ibuprofen and pseudoephedrine
What is the most important information I should know about ibuprofen and pseudoephedrine?
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning, especially in older adults.
Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
What is ibuprofen and pseudoephedrine?
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Ibuprofen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Ibuprofen and pseudoephedrine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking ibuprofen and pseudoephedrine?
Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen and pseudoephedrine, especially in older adults.
You should not use this medicine if you are allergic to ibuprofen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Do not give ibuprofen to a child younger than 12 years old.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
- heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
- a history of heart attack, stroke, or blood clot;
- a history of stomach ulcers or bleeding;
- liver or kidney disease;
- a thyroid disorder;
- diabetes; or
- enlarged prostate, urination problems.
Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Do not use ibuprofen and pseudoephedrine without a doctor's advice if you are pregnant.
It is not known whether ibuprofen and pseudoephedrine passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.
How should I take ibuprofen and pseudoephedrine?
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. An overdose of ibuprofen can damage your stomach or intestines.
Take this medicine with food or milk to lessen stomach upset.
Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medication for 7 days.
If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Since ibuprofen and pseudoephedrine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include vomiting, stomach pain, diarrhea, ringing in your ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or seizure (convulsions).
What should I avoid while taking ibuprofen and pseudoephedrine?
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking ibuprofen.
Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).
Ask a doctor or pharmacist before using any other cough, cold, or pain medicine. Many combination medicines contain ibuprofen or pseudoephedrine. Taking certain products together can cause you to get too much of this medicine.
What other drugs will affect ibuprofen and pseudoephedrine?
Ask your doctor before using ibuprofen and pseudoephedrine if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine (Paxil), sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use ibuprofen and pseudoephedrine if you are also using any of the following drugs:
- a blood thinner (warfarin, Coumadin, Jantoven);
- heart or blood pressure medication, including a diuretic or "water pill"; or
- steroid medicine (such as prednisone).
This list is not complete. Other drugs may interact with ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about ibuprofen and pseudoephedrine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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If you are looking for a combination product to help with the symptoms of congested sinuses, then you could try Sudafed sinus pressure and pain tablets, containing the painkiller ibuprofen 200mg and a decongestant pseudoephedrine 30mg.
Our resident pharmacist Rita Ghelani offers her expert advice on how Sudafed sinus pressure and pain tablets help with the symptoms of cold and blocked sinuses, how to they work and the possible side effects.
What are Sudafed sinus pressure and pain tablets used for?
Relieving symptoms of colds and flu, such as headache, sore throat, aches and pains, fever, blocked nose and sinus congestion and pain.
How do Sudafed sinus pressure and pain tablets work?
Sudafed sinus pressure and pain tablets contain painkiller ibuprofen and pseudoephedrine hydrochloride.
Ibuprofen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). It relieves mild to moderate pain, inflammation and fever.
Ibuprofen works by blocking the action of an enzyme in the body called cyclo-oxygenase (COX). COX is involved in making substances called prostaglandins, in response to injury and in certain diseases and conditions. The prostaglandins cause pain, swelling and inflammation. Ibuprofen reduces inflammation and pain by reducing the production of these prostaglandins.
Ibuprofen brings down a fever by reducing the production of prostaglandins in the brain. Fever is associated with an increase in prostaglandins in the brain, which cause the body temperature to increase.
Pseudoephedrine works by causing the blood vessels in the linings of the nasal passages and sinuses to contract and narrow. This decreases blood flow into the linings of the nose and sinuses, which reduces the feeling of congestion and also reduces the production of mucus.
Dosage instructions for Sudafed sinus pressure and pain tablets
- Adults and adolescents over 12 years of age should take one or two tablets up to three times a day as needed to relieve symptoms.
- Leave at least four hours between doses.
- Do not take more than six tablets in 24 hours.
- The tablets should preferably be taken with or after food.
- This medicine should be used for the shortest possible time to relieve symptoms. If your symptoms persist despite treatment or get worse, get medical advice from your doctor or pharmacist. Do not use this medicine for more than 10 days without consulting a doctor.
Sudafed sinus pressure and pain tablets should not be taken by
- Children under 12 years of age.
