Patient Medication Information: uses, side effects, how to take - Motrin Ib Menstrual Pain
ABOUT THIS MEDICATION
What the medication is used for:
Since everyone’s pain is different, MOTRIN® IB Menstrual Pain offers 2 levels of pain relief to suit your needs. So you can choose your relief, MOTRIN® IB Menstrual Pain products are available in two strengths, including Motrin® IB Menstrual Pain (200 mg) and Super Strength MOTRIN® IB Menstrual Pain (400 mg).
MOTRIN® IB Menstrual Pain 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
MOTRIN® IB Menstrual Pain 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:
MOTRIN® IB Menstrual Pain 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:
MOTRIN® IB Menstrual Pain 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 nonmedicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, rash, 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 pregnant or nursing, unless advised otherwise by a doctor
What the medicinal ingredient is:
Ibuprofen
What the important nonmedicinal ingredients are:
MOTRIN® IB Menstrual Pain (ibuprofen) 200 mg white, sweet-coated, easy to swallow tablets, printed with “Motrin IB” in black ink, contain: colloidal silicon dioxide, corn starch, hypromellose, iron oxide black, polyethylene glycol, pregelatinized starch, propylene glycol, sodium cyclamate, sodium starch glycolate, stearic acid and titanium dioxide.
Super Strength MOTRIN® IB Menstrual Pain (ibuprofen) 400 mg orange, sweet-coated, easy to swallow tablets, printed with “MOTRIN 400 mg” in black ink, contain: carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6,
hypromellose, iron oxide black, polydextrose, polyethylene glycol, propylene glycol, sodium cyclamate, sodium starch glycolate, stearic acid, titanium dioxide
What dosage forms it comes in:
Tablets: 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.
BEFORE you use MOTRIN® IB Menstrual Pain talk to your doctor or pharmacist if you:
have high blood pressure, asthma, heart failure,
kidney or liver disease, 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 nursing an infant.
- 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)
- stomach ulcers.
They may recommend an alternative analgesic such as acetaminophen.
Children’s MOTRIN® formulations are available to treat children under 12 years of age.
INTERACTIONS WITH THIS MEDICATION
Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.
Drugs that may interact with MOTRIN® IB Menstrual Pain 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 preventive 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 | SINGLE | MAXIMUM | ||||||
| (IBUPROFEN | ORAL | DAILY DOSE | |||||||
| MG/TABLET) | DOSE | (1200 MG) | |||||||
MOTRIN® IB Menstrual Pain | 200 mg | 1 or 2 tablets | 6 tablets | ||||||
Super Strength MOTRIN® IB Menstrual Pain | 400 mg | 1 tablet | 3 tablets | ||||||
The single oral dose may be taken every 4-6 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. MOTRIN® IB Menstrual Pain 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.
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
- a dose more often than every 4-6 hours
- this product longer than the recommended period of time
- more than the smallest dose that will relieve your symptoms
Overdose:
In case of overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.
Missed Dose:
If you miss a 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, consult a doctor or pharmacist: nausea, vomiting, diarrhea; heartburn, bloating or constipation; minor skin rash or itching; vomiting any blood or have tarry stools.
If you experience dizziness, blurred vision, or hearing problems while taking MOTRIN® IB Menstrual Pain, please use caution when carrying out activities requiring alertness.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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 | |||
| Common |
| T | ||
| Uncommon | ||||
- Blurred / reduced vision
| T |
- Vision colour changes
| T |
- Ringing in ears
| T |
Blood in urine or stool
T
Swelling of mouth, throat and extremitie s
T
Difficulty breathing
T
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom / effect
| Talk with your doctor or pharmacist | Stop taking drug and | ||
T T T | T | T T | ||
This is not a complete list of side effects. For any unexpected side effects while taking MOTRIN® IB Menstrual Pain, talk to your doctor or pharmacist.
HOW TO STORE IT
Keep this medication out of the reach of children.
Store away from heat and direct light.
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, 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.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by request at www.motrin.ca or by contacting the sponsor, McNeil Consumer Healthcare at:
McNeil Consumer Healthcare
division of Johnson & Johnson Inc.
Markham, Canada
L3R 5L2
? 1 888 6MOTRIN / 1 888 666-8746
Last revised: September 20, 2012
© J&J Inc. 2012
