Consumer Information for: APO-OXYCODONE/ACET

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-OXYCODONE/ACET is used to treat pain in adults.

What it does

Acetaminophen reduces pain and fever.

When it should not be used
  • your doctor did not prescribe it for you
  • your pain is mild
  • you are allergic to oxycodone hydrochloride, acetaminophen or any of the other ingredients in APOOXYCODONE/ACET (see What are the ingredients in APO-OXYCODONE/ACET?)
  • you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
  • you have severe asthma, trouble breathing, or other breathing problems
  • you have any heart problems
  • you have severe liver disease
  • you have bowel blockage or narrowing of the stomach or intestines
  • you have severe pain in your abdomen
  • you have a head injury
  • you are at risk for seizures
  • you have a brain tumor
  • you suffer from alcoholism
  • you are taking or have taken within the past 2 weeks a monoamine oxidase inhibitor (MAOI) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
  • you are going to have, or recently had, a planned surgery
  • you are pregnant or planning to become pregnant or you are in labour
  • you are breastfeeding

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

  • have a history of illicit or prescription drug or alcohol abuse.
  • have severe kidney, liver or lung disease
  • are taking other products containing acetaminophen. Acetaminophen can cause decreased liver function. Taking more than the maximum daily dose of acetaminophen may cause severe or possibly fatal liver damage. People with liver disease or reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
  • have heart disease
  • have low blood pressure
  • have past or current depression
  • suffer from chronic or severe constipation
  • have problems with your adrenal or prostate gland
  • have, or had in the past, hallucinations or other severe mental problems
  • suffer from migraines
  • are planning to become pregnant.

DO NOT take with other products containing acetaminophen. Taking more than the maximum daily dose of acetaminophen may cause severe or possibly fatal liver damage.

What the medicinal ingredient is

oxycodone hydrochloride and acetaminophen

What the non-medicinal ingredients are

microcrystalline cellulose, povidone, starch, sodium starch glycolate and stearic acid.

What dosage form it comes in

Each APO-OXYCODONE/ACET tablet contains 5 mg oxycodone hydrochloride and 325 mg acetaminophen.

Warnings and precautions

Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is life-threatening.

Do not use APO-OXYCODONE/ACET while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. APO-OXYCODONE/ACET can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Interactions with this medication
  • Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking APO-OXYCODONE/ACET. It can lead to:
    • drowsiness
    • unusually slow or weak breathing
    • serious side effects or
    • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by APO-OXYCODONE/ACET
  • other opioid analgesics (drugs used to treat pain)
  • other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen), or oxycodone
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
  • antidepressants (for depression and mood disorders). Do not take APO-OXYCODONE/ACET with MAO inhibitors (MAOI) or if you have taken MAOI’s in the last 14 days.
  • drugs used to treat serious mental or emotional disorders (such as schizophrenia)
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (drugs used for the prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • some heart medication (such as beta blockers)
  • drugs used to treat migraines (e.g. triptans)
  • St. John’s Wort
Proper use of this medication
  • usually every 4 to 6 hours, or as directed by your doctor.
  • with a full glass of water

Usual Dose

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take APO-OXYCODONE/ACET for up to 7 days. If you need to take APO-OXYCODONE/ACET for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need APO-OXYCODONE/ACET. Be sure to use APO-OXYCODONE/ACET only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking APO-OXYCODONE/ACET, tell your doctor immediately.

Overdose

If you think you have taken too much APO-OXYCODONE/ACET, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

  • unusually slow or weak breathing
  • dizziness
  • confusion
  • extreme drowsiness

Missed Dose

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-OXYCODONE/ACET. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Drowsiness
  • Insomnia
  • Dizziness
  • Fainting
  • Nausea, vomiting, or a poor appetite
  • Dry mouth
  • Headache
  • Problems with vision
  • Weakness, uncoordinated muscle movement
  • Itching
  • Light headedness
  • Sweating
  • Constipation
  • Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using APOOXYCODONE/ACET.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Rare
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone cold and clammy skin.     ✔
Respiratory Depression: slow, shallow or weak breathing.     ✔
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing.     ✔
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea.     ✔
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating.   ✔  
Fast, Slow or Irregular Heartbeat: heart palpitations.   ✔  
Low Blood Pressure: dizziness, fainting, light-headedness. ✔    
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea     ✔
Very Rare
Serious Skin Reactions (Acute Generalized Exanthematous Pustulosis, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or joint pain, yellowing of the skin or eyes, dark urine.     ✔
Liver Injury: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite.   ✔  
Unknown
Convulsions (seizures)     ✔

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 unused or expired APO-OXYCODONE/ACET in a secure place to prevent theft, misuse or accidental exposure.
  • Store at room temperature (15°C to 30°C).
  • Keep APO-OXYCODONE/ACET out of the sight and reach of children and pets.
  • Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes APOOXYCODONE/ACET, get emergency help right away.

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

APO-OXYCODONE/ACET should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about APO-OXYCODONE/ACET:

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: May 27, 2019

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