Cold and Sinus Plus: Uses, Side Effects and Dosage

What the medication is used for:

Temporarily relieves the combined symptoms associated with colds including: stuffy nose, fever, minor body aches, sore throat, headache, runny nose, sneezing, itchy, watery eyes, and sinus pain.

What it does:

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

Chlorpheniramine maleate is an antihistamine.

When it should not be used:

Do not use COLD AND SINUS Plus if you have or are:

• allergic/hypersensitive to acetyl salicylic acid

  (ASA), ibuprofen, other salicylates, other non-steroidal anti-inflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic amines, chlorpheniramine maleate or any of COLD AND SINUS Plus’s ingredients (Refer to the nonmedicinal ingredients section of this insert),

• peptic ulcer disease or gastrointestinal

  bleeding,

• taking monoamino 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, pseudoephedrine hydrochloride and chlorpheniramine maleate.

What the important nonmedicinal ingredients are: Microcrystalline cellulose, maize starch, crosscarmellose sodium, pregelatinized starch, povidone, colloidal silicon dioxide, stearic acid and aquarius BP 13025 (contains: hypromellose, titanium dioxide, polyethylene glycol, FD&C yellow#6 and FD&C red#40).

What dosage forms it comes in:

Each Tablet contains ibuprofen 200mg, pseudoephedrine hydrochloride 30mg and chlorpheniramine maleate 2mg.

Serious Waring 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 AND SINUS Plus talk to your doctor or pharmacist if you have or are:

• 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

• taking sedatives or tranquilizers (as they may

  increase drowsiness), or 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

  within the past 2 weeks.

• ASA or other anti-inflammatory medication.

Drugs that may interact with Cold and Sinus Plus include:

• Acetaminophen
• Acetylsalicylic acid (ASA)
• Allergy medications
• Anticoagulants (blood thinning medications) • Anti-depressants

• 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
• Tranquilizers or other sedating drugs

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. Alcohol may increase drowsiness.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults and children over 12-65 years old: 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 a physician. Do not use longer than 3 days for a fever or 5 days for pain relief or cold symptoms.

Incase of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control center, even if there are no symptoms.

Missed Dose:

Continue to take 1 or 2 caplets every 4-6 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 and Sinus Plus may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, dry mouth, nervousness or sleeplessness.

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

The risk of having side effects may be decreased by using the smallest dose for the shortest duration of time.

This product may cause drowsiness. Be careful when driving motor vehicles or operating heavy machinery.

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

HOW TO STORE IT

Store at room temperature (15°-30°C); avoid excessive heat.

Keep out of 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, Marcan Pharmaceuticals Inc.

Marcan Pharmaceuticals Inc.

77 Auriga, Drive, Unit # 4

Ottawa, Canada, K2E 7Z7

Date of Preparation: September 27, 2016