Ibuprofen (Pharmascience): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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, bursitis

  and tendonitis pain

IBUPROFEN is also an effective fever reducer and will provide relief from the aches and fever 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:

IBUPROFEN start 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 should not be used if you:

• 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 complete or partial syndrome of ASA intolerance.

• 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, unless advised otherwise by a doctor

What the medicinal ingredient is:

Ibuprofen

What the important nonmedicinal ingredients are:

IBUPROFEN tablets contain the following non-medicinal ingredients in alphabetical order: Colloidal Silicon Dioxide, Dextrose Monohydrate, Hypromellose, Iron Oxide Red, Lactose Monohydrate, Lecithin, Maltodextrin, Povidone, Pregelatinized Starch, Sodium Caroxymethylcellulose, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide and Triacetin.

What dosage forms it comes in:

Tablets: 400 mg

IBUPROFEN tablets are available as red-brown, capsule-shaped, coated tablet, debossed with “ IBU 400" on one side and nothing on the other side .

IBUPROFEN contain ibuprofen 400 mg

WARNINGS AND PRECAUTIONS

Keep this medication out of reach of children.

BEFORE you use IBUPROFEN talk to your doctor or pharmacist if you:

• have stomach ulcers, 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)

They may recommend an alternative analgesic such as

acetaminophen.

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 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.

PROPER USE OF THIS MEDICATION

Usual Adult 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 year of age.

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. 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.

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, caplets in

  each single dose

• 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 accidental overdose, even if there are no symptoms, call a doctor or Poison Control Center at once.

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 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.

HOW TO STORE IT

Tablets and caplets: Store away from heat and direct light at controlled room temperature (15°C - 30°C).

REPORTING SUSPECTED SIDE EFFECTS

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.

Note: Should you require information related to the management of side effect, please contact your health care provider before notifying Canada Vigilance. 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 contacting the sponsor, Pharmascience Inc., at:

1-888-550-6060

Pharmascience Inc.

Montreal, Canada H4P 2T4

Date of preparation: October 19, 2012