Patient Medication Information: uses, side effects, how to take - Teva-Oxycodan
Serious Warnings and Precautions
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Seek immediate medical help for your baby.
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What is TEVA-OXYCODAN used for?
TEVA-OXYCODAN is used in adults to relieve mild to moderately severe pain, including conditions associated with fever and/or inflammation.
It is NOT used “as-needed” to treat pain that you only have once in a while.
How does TEVA-OXYCODAN work?
TEVA-OXYCODAN contains 2 drugs that work together.
- Oxycodone is a painkiller belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
- Acetylsalicylic acid (ASA) belongs to the group of medications called analgesics (pain relievers), antipyretics (fever reducers), and antiinflammatories (inflammation reducers) It reduces the amount of prostaglandin made in the body and this lowers pain, fever and swelling.
What are the ingredients in TEVA-OXYCODAN?
Medicinal ingredients: oxycodone hydrochloride and acetylsalicylic acid (ASA)
Non-medicinal ingredients: colloidal silicon dioxide, FD&C yellow #5 aluminum lake, lactose, microcrystalline cellulose, sodium starch glycolate and stearic acid.
TEVA-OXYCODAN comes in the following dosage forms:
Tablets; 5 mg oxycodone hydrochloride and 325 mg ASA.
Do not use TEVA-OXYCODAN if:
- your healthcare professional did not prescribe it for you
- you are allergic to oxycodone hydrochloride, ASA or any of the other ingredients in TEVA-OXYCODAN
- you have mild pain that can be controlled by the occasional use of painkillers, including those available without a prescription
- you have severe asthma, trouble breathing, or other breathing problems
- you have any heart problems
- you have bowel blockage or narrowing of the stomach or intestines
- you have appendicitis or a problem with your pancreas called pancreatitis
- you have a condition where the bowel does not work properly (ileus) or you have severe pain in your abdomen
- you have increased pressure in your skull or a head injury
- you have severe CNS depression (nervous system slows down)
- you have or have a history of epilepsy
you suffer from alcoholism or alcohol withdrawal
- 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 and delivery
- you are breastfeeding
- you have a condition such as hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage that makes you more likely to have bleeding problems
- you have nasal polyps, allergic reaction or breathing problems to ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- you have stomach ulcers or other serious stomach or bowel sores
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-OXYCODAN. Talk about any health conditions or problems you may have, including if you:
- have a history of illicit or prescription drug or alcohol abuse.
- are taking any other medications, including natural health products, salicylates or other pain and fever relief medications (nonsteroidal anti-inflammatory drugs (NSAIDS)), or prescription medications
- have severe kidney, liver or lung problems
- have low blood pressure
- have or have had problems with your mood (such as depression or anxiety), hallucinations, or other mental health problems
- suffer from chronic or severe constipation
- have problems with your adrenal or prostate gland
- suffer from migraines
- have nasal polyps or asthma
- have a history of bleeding problems
- have a blood clotting disorder or are taking blood thinners
- are planning on drinking alcohol. Drinking alcohol while taking TEVA-OXYCODAN may cause dangerous side effects. Do not drink alcohol while taking TEVA-OXYCODAN.
- are planning to breastfeed
- have circulatory problems (body does not get enough oxygen and nutrients to function properly due to lack of blood flow)
- have a fever, the flu or chickenpox
- are 65 years of age or older
Other warnings you should know about:
Taking TEVA-OXYCODAN can cause the following serious side effects:
Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:
- nausea, vomiting
- feeling tired, weak or dizzy
- decreased appetite
You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your healthcare professional may do tests, give you another medication, and slowly take you off TEVA-OXYCODAN.
Serious Skin Reactions: Use of some NSAIDs, such as TEVA-OXYCODAN, have been associated with rare post-market cases of serious, fatal or otherwise life-threatening skin reactions, including:
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome,
- toxic epidermal necrolysis (TEN),
- exfoliative dermatitis and
- erythema multiforme.
