Bar-Hydromorphone CR: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take BAR-HYDROmorphone CR as prescribed you are at risk for opioid addiction, abuse, and misuse that 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 BAR-

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

• If you took BAR-HYDROmorphone CR 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 BAR-HYDROmorphone CR with other opioids 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 BAR-HYDROmorphone CR used for?

BAR-HYDROmorphone CR is used for the long-term management of pain, when:

• the pain is severe enough to require daily, around-the-clock pain medication
• the doctor determines that other treatment options are not able to effectively manage your pain

BAR-HYDROmorphone CR is NOT used (“as needed”) to treat pain that you only have once in a while.

How does BAR-HYDROmorphone CR work?

BAR-HYDROmorphone CR is an oral controlled release capsule that slowly releases HYDROmorphone over a 12 hour period.

BAR-HYDROmorphone CR contains HYDROmorphone which is a pain medication belonging to the class of medicines 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 BAR-HYDROmorphone CR?

Medicinal ingredient: HYDROmorphone hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hydroxypropyl methylcellulose, and microcrystalline cellulose

In addition, the capsule shells contain the following ingredients:

All capsules: gelatin, titanium dioxide

3 mg: D&C Yellow No.10, FD&C Green No.3

4.5 mg: FD&C Blue No.1, FD&C Red No.3

6 mg: D&C Red No.28, FD&C Blue No.1, FD&C Red No.40 9 mg: FD&C Blue No.1

12 mg: D&C Red No.28, D&C Yellow No.10, FD&C Blue No.1, FD&C Red No.40 18 mg: yellow iron oxide

24 mg: black iron oxide

30 mg: FD&C Red No.3, red iron oxide, yellow iron oxide

BAR-HYDROmorphone CR comes in the following dosage forms:

Controlled Release Capsules: 3 mg, 4.5 mg, 6 mg, 9 mg, 12 mg, 18 mg, 24 mg and 30 mg

Do not use BAR-HYDROmorphone CR if:

• your doctor did not prescribe it for you

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

  BAR-HYDROmorphone CR

• you have mild or short term pain that can be controlled by the occasional use of pain medications, including those available without a prescription
• you have severe asthma, trouble breathing or other lung problems
• you have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen
• you have gallbladder disease, bile duct disease or problems with your pancreas
• you have a head injury
• if you are at risk for seizures
• you suffer from alcoholism
• you are taking, or have taken within the past 2 weeks, a monoamine oxidase inhibitor medication (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
• you are pregnant or plan to become pregnant, breast-feeding, or in labour
• you are under 18 years of age
• you are going to have, or recently had, a planned surgery

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BAR-HYDROmorphone CR. 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
• 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

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 BAR-HYDROmorphone CR while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. BAR-HYDROmorphone CR 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 BAR-HYDROmorphone CR. BAR-HYDROmorphone CR can cause:

• drowsiness
• dizziness
• 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 BAR-HYDROmorphone CR.

Serotonin Syndrome: BAR-HYDROmorphone CR 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 BAR-HYDROmorphone CR 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.

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 BAR-HYDROmorphone CR:

• alcohol, including prescription and non-prescription medications containing alcohol.

  Do not drink alcohol while taking BAR-HYDROmorphone CR. This 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 BAR-

  HYDROmorphone CR

• other 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 BAR-

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

• drugs used to treat serious mental or emotional disorders, such as schizophrenia
• antihistamines (for allergies)
• anti-emetics (for prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• warfarin and other coumarin anticoagulants (for prevention/treatment of blood clots)
• some heart medication (beta blockers)
• St. John’s Wort

How to take BAR-HYDROmorphone CR:

Take BAR-HYDROmorphone CR

• exactly as prescribed
• every 12 hours

BAR-HYDROmorphone CR can be swallowed whole or sprinkled on applesauce or custard.

Swallowed:

• swallow the capsule whole
• take the capsule with a full glass of water
• do not cut, break, chew, dissolve or crush the capsule - this can be dangerous and life threatening

Sprinkled:

• measure a tablespoon of warm or cold (4° - 40°C) applesauce or room temperature custard
• open the capsule
• sprinkle contents onto the tablespoon
• ensure the capsule is emptied of all contents
• take the entire tablespoon as soon as possible
• do not chew the contents (beads)
• rinse your mouth and swallow the water
• do not keep any of the food/medicine mixture for another dose

If you do not remember when you sprinkled the medicine on the applesauce or custard, or which food you sprinkled the medicine on, throw out the food/medicine mixture.

Do not take a single dose greater than 12 mg of BAR-HYDROmorphone CR every 12 hours unless you are “opioid tolerant”. Your doctor will tell you when you are “opioid tolerant” to a certain dose of BAR-HYDROmorphone CR.

BAR-HYDROmorphone CR is not recommended for rectal administration.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor. Taking higher doses can lead to more side effects and greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need BAR-HYDROmorphone CR. Be sure to use BAR-HYDROmorphone CR only for the condition for which it was prescribed.

Should your pain increase or any other complaint develop as a result of taking BAR-HYDROmorphone CR, tell your doctor immediately.

Stopping your Medication:

You should not stop taking BAR-HYDROmorphone CR all at once 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 BAR-HYDROmorphone CR. 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 BAR-HYDROmorphone CR.

Refilling Prescriptions for BAR-HYDROmorphone CR:

A new written prescription is required from your doctor each time you need more BAR-HYDROmorphone CR. 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 BAR-HYDROmorphone CR, 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 (e.g., 8 o’clock in the morning and 8 o’clock in the evening). If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using BAR-HYDROmorphone CR?

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

Side effects may include:

• Confusion
• Constipation
• Dizziness
• Drowsiness
• Light-headedness
• Nausea, vomiting, or poor appetite
• Lack of muscle strength
• Sleepiness
• Sweating
• Low sex drive, impotence (erectile dysfunction), infertility
• Itching
• Dry mouth
• Insomnia
• Abdominal pain
• Headache
• Anxiety
• Problems with vision
• Weakness, uncoordinated muscle movement

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

If nausea and vomiting become troublesome during prolonged therapy with BAR-HYDROmorphone CR, talk to your doctor or pharmacist.

Serious side effects and what to do about them

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/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.

Storage:

• Keep unused or expired BAR-HYDROmorphone CR in a secure place to prevent theft, misuse or accidental exposure.
• Store at room temperature (15° - 25°C). Keep in a dry place.
• Keep BAR-HYDROmorphone CR 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 BAR-HYDROmorphone CR, get emergency help right away.

Disposal:

BAR-HYDROmorphone CR 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 BAR-HYDROmorphone CR:

• 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 by calling 1-800-387-4501.

Last revised: August 22, 2018