An Educational Resource
Patient
Evolving Treatment Empowering Patients
A patient’s guide
for the treatment of
opioid dependence
Now available—
2 mg, 4 mg, 8 mg, and 12 mg
dosage strengths
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription
medicine used for maintenance treatment of opioid dependence as part of a
complete treatment plan to include counseling and behavioral therapy.
Selected Safety Information
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious
negative effects, including anaphylactic shock, have been reported.
Please see accompanying full
Product Information.
Welcome to
Your Treatment
Opioid dependence is a challenging disease that often requires medication-assisted
treatment along with counseling to provide the best possibility of success. A number
of studies with patients have shown that treatment with buprenorphine, the main
ingredient in SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), along
with counseling, helps patients stay with their treatment and reduces their opioid use
by suppressing withdrawal symptoms and decreasing cravings.
The purpose of this brochure is to give you an overview of opioid dependence and
an introduction to treatment including SUBOXONE Film and counseling. If you have
additional questions about treatment or SUBOXONE Film, please speak with your
physician. You can also find Important Safety Information and other helpful information
on suboxone.com.
Supporting Your Opioid-Dependence Treatment
Treatment with
SUBOXONE Film
to manage
physical symptoms
Treatment with
counseling to
address behavioral
components
Supporting
Your
Treatment
Additional Support from friends,
family, and/or an external support system,
such as the Here to Help® Program
2
Please see Important Safety Information on page 21.
Please see accompanying full Product Information.
Table of
Contents
Understanding Opioid Dependence
4
About SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) 8
About Your Treatment
12
Built-in Support From the Here to Help® Program
16
Important Information for SUBOXONE Film Patients
18
Information About
Opioid Dependence
What are opioids?
Opioids are drugs that either are derived from opiates (drugs created directly from
opium, such as morphine or codeine) or are chemically related to opiates or opium.
Examples of opioids include some prescription painkillers (such as oxycodone,
hydrocodone, buprenorphine, methadone) and heroin.
What is opioid dependence?
Dependence on opioids is often an unexpected side effect of proper pain treatment,
or repeated, recreational use of prescription pain medications or heroin. Regardless
of how dependence begins, once it has developed, it is considered a disease that
must be medically treated.
What are common characteristics of opioid dependence?*
• Opioid tolerance (the need to take more drug to get the same effect, or getting
less effect from the same amount of the drug)
• Withdrawal symptoms that occur when opioids are not used
– Taking other drugs to help relieve the symptoms
• Taking larger amounts of opioids than planned and for longer periods of time
• Persistent desire or unsuccessful attempts to quit
• Spending a lot of time and effort to obtain, use, and recover from opioid use
• Giving up or reducing social or recreational activities; missing work
• Continued opioid use regardless of negative consequences
Patients displaying 3 or more of the above in a 12-month period are considered
opioid-dependent.
Selected Safety Information
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) can be abused in
a manner similar to other opioids, legal or illicit.
SUBOXONE Film contains buprenorphine, an opioid that can cause physical
dependence with chronic use. Physical dependence is not the same as addiction.
Your doctor can tell you more about the difference between physical dependence
and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking
to your doctor. You could become sick with uncomfortable withdrawal symptoms
because your body has become used to this medicine.
*Source: American Psychiatric Association. DSM-IV criteria for substance dependence and abuse. In: Diagnostic and Statistical
Manual of Mental Disorders [DSM-IV-TR]. 4th ed. Text Revision. Washington, DC: American Psychiatric Association; 2000.
4
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
Understanding
Opioid Dependence
Why is opioid dependence a chronic disease?
The development of opioid dependence causes complex, long-term changes in the
structure and functioning of the brain. The significant changes to brain “circuitry”
have led medical experts, including the World Health Organization and the National
Institute on Drug Abuse, to classify opioid dependence as a disease that interferes
with normal brain functioning.
Non–Opioid-Dependent and Opioid-Dependent Brain Images
Positron Emission
Tomography (PET) scan
images show changes
in brain activity caused
by opioid dependence.
The lack of red in the
opioid-dependent brain
shows a reduction in
brain activity in these
regions.