- People who have ever had an allergic reaction after taking aspirin or other NSAIDs such as diclofenac (for example an asthma attack, itchy rash, nasal inflammation (rhinitis) or swelling of the lips, tongue and throat).
- People with an active peptic ulcer or bleeding in the gut; those who've had two or more episodes of this in the past; and people who have ever experienced bleeding or perforation in the gut as a result of taking an NSAID.
- People with severe kidney failure or liver failure.
- People with severe heart failure, heart disease or high blood pressure (hypertension).
- People with an overactive thyroid gland (hyperthyroidism).
- People with a tumour of the adrenal gland (phaeochromocytoma).
- People with diabetes.
- People with closed angle glaucoma.
- Men with an enlarged prostate gland.
- People who have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days.
- People taking any other NSAID painkillers, including COX-2 inhibitors such as celecoxib.
- Ibuprofen is not recommended for women who are trying to get pregnant because it can temporarily reduce female fertility.
Sudafed sinus pressure and pain tablets should be used with caution by
- Elderly people.
- People with a history of asthma or allergies.
- People with a history of disorders affecting the stomach or intestines, such as ulceration or bleeding, or inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- People with kidney or liver problems.
- People with a history of heart disease or stroke.
- People with high cholesterol levels.
- People with blood circulation problems such as Raynaud's disease.
- People with blood clotting problems or taking anticoagulant medicines.
- People with diseases affecting connective tissue, such as systemic lupus erythematosus.
Is it safe to take Sudafed sinus pressure and pain tablets if pregnant?
Sudafed sinus pressure and pain is not recommended for use during pregnancy, particularly in the third trimester. In the third trimester the ibuprofen may delay labour, increase the length of labour and cause complications in the new-born baby. Get advice from your doctor, pharmacist or midwife if you need to treat cold and flu symptoms while you are pregnant.
Is it safe to take Sudafed sinus pressure and pain tablets if breastfeeding?
Sudafed sinus pressure and pain is best avoided by mothers who are breastfeeding, because decongestants such as pseudoephedrine can temporarily decrease the production of breast milk. Ask your doctor or pharmacist for further advice.
Possible side effects of Sudafed sinus pressure and pain tablets
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that may be associated with Sudafed sinus pressure and pain. Just because a side effect is stated here doesn't mean that all people using this medicine will experience that or any side effect.
- Disturbances of the gut such as nausea, vomiting, diarrhoea, indigestion or abdominal pain. These can mainly be avoided by taking the medicine with food or milk.
- Skin rashes.
- Dry mouth.
- Increased heart rate (tachycardia).
- Ulceration or bleeding in the stomach or intestines. This is more likely in elderly people. If any signs of bleeding from the stomach or bowels are experienced, such as vomiting blood and/or passing black/tarry/bloodstained stools, you should stop taking this medicine and consult your doctor immediately.
- Liver or kidney disorders.
- Difficulty sleeping (insomnia).
- Difficulty passing urine (urinary retention).
- Anxiety, restlessness or tremor.
- Seeing or hearing things that aren't really there (hallucinations).
- Allergic reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat or tongue (angioedema), itchy blistering rash or anaphylactic shock. Stop taking this medicine and get immediate medical advice if you think you've had an allergic reaction.
For more information about the possible side effects of Sudafed, read the information provided with the medicine or talk to your doctor or pharmacist. You can find a copy of this here
If you think you have experienced a side effect after taking Sudafed sinus pressure and pain tablets you can report using the yellow card website.
Can I take Sudafed sinus pressure and pain tablets with other medicines?
If you're already taking any other medicines, check with your pharmacist before taking Sudafed sinus pressure and pain tablets.
Painkillers with Sudafed sinus pressure and pain tablets
Do not take these tablets with other medicines that contain ibuprofen, as this can easily result in exceeding the maximum recommended daily dose of ibuprofen. Many cold and flu remedies and over-the-counter painkillers contain ibuprofen, so be sure to check the ingredients of any other medicines before taking them with this one. Ask your pharmacist for further advice. It is okay to take paracetamol with this medicine if needed.
