Patient Medication Information: uses, side effects, how to take - Ibuprofen Tablets
ABOUT THIS MEDICATION
What the medication is used for:
for fast and effective relief of muscle aches and pain, joint and body pain, backache, muscle sprains and strains, pain of inflammation associated with conditions including arthritis and physical or athletic overexertion (e.g. sprains or strains), headache including tension headache, migraine pain, dental pain, menstrual pain, aches and pain due to the common cold and flu and for reduction of fever.
What it does:
Ibuprofen reduces pain and fever.
When it should not be used:
Do not take IBUPROFEN TABLETS if you have or are:
- peptic ulcer disease or gastrointestinal bleeding, ➢ taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication including any other ibuprofen product,
allergic/hypersensitive to ASA, ibuprofen, other
salicylates, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of IBUPROFEN TABLETS ingredients (Refer to the nonmedicinal ingredients on outer carton or composition section),
nasal polyps (swelling of the inside of the nose), or
allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), uticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms,
- dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake,
- diagnosed with severe high blood pressure or have severe coronary artery disease, ➢ serious liver or kidney disease,
- Systemic Lupus Erythematosus,
or if you are pregnant or nursing.
What the medicinal ingredient is:
Ibuprofen
What the important nonmedicinal ingredients are: Pregelatinized starch, Microcrystalline cellulose, Povidone, Sodium lauryl sulphate, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate, Coating agent contains: Hypromellose,
Polydextrose, Polyethylene Glycol, Titanium Dioxide, Red Iron Oxide, Yellow Iron Oxide, and Gloss coat contains: Sodium Carboxymethylcellulose, Maltodextrin/Dextrin, Dextrose monohydrate, Lecithin (soya).
What dosage forms it comes in:
Each tablet contains ibuprofen, 200 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.
BEFORE you use IBUPROFEN TABLETS talk to your doctor or pharmacist if:
- you have peptic ulcers, diabetes, high blood pressure, heart failure or thyroid disease, asthma, kidney or liver disease, glaucoma, blood clotting disorder (such as hemophilia), any other serious disease, are under doctor’s care for any serious condition, are pregnant or nursing or are taking any other drug including over the counter drugs.
Use with caution in the elderly.
INTERACTIONS WITH THIS MEDICATION
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 preventive benefits of ASA.
- ASA or other anti-inflammatory medication.
Drugs that may interact with IBUPROFEN TABLETS include: acetaminophen, anticoagulants (blood thinners), digoxin, oral antidiabetic agents and insulin, diuretics, methotrexate, lithium, protein-bound drugs including probenecid, thyroxine, antibiotics (e.g. cyclosporine), phenytoin, corticosteroids or benzodiazapenes, other NSAIDs, or medications for high blood pressure. Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults and children over 12: Take 1 (every 4 hours) or 2 (every 6 to 8 hours) tablets as needed. Do not exceed 6 tablets in 24 hours, unless directed by a physician. Do not use longer than 3 days for a fever or 5 days for pain relief.
IMPORTANT: PLEASE READ Overdose:
In case of overdose, contact a health care practitioner, hospital emergency department or regional poison control centre immediately.
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 abdominal pain, heartburn, nausea or vomiting, bloating, diarrhea or constipation, ringing or buzzing in the ears, nervousness, sleeplessness, dizziness or any change in vision, itching, fluid retention, skin rashes, skin reddening, blisters, blood in vomit, bloody or black stools, or any other side effect or unexplained symptoms develop while taking IBUPROFEN TABLETS, discontinue use immediately and contact a physician.
Side effects may be minimized by using the smallest dose for the shortest duration of time.
This is not a complete list of side effects. For any unexpected effects while taking IBUPROFEN TABLETS, contact your doctor or pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
--------------------------------------------------------------------------$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345
$ Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
HOW TO STORE IT
Should be stored in tightly-closed containers under room temperature (15°C -30°C), protected from light.
Keep out of reach of children. This package contains enough medicine to seriously harm a child. This package is not child resistant.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor:
Marcan Pharmaceuticals Inc.
Unit#4, 77 Auriga Drive, Ottawa, ON, K2E 7Z7
Phone# 613 228 2600 www.marcanpharma.com
Last revised: August 19, 2016.
IMPORTANT: PLEASE READ