Patient Medication Information: uses, side effects, how to take - Ibuprofen Liquid Filled Capsules
ABOUT THIS MEDICATION
What the medication is used for:
Temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound..
Fast and effective temporary 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, dental pain, menstrual pain, aches and pain due to the common cold and flu and for reduction of fever. Clinical studies show long lasting pain relief for up to 8 hours.
What it does:
EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES is a nonsteroidal anti-inflammatory drug (NSAID) that can reduce the chemicals produced by your body which cause pain and inflammation..
When it should not be used:
Do not use take EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES if you have or are:
have active or recurrent stomach ulcer,
gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis),
taking acetylsalicylic acid (ASA) or any
other NSAID including any other ibuprofen product,
allergic/hypersensitive to ASA, ibuprofen,
other salicylates, other NSAIDs or any of EXTRA STRENGTH IBUPROFEN
LIQUID FILLED CAPSULES 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), urticaria/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,
- right before or after heart surgery,
- serious liver or kidney disease,
- high potassium in the blood,
- Systemic Lupus Erythematosus,
or if you are in your third trimester of pregnancy.
EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES should NOT be used in patients under 12 years of age since the safety and effectiveness have NOT been established.
What the medicinal ingredient is:
Ibuprofen.
What the non-medicinal ingredients are:
This is a complete listing of non-medicinal ingredients (in alphabetical order): Castor oil, gelatin, mannitol, hydrogenated castor oil, Polyoxyl 40 NF povidone, purified water, sorbitan, and sorbitol
What dosage forms it comes in:
Capsules, 400 mg
WARNINGS AND PRECAUTIONS
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,
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including the elderly or those using diuretics.
Stop use immediately if you have difficulty or pain
when urinating.
- Use during pregnancy or nursing should be avoided.
Before you use EXTRA STRENGTH
IBUPROFEN LIQUID FILLED CAPSULES medication talk to your doctor or pharmacist if:
you have previous or current stomach 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, you are trying to conceive, in your first or second trimester of pregnancy or if you are breastfeeding or are taking any other drug including over the counter drugs.
Use with caution in the elderly.
Long-term continuous use may increase the risk of heart attack or stroke.
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
INTERACTIONS WITH THIS MEDICATION
Do not use EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES 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.
Talk to your doctor or pharmacist if you are taking other medication (prescription or non-prescription) such as any of the following (NOT a complete list): acetaminophen, anticoagulants (blood thinners), digoxin, oral antidiabetic agents and insulin, diuretics, methotrexate, lithium, protein-bound drugs including probenecid, thyroxine, antibiotics, cyclosporine, phenytoin, corticosteroids or benzodiazepines, 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:
For migraine headache: Adults and children 12 years and over. Take 1 (every 4 hours) or 2 (every 6-8 hours) capsule at the first sign of symptoms as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.
For all other uses: Adults and children 12 years and over: Take 1 capsule (every 4 hours or 2 (every 6-8 hours) as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.
Do not use longer than 3 days for a fever or 5 days for pain relief. Do not give to children under 12.
Overdose:
If you think you have taken too much EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES, 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
Take with food or milk if upset stomach occurs. 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, shortness of breath, wheezing, any trouble breathing or chest tightness, hives, swelling or itching, skin rashes, skin reddening, blisters, blood in vomit, bloody or black stools, jaundice (yellowing of the eyes or skin due to liver problem), or any other side effect or unexplained symptoms develop while taking EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES, discontinue use immediately and contact a doctor.
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 EXTRA
STRENGTH IBUPROFEN LIQUID FILLED CAPSULES, contact your doctor or pharmacist.
Reporting Side Effects
You can report any suspected side effects associated
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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.
HOW TO STORE IT
Store at room temperature between 15°C to 30°C. Protect from heat and humidity.
Caution: Keep out of reach and sight of children. This package contains enough medicine to seriously harm a child.
Do not keep outdated medicine or medicine no longer needed.
MORE INFORMATION
If you want more information about EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website
(http://www.apotex.ca/products), or by calling 1-800-667-4708.