Teva-Oxycodone CR: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TEVA-OXYCODONE CR used for?

TEVA-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

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

How does TEVA-OXYCODONE CR work?

TEVA-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 TEVA-OXYCODONE CR?

Medicinal ingredients: Oxycodone Hydrochloride

TEVA-OXYCODONE CR 10 mg

Colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, talc and titanium dioxide.

TEVA-OXYCODONE CR 20 mg

Colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polydextrose, silicified microcrystalline cellulose, synthetic iron oxide red, triacetin and titanium dioxide.

TEVA-OXYCODONE CR 40 mg

Colloidal silicon dioxide, D&C Yellow No. 10 Aluminum lake, FD&C Red No. 40 Aluminium lake, iron oxide yellow, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc and titanium dioxide.

TEVA-OXYCODONE CR 80 mg

Colloidal silicon dioxide, FD&C Blue No. 2 Aluminium lake, FD&C Red No. 40 Aluminium lake , FD&C Yellow No. 5 Aluminium lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, soya bean lecithin, talc and titanium dioxide.

TEVA-OXYCODONE CR comes in the following dosage forms:

10 mg tablets are round, unscored, white to off-white, biconvex, controlled release tablet, engraved with "N" on one side and "10" on the other side. They are available in white HDPE bottles of 50 or 100 tablets or in 100 unit dose blister packages.

20 mg tablets are round, unscored, pink, biconvex, controlled release tablet, engraved with "N" on one side and "20" on the other side. They are available in white HDPE bottles of 50 or 100 tablets or in 100 unit dose blister packages.

40 mg tablets are round, unscored, yellow, biconvex, controlled release tablet, engraved with "N" on one side and "40" on the other side. They are available in white HDPE bottles of 50 or 100 tablets or in 20 unit dose blister packages.

80 mg tablets are round, unscored, green, biconvex, controlled release tablet, engraved with "N" on one side and "80" on the other side. They are available in white HDPE bottles of 50 or 100 tablets or in 20 unit dose blister packages.

Do not use TEVA-OXYCODONE CR if:

• you are allergic to oxycodone hydrochloride, other opioids, or any of the other ingredients of TEVA-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 TEVA-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 TEVA-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 TEVA-OXYCODONE CR:

• alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking TEVA-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 TEVA-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 TEVA-OXYCODONE CR with monoamine oxide (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with TEVA-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 TEVA-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. TEVA-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 TEVA-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 TEVA-OXYCODONE CR. Be sure to use TEVA-OXYCODONE CR only for the condition for which it was prescribed.

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 TEVA-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 TEVA-OXYCODONE CR:

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

What are possible side effects from using TEVA-OXYCODONE CR?

These are not all the possible side effects you may feel when taking TEVA-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 TEVA-OXYCODONE CR.

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 TEVA-OXYCODONE CR Tablets between 15° and 30°C. Keep container tightly closed. Protect from moisture.

Keep unused or expired TEVA-OXYCODONE CR in a secure place to prevent theft, misuse or accidental exposure.

Keep TEVA-OXYCODONE CR under lock, out of sight and reach of children and pets.

Disposal:

TEVA-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 TEVA-OXYCODONE CR:

Talk to your healthcare professionalFind the full product monograph that is prepared for health professionals and includes this consumer medication information by visiting the Health Canada website; the manufacturer’s website www.tevacanada.com, or by calling

1-800-268-4127 ext. 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last Revised : August 19, 2014