Sandoz Oxycodone CR: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is Sandoz Oxycodone CR used for?

Sandoz 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

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

How does Sandoz Oxycodone CR work?

Sandoz Oxycodone CR contains oxycodone which is a pain medication 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 Sandoz Oxycodone CR?

Medicinal ingredients: Oxycodone Hydrochloride

Non-medicinal ingredients: Sandoz Oxycodone CR Tablets: microcrystalline cellulose, copovidone, behenoyl polyoxylglycerides, hypromellose, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica, stearic acid, triglycerides, titanium dioxide, hydrogenated castor oil.

In addition, the tablet coatings contain the following colouring agents:

5 mg: Indigo carmine, hydrated aluminum oxide, quinoline yellow

10 mg – none

20 mg – red iron oxide

40 mg – yellow iron oxide

80 mg – hydrated aluminium oxide, indigo carmine, black iron oxide, quinolone yellow

Sandoz Oxycodone CR comes in the following dosage forms:

Sandoz Oxycodone CR Tablets: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg.

Do not use Sandoz Oxycodone CR if:

• you are allergic to oxycodone hydrochloride, other opioids, or any of the other ingredients of Sandoz Oxycodone CR
• your pain can be controlled by the occasional use of pain medications including those available without a prescription
• you have severe asthma, trouble breathing, or any heart problems
• you have bowel blockage or narrowing of the stomach or intestines (eg. paralytic ileus)
• you have severe pain in your abdomen
• you have a head injury or other risks for seizures

• you suffer from alcoholism

• you have an irregular heartbeat

• you are pregnant or plan to become pregnant, breastfeeding, or in labour

• you are under 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Oxycodone CR. Talk about any health conditions or problems you

may have, including if you:

• have severe kidney, liver disease
• are going to have or recently had, a planned surgery
• Have a history of illicit or prescription drug or alcohol abuse
• 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

Other warnings you should know about:

There are important differences between physical dependence and addiction, and each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to Sandoz Oxycodone CR. Drowsiness, dizziness, or light-headedness, can especially occur after the first dose and when the dose is increased.

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 Sandoz Oxycodone CR:

• alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking Sandoz Oxycodone CR. This can lead to drowsiness, depressed breathing, serious side effects or a fatal overdose.
• other sedative drugs which may enhance the drowsiness caused by Sandoz 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 Sandoz Oxycodone CR with monoamine oxide (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with Sandoz 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

How to take Sandoz Oxycodone CR:

Swallow whole. Do not break, chew, dissolve or crush the tablet as this leads to quick release and absorption of a higher dose of oxycodone over a short period of time that may cause death.

Usual dose:

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

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly.

Your dose of Sandoz 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 Sandoz Oxycodone CR. Be sure to use Sandoz Oxycodone CR only for the condition for which it was prescribed.

You may see tablets in your stools (bowel movements) when using Sandoz Oxycodone CR. Do not be concerned, your body has absorbed the medicine.

Overdose:

Signs of overdose may include abnormally slow or weak breathing, dizziness, confusion or extreme drowsiness.

Missed Dose:

It is important that you do not miss any doss. If you miss one 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 succession, talk to your doctor before restarting your medication.

Discontinuation:

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

Consult your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms such as body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, unexplained fever, weakness and yawning

Refilling Prescriptions for Sandoz Oxycodone CR:

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

What are possible side effects from using Sandoz Oxycodone CR?

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

Side effects may include:

• Drowsiness,
• Dizziness,
• Dry mouth
• Nausea and/or vomiting,
• Headache
• Problems with vision
• Lack of muscle strength
• Itching
• Sweating
• Constipation

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

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:

Store between 15° and 30°C.

Keep unused or expired Sandoz Oxycodone CR in a secure place to prevent theft, misuse or accidental exposure.

Keep Sandoz Oxycodone CR under lock, out of sight and reach of children and pets.

Disposal:

Sandoz 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 Sandoz 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 Health Canada website; the manufacturer’s website www.sandoz.com or by calling 1-800-361-3062 Or by e-mail at : medinfo@sandoz.com

Last Revised : August 20, 2014