Consumer Information for: M-EDIAT

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-EDIAT is a medicine used to manage your pain.

What it does

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

What the medicinal ingredient is

Morphine sulfate

What the non-medicinal ingredients are

Hypromellose, maize starch, sucrose, talc; capsule shell contains gelatin and colouring agent (5 mg capsule – indigo carmine; 10 mg capsule – azorubine; 20 mg capsule – allura red AC (FD&C Red No. 40), brilliant blue FCF (FD&C Blue No. 1); 30 mg capsule – indigo carmine, quinoline yellow WS (D&C Yellow No. 10)).

What dosage form it comes in

M-EDIAT capsules are available in 4 strengths:
5 mg (light blue capsule with “5 mg” printed in white)
10 mg (red capsule with “10 mg” printed in white)
20 mg (blue capsule with “20 mg” printed in white)
30 mg (dark green capsule with “30 mg” printed in white)

When it should not be used
  • your doctor did not prescribe it for you
  • you are allergic to morphine, or any of the other ingredients in M-EDIAT
  • you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
  • you have severe asthma, trouble breathing, or other breathing problems
  • you have any heart problems
  • you have bowel blockage or narrowing of the stomach or intestines
  • you have severe pain in your abdomen
  • you have a head injury
  • you are at risk for seizures
  • you have a brain tumor
  • you suffer from alcoholism
  • you are taking, or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOI) (such as phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline)
  • you are going to have, or recently had, a planned surgery
  • you are pregnant or planning to become pregnant or you are in labour
  • you are breastfeeding
Warnings and precautions

Serious Warnings and Precautions

  • Even if you take M-EDIAT as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.

  • When you take M-EDIAT it must be swallowed whole or the capsules may be opened and the contents sprinkled on food. Do not cut, break, crush, chew, or dissolve the capsules. This can be dangerous and can lead to death or seriously harm you.

  • You may get life-threatening breathing problems while taking M-EDIAT. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.

  • You should never give anyone your M-EDIAT. They could die from taking it. If a person has not been prescribed M-EDIAT, taking even one dose can cause a fatal overdose. This is especially true for children.

  • If you took M-EDIAT 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-EDIAT 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 MEDIAT. 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
  • have problems with your thyroid, adrenal or prostate gland
  • 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 M-EDIAT while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. M-EDIAT can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking M-EDIAT, 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 M-EDIAT. 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 M-EDIAT. M-EDIAT 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 M-EDIAT.

Serotonin Syndrome: M-EDIAT 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 M-EDIAT 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. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking M-EDIAT. It can lead to:
    • drowsiness
    • unusually slow or weak breathing
    • serious side effects or
    • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by M-EDIAT
  • other opioid analgesics (drugs used to treat pain)
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
  • antidepressants (for depression and mood disorders). Do not take M-EDIAT with MAO inhibitors (MAOI) or if you have taken MAOI’s in the last 14 days.
  • drugs used to treat serious mental or emotional disorders (such as schizophrenia)
  • anticonvulsants (used to treat seizures)
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (drugs used for the prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • some heart medications (such as beta blockers)
  • anticoagulants (blood thinners)
  • drugs used to treat migraines (e.g. triptans)
  • St. John’s Wort
Proper use of this medication

Take M-EDIAT capsules:

  • regularly, usually every 4 to 6 hours, as directed by your doctor.
  • with a full glass of water

Swallow whole or the capsules may be opened and the contents sprinkled on food. Do not cut, break, crush, chew or dissolve the capsules. This can be dangerous and can lead to death or seriously harm you.

Usual Adult Starting Dose

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take M-EDIAT for up to 7 days. If you need to take M-EDIAT for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. 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-EDIAT. Be sure to use M-EDIAT only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking M-EDIAT, tell your doctor immediately.

Stopping your Medication

If you have been taking M-EDIAT for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking M-EDIAT. 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 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-EDIAT.

Refilling your Prescription for M-EDIAT

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

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

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

Side effects may include:

  • Drowsiness
  • Insomnia
  • Dizziness
  • Fainting
  • Nausea, vomiting, or a poor appetite
  • Dry mouth
  • Headache
  • Problems with vision
  • Weakness, uncoordinated muscle movement
  • Itching
  • Sweating
  • Constipation
  • Low sex drive, impotence (erectile dysfunction), infertility

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

Serious side effects and what to do about them
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, 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

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.

3 ways to report:

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

How to store
  • Store capsules at room temperature (15˚ - 30˚C). Keep in a dry place.
  • Keep unused or expired M-EDIAT in a secure place to prevent theft, misuse or accidental exposure.
  • Keep M-EDIAT 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 accidently takes M-EDIAT, get emergency help right away.

Disposal:

M-EDIAT should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

More information

This leaflet was prepared by Ethypharm Inc.

Last Revised: August 15, 2018

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