Metadol-D (Paladin Pharma): Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take METADOL-D^® as prescribed you are at a risk for opioid addiction, abuse and misuse. This 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 METADOL-D, 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 METADOL-D. They could die from taking it. If a person has not been prescribed METADOL-D, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took METADOL-D 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 METADOL-D 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 METADOL-D^® used for?

METADOL-D is used in conjunction with appropriate social and medical services as a substitution treatment for opioid drug dependence. Only a qualified doctor can prescribe METADOL-D. METADOL-D needs to be taken under daily supervision of a healthcare professional.

How does METADOL-D^® work?

METADOL-D contains methadone hydrochloride which is a medication belonging to the class of medicines known as opioids which also includes the illicit drug heroin, and the prescription drugs codeine, fentanyl, hydromorphine and morphine.

METADOL-D acts by supressing the symptoms of opioid withdrawal without producing a “high”, while the long-acting nature of the drug allows for once-a-day maintenance dosing.

What are the ingredients in METADOL-D^®?

Medicinal ingredient: methadone hydrochloride

Non-medicinal ingredients:

• METADOL-D tablets contain lactose, magnesium stearate and microcrystalline cellulose.

  The following tablet strengths also contain:

  1 mg: FD&C Blue No.1

  5 mg: FD&C Yellow No. 6

  10 mg: D&C Yellow No. 10 Aluminum, FD&C Blue No.1

• METADOL-D oral solution contains citric acid, dextrose, glycerin, methylparaben, polyethylene glycol, sodium benzoate, sodium cyclamate and water.
• METADOL-D oral concentrate contains citric acid, dextrose, glycerin, propylene glycol, sodium benzoate, sodium cyclamate and water.

METADOL-D^® comes in the following dosage forms:

METADOL-D tablets: 1 mg, 5mg, 10 mg, and 25 mg

METADOL-D Oral Solution: 1mg/mL

METADOL-D Oral Concentrate: 10mg/mL

Do not use METADOL-D^® if:

• your doctor did not prescribe it for you

• you are allergic to methadone hydrochloride or any of the other ingredients in

  METADOL-D

• you have severe asthma, trouble breathing, or any heart problems
• you have bowel blockage or narrowing of the stomach or intestines
• you have a severe diarrhea caused by antibiotics
• you have a head injury or other risks for seizures
• you suffer from alcoholism
• you have taken a certain type of antidepressant (MAO inhibitors) within the last 14 days.

Do not use METADOL-D^® tablets if:

• You have rare inherited diseases which affect how your body uses the sugar lactose

  (because lactose is an ingredient in METADOL-D).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take METADOL-D^®. Talk about any health conditions or problems you may have, including if you:

• have a history of 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
• suffer from migraine
• have, or had in the past abdominal pain, thyroid gland problems, prostate problems, unusual narrowing of the urethra, adrenal gland problems such as Addison’s disease, seizure, convulsions, hallucinations, or severe mental problems.
• you are pregnant or plan to become pregnant, breast-feeding, or in labour

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: Opioids can be transferred to your baby through breast milk, or while still in the womb. METADOL-D 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 METADOL-D. METADOL-D 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 METADOL-D.

Serotonin toxicity (also known as Serotonin syndrome): METADOL-D 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 toxicity if you take METADOL-D with certain anti-depressants or migraine medications.

Serotonin toxicity 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 METADOL-D^®:

• alcohol, including prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking METADOL-D. It 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 METADOL-D
• 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 METADOL-D with

  MAO inhibitors or if you have taken MAOi’s in the last 14 days before treatment with METADOL-D.

• drugs used to treat serious mental or emotional disorders such as schizophrenia
• drugs used for the treatment of epilepsy (e.g. phenytoin, carbamazepine);
• antihistamines (for allergies) or cold medicines
• anti-emetics (for prevention of vomiting)
• diuretics
• 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
• drugs that use a system called CYP3A4 in the body (e.g. erythromycin, sertraline)
• any non-prescription, (over the counter) medication including laxatives
• St. John’s Wort (primarily used for the treatment of depressive moods) or any herbal remedies

How to take METADOL-D^®:

For METADOL-D tablets: Swallow whole. Do not break, chew, dissolve or crush.

Usual Adult Starting Dose:

Dosing of METADOL-D is patient-specific and varies based on use and symptoms. Take exactly as directed by your doctor or pharmacist. If taking the solution, measure the dose carefully using a measuring spoon or medicine cup.

The dose should be taken all at once, and preferably at the same time every day.

You should not change your dose of METADOL-D unless you discuss this with your doctor or pharmacist and a dose change is recommended.

If you develop any side effect as a result of taking METADOL-D, tell your doctor immediately.

Your prescribed dose of METADOL-D Oral Solution and Oral Concentrate will be dispensed to you in either grape Kool-Aid^®, orange Tang^®, Allen’s^® apple juice, tangerine-grapefruit or lemonade Crystal Light^®. Any remaining solution should be refrigerated (2^oC to 8^oC) for not more than 14 days or 7 days if diluted in Allen’s^® Apple Juice.

Stopping your Medication:

You should not suddenly stop taking METADOL-D 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 METADOL-D. 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 METADOL-D.

Refilling Prescriptions for METADOL-D^®:

A new written prescription is required from your doctor each time you need more METADOL-D. 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.

Occasionally, the brand of methadone prescribed by your doctor or dispensed by pharmacist may change. Should you experience any side effects, discuss with your doctor or pharmacist.

Overdose:

If you think you have taken too much METADOL-D^®, 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:

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. Do not take two doses at the same time. If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using METADOL-D^®?

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

Side effects may include:

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

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

Get emergency medical help right away if you have:

• Fast or slow or skipped heartbeat, chest pain, chest tightness, fainting or feel very dizzy;
• Serotonin Syndrome: a combination of most or all of the following symptoms: agitation, confusion, delirium, rapid heart rate and high blood pressure, stiffness, lack of coordination, nausea, vomiting, diarrhea, sweating, fever, shivering, seizure and coma.

Serious side effects and what to do about them

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:

• Online at MedEffect: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html).

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.

Storage:

Your pharmacist or other health professional will store this product.

In the case of take-home doses:

• Keep unused or expired METADOL-D^® in a secure place to prevent theft, misuse or accidental exposure.
• Store at room temperature (15°- 30°C). Keep in a dry place.
• Protect METADOL-D Oral Concentrate and METADOL-D Oral Solution from light and freezing. Keep dispensed bottles tightly closed.
• Keep METADOL-D 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 METADOL-D, get emergency help right away.

Disposal:

METADOL-D^® 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 METADOL-D^®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this consumer 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.paladinlabs.com or by calling 1-888-867-7426

Last Revised: February 25, 2021