Patient Medication Information: uses, side effects, how to take - PMS-Oxycodone CR
Serious Warnings and Precautions
Seek immediate medical help for your baby.
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What is pms-OXYCODONE CR used for?
pms-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
pms-OXYCODONE CR is NOT used (“as needed”) to treat pain that you only have once in a while.
How does pms-OXYCODONE CR work?
pms-OXYCODONE CR is an oral controlled release tablet that slowly releases oxycodone hydrochloride over a 12-hour period.
pms-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 pms-OXYCODONE CR?
Medicinal ingredients: Oxycodone Hydrochloride
Non-medicinal ingredients: Colloidal Silicon Dioxide, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Maltodextrin, Medium Chain Triglycerides, Polydextrose, Talc, Titanium Dioxide, and the following colouring agents:
5 mg: FD&C Blue No.1 Aluminum Lake, Iron Oxide Yellow
15 mg: FD&C Blue No.2 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 FCF Aluminum Lake.
20 mg: Iron Oxide Red.
30 mg: Black Iron Oxide, Yellow Iron Oxide, Red Iron Oxide.
40 mg: D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake.
60 mg: FD&C Blue No.1 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, FD&C Yellow No.5.
80 mg: FD&C Blue No.2 Aluminum Lake, Iron Oxide Yellow.
pms-OXYCODONE CR comes in the following dosage forms:
Controlled Release Tablets: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg
Do not use pms-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 pms-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 (eg. paralytic ileus)
- 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, breastfeeding, 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 pms-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 pms-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. pms-OXYCODONE CR can then cause life-threatening breathing problems in your unborn baby or nursing infant.
If you are pregnant and are taking pms-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 pms-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 pms-OXYCODONE CR.
pms-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 pms-OXYCODONE CR.
Serotonin Syndrome
pms-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 pms-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;
- 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 pms-OXYCODONE CR:
alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking pms-OXYCODONE CR. This can lead to:
- drowsiness,
- unusually slow or weak breathing,
- serious side effects
- fatal overdose.
- other sedative drugs which may enhance the drowsiness caused by pms-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 pms-OXYCODONE CR with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with pms-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 pms-OXYCODONE CR:
pms-OXYCODONE CR tablets are designed to work properly over 12 hours when swallowed whole.
Swallow whole. Do not cut, break, chew, dissolve or crush pms-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 pms-OXYCODONE CR unless you are “opioid tolerant”. Your doctor will tell you when you are “opioid tolerant” to a certain dose of pms-OXYCODONE CR.
pms-OXYCODONE CR can be taken with or without food.
pms-OXYCODONE CR is not recommended for rectal administration.
Usual Adult Starting 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 pms-OXYCODONE CR. Be sure to use pms-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 pms-OXYCODONE CR, tell your doctor immediately.
Stopping your Medication:
You should not stop taking pms-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 pms-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 pms-OXYCODONE CR.
Refilling Prescriptions for pms-OXYCODONE CR:
A new written prescription is required from your doctor each time you need more pms-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 abnormally slow or weak breathing, dizziness, confusion or extreme drowsiness.
| If you think you, or a person you are caring for, have taken too much pms-OXYCODONE CR, contact a 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 or
- 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 pms-OXYCODONE CR?
These are not all the possible side affects you may feel when taking pms-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 pms-OXYCODONE CR.
If nausea and vomiting become troublesome during prolonged therapy with pms-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:
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:
- Keep unused or expired pms-OXYCODONE CR in a secure place to prevent theft, misuse or accidental exposure.
- Store pms-OXYCODONE CR tablets between 15°C and 30°C.
- Keep pms-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 pms-OXYCODONE CR, get emergency help right away.
Keep pms-OXYCODONE CR under lock, out of sight and reach of children and pets.
Disposal:
pms-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 pms-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); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.