Consumer Information for: APO-IBUPROFEN CAPLET

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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

APO-IBUPROFEN products 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

APO-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.

What it does

APO-IBUPROFEN ibuprofen starts to work fast and treats pain where it starts.

Ibuprofen is a member of a class of drugs called nonsteroidal 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.

When it should not be used

APO-IBUPROFEN should not be used if you:

  • are taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication, including any other ibuprofen product.
  • are 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 below). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
  • have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe lifethreatening anaphylactic reactions), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
  • have been diagnosed with severe high blood pressure or have severe coronary artery disease.
  • are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
  • have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis).
  • have liver or kidney disease.
  • have systemic lupus erythematosus.
  • are in your third trimester of pregnancy.
  • right before or after heart surgery.
What the medicinal ingredient is

Ibuprofen

What the non-medicinal ingredients are

APO-IBUPROFEN 200 mg is a yellow, round, biconvex film-coated tablet, engraved “IBU” over “200” on one side, plain on the other. APOIBUPROFEN 200 mg tablets contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, FD&C Yellow No. 6, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

APO-IBUPROFEN 200 mg is a reddish-brown, round, biconvex film-coated tablet engraved “IBU” over “200” on one side, plain on the other. APO-IBUPROFEN CAPLET is a reddish-brown, capsule-shaped, biconvex film-coated tablet engraved “200” on one side and “IBU” on the other side. APOIBUPROFEN 200 mg tablets and caplets contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

APO-IBUPROFEN 300 mg is a white, round, biconvex film-coated tablet engraved “APO” over “300” on one side, plain on the other. APO-IBUPROFEN 300 mg tablets contain: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

APO-IBUPROFEN 400 mg is an orange, round, biconvex film-coated tablet engraved “IBU” over “400” on one side, plain on the other side. APOIBUPROFEN 400 mg tablets contain: colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

APO-IBUPROFEN CAPLET 400 mg is a reddishbrown, capsule shaped, biconvex film-coated tablet engraved “IBU 400” on one side, plain on the other. APO-IBUPROFEN 400 mg caplets contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

What dosage form it comes in

Tablets: 200 mg, 300 mg, 400 mg
Caplets: 200 mg, 400 mg

Warnings and precautions

Serious Warnings and Precautions

Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer

Keep this medication out of the reach of children.

BEFORE you use APO-IBUPROFEN talk to your physician or pharmacist 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, systemic lupus erythematosus, or any other serious disease or condition.
  • are taking anticoagulant (blood thinning medication), oral corticosteroid or any other drug.
  • are trying to conceive, in your first or second trimester of pregnancy or nursing.
  • are over 65 years of age.
  • are taking low-dose ASA.
  • suffer from asthma or have nasal polyps (a swelling inside the nose).
  • are dehydrated (severe fluid loss).
  • 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).
  • suffer from hyperkalemia (high levels of potassium in your blood).

They may recommend an alternative analgesic such as acetaminophen.

Long-term continuous use may increase the risk of heart attack or stroke.

Interactions with this medication

Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.

Drugs that may interact with APO-IBUPROFEN include: acetylsalicylic acid (ASA) or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), oral steroids (glucocorticoids), lithium, diabetes medications (hypoglycemics), methotrexate, phenytoin, acetaminophen and digoxin.

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.

Proper use of this medication

Usual Dose

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

PRODUCT STRENGTH (IBUPROFEN MG/TABLET) SINGLE ORAL DOSE MAXIMUM DAILY DOSE (1200 MG)
APO-IBUPROFEN;
APO-IBUPROFEN CAPLET 		200 mg 1 or 2 tablets 6 tablets
APO-IBUPROFEN 300 mg 1 tablet 4 tablets
APO-IBUPROFEN
APO-IBUPROFEN CAPLET 		400 mg 1 tablet 3 tablets

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. Take with food or milk if mild stomach upset occurs with use. APO-IBUPROFEN should not be taken for pain for more than 5 consecutive days or for fever for more than 3 days without first talking to your doctor or dentist.

Use the lowest effective dose for the shortest duration. Do not take this product while taking ASA, other ibuprofen containing products or any other pain or fever medicine.

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

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

Overdose

If you think you have taken too much APOIBUPROFEN, contact your 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.

Side effects and what to do about them

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, sudden abdominal pain or long-term abdominal pain with loss of appetite and/or jaundice and/or new onset of itching, diarrhea; heartburn, bloating or constipation; fluid retention; skin rash or itching; dizziness; any change in vision; ringing or buzzing in the ears, vomiting blood or have tarry stools, jaundice (yellowing of the eyes or skin due to liver problems).

If you experience dizziness, blurred vision, or hearing problems while taking APO-IBUPROFEN, please use caution when carrying out activities requiring alertness.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking APO-IBUPROFEN, contact your doctor or pharmaci

How to store

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

Keep out of the reach and sight of children.

Reporting side effects

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

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

If you want more information about APOIBUPROFEN:

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9

Last revised: October 19, 2020

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