Language selection

Government of Canada

Search

Details for: COMBOGESIC

Company: BIOSYENT PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02488280COMBOGESICACETAMINOPHEN; IBUPROFEN325 MG; 97.5 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

COMBOGESIC® (Acetaminophen/Ibuprofen) is indicated for the:

  • short term management of mild to moderate acute pain
  • reduction of fever.
What it does

COMBOGESIC® contains acetaminophen and ibuprofen. Acetaminophen works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness or soreness).

When it should not be used

Do not use COMBOGESIC® if:

  • you are planning to have or have recently had heart bypass surgery
  • you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
  • you are in the third trimester of pregnancy (after 28 weeks)
  • you are allergic to any medicine containing acetaminophen, ibuprofen, any of the ingredients mentioned above,ASA (Acetylsalicylic Acid) or other NSAIDs
  • you have asthma, urticaria or allergic-type reactions after taking ASA or other NSAIDs
  • you have an autoimmune disease such as Lupus erythematosus or other connective tissue disorders
  • you have bleeding from the stomach or gut (active)
  • you have bleeding in the brain or other bleeding disorders
  • you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
  • you have liver disease (active or severe)
  • you have kidney disease (severe or worsening)
  • you have high potassium in the blood
  • you are under the age of 18 years
  • you regularly drink large quantities of alcohol
  • you have blood-formation disturbances.
What the medicinal ingredient is

acetaminophen and ibuprofen.

What the non-medicinal ingredients are

croscarmellose sodium, corn/maize starch, magnesium stearate, microcrystalline cellulose, Opadry white OYLS 58900 film coating (containing hypromellose, lactose monohydrate, macrogol, sodium citrate dihydrate, titanium dioxide), pregelatinized starch, and talc.

What dosage form it comes in

Acetaminophen 325 mg/Ibuprofen 97.5 mg tablets.

Warnings and precautions

Serious Warnings and Precautions

If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than COMBOGESIC®:

  • Heart attack or angina
  • Stroke or mini-stroke
  • Loss of vision
  • Current pregnancy (less than 28 weeks)
  • Congestive Heart Failure

COMBOGESIC® may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

COMBOGESIC® is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Stomach bleeding warning: This product may cause stomach bleeding. Symptoms may include feeling faint, vomiting blood, bloody or black stools. The chance of stomach bleeding is higher if you:

  • are aged 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.

Liver warning: COMBOGESIC® contains acetaminophen, which has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 milligrams per day.
Severe or possibly fatal liver damage may occurif you take:

  • more than the recommended dose in 24 hours
  • with other drugs containing acetaminophen
  • while drinking three (3) or more alcoholic drinks every day.

Symptoms of liver damage may include yellowing of the skin/eyes, dark urine, nausea, vomiting, stomach pain, unusual tiredness, and/orloss of appetite.

Allergy alert: acetaminophen may cause serious skin reactions. Symptoms may include skin reddening, blisters, or rash. If any of the above noted symptoms occur, stop use and seek medical help right away.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COMBOGESIC®. Talk about any health conditions or problems you may have, including if you:

  • have liver disease, hepatitis, kidney disease or difficulty urinating
  • are allergic to acetaminophen, ibuprofen, or other NSAIDs
  • are a drug user
  • are trying to conceive, are in your first or second trimester of pregnancy or if you a breastfeeding
  • currently have an infection
  • plan to have surgery
  • take any other medication especially daily low-dose ASA (81 to 325 mg)
  • take the blood thinning drug warfarin
  • have or have had other medical conditions including:
    • heartburn, indigestion, stomach ulcer or any other stomach problems
    • vomiting blood or bleeding from back passage
    • severe skin reactions such as exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome
    • liver or kidney disease
    • asthma
    • vision problems
    • high blood pressure
    • high cholesterol
    • diabetes mellitus or you are on a low sugar diet
    • poor circulation to your extremities
    • smoker or ex-smoker
    • family history of heart disease or stroke
    • tendency to bleed or other blood problems
    • bowel or intestinal problems such as ulcerative colitis or Crohn’s Disease
    • swelling of ankles or feet
    • diarrhoea
    • inherited genetic or acquired disorder of certain enzymes that manifest with either neurological complications or skin problems or occasionally both i.e. porphyria
    • smallpox.

Other warnings you should know about:

Tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery.