You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Serotonin Toxicity (also known as serotonin syndrome): TEVA-OXYCODAN can cause Serotonin Toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Toxicity if you take TEVA-OXYCODAN with certain anti-depressants or migraine medications.
Serotonin Toxicity symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
- Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices you stop breathing from time to time while sleeping.
See the Serious side effects and what to do about them table below for more information on these and other serious side effects.
Pregnancy, nursing, labour and delivery: Do not use TEVA-OXYCODAN while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. TEVA-OXYCODAN can then cause life-threatening breathing problems in your unborn baby or nursing infant. If you become pregnant while taking TEVA-OXYCODAN, tell your healthcare professional right away.
If you are pregnant and are taking TEVA-OXYCODAN, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your healthcare professional will monitor and guide you on how to slowly stop taking TEVA-OXYCODAN. This may help avoid serious harm to your unborn baby.
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to TEVA-OXYCODAN. TEVA-OXYCODAN can cause:
- drowsiness
- dizziness or
- lightheadedness
This can usually occur after you take your first dose and when your dose is increased. Taking TEVA-OXYCODAN with other medicines that affect your nervous system can make these side effects worse. This includes:
- other opioids,
- phenothiazine (used to treat mental health problems and prevent vomiting during chemotherapy),
- sedatives and hypnotics (used to cause relaxation and help you sleep), and
- alcohol.
Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.
Drug addiction, dependence, and tolerance: Like any opioid, if you use TEVA-OXYCODAN for a long time, it may cause mental and physical dependence. Oxycodone hydrochloride also has the potential to cause addiction. There are important differences between physical dependence and addiction. If you use opioids for a long time, you may develop tolerance. Tolerance means that, over time, a higher dose may be needed to get the same level of pain relief. It is important that you talk to your healthcare professional if you have questions or concerns about addiction, physical dependence, or tolerance. Your healthcare professional should prescribe and administer TEVA-OXYCODAN with the same degree of caution appropriate to the use of other oral opioid medications. It is not recommended to use these products for a long period of time.
Worsened pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your healthcare professional if you notice a change like this in your pain while you are taking TEVA-OXYCODAN.
Testing and check-ups: Tell any healthcare professional that you see that you are taking TEVA-OXYCODAN. TEVA-OXYCODAN can cause abnormal blood and urine test results. Your healthcare professional will decide when to perform these tests and will interpret the results.
Your healthcare professional will regularly monitor your health. This includes monitoring for signs of:
- misuse and abuse
- low blood pressure
- sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping)
- respiratory depression and sedation (slow, shallow, or weak breathing)
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Taking TEVA-OXYCODAN with the following medicines can cause serious side effects, including breathing problems that can lead to death:
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The following may interact with TEVA-OXYCODAN:
- medicines used to treat migraines (e.g. triptans)
- other medications that contain ASA (including over-the-counter preparations containing ASA), or oxycodone
- anticoagulants, used for prevention or treatment of blood clots
- antiretrovirals, used to treat viral infections
- antifungals, used to treat fungal infections
- antibiotics, used to treat bacterial infections
- grapefruit juice
- anticonvulsants, used to treat seizures
- corticosteroids, used to treat inflammation
- oral medicines to treat diabetes and/or insulin
- medicines used to suppress the immune system such as methotrexate
- NSAIDS (non-steroidal anti-inflammatory drugs) to treat pain such as ibuprofen and naproxen
- drugs medicines used to treat gout such as probenecid and sulfinpyrazone
How to take TEVA-OXYCODAN:
- Take TEVA-OXYCODAN exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- TEVA-OXYCODAN must be taken orally, by mouth. Do NOT take the TEVA-OXYCODAN tablets using any other route as this can cause serious harm, including death.
- Swallow the tablet whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
- Review your pain regularly with your healthcare professional to determine if you still need TEVA-OXYCODAN. Be sure to take TEVA-OXYCODAN only for the condition for which is was prescribed.
Usual Dose:
Your dose is tailored/personalized just for you. Take it exactly as your healthcare professional has told you. Do not increase or decrease your dose without talking to your healthcare professional. Taking higher doses can lead to more side effects and a greater change of overdose.