Don't take Sudafed sinus pressure and pain tablets with painkilling doses of aspirin or any other oral NSAID, for example diclofenac or naproxen, as this increases the risk of side effects on the stomach and intestines. People taking selective inhibitors of COX-2 such as celecoxib or etoricoxib should avoid this medicine for the same reason.
Other cold & flu remedies with Sudafed sinus pressure and pain tablets
You should not use this medicine with other cough, cold and flu or decongestant medicines, unless they have been specifically recommended by your pharmacist.
Other medicine interactions with Sudafed sinus pressure and pain tablets
Avoid taking this medicine if you're already taking any of the following medicines because the combination may increase your blood pressure:
- appetite suppressants
- amphetamine-like stimulants, including methylphenidate, dexamfetamine and modafinil
- other decongestants (often found in other non-prescription cough and cold remedies)
- the antibiotic linezolid
- tricyclic antidepressants, such as amitriptyline.
If you're taking medicines for high blood pressure you shouldn't take this medicine as well, because the pseudoephedrine may make your blood pressure medicine less effective.
You're more at risk of ulceration or bleeding in your gut if you take ibuprofen with corticosteroids such as prednisolone. There may also be an increased risk of bleeding in the gut if you take ibuprofen with other medicines that can increase the risk of bleeding, such as those below. If you're taking one of these, you shouldn't take Sudafed sinus pressure and pain tablets unless advised to by your doctor:
- anti-blood-clotting (anticoagulant) medicines such as warfarin, dabigatran, apixaban, edoxaban, rivaroxaban, heparin and low molecular weight heparins such asenoxaparin
- antiplatelet medicines to reduce the risk of blood clots or 'thin the blood', such as dipyridamole, clopidogrel, prasugrel, low-dose aspirin
- ginko biloba (a herbal remedy)
- SSRI antidepressants, such as fluoxetine, paroxetine, citalopram
There may be an increased risk of side effects on the kidneys if ibuprofen is taken in combination with any of the following medicines:
- ACE inhibitors, such asenalapril
- diuretics, such as furosemide (ibuprofen may also reduce the effectiveness of diuretic medicines)
Ibuprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines:
If ibuprofen is taken with quinolone antibiotics, such as ciprofloxacin or norfloxacin there may be an increased risk of seizures (fits), particularly if you suffer from epilepsy.
Last updated 21.11.2019
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How does this medication work? What will it do for me?
This product is a combination of 2 medications: ibuprofen and pseudoephedrine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation by reducing a substance in the body that leads to inflammation and pain. Pseudoephedrine is a decongestant that relieves the symptoms of nasal and sinus congestion by reducing swelling in nasal passages and sinuses.
This medication is used to relieve nasal congestion, sinus congestion, sinus pain, fever, headache, sore throat, and body aches and pains that are associated with the common cold, sinusitis, or the flu.
Your doctor or pharmacist may have suggested this medication for conditions other than the ones listed in this drug information article. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor or pharmacist.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor or pharmacist has not recommended it.
What form(s) does this medication come in?
Ibuprofen and Pseudoephedrine by McNeil Consumer Healthcare is no longer being manufactured for sale in Canada. For brands that may still be available, search under ibuprofen - pseudoephedrine. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.
How should I use this medication?
The usual recommended dose for adults and children older than 12 years is 1 or 2 caplets or liqui-gels every 4 to 6 hours as needed. Do not take more than 6 caplets or liqui-gels in 24 hours unless recommended by your doctor. Do not take for more than 3 days for a fever or for more than 5 days for cold symptoms.
