Patient Medication Information: uses, side effects, how to take - PMS-Methadone Hydrochloride Oral Concentrate
Serious Warnings and Precautions
Dangerous side effects and death may occur when pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE is used with alcohol or with other medications that may cause drowsiness such as antidepressants, antihistamines, muscle relaxants or sleeping medications. |
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In some patients, pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE may cause heartbeat problems that can be life-threatening in rare cases. Symptoms may include fainting, palpitations (feeling a rapid, pounding or irregular heartbeat), or loss of consciousness.
Seek immediate medical help for your baby.
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What is pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE used for?
pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE is used in conjunction with appropriate social and medical services as a substitution treatment for opioid drug dependence. Only a qualified healthcare professional can prescribe pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE needs to be taken under daily supervision of a healthcare professional.
How does pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE work?
Methadone belongs to a class of drugs that is commonly referred to as opioids or narcotics which also includes the illicit drug heroin, and the prescription drugs codeine, fentanyl, hydromorphine and morphine.
Methadone acts to suppress 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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE?
Medicinal ingredients: Methadone hydrochloride
Non-medicinal ingredients:
pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE contains: natural and artificial cherry flavor, citric acid anhydrous, FD&C Red No. 40, D&C Red No. 33, methylparaben, poloxamer 407, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sucrose.
- pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE (Sugar-Free) contains: citric acid anhydrous, purified water, and sodium benzoate.
pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE comes in the following dosage forms:
Oral concentrate, cherry flavor: 10 mg/mL
Oral concentrate, dye-free, sugar-free, unflavored: 10 mg/mL
Do not use pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE if:
- you are allergic to methadone hydrochloride or any of the other ingredients in pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE
- you have severe asthma, trouble breathing, or other breathing problems
- you are taking or have taken within the past 2 weeks a monoamine oxidase inhibitor (MAOI) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
- you have severe diarrhea caused by antibiotics
- 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 suffer from alcoholism
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. 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, lung disease
- have heart disease
- have low blood pressure
- have or had depression
- have problems with your thyroid, adrenal or prostate gland
- suffer from chronic or severe constipation
- have, or had in the past, hallucinations or other severe mental problems
- suffer from migraines
- you are going to have a planned surgery
- you are pregnant or plan 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 healthcare professional if you have questions or concerns about abuse, addiction or physical dependence.
Pregnancy, nursing, labour and delivery: The use of pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE during labour or delivery is not recommended. Opioids can be transferred to your baby through breast milk, or while still in the womb. pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE 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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE 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 healthcare professional may do tests, give you another medication, and slowly take you off pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE.
Serotonin toxicity (also known as serotonin syndrome): pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE can cause serotonin toxicity, 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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE with certain antidepressants 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.
- You should call your healthcare professional immediately if you feel dizzy, lightheaded, or faint or have palpitations (feeling a rapid, pounding or irregular heartbeat) after taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE;
- You should not drink alcohol or take medicines that may cause drowsiness and/or slow, shallow breathing (like sleeping aids or muscle relaxers) when taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE;
- If you become pregnant or plan to become pregnant, talk with your healthcare professional about the risks related both to taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE during pregnancy, and to stopping pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE;
- Stopping treatment with pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE may result in a return to narcotic drug use;
- If you suddenly stop taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, you may experience withdrawal symptoms. If you and your healthcare professional decide that you should stop taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, consider slowly lowering the dose instead of suddenly stopping the treatment. Your healthcare professional can provide you with an appropriate dosing schedule.
If you are pregnant or breastfeeding, then speak with your healthcare professional about the risks and benefits of breastfeeding while taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE such as the following:
- Your baby will receive a small amount of pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE through your breast milk;
- Your baby may experience withdrawal symptoms if you suddenly stop breastfeeding.
- Talk with your healthcare professional about developing a plan to slowly wean your baby;
- You should not drink alcohol or use drugs of abuse while breastfeeding, because doing so will expose your baby to additional risks;
- When starting pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE treatment or increasing the dose while breastfeeding, closely watch your baby for changes in behavior or breathing patterns.
