Patient Medication Information: uses, side effects, how to take - Cold + Sinus Daytime
What the medication is used for:
Fast, 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 Daytime 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 aminesor any of Cold + Sinus Daytime ingredients (Refer to the nonmedicinal 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:
Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, iron oxide yellow, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, talc, titanium dioxide, xanthan gum.
What dosage forms it comes in:
Each caplet contains ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg.
Serious Warnings and Precautions
- Cation 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 Daytime 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.
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 Daytime include:
- Acetaminophen
- Acetylsalicylic Acid (ASA)
- Allergy medications
- Anticoagulants (blood thinning medications)
- Antidepressants
- Anti-hypertensives (blood pressure medications)
- Antibiotics (levofloxacin)
- Benzodiazapines
- Cold medications
- Corticosteroids
- Cyclosporine
Diabetes medication (including insulin and oral
antidiabetic agents)
- Digoxin
- Diuretics (water pills)
- Lithium
- Methotrexate
- 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.
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 unless directed by 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 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.
Cold + Sinus Daytime 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||||||||
| Symptom / effect | Talk with your doctor or pharmacist | Seek immediate emergency medical assistance | ||||||||
| Only if severe | In all cases | |||||||||
| Uncommon | Symptoms of allergic reaction, including: rash, severe itching/redness, blisters, swelling or trouble breathing | √ | ||||||||
Blood in vomit, bloody or black stools | √ | |||||||||
Abdominal pain, vomiting, diarrhea | √ | |||||||||
Ringing or buzzing in the ears / dizziness | √ | |||||||||
| Change in vision, | √ | |||||||||
| Fluid retention | √ | |||||||||
This is not a complete list of side effects. For any unexpected effects while taking Cold + Sinus Daytime, 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.
Report online at
www.healthcanada.gc.ca/medeffect
- 2. Call toll-free at 1-866-234-2345
- 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.
Store in tightly closed containers at room temperature (15-30˚C). Keep out of the reach of children. This package contains enough medicine to seriously harm a child.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Vita Health Products Inc., 150 Beghin Avenue, Winnipeg, MB R2J 3W2, at: 1-800-665-8820.
Date of Revision: October 31, 2011