Non–opioiddependent brain
Opioid-dependent
brain
Reprinted by permission
of Nature Publishing Group:
Neuropsychopharmacology.
1997;16:174-182.
Typically, the changes that cause opioid dependence will not correct themselves
right away, even though the misuse of opioids has stopped. In fact, these changes
can trigger cravings months and even years after a patient has stopped using
opioids. Consequently, overcoming opioid dependence is not simply a matter of
eliminating drugs from the body.
Opioid-dependence treatment is like that of other chronic diseases, such as
diabetes or asthma, where medication and behavioral changes can make a big
difference in the end result.
To help increase the likelihood of your success, treatment utilizing
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)
should be accompanied by counseling so that effective change in
your life is more likely.
Selected Safety Information
SUBOXONE Film can cause serious life-threatening breathing problems, overdose
and death, particularly when taken by the intravenous (IV) route in combination with
benzodiazepines or other medications that act on the central nervous system
(ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed
benzodiazepines or other medications that act on the nervous system while
taking SUBOXONE Film.
Why opioid dependence affects behavior
The need to satisfy cravings or avoid withdrawal can be so intense that people who
want to stop taking opioids find it difficult to do. Or, they may find themselves doing
things they wouldn’t ordinarily do in order to obtain more of the drug they crave.
For this reason, even though opioid dependence is a medical condition and not
a moral failing, it can drive behavior.
Why are some people more likely to become dependent?
Substances such as opioids that produce pleasurable feelings sometimes cause
patients to desire those feelings again and again. This increases the likelihood
that those substances will be taken repeatedly or abused, although not everyone
becomes dependent on them. While the specific causes vary from person to person,
certain factors, such as the drug itself, family history, and the individual’s environment,
are known to be important in the development of opioid dependence.
Some people may be genetically predisposed to opioid dependence. This means
that having a family member who has been dependent on opioids or other drugs may
make a person more likely to become dependent on drugs themselves. People also
absorb drugs differently. Depending on levels of the drug in the blood, each person
may be affected by the drug in different ways. Many people may be negatively
influenced by those around them to abuse opioids, which may increase drug use
and dependence.
Selected Safety Information
You should not drink alcohol while taking SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII), as this can lead to loss of consciousness or even death.
Death has been reported in those who are not opioid dependent.
Your doctor may monitor liver function before and during treatment.
6
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
Why do prescription pain medications result
in dependence in some people?
Even when used properly, opioid medications prescribed for acute, chronic,
or postoperative pain can cause symptoms of tolerance and withdrawal. This
can cause the brain to want more opioids, setting up the cycle of craving.
Tolerance means that more of the drug is needed to get the same pain relief.
Developing tolerance for a drug does not mean that person is dependent
on it or is abusing it.
Physical dependence is typically associated with tolerance, and also with
withdrawal—uncomfortable symptoms that develop when a person stops taking
an opioid drug or opioid medication. Symptoms of withdrawal include pain, cramps,
vomiting, diarrhea, anxiety, sleep problems, and cravings.
Psychological dependence involves continued drug use for reasons other than
tolerance and withdrawal, such as to experience a drug’s pleasurable effects.
People with a clinical need for pain relief should not be transferred to
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII).
SUBOXONE Film is not indicated for the treatment of pain.
How common is opioid dependence?
Opioid dependence is more common than many people think. Men and women of all
ages, races, ethnic groups, and educational levels can become dependent on opioids.
According to the National Survey on Drug Use and Health*:
• Approximately 2 million Americans were dependent on opioid prescription
painkillers or heroin in 2010
• Between 2002 and 2010, the number of Americans reporting heroin abuse or
dependence increased by 68%, from 214,000 to 359,000
A recent national survey, Prescription Painkiller/Heroin Addiction and Treatment,†
found that nearly half of the public is unaware that misusing opioid prescription
painkillers is as harmful as abusing heroin. Fortunately, as more people come to
understand that opioid dependence is a medical condition and not a moral failing,
more people are getting treatment in the privacy of a doctor’s office.
