Patient Medication Information: uses, side effects, how to take - Super Strength Motrin Ib Liquid Gels
ABOUT THIS MEDICATION
What the medication is used for:
SUPER STRENGTH MOTRIN® IB LIQUID GELS is indicated for treatment of pain associated with migraine.
SUPER STRENGTH MOTRIN® IB LIQUID GELS is also indicated for headaches and the temporary relief of menstrual pain (dysmenorrhea), toothache (dental pain), minor aches and pains in muscles, bones and joints and for reduction of fever and for temporary relief of mild to moderate pain.
What it does:
SUPER STRENGTH MOTRIN® IB LIQUID GELS contains ibuprofen, which belongs to the class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs), which act by decreasing the prostaglandin synthesis, which are naturally occurring substances in the body involved in the production of pain and inflammation.
When it should not be used:
Do not use this product if you:
are taking acetylsalicylic acid (ASA) or any other
non-steroidal anti-inflammatory medication, including any other ibuprofen product.
- have been diagnosed with severe high blood pressure or have severe coronary artery disease.
have an active peptic ulcer (ulcer in the lining of the
stomach or the first part of the small intestine), a history of recurrent ulceration (frequent ulcers) or active inflammatory disease of the gastrointestinal system.
have a known or suspected allergy to the drug or
other anti-inflammatory drugs, or to any other component of this formulation (see “What the important nonmedicinal ingredients are”) Check with your doctor if you are not sure.
are allergic to other related medicines of the NSAID
group (such as ASA, diclofenac, diflunisal, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, mefenamic acid, piroxicam, sulindac,
tiaprofenic acid, tolmetin, nabumetone or tenoxicam).
- have nasal polyps (small, sac-like growths of the lining of the sinuses), or in whom asthma, anaphylaxis (sudden, severe, potentially fatal, allergic reaction), urticaria /hives (red, itchy elevation of the skin surface), rhinitis (an inflammation of the inner lining of the nose ) or other allergic symptoms are suddenly caused by ASA or other NSAIDs. If you have the above medical problems, you are at risk of a severe reaction even if you have taken NSAIDs in the past without any adverse effects.
- have liver disease
- have severe kidney disease. Individuals with lesser degrees of kidney disease are at risk of worsening of their renal function when prescribed NSAIDs and must be monitored.
- are also taking another NSAID.
- are a either a child with kidney disease or a child who has suffered significant fluid loss.
- are 12 years of age unless directed by a physician.
are pregnant or nursing, unless advised otherwise by a doctor.
- have systemic lupus erythematosus.
What the medicinal ingredient is:
Ibuprofen.
What the important nonmedicinal ingredients are:
This is a complete listing of nonmedicinal ingredients: castor oil, gelatin, PEG-40 hydrogenated castor oil, povidone, purified water, sorbitan, sorbitol, and titanium dioxide.
What dosage forms it comes in:
Capsules, 400 mg
WARNINGS AND PRECAUTIONS
SERIOUS WARNINGS AND PRECAUTIONS
History of peptic ulcers, gastrointestinal bleeding or other diseases of the gastrointestinal tract.
Always Remember: Before taking this medication tell your doctor, dentist or pharmacist if you:
- have a history of stomach upset/ulcers, or liver or kidney diseases; heart failure, or if you or a family member has had asthma, nasal polyps (sac-like growth of the inner lining of the nose), chronic sinusitis or chronic hives.
- are pregnant or breastfeeding or intend to become pregnant or breastfeed while taking this medicine;
- are taking any other medication (either prescription or non-prescription) ( Please see the “Interactions with this medication” section);
- have any other medical problems such as alcohol abuse, bleeding problems.
- have blood or urine disorders, high blood pressure, diabetes, or are on any special diet, such as low sodium or low sugar.
Stomach problems may be more likely to occur if you drink alcoholic beverages. Therefore do not drink alcoholic beverages while taking this medication.
While taking this medication:
Tell any doctor, dentist or pharmacist that you
consult or see, that you are taking this medication.
Be cautious about driving or participating in
activities that require alertness if you are drowsy, dizzy or light-headed after taking this medication.
