Ibuprofen and Pseudoephedrine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ibuprofen and Pseudoephedrine Caplets contain the pain reliever and fever reducing agent ibuprofen, and the nasal decongestant pseudoephedrine hydrochloride. This medication is recommended for relief of nasal congestion, sinus pain, headache, fever, body aches and pains due to colds.

What it does:

Ibuprofen and Pseudoephedrine will temporarily relieve the pain, body aches, nasal congestion and fever of a cold, sinusitis or flu.

When it should not be used:

• Should not be used in patients who are taking

  acetylsalicylic acid (ASA), other salicylates or other antiinflammatory agents including ibuprofen.

• Do not use if you have shown sensitivity to its ingredients

  (ibuprofen, pseudoephedrine) or the nonmedicinal ingredients (see complete list of nonmedicinal ingredients), or if allergic to products containing ASA, other salicylates or other antiinflammatory agents.

• If underlying condition requires continued use for more

  than 5 days. Overuse is hazardous.

• Should not be used during pregnancy, in nursing mothers

  or in pediatric patients because its safety under these conditions has not been established.

• Should not be taken by patients with active peptic ulcer

  disease or gastrointestinal bleeding.

What the medicinal ingredient is:

Ibuprofen and pseudoephedrine hydrochloride

What the nonmedicinal ingredients are:

Calcium stearate, Celluloses, Hypromellose, Parabens, Povidone, Propylene Glycol, Sodium Lauryl Sulfate, Starch, Stearic acid, Titanium Dioxide, Wax.

What dosage forms it comes in:

Ibuprofen and Pseudoephedrine is supplied as white caplets, for oral administration containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Ibuprofen and Pseudoephedrine should be used only under the supervision of a doctor in patients with the following conditions:

• history of upper gastrointestinal tract disease
• high blood pressure,
• heart disease,
• diabetes,
• narrow angle glaucoma,
• thyroid disease,
• difficulty in urination due to enlargement of the prostate gland

BEFORE you use Ibuprofen and Pseudoephedrine talk to your doctor or pharmacist if you have or have had:

• Previously exhibited a rash or other sensitivity to any medication.
• High blood pressure, heart disease or are taking a drug for depression including monoamine oxidase (MAO) inhibitor drugs.
• Aseptic meningitis, fever, or rash or have systemic lupus erythematosus.
• Diabetes, thyroid disease or enlarged prostate, or difficulty urinating due to enlarged prostate.
• Kidney or liver disease.
• Glaucoma or blurred vision.
• Other serious diseases.

Before taking Ibuprofen and Pseudoephedrine talk to your doctor:

• If you are under the age of twelve.
• If you are going to have an operation or a medical procedure.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Ibuprofen and Pseudoephedrine include: Monoamine oxidase (MAO) inhibitors, anticoagulants, Acetylsalicylic Acid (ASA), other NSAIDs, acetaminophen, antidiabetic agents and insulin, furosemide, pindolol, digoxin, phenytoin, and lithium salts.

PROPER USE OF THIS MEDICATION

Usual dose:

• Adults and children over 12 years: Take 1 or 2 caplets every four hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.

• Do not give to children under 12 years of age, except

  under the advice and supervision of a physician.

• Keep out of reach of children. Each package contains

  sufficient medicine to seriously harm a child.

Overdose:

Signs of overdose include nausea, heartburn or stomach pain, dizziness, headache or nervousness, rapid eye movement or lack of response to moderate pain, respiratory distress (breathing may be rapid and deep or shallow), flushing or bluish colouration of skin or mucous membranes, rapid, weak heartbeats or palpitations. In case of suspected overdose or if any of these symptoms occur stop taking the drug and immediately contact your doctor or the Poison Control centre at once. If emergency help is not available, vomiting should be induced at once (within 30 minutes) by syrup of ipecac. VOMITING SHOULD NEVER BE INDUCED IN UNCONCIOUS INDIVIDUALS OR IN CHILDREN UNDER 1 YEAR WITHOUT MEDICAL HELP.

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, dizziness or any change in vision, fluid retention, itching, skin rashes or any other side effect or unexplained symptoms develop while taking Ibuprofen and Pseudoephedrine, discontinue use immediately and contact a physician.

This is not a complete list of side effects. For any unexpected effects while taking Ibuprofen and Pseudoephedrine, contact your doctor or pharmacist.

HOW TO STORE IT

Recommended storage condition is between 15 and 25 °C. Protect from light. Keep dry.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals is available from McNeil Consumer Healthcare, Markham, Ontario L3R 5L2

Last revised: January 18, 2007