Patient Medication Information: uses, side effects, how to take - Ran-Oxycodone CR

Serious Warnings and Precautions

Even if you take RAN-OXYCODONE CR as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose and death. To understand your risk of opioid addiction, abuse, and misuse you should speak to your prescriber (e.g., doctor).
Life-threatening breathing problems can happen while taking RAN-OXYCODONE CR, especially if not taken as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
Never give anyone your RAN-OXYCODONE CR. They could die from taking it. If a person has not been prescribed RAN-OXYCODONE CR, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took RAN-OXYCODONE CR while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever

Seek immediate medical help for your baby.

Taking RAN-OXYCODONE CR with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

What is RAN-OXYCODONE CR used for?

RAN-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

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

How does RAN-OXYCODONE CR work?

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

RAN-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 RAN-OXYCODONE CR?

Medicinal ingredient: oxycodone hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, and povidone.

In addition, the tablet coating contains the following: D&C Yellow No.10 Aluminum Lake (for 80 mg tablet), FD&C Blue No.2 (for 15 mg and 80 mg tablet), FD&C Red No.40 (for 60 mg tablet), FD&C Yellow No.5 (for 40 mg tablet), FD&C Yellow No.6 (for 60 mg tablet), iron oxide ((yellow) for 40 mg tablet), iron oxide ((black, yellow) for 15 mg tablet), iron oxide ((red, yellow) for 20 mg tablet), talc (for 20 mg, 40 mg and 80 mg tablet), hypromellose, macrogol, and titanium dioxide.

RAN-OXYCODONE CR comes in the following dosage forms:

RAN-OXYCODONE CR Controlled Release Tablets: 15 mg, 20 mg, 40 mg, 60 mg and 80 mg.

Do not use RAN-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 RAN-OXYCODONE CR (see What are the ingredients in RAN-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 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 (MOI) medication (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
you are pregnant or plan to become pregnant, or you are in labour
you are breastfeeding
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 RAN-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 a history of sleep apnea
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
are planning to become pregnant

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 RAN-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. RAN-OXYCODONE CR can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking RAN-OXYCODONE CR, 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 doctor will monitor and guide you on how to slowly stop taking RAN-OXYCODONE CR. 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 RAN-OXYCODONE CR. RAN-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 RAN-OXYCODONE CR.

Serotonin Syndrome

RAN-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 RAN-OXYCODONE CR with certain anti-depressants 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; and
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.

Sleep Apnea Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.

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 RAN-OXYCODONE CR:

alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking RAN-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 RAN-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 RAN-OXYCODONE CR with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with RAN-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 medication (beta blockers)
anti-retroviral, azole-anti-fungal and macrolide-antibiotic drugs
grapefruit juice
St. John’s Wort

How to take RAN-OXYCODONE CR:

RAN-OXYCODONE CR tablets are designed to work properly over 12 hours when swallowed whole.

Swallow whole. Do not cut, break, chew, dissolve or crush RAN-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.

Do not take the 60 mg or 80 mg strength or a single dose of 40 mg or more of RAN-OXYCODONE CR unless you are “opioid tolerant”. Your doctor will tell you when you are “opioid tolerant” to a certain dose of RAN-OXYCODONE CR.

RAN-OXYCODONE CR can be taken with or without food.

RAN-OXYCODONE CR is not recommended for rectal administration.

Usual Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor. Taking higher doses can lead to more side effects and a greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need RAN-OXYCODONE CR. Be sure to use RAN-OXYCODONE CR only for the condition for which it was prescribed.

Should your pain increase or any other complaint develop as a result of taking RAN-OXYCODONE CR, tell your doctor immediately

Stopping your Medication:

You should not stop taking RAN-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 RAN-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 RAN-OXYCODONE CR.

Refilling Prescriptions for RAN-OXYCODONE CR:

A new written prescription is required from your doctor each time you need more RAN-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:

If you think you have taken too much RAN-OXYCODONE CR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

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 RAN-OXYCODONE CR?

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

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

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
RARE
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin.			√
Respiratory Depression: slow, shallow or weak breathing.			√
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing.			√
Bowel Blockage (Impaction): abdominal pain, severe constipation, nausea.			√
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating.		√

Fast, Slow or Irregular Heartbeat: heart palpitations.		√
Low Blood Pressure: dizziness, fainting, light-headedness.	√
Serotonin syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea.			√

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for more information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

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

Disposal:

RAN-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 RAN-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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-840-1340.

Ranbaxy Pharmaceuticals Canada Inc.

Brampton, ON

L6T 1C1

Last revised: May 06, 2021

All brands are the property of their respective owners.

Ran-Oxycodone CR: Uses, Side Effects and Dosage