Opana ER: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take OPANA ER as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose and death.
• Life-threatening breathing problems can happen while taking OPANA ER, especially if not taken as directed.
• Never give anyone your OPANA ER. They could die from taking it. If a person has not been prescribed OPANA ER, taking even one dose can cause a fatal overdose. This is especially true for children.

• Babies born to mothers who have taken OPANA ER (for short or long periods, in small or large doses) during their pregnancy can suffer life-threatening withdrawal symptoms. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has breathing changes (weak, difficult or fast), is unusually difficult to comfort, has tremors (shakiness), or has increased stools, sneezing, yawning, vomiting, or fever, seek immediate medical help for your baby.

What is OPANA ER used for?

OPANA ER is used for the long-term management of pain, when:

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

OPANA ER is NOT used (“as needed”) to treat pain that you only have once in a while.

How does OPANA ER work?

OPANA ER is a painkiller belonging to the class of medicines known as opioids. OPANA ER is gradually released into your blood stream and interacts with proteins in the body called “opioid receptors” that are responsible for different opioid effects (desirable and undesirable). These receptors are found in the brain, the spinal cord and the gastrointestinal tract. It relieves pain by

acting on opioid receptors found on specific nerve cells of the spinal cord and brain.

What are the ingredients in OPANA ER?

Medicinal ingredients: Oxymorphone hydrochloride.

Non-medicinal ingredients: Calcium sulfate dehydrate, Dextrose monohydrate, Ethylcellulose, Locust bean gum, Silicified Microcrystalline Cellulose, Sodium Stearyl Fumarate, Purified Water, USP, Methylparaben, Opadry Clear, Opadry Pink, Opadry Gray, Opadry Lt Orange, Opadry White, Opadry Lt Green, Opadry Red, Opadry II Yellow, Xanthum gum.

OPANA ER comes in the following dosage forms:

OPANA ER is available in Extended Release Tablets of 5 mg, 10 mg, 20 mg & 40 mg.

Do not use OPANA ER if:

• you are allergic to Oxymorphone Hydrochloride or any of the other ingredients of

  OAPANA ER or to other opioids (drugs similar to morphine) such as codeine.

• your pain can be controlled by the occasional use of painkillers including those available without a prescription
• you have severe asthma, trouble breathing, or any heart problems
• you have bowel blockage or narrowing of the stomach or intestines
• you have a head injury or other risks for seizures
• you suffer from alcoholism or have convulsions
• you are going to have, or recently had, a planned surgery
• you have moderate and severe problems in the liver.
• you are pregnant or plan to become pregnant, breastfeeding, or in labour
• you are under 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OPANA ER. 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 disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have trouble breathing or lung problems
• have a head injury or brain problems
• have adrenal gland problems, such as Addison’s disease
• have convulsions or seizures
• have thyroid problems
• have problems urinating or prostate problems
• have pancreas problems
• have severe mental problems or hallucinations (see or hear things that are not really there)

Other warnings you should know about:

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to OPANA ER. Drowsiness, dizziness, or lightheadedness, can especially occur after the first dose and when the dose is increased.

To avoid changes in the amount of the medication in your blood stream, OPANA ER MUST be taken at least one hour before, or two hours after eating.

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 OPANA ER:

• alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking OPANA ER. This can lead to drowsiness, depressed breathing, serious side effects or a fatal overdose
• other sedative drugs which may enhance the drowsiness caused by OPANA ER
• 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 OPANA ER with MAO inhibitors or if you have taken MAO in the last 14 days before treatment with OPANA ER.
• 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)
• anti-retroviral, anti-fungal and antibiotic drugs

Do not take any new medicines while using OPANA ER until you have talked to your doctor and pharmacist and they have told you it is safe.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How to take OPANA ER:

Swallow whole. Do not break, chew, dissolve or crush.

If OPANA ER tablets are crushed, chewed, dissolved or broken, oxymorphone will be released too fast. This can lead to serious and life-threatening breathing problems. Life-threatening breathing problems can also happen because of an overdose or if the dose you are using is too high for you. Get emergency medical help immediately if you:

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

You MUST take OPANA ER on an empty stomach (at least one hour before or two hours after eating. Taking OPANA ER with food may result in more drug in your bloodstream and may lead to serious medical consequences.

Do not drink alcohol while using OPANA ER. It may increase the chance of having dangerous side effects including overdose and death.

You should only take OPANA ER twice a day (every 12 hours, or as directed by your doctor) to manage your pain.

Do not change your dose unless your doctor tells you to change it.

Do not take OPANA ER more often than prescribed.

While most patients obtain adequate pain relief with OPANA ER, your pain may vary and occasionally break through. This is not unusual. If this occurs, your doctor may prescribe additional pain medication.

It is important to let your doctor know whether or not your pain is under control. If you frequently need additional short-acting pain medication, or if pain is waking you at night, you may need a change in your OPANA ER dose.

If you continue to have pain, call your doctor.

Always follow your doctor's instructions carefully and do not change or stop your OPANA ER medication without first consulting with your doctor.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly.

You should not stop taking OPANA ER all at once if you have been taking it for more than a few days without talking to your doctor. OPANA ER can cause physical dependence. You can get sick with withdrawal symptoms if you stop OPANA ER all at once, because your body has become used to it.

Overdose:

Signs of overdose may include abnormally slow or weak breathing, dizziness, confusion or extreme drowsiness.

If you think you have taken too much OPANA ER, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss one 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 succession, talk to your doctor before restarting your medication.

Refilling Prescriptions for OPANA ER:

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

What are possible side effects from using OPANA ER?

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

Side effects may include:

• Drowsiness, insomnia
• Dizziness, fainting
• Nausea, vomiting, poor appetite, dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Sedation

Talk with your doctor or pharmacist about ways to prevent constipation when you start using OPANA ER.

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;
• 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 0701E

  Ottawa, ON

K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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:

Store OPANA ER at room temperature between 15º to 30 ºC.

Keep unused or expired OPANA ER in a secure place to prevent theft, misuse or accidental exposure.

Keep out of sight and reach of children and pets.

Disposal:

OPANA ER should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

Do not give to other people, even if they have the same symptoms you have. It may harm them, even causing death, and it is against the law.

After you stop taking OPANA ER, return any unused medication to the pharmacy for safe disposal.

If you want more information about OPANA ER:

• 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 or the sponsor website at http://www.paladinlabs.com or by calling at 1-888-867-7426.

Last Revised: June 21, 2016