*Substance Abuse and Mental Health Services Administration. (2011). Results from the 2010 National Survey
on Drug Use and Health. Summary of National Findings (Office of Applied Studies, NSDUH Series H-41, HHS
Publication No. (SMA 111-4658 Findings). Rockville, MD.
†
Prescription Painkiller/Heroin Addiction and Treatment: Public and Patient Perceptions. Conducted by
Schulman, Ronca, & Bucuvalas, Inc. Silver Spring, MD; 2006. http://www.srbi.com/National_Executive_
Summary-Public.pdf. Accessed July 27, 2010.
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a
prescription medicine used for maintenance treatment of opioid dependence as
part of a complete treatment plan to include counseling and behavioral therapy.
What You Need to Know
About SUBOXONE® (buprenorphine
and naloxone) Sublingual Film (CIII)
What is SUBOXONE Film?
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a medication
indicated for maintenance treatment of opioid dependence in a doctor’s office setting and
should be used as part of a complete treatment plan to include counseling and support.
The benefits of treatment with SUBOXONE Film
When medication-assisted treatment is combined with counseling, there is a greater
opportunity for treatment success. The active ingredient in SUBOXONE Film can help
patients stay in treatment by suppressing cravings and reducing withdrawal symptoms. The
latest form of medication-assisted treatment, SUBOXONE Film, provides an evolved patient
experience* that includes a built-in support system, the Here to Help® Program, which helps
patients stay connected to the resources they need to overcome opioid dependence.
SUBOXONE Film is individually packaged in unit-dose, child-resistant pouches, and
is easy to carry, faster to dissolve, and preferred by patients.* In fact, patients who had
tried both SUBOXONE Film and an older form of the same medicine, SUBOXONE®
(buprenorphine and naloxone) Sublingual Tablet (CIII), rated SUBOXONE Film
3 times better based on key attributes, including overall satisfaction.†
Everyday support from the Here to Help Program
The Here to Help Program, the free support program only for SUBOXONE Film
patients, includes exclusive access to online tools and resources, and informative
e-mails designed to support patients as they work to make their treatment a success.
To learn more about the Here to Help Program, turn to page 16.
Selected Safety Information
Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate
ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.
*Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA:
Patient preferred: Clinical trial participants preferred SUBOXONE Film over the SUBOXONE Tablet. Results from a
questionnaire collected at discharge of a 13-week, multicenter, open-label safety trial. Patients (n=159) were asked,
“Based on your previous experience with SUBOXONE Tablet and your current experience with SUBOXONE Film, which
product do you prefer?”
Dissolve time: The time required for both SUBOXONE Film and SUBOXONE Tablet dissolution is dependent on saliva quantity
and is subject to individual variation, and dose and strength taken. Mean dissolution time for all doses tested (8 mg, 2 mg) was
between 5 and 6.6 minutes for SUBOXONE Film and between 7 and 12.4 minutes for the SUBOXONE Tablet.
Taste: In a patient questionnaire, more than 71% of patients who have tried SUBOXONE Film rated the taste as neutral or
better on a 10-point scale. Results from a questionnaire collected at discharge of a 13-week, multicenter, open-label safety
trial. Patients were asked, “Please give this product (SUBOXONE Film) a score that shows how you would rate the flavor.”
10=extremely pleasant and 1=extremely unpleasant.
Portability: Because each unit of SUBOXONE Film is individually packaged in a compact, child-resistant pouch, it’s easy to
carry with you. Remember to keep this medication out of the sight and reach of children, and take your prescription label along
with you. If a child takes the medication, seek emergency care.
†
Results reported January 28, 2011, from a 30-minute online quantitative survey of 79 patients who were taking SUBOXONE Film
or had taken it within the prior 4 months. 52 patients were switched from SUBOXONE Tablet to SUBOXONE Film.
Please see suboxone.com for full Prescribing Information on the SUBOXONE Tablet.
8
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
How does SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII) benefit me?
SUBOXONE Film offers a way to treat opioid dependence—in a doctor’s office—with
privacy, confidentiality, and safety. Treatment with the film may conveniently fit into
your daily routine and may allow more time for work, family, and other activities.
Why is counseling an important part of treatment?