Sleep Apnea: Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia).
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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE:
Alcohol. This includes prescription and non-prescription medications that contain alcohol.
Do not drink alcohol while you are taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- 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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE with MAO inhibitors (MAOI) or if you have taken MAOIs in the last 14 days.
- drugs used to treat serious mental or emotional disorders (such as schizophrenia)
- antihistamines (drugs used to treat allergies)
- anti-emetics (drugs used for the prevention of vomiting)
- drugs used to treat muscle spasms and back pain
- drugs used to treat migraines (e.g., triptans)
- anti-epileptic drugs (used to treat seizures)
- anti-retroviral drugs (used to treat HIV)
- anti-fungal drugs (used to treat fungal infections)
- antibiotic drugs (used to treat bacterial infections)
- some heart medication (such as beta-blockers, anti-arrhythmic agents and calcium channel blockers)
- grapefruit juice
- St. John’s Wort
Be sure to tell your healthcare professional, dentist, pharmacist and all other healthcare professionals who are treating you that you are taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE.
How to take pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE:
Usual Adult Starting Dose
Dosing of pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE is patient-specific and varies based on use and symptoms. Take exactly as directed by your healthcare professional. The dose should be taken all at once, and preferably at the same time every day.
The dose of pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE will “hold” for longer periods of time as your treatment progresses. You should not change your dose of pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE unless you discuss this with your healthcare professional and your healthcare professional recommends a dose change. Taking higher doses can lead to more side effects and a greater chance of overdose.
If you develop any side effect as a result of taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, tell your healthcare professional immediately.
If you have been taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE for more than a few days you should not stop taking it all of a sudden.
Your healthcare professional will monitor and guide you on how to slowly stop taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. 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
- 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 pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE.
Refilling Your Prescription for pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE:
A new written prescription is required from your healthcare professional each time you need more pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. Therefore, it is important that you contact your healthcare professional before your current supply runs out.
Only obtain prescriptions for this medicine from the healthcare professional in charge of your treatment. Do not seek prescriptions from other healthcare professionals unless you switch to another healthcare professional for your pain management.
Occasionally, the brand of methadone prescribed by your healthcare professional or dispensed by your pharmacist may change. Should you experience any side effects, discuss with your healthcare professional or pharmacist.
Overdose:
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 one dose, take your next dose at your usual time. 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 healthcare professional before restarting your medication.
What are possible side effects from using pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE?
These are not all the possible side effects you may feel when taking pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE. 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
Talk with your healthcare professional or pharmacist about ways to prevent constipation when you start using pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE.
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.
If you think you, or a person you are caring for, have taken too much pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Overdose: confusion, hallucinations, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin, low blood sugar | √ | ||
Respiratory Depression: slow, shallow or weak breathing | √ | ||
Serotonin Toxicity: a reaction which may cause feelings of agitation, or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38°C), or rigid muscles | √ | ||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | √ | ||
Fast, Slow or Irregular Heartbeat: heart palpitations | √ | ||
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating | √ | ||
| Low Blood Pressure: dizziness, fainting, lightheadedness | √ | ||
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.
Storage:
Your pharmacist or other healthcare professional will store this product.
In the case of take-home doses:
- You should store pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, like other opioids, in a locked, secure place and out of the sight and reach of children and pets.
- Never take medicine in front of small children as they may want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidently takes pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE, get emergency help right away.
- pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE is a federally-controlled drug because of the potential for abuse. Protect your pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE from theft or any other access, and never provide your pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE to anyone else.
- Keep unused or expired pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE in a secure place to prevent theft, misuse or accidental exposure.
- Store at room temperature (15° - 30°C). Keep in a dry place.
Disposal:
pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE 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 (https://www.canada.ca/en/health- canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.
If you want more information about pms-METHADONE HYDROCHLORIDE ORAL CONCENTRATE:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.pharmascience.com or by calling 1-888-550-6060.