For the children's suspension, the dose depends on the child's age and weight and is given every 6 hours as needed. Do not give more than 4 doses a day unless recommended by your doctor. Use an oral syringe or medication cup to measure each dose of the suspension, as it gives a more accurate measurement than household teaspoons. Shake the suspension well before measuring a dose.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the one listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as recommended by your doctor or pharmacist. If you are taking this medication regularly and you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic or sensitive to ibuprofen, pseudoephedrine, or any ingredients of the medication
- are allergic to other NSAIDs (e.g., naproxen, ketoprofen, diclofenac) or ASA (acetylsalicylic acid)
- are about to have or have just had heart surgery
- are dehydrated due to vomiting, diarrhea, or not drinking enough fluids
- are taking another NSAID (e.g., naproxen, diclofenac, ketoprofen)
- are pregnant or breast-feeding
- have a stomach ulcer, intestinal ulcer, ulcerative colitis, or Crohn's disease
- have angioedema syndrome
- have experienced wheezing or difficulty breathing from ASA or other NSAIDs (e.g., naproxen, diclofenac, ketoprofen)
- have kidney disease, or reduced or worsening kidney function
- have nasal polyps
- have Raynaud's Syndrome
- have serious liver disease or reduced liver function
- have severe heart disease
- have severe high blood pressure
- have high levels of potassium in the blood
- have systemic lupus erythematosus
- have taken a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) within the last 14 days
- have thyroid disease
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- bloating or gas
- difficulty sleeping
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision or other eye symptoms
- fast, pounding heartbeat (palpitations)
- fluid retention
- ringing in the ears
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don 't stop bleeding)
- skin rash
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- symptoms of a severe allergic reaction (difficulty breathing, hives, swelling of the mouth or throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
June 8, 2021
Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.
Allergy: Some people who are allergic to acetylsalicylic acid (ASA) or other anti-inflammatory medications also experience allergic reactions to ibuprofen. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially anti-inflammatory medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Bleeding problems: If you have bleeding problems (e.g., hemophilia) or are taking anticoagulants (e.g., warfarin), you should not take this medication, unless recommended by your doctor.
Dependence and withdrawal: Physical dependence can occur with the use of pseudoephedrine for too long a period of time or at doses that are greater than the recommended amount. If this medication is stopped suddenly after using it for longer than recommended or at high doses, you may experience withdrawal symptoms such as anxiety, agitation, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.
Diabetes: Ibuprofen - pseudoephedrine may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness and dizziness: This medication can cause drowsiness and dizziness that may affect your ability to drive or operate machinery safely. If this medication affects you this way, do not perform these tasks.
Fluid retention: This medication can cause fluid retention. If you have heart failure or high blood pressure, fluid retention may worsen your condition. If you notice worsening of the symptoms of heart failure or your blood pressure increases while taking this medication, contact your doctor.
General: If your symptoms do not improve, contact your doctor. Do not use this medication for longer than 3 days for a fever or 5 days for pain or cold symptoms without consulting your doctor or pharmacist.
Glaucoma: This medication may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking this medication.
Heart problems: The cardiovascular system (heart and blood vessels) may be affected by the use of this medication. Ibuprofen can cause fluid to build up in the body. This alone can cause increased blood pressure and symptoms of congestive heart failure to become worse.
Pseudoephedrine can cause blood vessels to narrow, increasing blood pressure. It may also cause increased heart rate or irregular heartbeat. If you have a history of heart attack, angina, stroke or other conditions that can be worsened by changes to the heart and blood vessels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney problems: This medication may cause kidney problems. If you have reduced kidney function, heart failure, are taking diuretics (e.g., hydrochlorothiazide, furosemide), or are a senior, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Although rare, people taking ibuprofen-pseudoephedrine may have changes in liver function that produce abnormal liver test results. If you have a history of liver problems, discuss with your doctor or pharmacist how this medication may affect your medical condition and whether any special monitoring is needed.
Stomach ulcers and bleeding: Ibuprofen may cause ulcers or bleeding in the stomach or intestines. If you experience black, tarry stools, vomit that looks like coffee grounds, or stomach pain while taking this medication, contact your doctor immediately. If you have a history of stomach problems, discuss with your doctor or pharmacist how this medication may affect your medical condition and whether any special monitoring is needed.
Thyroid problems: If you have a thyroid condition, this medication may cause symptoms of overactive thyroid. If you are taking medications for an overactive thyroid or experience symptoms such as feeling hot all the time, weight loss without a change in your diet or amount of exercise you get, or feeling emotional, contact your doctor.
Urinary tract problems: This medication may cause bladder pain, painful or difficult urination, or increased frequency of urination. If you have an enlarged prostate gland, the difficulty urinating may be more pronounced. If these symptoms occur without an explanation (e.g., infection), stop taking this medication and contact your doctor.
Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication should not be used while breast-feeding.
