Supeudol 10 (Sandoz Canada, 10 mg): Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is Supeudol used for?

Supeudol is used in adults to manage moderate to severe pain.

It is NOT used “as-needed” to treat pain that you only have once in a while.

How does Supeudol work?

Supeudol 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.

What are the ingredients in Supeudol?

Medicinal ingredient: Oxycodone Hydrochloride

Tablets:

Non-medicinal ingredients: aluminium blue lake FD&C (for 5 mg only), croscarmellose sodium, dibasic calcium phosphate, magnesium stearate and microcrystalline cellulose.

Suppository:

Non-medicinal ingredient: hard fat.

Supeudol comes in the following dosage forms:

Supeudol Immediate Release Tablets: 5 and 10 mg.

Supeudol Suppository: 10 and 20 mg.

Do not use Supeudol if:

• your healthcare professional did not prescribe it for you.
• you are allergic to oxycodone hydrochloride, or any of the other ingredients in the Supeudol tablets or suppository.
• 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 with epilepsy.
• you suffer from alcoholism or alcohol withdrawal.
• you are being treated for narcotic withdrawal.
• you are opioid-dependent (need to keep taking opioids to avoid withdrawal symptoms).
• you have severe kidney problems.
• 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 surgery or operation, or have had a surgery in the last 24 hours.
• you are pregnant or planning to become pregnant or you are in labour and delivery.
• you are breastfeeding.

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 kidney, liver, or lung problems.
• have been told you are at risk of having heart problems or seizures.
• have low blood pressure.
• have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea).
• 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 thyroid, adrenal or prostate gland.
• have circulatory problems (e.g., body does not get enough oxygen and nutrients to function properly due to lack of blood flow).
• have bile duct or gallbladder problems.
• have a condition that causes weakness or frailty.
• have gastrointestinal (GI) problems.
• have difficulty urinating.
• are planning on drinking alcohol. Drinking alcohol while taking Supeudol may cause dangerous side effects, including death. Do not drink alcohol while taking Supeudol.
• are planning to breastfeed.
• are 65 years of age or older.
• have been told that you are “opioid tolerant”. Ask your healthcare professional if you are unsure.

Other warnings you should know about:

Taking Supeudol 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 Supeudol.

• Serotonin toxicity (also known as serotonin syndrome): Supeudol 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 Supeudol 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 coordination;
  • 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 that 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.

Drug addiction, dependence, and tolerance: Like any opioid, if you use Supeudol 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. This means that you may need higher doses of Supeudol to feel 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 Supeudol 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.

Pregnancy, nursing, labour and delivery: Do not use Supeudol while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. Supeudol can then cause life-threatening breathing problems in your unborn baby or nursing infant. If you become pregnant while taking Supeudol, tell your healthcare professional right away.

If you are pregnant and are taking Supeudol, 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 Supeudol. 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 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.

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.

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 Supeudol.

Testing and check-ups: Your healthcare professional will regularly monitor your health. This includes monitoring for signs of:

• misuse and abuse;
• sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping);
• respiratory depression and sedation (e.g., 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.

The following may interact with Supeudol:

• anticoagulants used to thin the blood and prevent blood clots (e.g., warfarin).
• medicines that can affect the heart (e.g., amiodarone and quinidine).
• medicines used to treat Parkinson’s Disease.
• antibiotics used to treat bacterial infections (e.g., clarithromycin and rifampin).
• antifungals used to treat fungal infections (e.g., ketoconazole and voriconazole).
• antiretrovirals used to treat viral infections (e.g., ritonavir).
• anticonvulsants used to treat seizures (e.g., carbamazepine, phenytoin).
• grapefruit juice.
• drugs used to treat migraines (e.g., triptans).

How to take Supeudol:

Tablets:

• Take Supeudol tablets exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Supeudol tablets must be taken orally, by mouth. Do NOT administer the Supeudol tablets via any other route as this can cause serious harm, including death.
• Swallow the whole tablet. Do not cut, break, crush, chew or dissolve Supeudol tablets. This can be dangerous and can lead to death or seriously harm you.

• Supeudol tablets can be taken with or without food.

• Review your pain regularly with your healthcare professional to determine if you still need Supeudol tablets. Be sure to use Supeudol tablets only for the condition for which it was prescribed.

Suppository:

1 suppository 3 or 4 times a day, or as required.

Remove suppository from packaging and insert into the rectum.

Usual dose:

Your dose is tailored/personalized just for you. Take it exactly as your healthcare professional has told you to. Do not increase or decrease your dose without consulting your healthcare professional. Taking higher doses can lead to more side effects and a greater chance of overdose.

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. Your healthcare professional will monitor and guide you on how to slowly stop taking Supeudol. 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 Supeudol.

Refilling your Prescription for Supeudol

A new written prescription is required from your healthcare professional each time you need more Supeudol. Therefore, it is important that you contact your healthcare professional before your current supply runs out.

Only obtain prescriptions for this medicine from the 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 overdose with Supeudol may include:

• unusually slow or weak breathing,
• dizziness,
• confusion,
• extreme drowsiness,
• shrinking of pupils,
• floppy muscles/low muscle tone,
• cold and clammy skin,
• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter),
• slow heart rate,
• low blood pressure,
• sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping),
• cardiac arrest (heart stops beating suddenly),
• pulmonary edema (build-up of fluid in the lungs).

If you think you, or a person you are caring for, have taken too much Supeudol, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

It is important that you do not miss any doses. If you miss:

• One dose: Skip the missed dose and take your next dose as scheduled. Do not take two doses at once to make-up for the missed dose.
• Several doses in a row: Talk to your healthcare professional before restarting your medication.

What are possible side effects from using Supeudol?

These are not all the possible side effects you may have when taking Supeudol. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• drowsiness,
• insomnia,
• dizziness,
• nausea, vomiting, or a poor appetite,
• dry mouth,
• headache,
• weakness, uncoordinated muscle movement,
• itching,
• sweating,
• constipation. Talk with your healthcare professional about ways to prevent constipation when you start using Supeudol.
• abdominal pain,
• fever,
• diarrhea,
• indigestion,
• tremor,
• abnormal dreams or thoughts,
• anxiety,
• confusion,
• depression,
• nervousness,
• rash,
• difficulty breathing,
• low sex drive, impotence (erectile dysfunction), infertility.

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 your healthcare professional.

Reporting Side Effects

Storage:

• Store tablets between 15 and 30°C. Protect from light. Protect from moisture.
• Store suppository below 25°C.
• Keep unused or expired Supeudol 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 Supeudol, get emergency help right away.
• 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.

If you want more information about Supeudol:

• 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.sandoz.ca, or by calling 1-800-361-3062.

Last revised: June 19, 2024