Patient Medication Information: uses, side effects, how to take - Riva-Oxycodone CR
ABOUT THIS MEDICATION
RIVA-OXYCODONE CR is a controlled substance (opioid class of drugs - Schedule 1) because it contains a narcotic pain killer that can be a target for people who abuse prescription medicines or street drugs.
Because of their properties that affect the mind and mental processes (psychoactive) and their potential for abuse, opioid pain medications are subject to the Controlled Drugs and Substances Act (CDSA) which provides control of substances that can alter mental processes and that may produce harm to health and to society when diverted or abused.
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th the exception of authorized use, all activities involving controlled substances are prohibited by law in Canada, under the CDSA.
What the medication is used for:
RIVA-OXYCODONE CR is an oral controlled release tablet that slowly releases oxycodone (an opioid analgesic) over a 12 hour period, and requires a dose every 12 hours to control your pain.
What it does:
Oxycodone is a medicine used to treat moderate to severe pain requiring the continuous use of an opioid analgesic preparation for several days or more.
Oxycodone belongs to a class of drugs which is commonly referred to as opiates, opioids or narcotics and also includes codeine, fentanyl, hydromorphone and morphine.
Your pain may increase or decrease occasionally and your doctor may need to change the amount of oxycodone you take daily (daily dosage).
When it should not be used:
RIVA-OXYCODONE CR should not be used if:
- Your doctor did not prescribe it for you;
- You are allergic to oxycodone, opioids or any other ingredient in the tablets; (see What the nonmedicinal ingredients are)
- Your pain is mild;
Your pain can be controlled by occasional use of
any painkillers;
You have severe asthma or severe lung
problems;
- You suffer from alcoholism;
- You have a head injury;
- You suffer from seizures;
You had surgery less than 12-24 hours ago and
you were not taking RIVA-OXYCODONE CR just before surgery;
You have a condition where the small bowel
does not work properly (paralytic ileus) or you have severe pain in your abdomen;
You are taking, or have taken within the past 2
weeks, a monoamine oxidase inhibitor medications (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline);
You are pregnant, in labour or breast-feeding.
Individuals under 18 years of age should not take RIVA-OXYCODONE CR tablets.
What the medicinal ingredient is:
Oxycodone Hydrochloride
What the important nonmedicinal ingredients are: RIVA-OXYCODONE CR Tablets contain: (all strengths): Lactose Monohydrate, Hydroxypropyl Methylcellulose, Magnesium Stearate , Colloidal Silicon Dioxide. 10 mg Film Coating: Hydroxypropyl methylcellulose, Titanium Dioxide, Polydextrose, Talc, Maltodextrin, and Medium Chain Triglycerides.
20 mg Film Coating: Hydroxypropyl
Methylcellulose, Titanium Dioxide, Polydextrose, Talc, Maltodextrin, Medium Chain Triglycerides, and Iron Oxide Red.
40 mg Film Coating: Hydroxypropyl
Methylcellulose, Titanium Dioxide, Polydextrose, Talc, Maltodextrin, Medium Chain Triglycerides, D&C Yellow No.10 Aluminum Lake & FD&C Yellow No. 6 Aluminum Lake.
80 mg Film Coating: Hydroxypropyl
Methylcellulose, Titanium Dioxide, Polydextrose, Talc, Maltodextrin, Medium Chain Triglycerides, FD&C Blue No.2 Aluminum Lake, and Iron Oxide Yellow .
What dosage forms it comes in:
RIVA-OXYCODONE CR Tablets; 10, 20, 40 and 80 mg.
WARNINGS AND PRECAUTIONS
RIVA-OXYCODONE CR tablets are designed to work properly over 12 hours when swallowed whole.
If RIVA-OXYCODONE CR tablets are abused by crushing, chewing, dissolving, snorting or injecting the product, this leads to quick release and absorption of a higher dose over a short period of time that may cause death.
You MUST NOT consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on RIVA-OXYCODONE CR therapy. This may result in more drug in your bloodstream and may lead to dangerous side effects like what happens when you take more than you prescribed dose. You can die from an overdose of this medication.
You must not take other drugs that affect the brain (CNS depressants) together with RIVA-OXYCODONE CR, as this may lead to more effects on the brain (CNS depression) that include shallow slow breathing (respiratory depression), low blood pressure (hypotension), feeling very sleepy (profound sedation) or losing consciousness (coma).
Keep RIVA-OXYCODONE CR out of the reach of children. You should not give RIVA-OXYCODONE CR to anyone as inappropriate use may have severe medical consequences, including death.
BEFORE you use RIVA-OXYCODONE CR, talk to your doctor or pharmacist if you have, or had in the past any other medical conditions, especially the following ones: trouble breathing or lung problems, head injury, liver or kidney problems, adrenal gland problems, such as Addison’s disease, convulsions or seizures, alcoholism, hallucinations or other severe mental problems, past or present substance abuse or drug addiction.
Tell your doctor or pharmacist if you are pregnant, plan to become pregnant, or are breastfeeding. RIVA-OXYCODONE CR will pass through the milk and may harm the baby. RIVA-OXYCODONE CR should not be used in patients who are pregnant or lactating.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking RIVA-OXYCODONE CR.
You should take the following precautions while taking
RIVA-OXYCODONE CR tablets:
You must not consume alcohol while taking
RIVA-OXYCODONE CR as it may increase the chance of experiencing dangerous side effects;
- Driving or other tasks requiring full alertness should not be attempted until you are sure that taking RIVA-OXYCODONE CR does not make you drowsy;
You must tell your doctor and pharmacist if you
are taking any other over-the counter or prescription medications - they will tell you what you should do.
