Rapid Message Testing with Consumer Panel - Opioid Analgesics Patient Counseling Guide

Data to Support Drug Product Communications as Used by the FDA

Opioid Analgesic Patient Counseling Guide

Rapid Message Testing with Consumer Panel - Opioid Analgesics Patient Counseling Guide

OMB: 0910-0695

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ELEVOX

Patient Counseling Guide

What You Need to Know About Opioid Pain Medicines
T his guide is for you! Keep this guide and the Medication Guide that comes with your
medicine so you understand all you need to know about your opioid pain medicine. Go
over this information with your healthcare provider. Then, ask your healthcare provider about
anything that you do not understand.
What are opioids?

• Take your opioid medicine exactly as prescribed.

Opioids are strong prescription pain medicines that
are also known as narcotics.

• Do not cut, break, chew, crush or dissolve your medicine.
If you cannot swallow your medicine whole, talk to your
healthcare provider.

What are the serious risks of using opioids?

• When your healthcare provider gives you the prescription, ask:

• Opioids have serious risks of addiction and overdose

»» How long should I take it?

•	 Too much opioid medicine in your body can cause your
breathing to stop – which could lead to death. This risk
is higher for people taking other medicines that make you
feel sleepy, or people with sleep apnea.

»» What should I do if I need to taper off the opioid medicine
(slowly take less medicine)?

•	 Addiction is when you crave opioids because they make
you feel good in some way; even though you know it is not
good to keep taking them. Addiction is a complex medical
condition that requires specific treatment.

Risk Factors for Opioid Abuse:
• you have a history of addiction
• family history of addiction
• comorbid psychiatric illness (mental health problems)
• use psychotropics (medicines to treat mental health
problems)
• under the age of 65
• You can get addicted to opioids even though you take them
exactly as prescribed, especially if taken for a long time.
• If you think you might be addicted, talk to your healthcare
provider right away.
• If you need opioids for more than a few days, your body
becomes “tolerant.” That means you must taper off the
opioid medicine (slowly take less medicine) when you no
longer needed it to avoid withdrawal symptoms. Tolerance
is not addiction. Tolerance is a physical effect that can be
treated by slowing taking less medicine.

How can I take opioid pain medicine safely?
• Tell your healthcare provider about all the medicines you
are taking, including vitamins, herbal supplements, and
other over-the-counter medicines.
• Read the Medication Guide that comes with your
prescription opioid medicine.
10/31/17

• Call your healthcare provider if the opioid medicine is not
controlling your pain. Do not increase the dose on your own.
• Do not share or give your opioid medicine to anyone else.
Your healthcare provider selected this opioid and the dose just
for you. A dose that is okay for you could cause an overdose
and death for someone else. Also, it is against the law.
• Store your opioid medicine
in a safe place where it
cannot be reached by
children or stolen by
family or visitors to your
home.
Many teenagers
like to experiment with
pain medicines. Use a lockbox to keep your opioid
medicine safe. Keep track
of the amount of medicine you have.
• Do not operate heavy machinery until you know how your
opioid medicine affects you. Your opioid medicine can
make you sleepy, dizzy, or lightheaded.

What should I avoid taking while I am taking
opioids?
Unless prescribed by your healthcare provider, you should
avoid taking alcohol or these medicines with an opioid
because it may cause you to stop breathing, which can lead
to death:
• Alcohol: Do not drink any kind of alcohol while you are
taking opioid medicines.
• Benzodiazepines (like Valium or Xanax)
• Muscle relaxants (like Soma or Flexeril)
• Sleep medicines (like Ambien or Lunesta)
• Other prescription opioid medicines
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ELEVOX
What other options are there to help with
my pain?
Opioids are not the only thing that can help you control
your pain. Ask your healthcare provider if your pain might
be helped with a non-opioid medication, physical therapy,
exercise, rest, acupuncture, types of behavioral therapy, or
patient self-help techniques.

What is naloxone?
• Naloxone is a medicine that reverses respiratory depression
(slowed or stopped breathing) resulting from taking too
much opioid medicine.
• Use naloxone if you have it and call 911 or go to the
emergency room right away if:
»» You or someone else has taken an opioid medicine and
is having trouble breathing, are short of breath, or are
unusually sleepy.
»» Someone else took an opioid medicine that was not
prescribed for them.
»» A child has accidentally taken the opioid medicine or you
think they might have
◊ Giving naloxone to a person who has not taken an
opioid medicine will not hurt them.
• If you took extra opioid medicine, by mistake or to reduce
pain, and are not having side effects but are uncertain
about whether you should use naloxone, call 911 or go to
the emergency room.

Patient Counseling Guide
•	 Remember: Naloxone is never a substitute for emergency
medical care. Always call 911 or go to the emergency
room if you’ve used or given naloxone.

Where can I get naloxone?
• There are some naloxone products that are designed for
people to use in their home
• Naloxone is sold in pharmacies. Ask you healthcare provider
for a naloxone prescription. In some states, you may not
need a prescription.
• When you get your naloxone package from the pharmacy,
read the instructions on how to use naloxone and ask the
pharmacist if anything is unclear.
• Tell your family about your naloxone and keep it in a place
where you or your family can get to it in an emergency.

When you no longer need your opioid
medicine, dispose of it as quickly as
possible.
• Flush it down the toilet. This will not hurt the
environment.
• Take it to your community drug take back program.

What things should I know about the specific opioid medicine that I am taking?

Your healthcare provider has prescribed Elevox for you. Read the Medication Guide for this medicine and remember this
other important information:

Dosing instructions:
Any specific interactions with your medicines:

What if I have more questions?
• Read the Medication Guide that comes with your opioid medicine prescription for more specific information about your medicine.
• Talk to your healthcare provider or pharmacist and ask them any questions you may have.
• Visit: https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm for more information about opioid
medicines.

10/31/17

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File Modified2017-11-17
File Created2017-11-16

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