Patient Medication Information: uses, side effects, how to take - Ibuprofen and Pseudoephedrine Hydrochloride Capsules
ABOUT THIS MEDICATION
What the medication is used for:
Fast, effective temporary relief of the symptoms of colds including sore throat pain, 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 Ibuprofen and Pseudoephedrine Hydrochloride Capsules if you have or are:
- allergic/hypersensitive to acetylsalicylic acid (ASA), ibuprofen, other salicylates, other non-steroidal anti- inflammatory drugs (NSAIDs), pseudoephedrine or other sympathomimetic amines, or any of Ibuprofen and Pseudoephedrine Hydrochloride Capsules ingredients (Refer to the nonmedicinal ingredients section of this insert),
- active or recurrent stomach ulcer or gastrointestinal bleeding or active inflammatory bowel disease (e.g. Crohn’s, colitis),
- taking a monoamine oxidase inhibitor (MAOI; e.g. drugs for depression or Parkinson’s disease) 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), urticaria/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,
- right before or after heart surgery,
- serious liver disease,
- severe kidney disease,
- thyroid disease,
- Raynaud’s Syndrome (a disorder of the circulatory system),
- Systemic Lupus Erythematosus,
or if you are in your third trimester of pregnancy
What the medicinal ingredients are:
Ibuprofen (present as free acid and potassium salt) and pseudoephedrine hydrochloride.
What the nonmedicinal ingredients are:
D&C Yellow no. 10, FD&C Red no. 40, gelatin, polyethylene glycol, potassium hydroxide, propylene glycol, and sorbitol sorbitan solution.
The sorbitol sorbitan solution contains sorbitan, sorbitol, mannitol and high polychains.
The capsule shells imprinted with black edible ink contains hypromellose, iron oxide black and propylene glycol.
What dosage forms it comes in:
Each capsule contains ibuprofen 200mg (present as free acid and potassium salt) and pseudoephedrine hydrochloride 30mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- If you have glaucoma or difficulty in urination due to an enlarged prostate, do not take this drug unless directed by a doctor.
- Caution in those with heart failure, high blood pressure or other conditions that may cause excess fluid collecting in tissues.
- Caution in patients at risk of gastrointestinal tract irritation, including those with a history of a peptic ulcer. The chance of stomach bleeding is higher if you are: age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner or steroid drug, take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs, have 3 or more alcoholic drinks every day while using this product.
- Caution in 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 Ibuprofen and Pseudoephedrine Hydrochloride Capsules 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, you are trying to conceive, in your first or second trimester of pregnancy or if you are breast feeding 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 within the past two weeks.
- ASA or other anti-inflammatory or pain medication.
Drugs that may interact with Ibuprofen and Pseudoephedrine Hydrochloride Capsules 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.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults and children 12 to 65 years: Take 1 or 2 capsules every 4 - 6 hours as needed. Do not exceed 6 capsules in 24 hours, unless directed by a doctor.
Do not give to children under 12 unless directed by doctor. Do not use longer than 3 days for a fever or 5 days for pain or cold symptoms.
Overdose:
If you think you have taken too much Ibuprofen and Pseudoephedrine Hydrochloride Capsules, contact your healthcare professional, hospital emergency department or regional poison control center immediately, even if there are no symptoms.
Missed Dose:
Continue to take 1 or 2 capsules every 4 to 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
Take with food or milk if upset stomach occurs.
Ibuprofen and Pseudoephedrine Hydrochloride Capsules 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 effects 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 | Τ | ||||
Blood in vomit, bloody or black stools | Τ | |||||
Abdominal pain, vomiting, diarrhea | Τ | |||||
Ringing or buzzing in the ears / dizziness | Τ | |||||
Change in vision, | Τ | |||||
| Fluid retention | Τ | |||||
This is not a complete list of side effects. For any unexpected effects while taking Ibuprofen and Pseudoephedrine Hydrochloride Capsules, contact your doctor or pharmacist.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects.
The Canada Vigilance Program does not provide medical advice.
HOW TO STORE IT
Store at room temperature (15 - 30℃). Protect from light.
Keep out of reach and sight of children. This package contains enough medicine to seriously harm a child.
MORE INFORMATION
If you want more information about Ibuprofen and Pseudoephedrine Hydrochloride Capsules:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer's website
https://www.catalent.com/index.php, or by calling 1-888-689-9794 ext. 2016.
Date prepared: January 28, 2020