SUBOXONE Film and counseling work together to provide the best results. While
SUBOXONE Film may address physical symptoms, only counseling can address
the behavioral aspects of opioid dependence.
For this reason, you should combine SUBOXONE Film and counseling to help you
through treatment and to help you remain on goal. Counseling can give you practical
strategies to make your treatment successful, assist in changing negative thinking
and behaviors, and help you rebuild your life.
Does SUBOXONE Film just substitute
one dependence for another?
Using medication-assisted treatment for opioid dependence is much like using
medication for other chronic illnesses, such as asthma or heart disease. It is meant
to help you stay healthy and successfully engaged in comprehensive treatment
that includes counseling and other services that address your medical and
psychological needs.
Medicine can be an important component for managing both the short- and long-term
effects of opioid dependence. You and your doctor can discuss the timing and
appropriateness of tapering off your doses until medication is no longer required.
The withdrawal symptoms of buprenorphine, the active ingredient in SUBOXONE Film,
are milder than those experienced with a full opioid agonist and can be managed with
your doctor’s supervision.
Selected Safety Information
Do not take SUBOXONE Film before the effects of other opioids (eg, heroin,
hydrocodone, methadone, morphine, oxycodone) have subsided as you may
experience withdrawal symptoms.
Injecting SUBOXONE Film may cause serious withdrawal symptoms such as pain,
cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
About SUBOXONE® Film
Studies with patients have shown that treatment with buprenorphine, the main
ingredient in SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), along
with counseling, helps reduce opioid use by suppressing withdrawal symptoms and
decreasing cravings.
SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII) ingredients
The main ingredient in SUBOXONE®
(buprenorphine and naloxone)
Sublingual Film (CIII) is buprenorphine.
Buprenorphine is a partial opioid
agonist that blocks other opioids
from attaching to opioid receptors
in the brain. The medication in
SUBOXONE Film has been shown
to help patients stay in treatment and reduce illicit drug use by suppressing withdrawal
symptoms and reducing cravings. SUBOXONE Film also has a naloxone component
that helps discourage abuse.
What is naloxone and why is it in SUBOXONE Film?
Naloxone is a medication that is used to reverse overdoses of opioids. It does this by
knocking other opioids off the receptors, preventing the negative effects of the misused
drug, such as respiratory depression (slowed breathing).
When SUBOXONE Film is placed under the tongue as prescribed, very little naloxone
is absorbed into the bloodstream. The patient should not feel the effects of naloxone.
The naloxone in SUBOXONE Film is there to deter people from injecting the medication.
When SUBOXONE Film is used incorrectly (by injection), its naloxone component can
cause withdrawal symptoms to rapidly occur in an individual dependent on a full
opioid agonist.
Why is it important to take SUBOXONE Film as directed?
It is important that you take SUBOXONE Film with your other medications exactly
as directed by your physician. Abuse or misuse of your medications while on
SUBOXONE Film can cause death.
Selected Safety Information
Do not take SUBOXONE Film before the effects of other opioids (eg, heroin,
hydrocodone, methadone, morphine, oxycodone) have subsided as you may
experience withdrawal symptoms.
SUBOXONE Film can cause serious life-threatening breathing problems, overdose
and death, particularly when taken by the intravenous (IV ) route in combination with
benzodiazepines or other medications that act on the central nervous system (ie,
sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed
benzodiazepines or other medications that act on the nervous system while taking
SUBOXONE Film.
10
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
What is the most important information I should know about
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)?
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) can cause serious and
life-threatening breathing problems. Call your doctor right away or get emergency help if
you feel faint, dizzy, or confused or your breathing gets much slower than is normal for
you. These can be signs of an overdose or other serious problems.
SUBOXONE Film contains an opioid that can cause physical dependence. However, do
not stop taking SUBOXONE Film without talking to your doctor. You could become sick
with uncomfortable withdrawal signs and symptoms because your body has become
used to this medicine. This is called physical dependence, which is not the same as drug
addiction. SUBOXONE Film is not for occasional or “as needed” use.
