Details for: IBUPROFEN CAPLETS
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02314762 | IBUPROFEN CAPLETS | IBUPROFEN | 200 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Since everyone’s pain is different, IBUPROFEN TABLETS,
IBUPROFEN CAPLETS and EXTRA STRENGTH
IBUPROFEN offers 2 levels of pain relief to suit your needs.
So you can choose your relief, IBUPROFEN TABLETS,
IBUPROFEN CAPLETS and EXTRA STRENGTH
IBUPROFEN products are available in two strengths, including
IBUPROFEN TABLETS OR IBUPROFEN CAPLETS (200
mg) and EXTRA STRENGTH IBUPROFEN (400 mg).
IBUPROFEN TABLETS, IBUPROFEN CAPLETS and
EXTRA STRENGTH 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,
Clinical studies show long lasting relief for up to 8 hours for fever and up to 6 hours for pain.
What it does
IBUPROFEN TABLETS, IBUPROFEN CAPLETS and
EXTRA STRENGTH IBUPROFEN 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.
When it should not be used
IBUPROFEN TABLETS, IBUPROFEN CAPLETS and EXTRA STRENGTH 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 life-threatening 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
IBUPROFEN TABLETS 200 mg, IBUPROFEN CAPLETS
200 mg contain the following non-medicinal ingredients in
alphabetical order: Colloidal silicon dioxide, Polyvinyl
Alcohol, Polyethylene Glycol, Povidone, Pre-gelatinized
Starch, Iron Oxide Red, Sodium Starch Glycolate, Starch,
Stearic Acid, Talc and Titanium Dioxide.
EXTRA STRENGTH IBUPROFEN 400 mg contain the
following non-medicinal ingredients in alphabetical order:
Colloidal Silicon dioxide, Polyethylene Glycol, Polyvinyl
Alcohol, , Povidone, Pre-gelatinized Starch, Iron Oxide Red,Sodium Starch Glycolate, Starch, Stearic Acid, Talc and
Titanium Dioxide.
What dosage form it comes in
Tablets: 200 mg
Caplets: 200 mg, 400mg
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 IBUPROFEN TABLETS, IBUPROFEN CAPLETS and EXTRA STRENGTH IBUPROFEN talk to your doctor 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 an 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 IBUPROFEN TABLETS,
IBUPROFEN CAPLETS and EXTRA STRENGTH
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
(81-325 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.
Children’s ibuprofen formulations are available to treat children
under 12 years of age.
| Product | Strength (Ibuprofen) mg/tablet | Single Oral Dose | Maximum Daily Dose (1,200 mg) |
|---|---|---|---|
| IBUPROFEN TABLETS, IBUPROFEN CAPLETS | 200 mg | 1 or 2 tablets, caplets | 6 tablets, caplets |
| EXTRA STRENGTH IBUPROFEN | 400 mg | 1 caplet | 3caplets |
The single oral dose may be taken every 4-6 hours as needed.
Do not take more than the maximum daily dose (1,200 mg in
24 hours) unless advised by a doctor. Take with food or milk if
mild stomach upset occurs with use. IBUPROFEN TABLETS,
IBUPROFEN CAPLETS and EXTRA STRENGTH
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 recommended number of tablets, caplets in each single dose
- a dose more often than every 4-6 hours
- this product longer than the recommended period of time
Overdose
If you think you have taken too much IBUPROFEN TABLETS, IBUPROFEN CAPLETS and EXTRA STRENGTH IBUPROFEN, 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, abdominal pain or diarrhea; heartburn,
bloating or constipation; fluid retention; skin rash or itching;
dizziness; any change in vision; ringing or buzzing in the ears,
vomiting any 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 IBUPROFEN TABLETS, IBUPROFEN
CAPLETS and EXTRA STRENGTH 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 IBUPROFEN TABLETS, IBUPROFEN
CAPLETS and EXTRA STRENGTH IBUPROFEN, contact
your doctor of pharmacist.
How to store
Tablets and caplets: Store away from heat and direct light at controlled room temperature (15°C - 30°C).
Reporting side effects
- 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.
More information
This document plus the full product monograph, prepared for
health professionals can be obtained by contacting the sponsor,
Pharmascience Inc., at 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com
Last revised: September 17, 2020