Consumer Information for: M-ESLON

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

M-ESLON is used for the long-term management of pain, when:

  • the pain is severe enough to require daily, around-the-clock painkillers
  • the doctor determines that other treatment options are not able to effectively treat your pain

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

What it does

M-ESLON contains morphine which is a pain medication belonging to the class of medicines known as opioids which includes codeine, fentanyl, morphine and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

When it should not be used

Do not use M-ESLON if:

  • your doctor did not prescribe it for you
  • you are allergic to morphine sulfate, other opioids, or any of the other ingredients of M-ESLON
  • 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 gallbladder disease, bile duct disease or problems with your pancreas
  • you have a head injury or other risks for seizures
  • you suffer from alcoholism
  • you are pregnant or plan to become pregnant, breastfeeding, or in labour
  • you have a surgical connection between tubular structures, such as blood vessels or loops of intestine
  • you have severe cirrhosis
  • you had surgery of the biliary tract
  • you are under 18 years of age
  • 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 going to have, or recently had, a planned surgery
What the medicinal ingredient is

morphine sulfate

What the non-medicinal ingredients are

dibutyl sebacate, maize starch, polyethylene glycol 4000, polymeric dispersion of ethylcellulose, sucrose, talc; capsule shell contains gelatin and coloring agent (10 mg : titanium dioxide, 15 mg : titanium dioxide , quinoline yellow WS (D&C Yellow No. 10), 30 mg : titanium dioxide , erythrosine (FD&C Red No. 3), 60 mg : titanium dioxide, sunset yellow FCF (FD&C Yellow No. 6), 100 mg : titanium dioxide, black iron oxide, 200 mg : titanium dioxide, allura red AC (FD&C Red No. 40), brilliant blue FCF (FD&C Blue No. 1).

What dosage form it comes in

M-ESLON is available in six capsule strengths:

10 mg (capsule printed with "M-ESLON" and "10" in black; opaque white cap and body)

15 mg (capsule printed with "M-ESLON" and "15" in black; opaque yellow cap and transparent natural body).

30 mg (capsule printed with "M-ESLON" and "30" in black; opaque pink cap and transparent natural body).

60 mg (capsule printed with "M-ESLON" and "60" in black; opaque orange cap and transparent natural body).

100 mg (capsule printed with "M-ESLON" and "100" in white opaque gray cap and transparent natural body).

200 mg (capsule printed with "M-ESLON" and "200" in white; opaque red cap and transparent natural body).

Warnings and precautions

Serious Warnings and Precautions

  • Even if you take M-ESLON as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose and death.
  • Life-threatening breathing problems can happen while taking M-ESLON, 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 M-ESLON. They could die from taking it. If a person has not been prescribed M-ESLON, taking even one dose can cause a fatal overdose. This is especially true for children.
  • If you took M-ESLON 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 M-ESLON 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 M-ESLON. 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 past or current depression
  • suffer from chronic or severe constipation
  • are going to have, or recently had, a planned surgery
  • have problems with your thyroid, adrenal or prostate gland
  • suffer from migraines
  • suffer from sickle cell disease

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 M-ESLON while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. M-ESLON 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 M-ESLON. M-ESLON can cause:

  • drowsiness
  • dizziness or
  • light headedness

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 M-ESLON

Serotonin Syndrome: M-ESLON 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 M-ESLON 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 M-ESLON may lead to sexual and reproductive problems such as:

  • decreases in sexual desire,
  • difficulty getting or keeping an erection,
  • infertility or
  • missing your menstrual period for 3 months or more in a row.

Increased sensitivity to pain: You may experience more pain despite already taking high doses of M-ESLON. Your doctor will decide whether you need to change your dose or change your medication.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with M-ESLON:

  • alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking M-ESLON. 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 M-ESLON
  • 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 M-ESLON with monamine oxidase inhibitors (MAOIs) or if you have taken MAOIs in the last 14 days before treatment with M-ESLON.
  • 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)
  • anti-retroviral, anti-fungal and antibiotic drugs
  • some heart medications (beta-blockers)
  • St. John’s Wort
  • rifampicin (an antibiotic)
Proper use of this medication

Swallow whole, or the capsules may be opened and the contents sprinkled on your food. Do not break, chew, dissolve or crush the capsule contents as it can cause rapid release and absorption of a potentially fatal dose of morphine sulfate

M-ESLON must be taken regularly every 12 hours (with 120 to 180 mL of water) to prevent pain all day and night. If your pain worsens, making you uncomfortable, contact your doctor immediately and she/he may decide that it is necessary to adjust your daily dosage of M-ESLON

Your starting dosage of M-ESLON will be clearly labeled on the medication bottle. Be sure to follow these directions on the label exactly; this is very important. If your dosage is changed, be sure to write it down at the time your doctor calls you or sees you. And follow the new directions exactly.

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 M-ESLON. Be sure to use M-ESLON only for the condition for which it was prescribed. Should your pain increase or any other complaint develop as a result of taking M-ESLON, tell your doctor immediately.

Stopping your Medication:
You should not stop taking M-ESLON 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 M-ESLON. 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 M-ESLON.

Refilling Prescriptions for M-ESLON:

A new written prescription is required from your doctor each time you need more M-ESLON. 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 M-ESLON, 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

Overdose can result in lung infection, loss of consciousness and death

Missed Dose

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. If you miss several doses in a row, talk to your doctor before restarting your medication

Side effects and what to do about them

What are possible side effects from using M-ESLON?

These are not all the possible side effects you may feel when taking M-ESLON. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Drowsiness, insomnia
  • Dizziness, fainting
  • Nausea, vomiting, poor appetite, dry mouth
  • Headache
  • Problems with vision
  • Weakness, uncoordinated muscle movement
  • Itching
  • Sweating
  • Constipation
  • Low sex drive, impotence (erectile dysfunction), infertility
  • Confusion
  • Light-headedness
  • Sleepiness

Talk with your doctor or pharmacist about ways to prevent constipation when you start using M-ESLON.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
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.     ✔
UNKNOWN
Increased response to pain and/or burning sensation.   ✔  

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 M-ESLON in a secure place to prevent theft, misuse or accidental exposure.
  • Store at room temperature (15°C - 30°C).
  • Keep M-ESLON 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 M-ESLON, get emergency help right away.

Disposal:

M-ESLON 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:

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

If you want more information about M-ESLON:

  • 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 Ethypharm Inc. website at www.ethypharm.com/ethypharm-canada/, or by calling Ethypharm Inc. at 1-800-347-1675.

This leaflet was prepared by Ethypharm Inc.

Last Revised: June 11, 2019

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