Jamp Methadone Oral Concentrate: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take JAMP Methadone Oral Concentrate as prescribed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.

• You may get life-threatening breathing problems while taking JAMP Methadone Oral Concentrate. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing. This is less likely to happen if you take it as prescribed by your doctor. Because this effect is long-lasting, breathing problems can happen hours after taking your dose. Breathing problems may be most likely when starting JAMP Methadone Oral Concentrate and when the dose is increased. Get emergency medical help immediately if you:

  • Have trouble breathing, or have slow or shallow breathing;
  • Have a slow or irregular heartbeat;
  • Have severe sleepiness;
  • Have cold, clammy skin;
  • Feel faint, dizzy, confused, or cannot think, walk or talk normally;
  • Have a seizure;
  • Have hallucinations.

Dangerous side effects and death may occur when JAMP Methadone Oral Concentrate is used with alcohol or with other medications that may cause drowsiness such as anti- depressants, anti-histamines, muscle relaxants or sleeping medications.

In some patients, JAMP Methadone 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.

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

What is JAMP Methadone Oral Concentrate used for?

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

How does JAMP Methadone 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 JAMP Methadone Oral Concentrate?

Medicinal ingredients: Methadone hydrochloride Non-medicinal ingredients:

• JAMP Methadone Oral Concentrate contains: citric acid monohydrate, colour brilliant blue FCF, glycerol, purified water, sodium benzoate and sorbitol (liquid non-crystallising).

JAMP Methadone Oral Concentrate comes in the following dosage forms:

Oral concentrate, Sugar-Free Solution Sweetened with Sorbitol: 10 mg/mL

Do not use JAMP Methadone Oral Concentrate if:

• you are allergic to methadone hydrochloride or any of the other ingredients in JAMP Methadone 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
• If you took JAMP Methadone Oral Concentrate 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 JAMP Methadone Oral Concentrate 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.

  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 JAMP Methadone 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 doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: The use of JAMP Methadone 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. JAMP Methadone 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 JAMP Methadone Oral Concentrate. JAMP Methadone 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 doctor may do tests, give you another medication, and slowly take you off JAMP Methadone Oral Concentrate.

Serotonin toxicity (also known as serotonin syndrome): JAMP Methadone 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 JAMP Methadone Oral Concentrate 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.

• You should call your doctor immediately if you feel dizzy, lightheaded, or faint or have palpitations (feeling a rapid, pounding or irregular heartbeat) after taking JAMP Methadone 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 JAMP Methadone Oral Concentrate;
• If you become pregnant or plan to become pregnant, talk with your doctor about the risks related both to taking JAMP Methadone Oral Concentrate during pregnancy, and to stopping JAMP Methadone Oral Concentrate;
• Stopping treatment with JAMP Methadone Oral Concentrate may result in a return to narcotic drug use;
• If you suddenly stop taking JAMP Methadone Oral Concentrate, you may experience withdrawal symptoms. If you and your doctor decide that you should stop taking JAMP Methadone Oral Concentrate, consider slowly lowering the dose instead of suddenly stopping the treatment. Your doctor can provide you with an appropriate dosing schedule.

• If you are pregnant or breastfeeding, then speak with your doctor about the risks and benefits of breastfeeding while taking JAMP Methadone Oral Concentrate such as the following:

  • Your baby will receive a small amount of JAMP Methadone Oral Concentrate through your breast milk;
  • Your baby may experience withdrawal symptoms if you suddenly stop breastfeeding.
  • Talk with your doctor 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 JAMP Methadone 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).

Intolerance to certain sugars: JAMP Methadone Oral Concentrate 10 mg/mL contains a sweetener called sorbitol. Talk to your doctor before taking this medicine if you have been told that you are intolerant to certain sugars. In some people, sorbitol may affect the amount of medication their body can absorb. Therefore, switching between JAMP Methadone Oral Concentrate 10 mg/mL and other methadone-containing products that do not contain sorbitol may cause changes in methadone blood levels. This can cause symptoms. If this happens, please contact your doctor.

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 JAMP Methadone Oral Concentrate:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol.

  Do not drink alcohol while you are taking JAMP Methadone 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)
• anti-depressants (for depression and mood disorders). Do not take Jamp Methadone Oral Concentrate 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)
• 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 doctor, dentist, pharmacist and all other health professionals who are treating you that you are taking JAMP Methadone Oral Concentrate.

How to take JAMP Methadone Oral Concentrate:

Usual Adult Starting Dose

Dosing of JAMP Methadone Oral Concentrate is patient-specific and varies based on use and symptoms. Take exactly as directed by your doctor. The dose should be taken all at once, and preferably at the same time every day.

The dose of JAMP Methadone Oral Concentrate will “hold” for longer periods of time as your treatment progresses. You should not change your dose of JAMP Methadone Oral Concentrate unless you discuss this with your doctor and your doctor 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 JAMP Methadone Oral Concentrate, tell your doctor immediately.

If you have been taking JAMP Methadone Oral Concentrate 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 JAMP Methadone 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 JAMP Methadone Oral Concentrate.

Refilling Your Prescription for JAMP Methadone Oral Concentrate:

A new written prescription is required from your doctor each time you need more JAMP Methadone Oral Concentrate. 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 your pharmacist may change. Should you experience any side effects, discuss with your doctor or pharmacist.

Overdose:

If you think you, or a person you are caring for, have taken too much JAMP Methadone Oral Concentrate, contact a 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 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 doctor before restarting your medication.

What are possible side effects from using JAMP Methadone Oral Concentrate?

These are not all the possible side effects you may feel when taking JAMP Methadone 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 doctor or pharmacist about ways to prevent constipation when you start using JAMP Methadone 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.

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.

Storage:

Your pharmacist or other health professional will store this product.

In the case of take-home doses:

• You should store JAMP Methadone 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 JAMP Methadone Oral Concentrate, get emergency help right away.
• JAMP Methadone Oral Concentrate is a federally-controlled drug because of the potential for abuse. Protect your JAMP Methadone Oral Concentrate from theft or any other access, and never provide your JAMP Methadone Oral Concentrate to anyone else.
• Keep unused or expired JAMP Methadone Oral Concentrate in a secure place to prevent theft, misuse or accidental exposure.
• Dispense in tight containers, protected from light. Store at room temperature (15°C to 30°C). Do not freeze.

Disposal:

JAMP Methadone 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.

If you want more information about JAMP Methadone 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); or the manufacturer’s website

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.

• (www.jamppharma.com), or by calling 1-866-399-9091.

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Last Revised: October 27, 2021