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

What is Naproxen Capsules 200 mg 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.

How does Naproxen Capsules 200 mg work?

Naproxen Capsules 200 mg are 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 treat pain where it starts.

What are the ingredients in Naproxen Capsules 200 mg?

Medicinal ingredients: Naproxen and naproxen sodium equivalent to 200 mg naproxen. Non-medicinal ingredients: FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan and sorbitol.

Naproxen Capsules 200 mg comes in the following dosage forms:

Soft gelatin capsules, 200 mg

Do not use Naproxen Capsules 200 mg if:

• You are:

  • allergic to naproxen, naproxen sodium, or any ingredient in the formulation
  • allergic to acetylsalicylic acid (ASA), other salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs)

  • in your third trimester of pregnancy

  • right before or after heart surgery

• You have:

  • an active peptic ulcer, a history of recurrent ulceration, or active gastrointestinal bleeding
  • inflammatory bowel disease
  • liver disease (active or severe)
  • kidney disease (severe or worsening)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Naproxen Capsules 200 mg. Talk about any health conditions or problems you may have, including 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

• Are:

  • trying to conceive
  • in your first or second trimester of pregnancy
  • breastfeeding

Other warnings you should know about: 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

  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

Driving and using machines: If you become drowsy, dizzy or lightheaded do not drive or operate machinery and contact your doctor or pharmacist.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Naproxen Capsules 200 mg:

• Anticoagulants (to decrease blood clotting)
• Antihypertensive drugs for your heart (including ACE inhibitors and beta-blockers)
• Cyclosporine
• Diuretics (“water pills”)
• Glucocorticoids
• Lithium
• Low dose ASA for doctor supervised daily preventive therapy (e.g. ASPIRIN® 81mg)
• Methotrexate
• NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)

• Taking Naproxen Capsules 200 mg with a meal may slightly delay its absorption.

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

How to take Naproxen Capsules 200 mg:

Drink a full glass of water with each dose. Do not use in children under 12 years.

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.

Overdose:

Missed dose:

If you miss taking your dose on time, do not worry; take your dose when you remember. Do not exceed more than two doses in 24 hours.

What are possible side effects from using Naproxen Capsules 200 mg?

These are not all the possible side effects you may have when taking Naproxen Capsules 200 mg. If you experience any side effects not listed here, tell your healthcare professional.

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.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store between 15 to 30°C (59 to 86°F).

CAUTION: This package contains enough drug to seriously harm a child.

Keep out of reach and sight of children.

If you want more information about Naproxen Capsules 200 mg:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://www.catalent.com/index.php, or by calling 1-888-689-9794 ext. 2016

Date of Authorization: March 06, 2025