Children: The caplets and liquid-gels should not be given to children less than 12 years old. The liquid form of the medication should not be given to children less than 6 years old.
Seniors: Seniors may be more likely to experience side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between ibuprofen - pseudoephedrine and any of the following:
- acetylsalicylic acid (ASA)
- alpha-agonists (e.g., clonidine, methyldopa)
- alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- angiotensin-converting enzyme inhibitors (ACEIs; captopril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- anticoagulants (e.g., dalteparin, enoxaparin, heparin, warfarin, apixaban, dabigatran, rivaroxaban)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., fluconazole, voriconazole)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- bisphosphonates (e.g., alendronate, etidronate)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
- decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
- diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, rosiglitazone)
- diuretics (e.g., hydrochlorothiazide, furosemide, triamterene)
- ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- fast-acting bronchodilators (e.g., salbutamol, terbutaline)
- herbs that may increase the risk of bleeding (e.g., cat's claw, dong quai, feverfew, garlic, ginger)
- long-acting bronchodilators (e.g., formoterol, salmeterol)
- lumacaftor and ivacaftor
- MAO inhibitors (i.e., moclobemide, phenelzine, selegiline)
- omega-3 fatty acids
- other NSAIDs (e.g., naproxen, diclofenac, ketorolac)
- pentosan polysulfate sodium
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
- sodium phosphates
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- thyroid replacements (e.g., dessicated thyroid, levothyroxine)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, and street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ibuprofen-and-pseudoephedrine-by-McNeil-Consumer-Healthcare
Consumer medicine information
1 Name of Medicine
Pseudoephedrine hydrochloride; ibuprofen.
6.7 Physicochemical Properties
CAS number.CAS Registry Number: 345-78-8 (pseudoephedrine hydrochloride).
CAS Registry Number: 15687-27-1 (ibuprofen).
2 Qualitative and Quantitative Composition
Sudafed Sinus + Anti-inflammatory Pain Relief caplets contain pseudoephedrine hydrochloride 30 mg and ibuprofen 200 mg.
Sudafed Sinus + Anti-inflammatory Pain Relief caplets also contain: methyl hydroxybenzoate, propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Sudafed Sinus + Anti-inflammatory Pain Relief caplets are white, capsule-shaped, film-coated tablets.
5 Pharmacological Properties
5.1 Pharmacodynamic Properties
Mechanism of action.Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.
Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.
Ibuprofen possesses analgesic, antipyretic and anti-inflammatory properties, similar to other non-steroidal anti-inflammatory drugs (NSAIDs). Its mechanism of action is unknown, but is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthetase inhibition.
Clinical trials.No data available.
5.2 Pharmacokinetic Properties
Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine.
Ibuprofen is well absorbed from the gastrointestinal tract. It is highly bound (90-99%) to plasma proteins and is extensively metabolised to inactive compounds in the liver, mainly by glucuronidation. Both the inactive metabolites and a small amount of unchanged ibuprofen are excreted rapidly and completely by the kidney, with 95% of the administered dose eliminated in the urine within four hours of ingestion. The elimination half-life of ibuprofen is in the range of 1.9 to 2.2 hours.
5.3 Preclinical Safety Data
Genotoxicity.No data available.
Carcinogenicity.No data available.
4 Clinical Particulars
4.1 Therapeutic Indications
Sudafed Sinus + Anti-inflammatory Pain Relief provides relief of symptoms of sinus pain with sinus congestion occurring as a result of cold and flu, allergic rhinitis or sinusitis.
Sudafed Sinus + Anti-inflammatory Pain Relief is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine or ibuprofen (or any of the other ingredients in the product), other nonsteroidal anti-inflammatory drugs or other salicylates;
with severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days;
known hypersensitivity to aspirin and other NSAIDs;
asthma that is aspirin or NSAID sensitive;
active gastrointestinal bleeding or peptic ulceration;
severe liver impairment;
undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG);
right before or after heart surgery.
Use of ibuprofen is contraindicated during the third trimester of pregnancy.
Use of ibuprofen is contraindicated right before or after heart surgery.
