Patient Medication Information: uses, side effects, how to take - Sudafed Sinus Advance
What is SUDAFED® SINUS ADVANCE used for?
- Relief of the symptoms of colds including nasal congestion, sinus pain, headache, fever, body aches and pains.
How does SUDAFED® SINUS ADVANCE work?
Ibuprofen reduces pain and fever. Pseudoephedrine hydrochloride is a nasal decongestant.
What are the ingredients in SUDAFED® SINUS ADVANCE
Serious Warnings and Precautions
SUDAFED® SINUS ADVANCE should be used only under the supervision of a doctor in patients with the following conditions:
history of active peptic ulcer disease or gastrointestinal bleeding. 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.
- risk of kidney problems, including the elderly or those using diuretics
Talk to your doctor if are you trying to conceive, in your first or second trimester of pregnancy or if breastfeeding
- high blood pressure,
- heart disease,
- diabetes,
- narrow angle glaucoma,
- thyroid disease,
- difficulty in urination due to enlargement of the prostate gland
Medicinal ingredients: Ibuprofen and pseudoephedrine hydrochloride
Non-medicinal ingredients:
Calcium stearate, candelilla wax, croscarmellose sodium, hydroxypropyl methylcellulose, methylparaben, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium lauryl sulfate, stearic acid, titanium dioxide.
SUDAFED® SINUS ADVANCE comes in the following dosage forms:
Tablets containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride.
Do not use SUDAFED® SINUS ADVANCE if:
You are:
- taking acetylsalicylic acid (ASA) or any other nonsteroidal anti-inflammatory medication including any other ibuprofen product.
- allergic/hypersensitive to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), ASA or other salicylates, pseudoephedrine or to any of the SUDAFED® SINUS ADVANCE ingredients (Refer to the inactive ingredients on outer carton or see Non-medicinal ingredients above) or any component of the container. Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
- taking a monoamine oxidase inhibitor (MAOI) (e.g. drugs for depression or Parkinson’s), or you have stopped taking an MAOI less than 14 days
- dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
- in your third trimester of pregnancy or if breastfeeding
a child less than 12 years old.
You have:
- peptic ulcer disease or gastrointestinal bleeding or any other active inflammatory disease of the gastrointestinal tract (e.g. colitis, Crohn’s disease).
- nasal polyps (swelling of the inside of the nose)
- asthma
- severe high blood pressure or heart disease.
- serious liver or severe kidney disease.
- thyroid disease
- Systemic Lupus Erythematosus.
- Raynaud’s disease (a disorder of the circulatory system).
- underlying condition, that requires continued use for more than 5 days. Overuse is hazardous.
- high potassium in the blood.
- You recently had or are about to have heart surgery.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SUDAFED® SINUS ADVANCE. Talk about any health conditions or problems you may have, including:
- history of active peptic ulcer disease or gastrointestinal bleeding.
- if you are pregnant or breastfeeding
- high blood pressure,
- heart disease,
- diabetes,
- narrow angle glaucoma,
- thyroid disease,
- difficulty in urination due to enlargement of the prostate gland
Other warnings you should know about:
- The use of NSAIDs, like SUDAFED® SINUS ADVANCE, in the second trimester of pregnancy should be restricted to the lowest dose necessary for shortest possible duration.
- At 20 weeks or later in pregnancy, your use of NSAIDs may need to be monitored by a health care practitioner due to the rare risk of kidney problems in the unborn baby which may result in decreased amniotic fluid volume and other complications.
Stop use and ask a doctor if
- you show signs of stomach bleeding
- pain / cold symptoms worsen or lasts more than 5 days
- fever worsens or lasts more than 3 days
- any new symptoms occurs
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SUDAFED® SINUS ADVANCE:
- acetaminophen
- Acetylsalicylic Acid (ASA)
- allergy medications
- antibiotics
- anticoagulants (blood thinning medications)
- Antidepressants
- antidiabetic agents and insulin
- anti-hypertensives (blood pressure medications)
- benzodiazepines
- cold medications
- corticosteroids
- cyclosporine
- diabetes medication
- digoxin
- furosemide and other diuretics (water pills)
- lithium salts
- methotrexate
- monoamine oxidase (MAO) inhibitors
- other Nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen and ibuprofen
- phenytoin
- pindolol
Do not smoke or drink alcohol while using this product.
How to take SUDAFED® SINUS ADVANCE:
Do not give to children under 12 years of age.
Usual dose:
- Adults 65 years and under and children 12 years and older: Take 1 or 2 caplets every four to six hours as needed. Do not exceed six caplets in 24 hours, unless directed by a physician.
Overdose:
If you think you, or a person you are caring for, have taken too much SUDAFED® SINUS ADVANCE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
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.
Missed Dose:
Continue to take 1 or 2 caplets every 4 to 6 hours as needed after a missed dose. Do not take twice the recommended dose following a missed dose.
What are possible side effects from using SUDAFED® SINUS ADVANCE?
These are not all the possible side effects you may have when taking SUDAFED® SINUS ADVANCE. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
abdominal pain, heartburn, nausea or vomiting, bloating, fluid retention, itching, skin rashes, redness, blisters, breathing problems, headache, nervousness, ringing or buzzing in the ears, dizziness | √ | √ | |
| cramps, decreased appetite, diarrhea, constipation, indigestion | √ | ||
| UNCOMMON | |||
Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, chest pain, shock or a fast, irregular heartbeat. Bleeding, severe itching, swelling of lymph nodes, blood in vomit, bloody or black stools, jaundice | √ | ||
| any change in vision, insomnia, depression | √ | √ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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.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.
Storage:
Store at 15 to 30°C. Protect from light. Keep dry. Keep out of reach and sight of children. Each package contains sufficient medicine to seriously harm a child.
If you want more information about SUDAFED® SINUS ADVANCE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.sudafed.ca, or by calling 1-800-661-4659.