When using this product

  • take with food or milk if upset stomach occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask a doctor if:

  • you have signs of stomach bleeding (see Serious Warnings and Precautions – Stomach bleeding warning)
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear.
Interactions with this medication

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 COMBOGESIC®:

  • medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
  • medicines that reduce high blood pressure (ACE-inhibitors, beta-blockers, angiotensin-II receptor antagonists)
  • medicines to treat epilepsy or fits
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • probenecid, a medicine used to treat gout
  • zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency disease)
  • medicines used to treat tuberculosis such as isoniazid
  • salicylates or other NSAID medicines
  • diuretics, also called fluid tablets
  • lithium, a medicine used to treat some types of depression
  • methotrexate, a medicine used to treat arthritis and some types of cancer
  • corticosteroids, such as prednisone, cortisone
  • metoclopramide, propantheline, antidepressants with anticholinergic properties, and narcotic analgesics
  • cholestyramine, a medicine used to reduce raised serum lipid levels
  • tacrolimus or ciclosporin, immunosuppressive drugs used after organ transplant
  • sulphonylureas, a medicine used to treat diabetes
  • some antibiotics (such as quinolone antibiotics or co-trimoxazole)
  • cardiac glycosides, medicines to strengthen the heart.
Proper use of this medication

Take COMBOGESIC® only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider has recommended. If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much COMBOGESIC® may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using COMBOGESIC® for more than 3 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

Usual Dose

Adults 18 years and over: The recommended adult dose of COMBOGESIC® is 1-2 tablets every 6 hours with a full glass of water. If pain or fever does not respond to 2 tablets, 3 tablets may be taken at your next dose, but only on the advice of your doctor. Do not take more than 12 tablets over a 24 hour period.

This product should not be taken by those under 18 years of age.

Overdose

Call a Poison Control Centre or a healthcare professional immediately, even if you do not notice any signs or symptoms. Early symptoms of liver damage may seem like the flu, or you may have nausea, vomiting, stomach pain, loss of appetite, yellowing of the skin/eyes, or dark urine.

Missed Dose

If you miss a dose, take it as soon as you remember. But if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking COMBOGESIC®. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
  • Vomiting blood or material that looks like coffee grounds
    		•      ✔
  • Bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
    		•      ✔
  • Swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
    		•      ✔
    Uncommon
  • Decrease in red blood cells, nose bleed and heavier periods (menstrual bleeding)
    		•      ✔
  • Allergic reactions – skin rash, tiredness, joint pain (e.g. serum sickness, lupus erythematosus syndrome, Henoch-Schönlein vasculitis, angioedema)
    		•      ✔
  • Enlargement of breast tissue in men; low blood sugar levels
    		•      ✔
  • Sleeplessness
    		•     ✔
  • Change in mood, for example depression, confusion, nervousness
    		•      ✔
  • Eye problems such as blurred vision (reversible), sore red eyes, itching
    		•      ✔
  • Thickened mucus
    		•      ✔
  • Severe pain or tenderness in the stomach; peptic/gastrointestinal ulcer
    		•      ✔
  • Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease) and complications of diverticula of the large bowel (perforation or fistula)
    		•      ✔
  • Inability to completely empty the bladder (urinary retention)
    		•      ✔
  • Abnormal laboratory test results (blood, liver and kidney enzyme test results)
    		•      ✔
    Rare
  • Tingling of the hands and feet
    		•      ✔
  • Abnormal dreams, seeing things (hallucinations)
    		•      ✔
  • Damage of the kidney tissue (particularly in long -term use)
    		•      ✔
  • High level of uric acid in your blood (hyperuricemia)
    		•      ✔
    Very Rare
  • Low potassium levels – weakness, fatigue, muscle cramps (hypokalaemia)
    		•      ✔
  • Signs of anemia, such as tiredness, headaches, being short of breath, and looking pale
    		•      ✔
  • Bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
    		•      ✔
  • Severe or persistent headache
    		•      ✔
  • Spinning sensation (vertigo)
    		•      ✔
  • Fast or irregular heartbeats, also called palpitations
    		•      ✔
  • Increase in blood pressure and possible heart problems
    		•      ✔
  • Inflammation of the oesophagus
    		•      ✔
  • Yellowing of the skin and/or eyes, also called jaundice
    		•      ✔
  • Liver damage (particularly in long term use)
    		•      ✔
  • Loss of hair
    		•      ✔
  • Increase in sweating
    		•      ✔
  • Signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
    		•      ✔

    If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

    How to store

    Keep your medicine in the original pack until it is time to take.
    Do not use this medicine after the expiry date which is stated on the carton and on the blister.
    Do not use this medicine if you notice packaging is torn or shows signs of tampering.
    Store at room temperature (15 to 30°C).
    Do not store COMBOGESIC® or any other medicine in the bathroom near a sink.
    Do not leave it on a windowsill or in the car.
    Heat and dampness can destroy some medicines.
    A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

    Keep out of reach and sight of children.

    Reporting side effects

    Reporting Side Effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    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.

    More information

    If you want more information about COMBOGESIC®:

    • 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 (http://hc-sc.gc.ca/index-eng.php); the sponsor’s website www.biosyent.com or by calling 1-888-439-0013.

    This leaflet was prepared by BioSyent Pharma Inc.

    Last Revised: June 10, 2021

    Date modified: