Patient Medication Information: uses, side effects, how to take - Morphine SR

Serious Warnings and Precautions

Even if you take 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 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 MORPHINE SR. They could die from taking it. If a person has not been prescribed MORPHINE SR, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took 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 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.

What is MORPHINE SR used for?

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

MORPHINE SR is NOT used (“as needed”) to treat pain that you only have once in a while.

How does MORPHINE SR work?

MORPHINE SR is an oral sustained release tablet that slowly releases morphine over a 12 hour period. 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.

What are the ingredients in MORPHINE SR?

Medicinal ingredient: Morphine sulfate

Non-medicinal ingredients: 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

MORPHINE SR comes in the following dosage forms:

Sustained Release Tablets: 15 mg, 30 mg and 60 mg.

Do not use MORPHINE SR if:

your doctor did not prescribe it for you
you are allergic to morphine, other opioids, or any of the other ingredients of 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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take 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 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. 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 MORPHINE SR. 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 MORPHINE SR.

Serotonin syndrome: 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 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.

The following may interact with MORPHINE SR:

alcohol, including prescription and non-prescription medications containing alcohol.
Do not drink alcohol while taking 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 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 MORPHINE SR with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with 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

How to take MORPHINE SR:

MORPHINE SR tablets are designed to work properly over 12 hours when swallowed whole.

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.

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 MORPHINE SR. Be sure to use MORPHINE SR only for the condition for which it was prescribed.

Should your pain increase or any other complaint as a result of taking MORPHINE SR, tell your doctor immediately.

Stopping your Medication:

You should not stop taking 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 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 MORPHINE SR.

Refilling Prescriptions for MORPHINE SR:

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

If you think you have taken too much MORPHINE SR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

What are possible side effects from using MORPHINE SR?

These are not all the possible side effects you may feel when taking 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 MORPHINE SR.

If nausea and vomiting become troublesome during prolonged therapy with MORPHINE SR, 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
Symptom/ effect	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, 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.

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 (http://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.

Storage:

Keep unused or expired MORPHINE SR in a secure place to prevent theft, misuse or accidental exposure.

MORPHINE SR 15 mg tablets: store tablets at room temperature (15°C - 25°C). Protect from light.

MORPHINE SR 30 and 60 mg tablets: Store tablets at room temperature (15°C - 30°C). Protect from light.

Keep 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 MORPHINE SR, get emergency help right away.

Disposal:

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.

If you want more information about MORPHINE SR:

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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-866-236-4076; or email quality@sanis.com.

Sanis Health Inc.

1 President's Choice Circle

Brampton, Ontario

L6Y 5S5

Morphine SR: Uses, Side Effects and Dosage