Cold + Sinus Caplets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Temporary relief of the symptoms of colds including sinus pain, nasal congestion, headache, fever, body aches and pains.

What it does:

Ibuprofen reduces pain and fever. Pseudoephedrine hydrochloride is a nasal decongestant.

When it should not be used:

Do not use Cold + Sinus Caplets if you have or are:

• allergic/hypersensitive to acetylsalicylic acid (ASA),

  ibuprofen, other salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic amines, or any of COLD + SINUS CAPLETS ingredients (Refer to the non medicinal ingredients section of this insert).

• peptic ulcer disease or gastrointestinal bleeding,

• taking a monoamine oxidase inhibitor (MAOI) or for 14 days

  after stopping the MAOI drug, ASA or other NSAIDs including any other ibuprofen product.

• nasal polyps (swelling of the inside of the nose),
• asthma,

• allergic manifestations such as anaphylaxis (sudden severe life

  threatening allergic reaction), uticaria/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,

• been diagnosed with severe high blood pressure or have heart

  disease,

• about to have or just had heart surgery,
• serious liver disease,
• severe kidney disease
• thyroid disease,
• Raynaud’s Syndrome (a disorder of the circulatory system),
• Systemic Lupus Erythematosus,

• pregnant or nursing.

What the medicinal ingredients are:

Ibuprofen and pseudoephedrine hydrochloride.

What the nonmedicinal ingredients are:

Corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide.

What dosage forms it comes in:

Each caplet contains ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Caution in patients at risk of gastrointestinal tract irritation.
• Patients at risk of kidney problems, including the elderly or those using diuretics.
• Use during pregnancy or nursing should be avoided.
• Stop use immediately if you have difficulty or pain when urinating.

BEFORE you use COLD + SINUS CAPLETS talk to your doctor or pharmacist if you have:

• blood clotting disorder (such as hemophilia)
• breathing problems or chronic lung disease (such as chronic bronchitis)
• diabetes,
• difficulty in urination due to prostate enlargement
• glaucoma
• high blood pressure
• mild to moderate kidney disease
• mild to moderate liver disease
• any other serious disease, are under doctor’s care for any serious condition, or are taking any other drug including over the counter drugs.

INTERACTIONS WITH THIS MEDICATION

Do not use this product if you are taking:

• a MAOI or if you have stopped taking one in the past two weeks.
• ASA or other anti-inflammatory medication.

Drugs that may interact with Cold + Sinus Caplets include:

• Acetaminophen
• Acetylsalicylic acid (ASA)
• Allergy medications
• Anticoagulants (blood thinning medications)
• Antidepressants
• Anti-hypertensives (blood pressure medication)
• Antibiotics (levofloxacin)
• Benzodiazapines
• Cold medications
• Corticosteroids
• Cyclosporine
• Diabetes medication (including oral antidiabetic agents and IMPORTANT: PLEASE READ insulin)
• Digoxin
• Diuretics (water pills)
• Lithium
• Methotreaxate
• Monoamine Oxidase Inhibitors

• Nonsteroidal anti-inflammatory drugs (NSAIDs); including

  naproxen and ibuprofen

• Phenytoin
• Probenecid
• Thyroxine

Tell your doctor or pharmacist what prescription or non-prescription drugs you are taking or plan to take.

Do not smoke or drink alcohol while using this product.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults under 65 years and children over 12: Take 1 or 2 caplets every 4 to 6 hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.

Do not give to children under 12 years unless directed by a physician. Do not use longer than 3 days for a fever or 5 days for pain or cold symptoms.

Overdose:

In case of accidental overdose, contact Poison Control Centre, hospital emergency department, or a doctor immediately, even if there are no symptoms.

Missed Dose:

Continue to take 1 or 2 caplets every 4 hours as needed after a missed dose. Do not take twice the recommended dose following a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Cold + Sinus Caplets may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness.

Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.

The risk of having side effect may be decreased 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 COLD + SINUS CAPLETS contact your doctor or pharmacist.

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:

1. 1. Report online at www.healthcanada.gc.ca/medeffect
2. 2. Call toll-free at 1-866-234-2345
3. 3.

   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 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.

HOW TO STORE IT

Store at room temperature (15-30˚C).

Keep out of the reach of children. This package contains enough medicine to seriously harm a child.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Vita Health Products Inc., at:

Vita Health Products Inc.

150 Beghin Avenue

Winnipeg, MB R2J 3W2

1-800-665-8820.

Product monograph available to physicians and pharmacists upon request.

Last revised: January 30, 2012