An overdose or even death can happen if you take benzodiazepines, sedatives,
tranquilizers, antidepressants, or alcohol while using SUBOXONE Film. Ask your doctor
what you should do if you are taking one of these.
Call your doctor right away or get emergency help if you feel sleepy and uncoordinated,
have blurred vision, have slurred speech, cannot think well or clearly, and/or have slowed
reflexes and breathing.
Do not inject (“shoot up”) SUBOXONE Film. Injecting this medicine may cause
life-threatening infections and other serious health problems. Injecting SUBOXONE Film
may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea,
anxiety, sleep problems, and cravings.
In an emergency, have family members tell emergency department staff that you
are physically dependent on an opioid and are being treated with SUBOXONE Film.
How long will I stay on SUBOXONE Film?
Length of therapy is up to you and your physician, and sometimes your therapist or
counselor. Longer-term therapy can give you time to make adjustments to negative
thinking and behaviors that influence drug use. Medication-assisted therapy with
counseling may help you minimize the possibility of relapse and increase your chance
of treatment success.
Selected Safety Information
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as
serious negative effects, including anaphylactic shock, have been reported.
What You Need to Know
About Treatment With
SUBOXONE® (buprenorphine and
naloxone) Sublingual Film (CIII)
What is a partial opioid agonist?
Opioid agonists are drugs or medications that stimulate activity at receptors in the
brain normally stimulated by naturally occurring opioids. A partial opioid agonist (such
as buprenorphine—the active ingredient in SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII) is an opioid that produces less than maximal effect as compared
to a full agonist (such as oxycodone, hydrocodone, morphine, methadone, or heroin)
when it binds to opioid receptors in the brain. The way different opioids work can be
explained using a lock and key example. Receptors are like a lock to a door. Only the
right key will fit the lock, and only opioid-like drugs fit opioid receptors.
A. With a full opioid agonist, the key fits
the lock, opens the door wide, and
produces full opioid effects (pleasurable
feelings, or “being high”), as well as
the side effects of these opioids.
B. With a partial opioid agonist such as
buprenorphine, the key fits the lock
but doesn’t open the door all the way,
so it produces less than full opioid
agonist effects and, at the appropriate
dose, blocks other opioids from fully
opening the door.
A
B
At the appropriate dose, SUBOXONE Film may be used to help
patients stay in treatment and reduce their illicit opioid use by:
• Suppressing opioid withdrawal symptoms
• Reducing opioid cravings
Selected Safety Information
Before taking SUBOXONE Film, tell your doctor if you are pregnant or plan to become pregnant.
If you become pregnant while taking SUBOXONE Film, alert your doctor immediately as there may
be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.
Before taking SUBOXONE Film, talk to your doctor if you are breast-feeding or plan to
breast-feed. SUBOXONE Film can pass into your milk and may harm the baby. Talk to your
doctor about the best way to feed your baby if you take SUBOXONE Film. Breast-feeding is
not recommended while taking SUBOXONE Film.
12
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
How does SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII) work?
Buprenorphine, the active ingredient in SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII), works by strongly binding to opioid receptors.
SUBOXONE Film Therapy
Opioid
1. When opioids attach to the mu receptors
,
dopamine is released, causing pleasurable feelings
to be produced.
Opioid receptor
Opioid
2. As opioids leave the receptors, pleasurable feelings
fade and withdrawal (-) symptoms (and possibly
cravings) begin.
SUBOXONE
SUBOXONE blocks opioid receptors
3. The primary active ingredient in SUBOXONE Film—
buprenorphine —attaches to the empty opioid
receptors, suppressing withdrawal symptoms
and reducing cravings. As a partial opioid agonist,
buprenorphine helps retain patients in treatment by
controlling withdrawal symptoms and cravings and
producing less of a euphoria or “high” than full
opioid agonists.
4. Buprenorphine attaches firmly to the receptors.
At adequate maintenance doses, buprenorphine
fills most receptors and blocks other opioids from
attaching. Buprenorphine has a long duration of
action, so its effects do not wear off quickly.
Selected Safety Information
Do not drive, operate heavy machinery, or perform any other dangerous activities until
you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can
cause drowsiness and slow reaction times during dose-adjustment periods.