Sudafed Sinus + Anti-inflammatory Pain Relief should not be taken with other products containing ibuprofen or with other anti-inflammatory medicines.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
4.4 Special Warnings and Precautions for Use
Identified precautions.Sudafed Sinus + Anti-inflammatory Pain Relief should be used with caution in patients with hypertension, hyperthyroidism or thyroid disease, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy, previous history of gastrointestinal haemorrhage or ulcers, asthma who have not previously taken an NSAID, cardiac impairment or heart disease, fluid retention, alcohol dependence, pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy) and patients: taking a diuretic, taking anticoagulants, taking corticosteroids.
Due to the ibuprofen component, this medicine should be taken with caution when using other products containing aspirin and salicylates.
Ibuprofen may cause a severe allergic reaction, especially in patients allergic to aspirin. Symptoms include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters with or without pyrexia or erythema. If any of these symptoms occur, patients should stop use and seek medical help right away.
Due to the pseudoephedrine component, this medicine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
If signs and symptoms such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with this medicine should be discontinued and a physician should be consulted.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
Cardiovascular and cerebrovascular effects.Observational studies have indicated that NSAIDs may be associated with an increased risk of serious cardiovascular events, including myocardial infarction and stroke, which may increase with dose or duration of use.
Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk.
Patients should be advised to remain alert for such cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and the steps to take if they occur.
Fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Patients taking antihypertensives with NSAIDs may have an impaired antihypertensive response.
Sudafed Sinus + Anti-inflammatory Pain Relief should be used with caution in patients with hypertension (see Section 4.3 Contraindications, heart failure).
Use in hepatic impairment.Sudafed Sinus + Anti-inflammatory Pain Relief should be used with caution for patients with severe hepatic dysfunction or impairment.
As with other NSAIDs elevations of one or more liver function tests may occur in up to 15% of patients. These abnormalities may progress, may remain essentially unchanged, or may resolve with continued therapy. Meaningful elevations (three times the upper limit of normal) of ALT or AST occurred in controlled clinical trials in less than 1% of patients.
Patients should be advised to remain alert for hepatotoxicity and be informed about the signs and/or symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms).
Use in renal impairment.Sudafed Sinus + Anti-inflammatory Pain Relief should be used with caution for patients with severe kidney dysfunction or impairment.
Use in the elderly.Ibuprofen should not be taken by adults over the age of 65 without careful consideration of co-morbidities and co-medications because of an increased risk of adverse effects, in particular, heart failure, gastro-intestinal ulceration and renal impairment (see Section 4.3 Contraindications).
Paediatric use.Sudafed Sinus + Anti-inflammatory Pain Relief should not be used for children under 12 years of age.
Effects on laboratory test.No data available.
4.5 Interactions with Other Medicines and Other Forms of Interactions
The following interactions with pseudoephedrine have been noted.
Antidepressant medication, e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) - may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers - may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.
The following interactions with ibuprofen have been noted.
Anticoagulants, including warfarin - ibuprofen interferes with the stability of INR and may increase risk of severe bleeding and sometimes fatal haemorrhage, especially from the gastrointestinal tract. Ibuprofen should only be used in patients taking warfarin if absolutely necessary and they must be closely monitored.
Ibuprofen may decrease the cardioprotective and antiplatelet activity of aspirin.
Ibuprofen may decrease renal clearance and increase plasma concentration of lithium.
Ibuprofen may reduce the antihypertensive effect of ACE inhibitors, beta-blockers and diuretics and may cause natriuresis and hyperkalemia in patients under these treatments.
Ibuprofen reduces methotrexate clearance.
Ibuprofen may increase plasma levels of cardiac glycoside.
Ibuprofen may increase the risk of gastrointestinal bleeding especially if taken with corticosteroids or with alcohol use.
Ibuprofen may prolong bleeding time in patients treated with zidovudine.
Alcohol use may increase the risk of gastrointestinal bleeding when taking drugs in the NSAID class, including ibuprofen. Therefore, caution should be taken when using ibuprofen with alcohol.
Ibuprofen may also interact with probenecid, antidiabetic medicines and phenytoin.
4.6 Fertility, Pregnancy and Lactation
Effects on fertility.No data available.
4.8 Adverse Effects (Undesirable Effects)
Children and the elderly are more likely to experience adverse effects than other age groups.