Check with your doctor if you are not getting any
relief or if any problems develop.
Report any untoward reaction to your doctor. This
is very important as it will aid in the early detection and prevention of potential complications.
- Your regular medical check-ups are essential.
If you require more information on this drug,
consult your doctor or pharmacist.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with SUPER STRENGTH MOTRIN® IB LIQUID GELS include NSAIDs, high blood pressure medication, blood thinners, corticosteroids, methotrexate, cyclosporin, lithium, phenytoin, oral antidiabetic agents and insulin.
Drugs such as acetaminophen, digoxin and diuretics might potentially interact with SUPER STRENGTH MOTRIN® IB LIQUID GELS.
Do not take ASA, ASA- containing compounds or other drugs used to treat symptoms of arthritis while taking SUPER STRENGTH MOTRIN® IB LIQUID GELS, unless directed by a physician.
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 preventative benefits of ASA.
PROPER USE OF THIS MEDICATION
Consult your doctor if pain lasts for more than 5 consecutive days or fever more than 3 days.
Stomach upset is one of the common problems with NSAIDs. To lessen stomach upset, take this medicine immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhoea) occurs and continues, contact your doctor.
Usual Dose:
SUPER SRENGTH MOTRIN® IB LIQUID GELS 400 mg
Adults and children over 12: For the pain of migraine, take 1 capsule at the first sign of symptoms, and every four hours as needed. For all other uses, take 1 capsules every four hours as needed. Do not exceed three capsules in 24 hours, unless directed by a physician.
Overdose:
In case of overdose, contact a Poison Control Center or a doctor at once even if there are no symptoms.
Missed Dose:
If a dose is missed, resume dosing on the normal schedule without exceeding the maximum allowed for 24 hours.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its needed effects, SUPER STRENGTH MOTRIN® IB LIQUID GELS like other NSAID drugs may cause some unwanted effects especially when used for a long time or in large doses. However, at the maximum daily dose of 1200 mg, there are very few side effects seen and these are primarily only gastrointestinal.
The most common side effects with this medication are indigestion, nausea, or vomiting.
The other side effects, which might be seen, are abdominal pain, diarrhoea, flatulence, and constipation.
If these symptoms persist or become bothersome, contact your doctor.
The above do not require medical attention and will usually go away on their own.
Some people may become more sensitive to sunlight than they are normally. Brief exposure to sunlight or sunlamps may cause sunburn, blisters on the skin, skin rash, redness, itching or discolouration or vision changes. If this happens, check with your doctor.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
Only if severe | In all cases | ||
Uncommon Chills, fever, muscle aches or pains, or other flu-like symptoms shortly before or together with a skin rash | √ | ||
| Bloody or black tarry stools | √ | ||
| Hives or itching | √ | ||
| Blurred vision | √ | ||
| Swelling of feet or lower legs | √ | ||
| Hearing problems | √ | ||
| Mental confusion or depression | √ | ||
| Shortness of breath, troubled breathing, asthma, sinusitis (nasal congestion), wheezing, or tightness in the chest | √ | ||
| Vomiting blood | √ | ||
| Yellow discoloration of the skin or eyes, with or without fatigue | √ | ||
Any changes in the amount or colour of your urine (such as dark; red or brown), any pain or difficulty experienced in urination, loss of appetite, dizziness, or light headedness | √ | ||
In addition to checking with your doctor, if these serious side effects occur, stop taking this medication.
This is not a complete list of side effects. For any unexpected effects while taking SUPER STRENGTH MOTRIN® IB LIQUID GELS, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15-30°C). Protect from heat and humidity.
Caution: Keep out of reach of children. This package contains enough medicine to seriously harm a child.
Do not keep outdated medicine or medicine no longer needed.
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 0701D Ottawa, ON KIA OK9
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.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional. This leaflet plus the full product monograph, can be obtained by request at www.motrin.ca or by contacting McNeil Consumer Healthcare at:
McNeil Consumer Healthcare
Division of Johnson & Johnson Inc.
Markham, Canada
L3R 5L2
? 1 888 6MOTRIN / 1 888 666-8746
Date of Revision: September 13, 2012
© J&J Inc. 2012