Details for: TEVA-MORPHINE SR
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02302764 | TEVA-MORPHINE SR | MORPHINE SULFATE | 15 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02302772 | TEVA-MORPHINE SR | MORPHINE SULFATE | 30 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02302780 | TEVA-MORPHINE SR | MORPHINE SULFATE | 60 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02302799 | TEVA-MORPHINE SR | MORPHINE SULFATE | 100 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02302802 | TEVA-MORPHINE SR | MORPHINE SULFATE | 200 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TEVA-MORPHINE SR 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-MORPHINE SR is NOT used (“as needed”) to treat pain that you only have once in a while.
What it does
TEVA-MORPHINE SR is an oral sustained release tablet that slowly releases morphine over a 12 hour period. TEVA-MORPHINE SR contains morphine which is a pain medication belonging to the class of medicines known as opioids which includes codeine, fentanyl and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
When it should not be used
- your doctor did not prescribe it for you
- you are allergic to morphine, other opioids, or any of the other ingredients of TEVA-MORPHINE SR
- 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 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
- if 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, breast-feeding, or in labour
- are going to have, or recently had a planned surgery
What the medicinal ingredient is
Morphine sulfate
What the non-medicinal ingredients are
Tablet core (all strengths): Colloidal Silicon Dioxide, Hydroxypropyl
Methylcellulose, Lactose Monohydrate, Magnesium Stearate and Stearic Acid.
Tablet Coating:
Polyvinyl Alcohol (Partially Hydrolyzed), Polyethylene Glycol 3350, Talc, Titanium Dioxide
Additional coating ingredients specific to each strength:
| 15 mg : | D&C Yellow #10/Aluminum Lake FD&C Blue #1/Aluminum Lake FD&C Red #40/ Aluminum Lake |
| 30 mg : | FD&C Blue #2/ Aluminum Lake D&C Red #27/Aluminum Lake FD&C Yellow #6/Aluminum Lake |
| 60 mg : | FD&C Yellow #6/Aluminum Lake FD&C Red #40/Aluminum Lake |
| 100 mg : | FD&C Blue #2/Aluminum Lake FD&C Yellow #6/Aluminum Lake FD&C Red #40/Aluminum Lake |
| 200 mg : | D&C Red #30/Aluminum Lake FD&C Red #40/Aluminum Lake |
What dosage form it comes in
Sustained Release Tablets: 15 mg, 30 mg, 60 mg, 100 mg and 200 mg.
Warnings and precautions
Serious Warnings and Precautions
- Even if you take TEVA-MORPHINE SR 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 TEVA-MORPHINE SR, 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 TEVA-MORPHINE SR. They could die from taking it. If a person has not been prescribed TEVA-MORPHINE SR, taking even one dose can cause a fatal overdose. This is especially true for children.
- If you took TEVA-MORPHINE SR 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 TEVA-MORPHINE SR 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.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-MORPHINE SR. 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 problems with your thyroid, adrenal or prostate gland
- have past or current depression
- suffer from chronic or severe constipation
- have, or had in the past, hallucinations or other severe mental problems
- suffer from migraines
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 TEVA-MORPHINE SR while pregnant, nursing,
during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the
womb. TEVA-MORPHINE SR can then cause life-threatening breathing problems in your unborn baby or
nursing infant.
Driving and using machines: Before you do tasks which may require special attention, you should wait until
you know how you react to TEVA-MORPHINE SR. TEVA-MORPHINE SR can cause:
- drowsiness
- dizziness or
- lightheadedness
This can usually occur after you take your first dose and when your 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 of 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 TEVAMORPHINE
SR.
Serotonin syndrome: TEVA-MORPHINE SR can cause serotonin syndrome, a rare but potentially
lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work.
You may develop serotonin syndrome if you take TEVA-MORPHINE SR with certain antidepressants 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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,
minerals, natural supplements or alternative medicines.
Interactions with this medication
- alcohol, including prescription and non-prescription medications containing alcohol.
- Do not drink alcohol while taking TEVA-MORPHINE SR. 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 TEVA-MORPHINE SR
- 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-MORPHINE SR with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with TEVA-MORPHINE SR
- 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
- some heart medication (beta blockers)
- warfarin and other coumarin anticoagulants (for prevention/treatment of blood clots)
- St. John’s Wort
Proper use of this medication
TEVA-MORPHINE SR tablets are designed to work properly over 12 hours when swallowed whole.
TEVA-MORPHINE SR 100 mg and 200 mg tablets are for use in “opioid tolerant” patients only. Your
doctor will tell you when you are “opioid tolerant” to a certain dose of TEVA-MORPHINE SR.
Swallow whole. Do not cut, break, chew, dissolve or crush since this can cause the release of the entire 12-
hour dose of morphine, which can seriously harm you. Only the 200 mg tablet is scored and may be
broken in half. The half tablet must also be swallowed intact.
TEVA-MORPHINE SR tablets must be taken regularly, every 12 hours (with or without food and with
sufficient fluid, e.g., 4 to 6 oz. of water), to treat pain.
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 TEVA-MORPHINE SR. Be sure to
use TEVA-MORPHINE SR only for the condition for which it was prescribed.
Should your pain increase or any other complaint as a result of taking TEVA-MORPHINE SR, tell your doctor
immediately.
Stopping your Medication
You should not stop taking TEVA-MORPHINE SR 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 TEVA-MORPHINE SR. 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 TEVA-MORPHINE SR.
Refilling Prescriptions for TEVA-MORPHINE SR
A new written prescription is required from your doctor each time you need more TEVA-MORPHINE SR.
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
- 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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking TEVA-MORPHINE SR. If you experience
any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Constipation
- Dizziness
- Drowsiness
- Dry mouth
- Headache
- Itching
- Lack of muscle strength
- Nausea and/or vomiting
- Sweating
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using TEVAMORPHINE
SR.
If nausea and vomiting become troublesome during prolonged therapy with TEVA-MORPHINE SR, talk to
your doctor or pharmacist
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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, lightheadedness. | ✔ | ||
| Serotonin Syndrome: agitation or restlessness, less 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.
How to store
Keep unused or expired TEVA-MORPHINE SR in a secure place to prevent theft, misuse or accidental
exposure.
TEVA-MORPHINE SR 15 mg tablets: store tablets at room temperature (15°C - 25°C). Protect from light.
TEVA-MORPHINE SR 30, 60, 100 and 200 mg tablets: Store tablets at room temperature (15°C - 30°C).
Protect from light.
Keep TEVA-MORPHINE SR 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 TEVA-MORPHINE SR, get
emergency help right away.
Disposal:
TEVA-MORPHINE SR should never be thrown into household trash, where children and pets may find
it. It should be returned to a pharmacy for proper disposal.
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.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for 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.
More information
- 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer's website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9
Last revised: June 12, 2018