Pms Hydromorphone Sirop 1mg/mL: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take pms-HYDROmorphone 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).
• When you take pms-HYDROmorphone tablets they must be swallowed whole. Do not cut, break, crush, chew, or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

• Life-threatening breathing problems can happen while taking

  pms-HYDROmorphone, 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 pms-HYDROmorphone. They could die from taking it. If a person has not been prescribed pms-HYDROmorphone, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took pms-HYDROmorphone 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 pms-HYDROmorphone 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 pms-HYDROmorphone used for?

pms-HYDROmorphone is a pain medication used to control pain.

How does pms-HYDROmorphone work?

pms-HYDROmorphone contains HYDROmorphone which is a pain medication belonging to the class of drugs 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.

What are the ingredients in pms-HYDROmorphone?

Medicinal ingredient:

HYDROmorphone hydrochloride

Non-medicinal ingredients:

Syrup: Dextrose, Glycerin, Purified Water, Propylene Glycol and Sodium Benzoate. Suppositories: Wecobee (hydrogenated vegetable oil).

Tablets: Lactose Anhydrous, Magnesium Stearate and Microcrystalline Cellulose.

In addition, the tablet strengths listed below contain the following dyes: 1 mg: D&C Yellow #10 Aluminum Lake, FD&C Blend #1 Lake and FD&C Yellow #6 Aluminum Lake.

2 mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Lake.

4 mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake.

pms-HYDROmorphone comes in the following dosage forms:

Immediate Release Tablets: 1 mg (green), 2 mg (orange), 4 mg (yellow) and 8 mg (white). Oral liquid: 1 mg/mL

Suppositories: 3 mg

Do not use pms-HYDROmorphone if:

• your doctor did not prescribe it for you

• you are allergic to HYDROmorphone, or any of the other ingredients in

  pms-HYDROmorphone tablets, suppositories or oral liquid (see What are the ingredients in pms-HYDROmorphone?)

• 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

  (MOI) (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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-HYDROmorphone. 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 a history of sleep apnea
• have past or current depression
• suffer from chronic or severe constipation
• have problems with your adrenal or prostate gland
• have, or had in the past, hallucinations or other severe mental problems
• suffer from migraines
• are pregnant or 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 pms-HYDROmorphone while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. pms-HYDROmorphone can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant and are taking pms-HYDROmorphone, 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 pms-HYDROmorphone. 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 pms-HYDROmorphone. pms-HYDROmorphone 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 pms-HYDROmorphone.

Serotonin Syndrome

pms-HYDROmorphone 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 pms-HYDROmorphone with certain anti-depressants 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.

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 pms-HYDROmorphone:

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

  Do not drink alcohol while you are taking pms-HYDROmorphone. 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

  pms-HYDROmorphone

• other opioid analgesics (for pain)
• general anesthetics (used during surgery)
• drugs used to help you sleep or that help reduce anxiety (benzodiazepines)

• antidepressants (for depression and mood disorders). Do not take

  pms-HYDROmorphone with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with pms-HYDROmorphone

• drugs used to treat serious mental or emotional disorders, such as schizophrenia
• antihistamines (for allergies)
• anti-emetics (for the prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• some heart medications (such as beta blockers)
• drugs used to treat migraines (e.g., triptans)
• St. John’s Wort

How to take pms-HYDROmorphone:

Take pms-HYDROmorphone tablets, oral liquid:

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

Take pms-HYDROMORPHONE suppositories:

• one rectal suppository (3 mg) may be useful at bedtime, as a replacement for your last daily dose of tablet or liquid.
• make sure that the plastic wrapping is fully removed before placing the suppository into the rectum. It is best to do this after emptying your bowels.
• Do not take a suppository by mouth.

pms-HYDROmorphone tablets:

Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

Usual 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 pms-HYDROmorphone for up to 7 days. If you need to take pms-HYDROmorphone 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 pms-HYDROmorphone. Be sure to use pms-HYDROmorphone only for the condition for which it was prescribed.

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

Stopping your Medication:

If you have been taking pms-HYDROmorphone 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 pms-HYDROmorphone. 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 pms-HYDROmorphone.

Refilling your Prescription for pms-HYDROmorphone:

A new written prescription is required from your doctor each time you need more pms-HYDROmorphone. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medication 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 pms-HYDROmorphone, 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 tablet / oral solution 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.

What are possible side effects from using pms-HYDROmorphone?

These are not all the possible side effects you may feel when taking pms-HYDROmorphone. 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
• lack of muscle strength
• itching
• light-headedness
• sweating
• constipation
• confusion
• anxiety
• abdominal pain
• low sex drive, impotence (erectile dysfunction), infertility

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

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

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/medeffectcanada/adverse-reaction-reporting/drug.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.

Storage:

• Keep unused or expired pms-HYDROmorphone in a secure place to prevent theft, misuse or accidental exposure.
• Store the tablets, syrup and suppositories at 15-30^oC. Protect from light.
• Keep pms-HYDROmorphone 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 pms-HYDROmorphone, get emergency help right away.

Disposal:

pms-HYDROmorphone 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 pms-HYDROmorphone:

• Talk to your healthcare professional.

• Find the full prescribing information 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 by contacting the sponsor Pharmascience Inc. at: 1-888-550-6060.

  Pharmascience Inc.

  Montréal, Canada

  H4P 2T4

Last revised: October 14, 2020