Abuse, Addiction and Physical Dependence
There is a risk of abuse or addiction with all opioids. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking opioids, such as RIVA-OXYCODONE CR. Patients who have taken RIVA-OXYCODONE CR for a period of time may develop physical dependence, and should not abruptly stop taking it. See ‘Discontinuation:’ section of this leaflet.
While there are important differences between physical dependence and addiction, 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.
For more information on the use of this type of medication go to www.healthcanada.gc.ca/iyh. This site provides Health Canada endorsed information on the safe use of opioid medications.
INTERACTIONS WITH THIS MEDICATION
You should not take RIVA-OXYCODONE CR if
you are currently taking (or recently stopped taking) one of the medicines known as monoamine oxidase inhibitor medications (e.g. Phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
Drugs that may interact with RIVA-OXYCODONE CR include:
- Alcohol or other sedative drugs may enhance the drowsiness caused by oxycodone;
Other opioids, anaesthetics, sedatives,
hypnotics, antidepressants, sleeping aids, phenothiazines, neuroleptics, some heart medications (e.g., beta-blockers), chloral hydrate and glutethimide;
Antihistamines or sleep aids (these medicines
could make you drowsy and depress your breathing);
Any nonprescription, (over- the-counter)
medications;
- Any herbal remedies.
PROPER USE OF THIS MEDICATION
RIVA-OXYCODONE CR tablets must be swallowed whole and should not be broken, chewed, dissolved or crushed since this can lead to the release and absorption of an excessive dose of oxycodone which can seriously harm you. This is
very dangerous. You could die from an overdose of the medicine.
RIVA-OXYCODONE CR is not recommended for rectal administration.
Usual dose:
Take the dose prescribed by your doctor. RIVA-OXYCODONE CR tablets should be taken every 12 hours with a glass of water.
Your dose of RIVA-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 RIVA-OXYCODONE CR. Be sure to use RIVA-OXYCODONE CR only for the condition for which it was prescribed.
You may see tablets in your stools (bowel movements) when using RIVA-OXYCODONE CR. Do not be concerned, your body has absorbed the medicine.
D
o
not drink alcohol while using RIVA-OXYCODONE CR. It may increase the chance of having dangerous side effects including overdose and death.
Discontinuation:
After you stop taking RIVA-OXYCODONE CR you should take the unused tablets to your pharmacist to be destroyed.
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.
You should not stop taking RIVA-OXYCODONE CR all at once if you have been taking it for more than a few days.
Reordering RIVA-OXYCODONE CR:
A new written prescription is required from your do
c
tor each time you need more RIVA-
OXYCODONE CR. Therefore, it is important that you contact your doctor at least three working days before your current supply runs out.
Overdose:
The most important sign of overdose is decreased breathing (abnormally slow or weak breathing), dizziness, confusion or extreme drowsiness.
If you accidentally take an overdose of RIVA-OXYCODONE CR, call your doctor and/or your local emergency number and/or a Regional Poison Control Centre immediately or go to a hospital emergency and take any remaining tablets and the container with you, even though you may not feel sick.
Missed Dose:
It is very important that you do not miss any doses. 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, unless your doctor tells you to. If you miss several doses in succession, talk to your doctor before restarting your medication.
Do not seek additional prescriptions for this medicine from any other doctor - unless responsibility for your pain management has been transferred to another doctor.
Should your pain increase, or any other complaint develop as a result of taking RIVA-OXYCODONE CR, tell your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects you may experience are constipation, nausea, drowsiness, dizziness, vomiting, itching, headache, dry mouth, weakness and sweating. Tell your doctor about these problems if they arise. Your doctor may order a laxative and stool softener to help relieve your constipation while you are taking RIVA-OXYCODONE CR.
If you experience any symptoms related to difficulty in breathing, such as tight chest or wheezing, fainting, or rapid heartbeat, seek immediate emergency medical assistance.
RIVA-OXYCODONE CR can cause physical dependence. Your body will get used to RIVA-OXYCODONE CR if you take it more than a few days. You can get sick with withdrawal symptoms if you stop taking RIVA-OXYCODONE CR all at once. You can avoid getting sick with withdrawal symptoms by stopping RIVA-OXYCODONE CR slowly. Your doctor will tell you how to do this. See withdrawal reactions listed within the Discontinuation section of this leaflet.
Opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety and shivering are also possible after converting from your previous opioid analgesic to RIVA-OXYCODONE CR, or converting from RIVA-OXYCODONE CR to another opioid. Contact your doctor if you experience these symptoms when switching to or from RIVA-OXYCODONE CR.
This is not a complete list of side effects. For any unexpected effects while taking RIVA-OXYCODONE CR, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15° and 30°C. Keep container tightly closed. Protect from moisture.
Keep RIVA-OXYCODONE CR in a secure place to prevent theft and misuse.
Do not give RIVA-OXYCODONE CR to anyone other than the person for whom it was prescribed, since it may seriously harm them, including death.
Keep RIVA-OXYCODONE CR out of the reach of children. Accidental overdose by a child is dangerous and may result in death.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report on line at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and -Fax toll-free to 1-866-678-6789 or -Mail to: Canada Vigilance Program Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
P
o
stage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the distributor, Laboratoire Riva Inc,, at: 1-800-363-7988.
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Québec, J7C 3V4