Act Oxycodone CR: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is ACT OXYCODONE CR used for?

ACT OXYCODONE CR is used for the long-term management of pain, when:

• the pain is severe enough to require daily, around-the-clock pain medication
• the doctor determines that other treatment options are not able to effectively manage your pain

ACT OXYCODONE CR is NOT used (“as needed”) to treat pain that you only have once in a while.

How does ACT OXYCODONE CR work?

ACT OXYCODONE CR is an oral controlled release tablet that slowly releases oxycodone hydrochloride over a 12 hour period.

ACT OXYCODONE CR contains oxycodone which is a pain medication belonging to the class of medicines known as opioids which includes codeine, fentanyl and morphine. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in ACT OXYCODONE CR?

Medicinal ingredients: oxycodone hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, hydroxyl propyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl acetate and povidone. Coating ingredients include: hypromellose, hydroxypropl cellulose, polyethylene glycol, titanium dioxide, iron oxide yellow (20 mg, 40 mg and 80 mg), iron oxide red (20 mg and 40 mg) and FD&C Blue Aluminium Lake (5 mg and 80 mg).

ACT OXYCODONE CR comes in the following dosage forms:

Controlled release tablets, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.

Do not use ACT OXYCODONE CR if:

• your doctor did not prescribe it for you;
• you are allergic to oxycodone hydrochloride, other opioids, or any of the other ingredients of ACT OXYCODONE CR;
• you have mild or short term pain that can be controlled by the occasional use of pain medications, including those available without a prescription;

• you have difficulty in swallowing or have been diagnosed with narrowing of the

  esophagus;

• you have severe asthma, trouble breathing, or other lung problems;
• you have a condition where the small bowel does not work properly (paralytic ileus) 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
• medication (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or
• selegiline);
• you are pregnant or plan to become pregnant, breast-feeding, or in labour;
• you are under 18 years of age;
• you are going to have, or recently had, a planned surgery.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACT OXYCODONE CR. 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;
• have heart disease;
• have low blood pressure;
• have past or current depression;
• have problems with your thyroid, adrenal or prostate gland;
• suffer from chronic or severe constipation;
• have, or had in the past hallucinations or other severe mental problems;
• suffer from migraines.

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

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

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to ACT OXYCODONE CR. ACT OXYCODONE CR can cause:

• drowsiness;
• dizziness;
• light-headedness.

This can usually occur after you take your first dose and when 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 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 ACT OXYCODONE CR.

Serotonin Syndrome: ACT OXYCODONE CR can cause serotonin syndrome, 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 syndrome if you take ACT OXYCODONE CR 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.

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 ACT OXYCODONE CR:

• alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking ACT OXYCODONE CR. This can lead to drowsiness, depressed breathing, unusually slow or weak breathing, serious side effects or a fatal overdose;
• other sedative drugs which may enhance the drowsiness caused by ACT OXYCODONE CR;
• other opioid analgesics (for pain);
• general anesthetics (used during surgery);
• drugs used to help you sleep or to reduce anxiety;
• antidepressants (for depression and mood disorders). Do not take ACT OXYCODONE CR with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with ACT OXYCODONE CR;
• drugs used to treat serious mental or emotional disorders, such as schizophrenia;
• antihistamines (for allergies);
• anti-emetics (for prevention of vomiting);
• drugs used to treat muscle spasms and back pain;
• warfarin and other coumarin anticoagulants (for prevention/treatment of blood clots);
• some heart medications (beta-blockers);
• anti-retroviral, azole-anti-fungal and macrolide-antibiotic drugs;
• grapefruit juice;
• St. John’s Wort.

How to take ACT OXYCODONE CR:

Swallow whole. Do not cut, break, chew, dissolve or crush ACT OXYCODONE CR tablets before swallowing since this can lead to the release and absorption of an excessive dose of oxycodone which can seriously harm you.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly. Taking higher doses can lead to more side effects and a greater chance of overdose.

Take the dose prescribed by your doctor. ACT OXYCODONE CR tablets should be taken every 12 hours with a glass of water.

Your dose of ACT OXYCODONE CR will be clearly labelled on the medication bottle. Be sure to follow the directions on the label exactly; this is very important. Do not increase or decrease your dose without consulting your doctor. If your dosage is changed by your doctor, be sure to write it down at the time your doctor calls or sees you, and follow the new directions exactly. Review your pain regularly with your doctor to determine if you still need ACT OXYCODONE CR. Be sure to use ACT OXYCODONE CR only for the condition for which it was prescribed.

Stopping your Medication:

You should not stop taking ACT OXYCODONE CR all at once if you have been taking it for more than a few days.

Your doctor will monitor and guide you on how to slowly stop taking ACT OXYCODONE CR. 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 with 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 ACT OXYCODONE CR.

Refilling Prescriptions for ACT OXYCODONE CR:

A new written prescription is required from your doctor each time you need more ACT OXYCODONE CR. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

Signs of overdose may include:

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

Missed Dose:

It is important that you do not miss any doses. If you miss a dose, take your next dose at your usual time. You should always try to get back on track with your regular dosing schedule (e.g., 8 o’clock in the morning and 8 o’clock in the evening). If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using ACT OXYCODONE CR?

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

Side effects may include:

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Itching
• Weakness, uncoordinated muscle movement
• Nausea and/or vomiting, or poor appetite
• Sweating
• Insomnia
• Abdominal pain
• Fever
• Diarrhea
• Indigestion
• Tremor
• Abnormal dreams or thoughts
• Anxiety
• Confusion
• Depression
• Nervousness
• Rash
• Difficulty breathing
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using ACT OXYCODONE CR.

If nausea and vomiting become troublesome during prolonged therapy with ACT OXYCODONE CR, talk to your doctor or pharmacist.

Serious side effects and what to do about them

Serious side effects and what to do about them

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.

Reporting Side Effects

Storage:

• Keep unused or expired ACT OXYCODONE CR in a secure place to prevent theft, misuse or accidental exposure.
• Store ACT OXYCODONE CR tablets between 15°C and 30°C. Keep container tightly closed. Protect from moisture.
• Keep ACT OXYCODONE CR 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 ACT OXYCODONE CR, get emergency help right away.

Disposal:

ACT OXYCODONE CR 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 ACT OXYCODONE CR:

• 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 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.

Last Revised: October 1, 2019