Clinical trial data.The safety of the combination of ibuprofen and pseudoephedrine from clinical trial data is based on data from 4 double-blind placebo-controlled single dose randomized studies in the treatment of sinus headache.
Table 1 includes adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.
Post marketing data.Adverse drug reactions identified during post-marketing experience with ibuprofen, pseudoephedrine and the combination of ibuprofen/ pseudoephedrine appear in Table 2. The frequency category was estimated from spontaneous reporting rates: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/1,000 and <1/100; Rare ≥ 1/10,000 and < 1/1,000; Very rare < 1/10,000; Not known (cannot be estimated from the available data).
Reporting suspected adverse effects.Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at: https://www.tga.gov.au/reporting-problems.
4.2 Dose and Method of Administration
The recommended dosage of Sudafed Sinus + Anti-inflammatory Pain Relief for adults and children over 12 years is 1 or 2 caplets with fluid every four to six hours when necessary. Do not exceed 6 caplets in 24 hours.
Sudafed Sinus + Anti-inflammatory Pain Relief should not be used for children under 12 years of age.
Sudafed Sinus + Anti-inflammatory Pain Relief should not be used for more than a few days at a time except on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. Excessive use can increase the risk of heart attack, stroke or liver damage.
4.7 Effects on Ability to Drive and Use Machines
It is not known if the combination of ibuprofen and pseudoephedrine has an effect on the ability to drive and use machines.
In case of overdose, immediately contact the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand call 0800 764 766) for advice.
7 Medicine Schedule (Poisons Standard)
6 Pharmaceutical Particulars
6.1 List of Excipients
Candelilla wax, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, stearic acid, methyl hydroxybenzoate, propyl hydroxybenzoate, Opadry Aqueous Film Coating YS-1-7034 Clear UK, Opadry Aqueous Film Coating YS-1-7717 White UK.
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3 Shelf Life
6.4 Special Precautions for Storage
Store below 25°C. Keep in a dry dark place.
6.5 Nature and Contents of Container
Sudafed Sinus + Anti-inflammatory Pain Relief caplets are available in blister packs of Alu/PVC/PVDC in the following sizes: 4 caplets; 12 caplets; 24 caplets.
6.6 Special Precautions for Disposal
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
Summary Table of Changes
In is there sudafed ibuprofen
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The medicines below all contain the following active ingredient(s): ibuprofen + pseudoephedrine. You can select a medicine from this list to find out more - including side effects, age restrictions, food interactions and whether the medicine is subsidised by the government on the pharmaceutical benefits scheme (PBS).
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SUDAFED PE® for Head Congestion + Pain Relief | SUDAFED®
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- Facial swelling
- Asthma (wheezing)
- Skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Ask a doctor before use if
- Stomach bleeding warning applies to you
- You have problems or serious side effects from taking pain relievers or fever reducers
- You have a history of stomach problems, such as heartburn
- You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- You are taking a diuretic
- Under a doctor’s care for any serious condition
- Taking any other product that contains phenylephrine or any other nasal decongestant
- Taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- Taking any other drug
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- Are age 60 or older
- Have had stomach ulcers or bleeding problems
- Take a blood thinning (anticoagular) or steroid drug
- Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- Have 3 or more alcoholic drinks every day while using this product
- Take more or for a longer time than directed
When using this product
- Take with food or milk if upset stomach occurs
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
- In children under 12 years of age because this product contains too much medication for children under this age
- If you have ever had an allergic reaction to any other pain reliever/fever reducer
- Right before or after heart surgery
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Stop use and ask a doctor if
You experience any of the following signs of stomach bleeding:
- Feel faint
- Vomit blood
- Have bloody or black stools
- Have stomach pain that does not get better
- You have symptoms of heart problems or stroke:
- Chest pain
- Trouble breathing
- Weakness in one part of side of body
- Slurred speech
- Leg swelling
- Pain gets worse or lasts more than 7 days
- Fever gets worse or lasts more than 3 days
- Nasal congestion lasts for more than 7 days
- Symptoms continue or get worse
- Redness or swelling is present in the painful area
- You get nervous, dizzy, or sleepless
- Any new symptoms appear
If pregnant or breast-feeding
- Ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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