Ibuprofen (Apotex): Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Caution in those with heart failure, high blood pressure or other conditions that may cause excess fluid collecting in tissues.
• Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer. The chance of stomach bleeding is higher if you are: age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner 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.
• Caution in patients at risk of kidney problems, including the elderly or those using diuretics.
• Stop use immediately if you have difficulty or pain when urinating.

• Talk to your doctor if you are trying to conceive, in your first or second trimester of pregnancy or if breastfeeding.

What is IBUPROFEN used for?

Since everyone’s pain is different, IBUPROFEN offers 3 levels of pain relief to suit your needs. So you can choose your relief, IBUPROFEN product is available in three strengths, including 200 mg, 300 mg and 400 mg tablets.

IBUPROFEN product provide fast and effective relief of PAIN from:

• headache, including mild to moderate migraine and tension headache
• menstrual cramps
• toothache (dental pain), including dental extraction
• inflammation from arthritis, muscle strain and sprains, muscles, bones and joints, including back pain

IBUPROFEN is also an effective fever reducer and will provide relief from the aches and pain due to the common cold and flu.

Clinical studies show long lasting relief for up to 8 hours for fever and up to 6 hours for pain.

How does IBUPROFEN work?

IBUPROFEN (ibuprofen tablets) starts to work fast and treats pain where it starts.

Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by blocking the production of substances called prostaglandins, which are involved in the development of pain and inflammation.

What are the ingredients in IBUPROFEN?

Medicinal ingredients: Ibuprofen

Non-medicinal ingredients:

IBUPROFEN 200 mg: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

IBUPROFEN 300 mg: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

IBUPROFEN 400 mg: colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6 hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

IBUPROFEN comes in the following dosage forms:

Tablets: 200 mg, 300 mg, 400 mg

Do not use IBUPROFEN if:

• You are:

  • taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication including any other ibuprofen product.
  • allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates, or to any ingredient in the formulation (see Non-medicinal ingredients above). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
  • dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
  • in your third trimester of pregnancy.

• You have:

  • nasal polyps (growth inside your nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
  • active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g., Crohn’s, colitis).
  • serious liver or kidney disease.
  • systemic lupus erythematosus.
  • high potassium in the blood.
• You recently had or are about to have heart surgery.

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

• have stomach ulcers, high blood pressure, asthma, heart failure or thyroid disease, kidney or liver disease, glaucoma, diabetes, alcoholism, a history of stomach bleeding, or any other serious disease or condition.
• are taking an anticoagulant (blood thinning medication), oral corticosteroid or any other drug.
• are pregnant or breastfeeding.
• are over 65 years of age.
• are taking low-dose ASA.
• have a blood-clotting disorder (e.g., hemophilia, sickle cell anemia, etc.).
• have a heart disease.
• have any unusual urinary symptoms (e.g., bladder problems).
• are on a special diet (e.g., low-sodium).

They may recommend an alternative analgesic such as acetaminophen.

Other warnings you should know about:

• Long-term continuous use may increase the risk of heart attack or stroke.
• The use of NSAIDs, like IBUPROFEN, in the second trimester of pregnancy should be restricted to the lowest dose necessary for shortest possible duration.
• At 20 weeks or later in pregnancy, your use of NSAIDs may need to be monitored by a doctor due to the rare risk of kidney problems in the unborn baby which may result in decreased amniotic fluid volume and other complications.

Stop use and ask a doctor if

• you show signs of stomach bleeding
• pain worsens or lasts more than 5 days
• fever worsens or lasts more than 3 days
• any new symptoms 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 IBUPROFEN:

• acetaminophen
• anticoagulants (blood thinners)
• ASA or other NSAIDs
• digoxin
• diuretics (water pills)
• lithium
• medications for high blood pressure
• methotrexate
• oral antidiabetic agents and insulin
• oral steroid (glucocorticoids)
• phenytoin

Do not use this product if you are taking daily low dose ASA (81 to 325 mg) without talking to a doctor or pharmacist. Ibuprofen may interfere with the preventative benefits of ASA.

How to take IBUPROFEN

Take with food or milk if mild stomach upset occurs with use.

Usual dose:

For accurate dosing of each product strength, refer to the dosage table and follow the instructions carefully.

The single oral dose may be taken every 4 to 6 hours as needed. Do not take more than the maximum daily dose (1200 mg in 24 hours) unless advised by a doctor.

Use the lowest effective dose for the shortest duration.

For effective use of this medicine, unless recommended by your doctor or dentist, DO NOT take:

• more than the recommended number of tablets in each single dose
• this product longer than the recommended period of time

Overdose:

If you think you, or a person you are caring for, have taken too much IBUPROFEN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

What are possible side effects from using IBUPROFEN?

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

The most common side effects with this medication are indigestion, nausea, vomiting, heartburn, dizziness, and skin rashes.

The other side effects, which might be seen, are sudden abdominal pain or long-term abdominal pain with the loss of appetite and/or jaundice and/or new onset of itching, diarrhoea, bloating, constipation, abdominal cramp, headache, nervousness, drowsiness, itching, decreased appetite, sleeplessness and fluid retention.

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately.

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

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.

Storage:

Store at room temperature (15°C to 30°C).

Keep out of reach and sight of children.

If you want more information about IBUPROFEN:

• 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 (http://www.apotex.ca/products); or by calling 1-800-667-4708.

Date of Authorization: December 23, 2025