Capsules 200 mg, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS 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.

HOW TO STORE IT

CAUTION: This package contains enough

drug to seriously harm a child. Keep out of children’s reach.

Store between 15°C to 30°C.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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

Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: February 15, 2023