Details for: SUPEUDOL
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02262983 | SUPEUDOL | OXYCODONE HYDROCHLORIDE | 20 MG | TABLET | ORAL |
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
Supeudol is a medicine used to treat moderate to severe pain..
What it does
Supeudol contains oxycodone which is a pain medication belonging to the class of drugs known as opioid which includes codeine, fentanyl, hydromorphone and morphine. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
When it should not be used
- you are allergic to oxycodone, opioids or any other ingredient in the tablets
- 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 bowel blockage or narrowing of the stomach or intestines or you have severe pain in your abdomen
- you have a head injury
- you are at risk for seizures
- 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 a planned surgery
- you are pregnant or planning to become pregnant or you are in labour
- you are breastfeeding
What the medicinal ingredient is
Oxycodone hydrochloride
What the non-medicinal ingredients are
dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
What dosage form it comes in
Supeudol Immediate Release Tablets: 20 mg.
Warnings and precautions
Serious Warnings and Precautions
- Even if you take Supeudol as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
- When you take Supeudol it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
- You may get life-threatening breathing problems while taking Supeudol. This is less likely to happen if you take it as prescribed by your doctor.
- You should never give anyone your Supeudol. They could die from taking it. If a person has not been prescribed Supeudol, taking even one dose can cause a fatal overdose. This is especially true for children.
- If you took Supeudol while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery.
If your baby has any of the following symptoms:- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever
Seek immediate medical help for your baby.
- Taking Supeudol with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Supeudol. 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 disease
- have severe liver disease
- have heart disease
- have low blood pressure
- have or had depression
- suffer from chronic or severe constipation
- have problems with your thyroid, adrenal or prostate gland
- have, or had in the past hallucinations or other severe mental problems
- suffer from migraines
- are pregnant or planning to become pregnant
Other warnings you should know about?
Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Supeudol. Supeudol can cause:
- drowsiness
- dizziness or
- light headedness
This can usually occur after you take your first dose and when your dose is increased.
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 doctor may do tests, give you another medication, and slowly take you off Supeudol.
Serotonin Syndrome: Supeudol can cause serotonin syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin syndrome if you take Supeudol with certain antidepressants or migraine medications.
Serotonin syndrome symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
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.
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 Supeudol:
- Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Supeudol. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other opioid analgesics (drugs used to treat pain)
- 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 Supeudol 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
- anti-retroviral drugs (used to treat viral infections)
- anti-fungal drugs (used to treat fungal infections)
- antibiotic drugs (used to treat bacterial infections)
- anticonvulsants (used to treat seizures)
- some heart medication (such as beta blockers)
- grapefruit juice
- drugs used to treat migraines (e.g. triptans)
- St. John’s Wort
Proper use of this medication
Usual Adult Starting 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.
Review your pain regularly with your doctor to determine if you still need Supeudol. Be sure to use Supeudol only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking Supeudol, tell your doctor immediately.
Stopping your Medication
If you have been taking Supeudol for more than a few days you should not stop taking it all of a sudden. You should check with your doctor for directions on how to slowly stop taking it. You should do it slowly to avoid uncomfortable symptoms such as having:
- body aches
- diarrhea
- gooseflesh
- 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
- 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 Supeudol.
Refilling your Prescription for Supeudol
A new written prescription is required from your doctor each time you need more Supeudol. Therefore, it is important that you contact your doctor before your current supply runs out.
Overdose
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 succession, 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 Oxy∙IR. 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
- Sweating
- Constipation
- Low sex drive, impotence (erectile dysfunction), infertility
| 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 get immediate medical help |
|---|---|---|---|
| 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 | ✔ | ||
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
Storage:
- Keep unused or expired Supeudol in a secure place to prevent theft, misuse or accidental exposure.
- Store tablets between 15 and 30°C. Protect from light. Protect from moisture
- Keep Supeudol under lock and out of sight and out of the 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 Supeudol get emergency help right away.
Disposal:
Supeudol should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- talk with 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; the manufacturer’s website http://www.sandoz.ca or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last revised: September 6, 2019.