Stopping your Medication
This medication may be habit-forming for long periods of time. If you have been taking TEVA-OXYCODAN for more than a few days you should not stop taking it all of a sudden. Your healthcare professional will monitor and guide you on how to slowly stop taking TEVA-OXYCODAN. You should do it slowly to avoid uncomfortable symptoms such as having:
- body aches
- diarrhea
- goosebumps
- loss of appetite
- nausea
- feeling nervous or restless
- runny nose
- sneezing
- tremors or shivering
- stomach cramps
- rapid heart rate (tachycardia)
- having trouble sleeping
- an unusual increase in sweating
- heart palpitations
- an unexplained fever
- weakness
- yawning
By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking TEVA-OXYCODAN.
Refilling your Prescription for TEVA-OXYCODAN:
A new written prescription is required from your healthcare professional each time you need more TEVA-OXYCODAN. Therefore, it is important that you contact your healthcare professional before your current supply runs out.
Only obtain prescriptions for this medicine from the doctor healthcare professional in charge of your treatment. Do not seek prescriptions from other healthcare professionals unless you switch to another healthcare professional for your pain management.
Overdose:
Signs of an overdose may include:
- unusually slow or weak breathing
- dizziness
- confusion
- extreme drowsiness
- floppy muscles/low muscle tone
- cold and clammy skin
- slow heart rate
- low blood pressure
- sleep apnea (a disorder which pauses in breathing or shallow breathing while sleeping)
- heart attack
- vomiting and abdominal pain
- acetone odour in breath
- sweating, abnormally high body temperature
- dehydration
- restlessness
- seizures
| If you think you have taken too much TEVA-OXYCODAN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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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 healthcare professional before restarting your medication.
What are possible side effects from using TEVA-OXYCODAN?
These are not all the possible side effects you may feel when taking TEVA-OXYCODAN. If you experience any side effects not listed here, tell 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. Talk to your healthcare professional about ways to prevent constipation when you start using TEVA-OXYCODAN.
- Low sex drive, impotence (erectile dysfunction), infertility
- Feeling of pleasure or excitement
- Feeling unhappy, uneasy or dissatisfied
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
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| Only if severe | In all cases | ||
| RARE | |||
| Allergic Reaction: difficulty swallowing or breathing, hives, rash, swelling of the face, lips, tongue or throat, | √ | ||
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | √ | ||
| Disorder of the adrenal gland: anorexia, dizziness, or low blood pressure, fatigue, nausea, vomiting, weakness, | √ | ||
| Fast, Slow or Irregular Heartbeat: heart palpitations | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness | √ | ||
| Overdose: cold and clammy skin, confusion, extreme sleepiness, hallucinations, , inability to walk normally, floppy muscles/low muscle tone, sedation, or dizziness, slow or weak breathing, | √ | ||
| Respiratory Depression: shallow or weak breathing slow, | √ | ||
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| Serious Skin Reactions: blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, fever, flu-like feeling, severe rash, swelling of face and/or legs, swollen lymph glands, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine | √ | ||
Serotonin toxicity (also known as serotonin syndrome): a reaction which may cause feelings of agitation or restlessness, heavy sweating, high body temperature (> 38 °C) or rigid muscles, flushing, muscle twitching, involuntary eye movements | √ | ||
| Sleep apnea: stop breathing for short periods during your normal nightly sleep. | √ | ||
| Withdrawal: anxiety, body aches, nausea, cold and clammy skin, diarrhea, shivering, vomiting, loss of appetite, sweating | √ |
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 to your healthcare professional.
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. |
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Storage:
- Store tablets at room temperature (15°C to 30°C).
- Keep unused or expired TEVA-OXYCODAN in a secure place to prevent theft, misuse or accidental exposure. It should be kept under lock, out of 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 TEVA-OXYCODAN, get emergency help right away.
- TEVA-OXYCODAN 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 TEVA-OXYCODAN:
- 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 http://www.tevacanada.com ; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com .