About Your Treatment
Opioid receptor
Stages of
Treatment
Induction
Your treatment will begin with the induction phase. You will be asked to arrive at
the doctor’s office in a moderate state of withdrawal. Being in a state of moderate
withdrawal is vital to having the medication work well.
If you are not in moderate withdrawal, the medication might actually make you feel
worse rather than better. This is called precipitated withdrawal. It is really important
to be truthful with your physician about the last time you used an opioid, what
opioid it was, how much you took, and what other drugs or medications you’ve
taken, so that he or she can make the best determination about the timing of your
first dose of buprenorphine.
Once you are given your first dose, you should begin to feel better within 30
minutes. Your physician may choose to give you additional doses while you are
in the office. It is important that you are honest about how you are feeling during
the induction in order for your physician to find the appropriate dose for you.
When you are leaving the office, the physician will likely give you a prescription
that will last until your next appointment. The physician may also want to discuss
counseling with you, since adding it to the taking of your medication has been
shown to provide better results. At the same time, your physician may suggest
enrolling in the Here to Help® Program, which can provide you with an added
support system. For more information, please see page 16.
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) can
be used at home as recommended by your doctor once you begin the
maintenance phase of treatment.
Selected Safety Information
Common side effects of SUBOXONE Film include nausea, vomiting, drug
withdrawal syndrome, headache, sweating, numb mouth, constipation, painful
tongue, redness of the mouth, intoxication (feeling lightheaded or drunk),
disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision,
back pain, fainting, dizziness, and sleepiness.
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as
serious negative effects, including anaphylactic shock, have been reported.
This is not a complete list of potential adverse events associated with
SUBOXONE Film. Please see full Prescribing Information for a complete list.
14
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
Stabilization and maintenance
This is the second phase of treatment. The goal of this phase is to keep you in
treatment so you can continue to be successful. During this period of time, your
doctor will work with you to make sure your dose of SUBOXONE® (buprenorphine
and naloxone) Sublingual Film (CIII) keeps your withdrawal symptoms under control
so that you can take the same dose regularly. This is called stabilization. Early on in
treatment, your doctor may ask you to visit him or her more often to evaluate the
effectiveness of your dose. Your doctor also may request urine samples from time
to time. It is during the maintenance phase when counseling is highly encouraged
so that you can begin making progress in changing negative thinking and behaviors
associated with opioid dependence.
In some situations, your physician may suggest a dose increase or there may be a
need to change the frequency of counseling and/or behavioral therapy. Occasionally,
as you achieve your treatment goals and are feeling confident about your progress,
your physician may suggest a dose decrease.
Medical taper
There are no time limits for treatment with SUBOXONE Film. Length of therapy is up
to your physician and you. If you and your physician agree that the time is right for
medical taper, your physician will slowly lower your dose (also known as a taper) of
SUBOXONE Film, taking care to minimize withdrawal symptoms.
If you feel at risk for relapse during a taper, let your physician know. You can be
restabilized and continue maintenance treatment if needed.
Tips for Medical Taper
• It may be helpful to increase counseling while you are lowering your dose to make
sure plans are in place to prevent relapse
• It is highly recommended to continue counseling, even if you are no longer taking
SUBOXONE Film
• Always remember that you can restart maintenance treatment with
SUBOXONE Film if necessary
Selected Safety Information
To report negative side effects associated with taking SUBOXONE Film, please call
1-877-782-6966. You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Full Access to the Online
Here to Help® Program
Why should I sign up for the Here to Help Program?
The Here to Help Program connects you to the support you need, when you need it,
to help you stay motivated on treatment, so you may have a better chance of success.
The Here to Help Program was designed to work as part of your treatment plan with
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII). Its unique, interactive
approach is built around known factors for treatment success.
Specifically, the Here to Help Program is:
• A personal support program, designed to work as part of a complete treatment
plan that includes counseling and SUBOXONE Film
• Focused on known factors for treatment success. Simple activities help you
learn to recognize issues that might put your treatment at risk, so you can make
plans to interrupt early signs of trouble. If you have a setback, you can find
essential guidance that could help you get back into treatment and help protect
your recovery
• Private, confidential, and secure. The Here to Help Program can help you track
your progress, but will never save your action plans or results. (You can
download them to your own computer or print them out to share with your doctor,
counselor, or others who support your treatment.) Only you can access your
program via the user name and password you create
Selected Safety Information
SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE Film contains buprenorphine, an opioid that can cause physical
dependence with chronic use. Physical dependence is not the same as addiction. Your
doctor can tell you more about the difference between physical dependence and drug
addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor.
You could become sick with uncomfortable withdrawal symptoms because your body
has become used to this medicine.
16
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
This program is designed to help you:
• Understand more about your condition, your treatment, and tips that can help
you succeed
• Improve vital life skills that could help strengthen your recovery
• Create solutions to deal with triggers, make positive changes, and maintain
focus on your relationships
How do I get started?
Register at HereToHelpProgram.com, or call 866-973-HERE (4373). Then be sure
to visit daily to develop your plan and learn the skills you need to succeed in treatment.
A copay card that can help you save
$
0 copay
for SUBOXONE Film
(up to $50 a month
in savings)*
NOTE: Present this card each time you fill your prescription.
Limit one prescription per month. Offer expires June 30, 2013.
Selected Safety Information
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) can cause serious
life-threatening breathing problems, overdose and death, particularly when taken by
the intravenous (IV) route in combination with benzodiazepines or other medications
that act on the central nervous system (ie, sedatives, tranquilizers, or alcohol). It is
extremely dangerous to take nonprescribed benzodiazepines or other medications
that act on the nervous system while taking SUBOXONE Film.
Built-in Support
See the details and print a card at
SuboxoneFilmCopay.com. If you
don’t have access to the Internet,
ask someone in our office to provide
you with a copay card. This offer is
subject to certain restrictions and is
void where prohibited by law.
Information About
Taking SUBOXONE® (buprenorphine
and naloxone) Sublingual Film (CIII)
How to take SUBOXONE Film
Administration instructions
• Please refer to the Medication Guide provided with your prescription for full
instructions on how to take SUBOXONE® (buprenorphine and naloxone)
Sublingual Film (CIII)
• Always take SUBOXONE Film exactly as prescribed by your doctor
• To open your medication package, fold along the dotted line and tear downward
at the slit. If you prefer, you can also use scissors to cut along the arrow
• Before taking SUBOXONE Film, drink some water to moisten your mouth.
This should help the film(s) dissolve more easily
• Make sure your hands are dry. Hold SUBOXONE Film between two fingers
by the outside edges of the film
• Place SUBOXONE Film under your tongue close to the base on either side
• The medication in SUBOXONE Film is absorbed into the bloodstream through
blood vessels under your tongue
• Allow the film to dissolve completely to ensure absorption
Selected Safety Information
Do not drive, operate heavy machinery, or perform any other dangerous activities until
you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can
cause drowsiness and slow reaction times during dose-adjustment periods.
18
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
• When placing SUBOXONE® (buprenorphine and naloxone) Sublingual Film(s) (CIII)
under your tongue:
— Place the film under your tongue close to the base on either side
— If you are directed to use 2 films at a time, place the second SUBOXONE
Film under your tongue on the opposite side. Try to avoid having the
SUBOXONE Films touch
— Keep the films in place until they are completely dissolved
— If you are directed to use a third SUBOXONE Film, place it under your
tongue on either side after the first 2 have dissolved
• Let SUBOXONE Film dissolve completely. Don’t chew or swallow the SUBOXONE
Film, as less medication will be absorbed into your bloodstream and you may not
get the amount of medicine you need
• Talking while the SUBOXONE Films are dissolving can interfere with how well the
medication in SUBOXONE Film is absorbed
Visit suboxone.com for additional information and to view video
instructions on how to take SUBOXONE Film.
Important Information for
SUBOXONE® Film Patients
Selected Safety Information
Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal
syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of
the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular
heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.
Additional
Information
Resources
Websites for More Information
• suboxone.com
• HereToHelpProgram.com
• buprenorphine.samhsa.gov (the Substance Abuse and Mental Health Services
Administration buprenorphine Website)
To report negative side effects associated with taking SUBOXONE® (buprenorphine and
naloxone) Sublingual Film (CIII), please call 1-877-782-6966. You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
The SUBOXONE Film Help Line is available from 9 AM to 7:30 PM Eastern time,
Monday through Friday, at 877-SUBOXONE (877-782-6966).
Selected Safety Information
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious
negative effects, including anaphylactic shock, have been reported.
20
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
Indication
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used
for maintenance treatment of opioid dependence as part of a complete treatment plan to include
counseling and behavioral therapy.
Important Safety Information
Do not take SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) if you are allergic to
buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been
reported.
SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE Sublingual Film contains buprenorphine, an opioid that can cause physical
dependence with chronic use. Physical dependence is not the same as addiction. Your doctor
can tell you more about the difference between physical dependence and drug addiction.
Do not stop taking SUBOXONE Sublingual Film suddenly without talking to your doctor. You
could become sick with uncomfortable withdrawal symptoms because your body has become
used to this medicine.
SUBOXONE Sublingual Film can cause serious life-threatening breathing problems, overdose and
death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines
or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is
extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the
nervous system while taking SUBOXONE Sublingual Film.
You should not drink alcohol while taking SUBOXONE, as this can lead to loss of consciousness
or even death.
Death has been reported in those who are not opioid dependent.
Your doctor may monitor liver function before and during treatment.
Keep SUBOXONE Sublingual Film out of the sight and reach of children. Accidental or deliberate
ingestion of SUBOXONE Sublingual Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE Sublingual Film before the effects of other opioids (eg, heroin,
hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience
withdrawal symptoms.
Injecting SUBOXONE may cause serious withdrawal symptoms such as pain, cramps, vomiting,
diarrhea, anxiety, sleep problems, and cravings.
Before taking SUBOXONE, tell your doctor if you are pregnant or plan to become pregnant.
If you become pregnant while taking SUBOXONE, alert your doctor immediately as there may
be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.
If you are pregnant or become pregnant while taking SUBOXONE, you should report it using
the contact information provided below.*
Before taking SUBOXONE, talk to your doctor if you are breast-feeding or plan to breast-feed.
SUBOXONE can pass into your milk and may harm the baby. Talk to your doctor about the best
way to feed your baby if you take SUBOXONE. Breast-feeding is not recommended while taking
SUBOXONE.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know
how SUBOXONE affects you. Buprenorphine in SUBOXONE can cause drowsiness and slow
reaction times during dose-adjustment periods.
Common side effects of SUBOXONE Sublingual Film include nausea, vomiting, drug withdrawal
syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth,
intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease
in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.
This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film.
Please see full Product Information for a complete list.
*To report negative side effects associated with taking SUBOXONE Sublingual Film, please call
1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see accompanying full Product
Information and Medication Guide.
Notes
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Please see Important Safety Information on page 21.
Please see accompanying full Product Information.
Notes
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Supporting Your Treatment
The goal of treatment is to help opioid-dependent people stop misusing opioids and regain
control over their lives. Medication is only one part of the treatment picture. Talk with your
doctor about how counseling can increase the likelihood of treatment success—and about
the difference the right support can make.
Treatment with
SUBOXONE®
(buprenorphine and
naloxone)
Sublingual Film (CIII)
to manage physical
symptoms
Treatment with
counseling to
address behavioral
components
Supporting
Your
Treatment
Additional Support from friends,
family, and/or an external support system,
such as the Here to Help® Program
Please visit suboxone.com for more information.
To report negative side effects associated with taking SUBOXONE Film, please call
1-877-782-6966. You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
SUBOXONE® and Here to Help® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
Please see additional Important Safety Information on page 21.
Please see accompanying full Product Information.
Manufactured for Reckitt Benckiser Pharmaceuticals Inc.,
Richmond, VA 23235 by MonoSol Rx LLC, Warren, NJ 07059
Copyright © 2013 Reckitt Benckiser Pharmaceuticals Inc.
TF08032R3
01/13
Printed in USA