Buprenorphine Hydrochloride + Naloxone Hydrochloride Dihydrate
Consumer Medicine Information
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WARNINGS:
Hazardous and harmful use
Although SUBOXONE FILM is indicated for the treatment of opioid dependence, it still
poses risks of hazardous and harmful use which can lead to overdose and death. The
doctor will monitor your ongoing risk during treatment with SUBOXONE FILM.
Life threatening respiratory depression
Serious, life-threatening respiratory depression may occur with the use of SUBOXONE
FILM. Talk to your doctor about situations which may increase the risk of respiratory
depression.
Concomitant use of medicines affecting the central nervous system, including alcohol
Use of SUBOXONE FILM with anti-anxiety medicines, sedatives, antihistamines, some
antidepressants, antipsychotics, cannabis and alcohol may result in profound sedation,
respiratory depression, coma and death.
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What is in this leaflet
This leaflet answers some common questions about SUBOXONE FILM. It does not contain
all the available information.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
SUBOXONE FILM against the benefits you may gain and he/she believes it will help in
your treatment.
If you have any concerns about taking SUBOXONE FILM, ask your doctor.
Keep this leaflet.
You may need to read it again.
What SUBOXONE FILM is used for
SUBOXONE FILM is used as part of a medical, social and psychological treatment program
for patients dependent on opioids like heroin, morphine, oxycodone or codeine. SUBOXONE
FILM is used to help such patients to regain control over their lives.
SUBOXONE FILM contain the active ingredients buprenorphine hydrochloride and naloxone
hydrochloride dihydrate. Buprenorphine acts as a substitute for opioids and it helps
withdrawal from opioids over a period of time. When taken sublingually (under the
tongue) or buccally (inside the cheek) as prescribed, naloxone has no effect, as it
is very poorly absorbed. However, if SUBOXONE FILM is injected, naloxone will act
to block the effects of other opioids like heroin, methadone, morphine, oxycodone
or codeine, leading to bad withdrawal symptoms. Therefore, naloxone is included in
SUBOXONE FILM to discourage misuse by injection, as it can cause very bad withdrawal
symptoms.
SUBOXONE FILM should be used exactly as prescribed by your doctor.
Ask your doctor if you have any questions about why SUBOXONE FILM has been prescribed
for you.
Before you take SUBOXONE FILM
SUBOXONE FILM is not suitable for everyone.
When you must not take SUBOXONE FILM
If you are under the age of 16 years.
If you are allergic to buprenorphine or to naloxone or to any of the other ingredients
in this medicine (see Product Description below).
If you have serious breathing problems.
If you have serious problems with your liver, or if your doctor detects the development
of such a problem during treatment.
If you are intoxicated due to CNS depressant medicines (e.g. tranquillisers, sedative/hypnotics,
narcotic analgesics, anti-anxiety medicines, antipsychotics), alcohol or have delirium
tremens (the 'shakes' and hallucinations).
Do not take SUBOXONE FILM if the package is torn, shows signs of tampering or the
films do not look quite right.
Before you start to use SUBOXONE FILM
Tell your doctor if you have any of the following before treatment, or develop them
during treatment, as your doctor may need to adjust your dose of SUBOXONE FILM.
if you are pregnant
if you are breastfeeding
asthma or other breathing problems
thyroid problems
prostate problems
problems with excess alcohol use
problems with drowsiness
Adrenal gland problems (e.g. Addison's disease)
Kyphoscoliosis (hunchback disease)
low blood pressure
urination problems
kidney problems
liver problems
if you have head injuries or in a condition where you have increased pressure within
your head
if you have problems related to the biliary tract
if you have severe mental problems or hallucinations (seeing or hearing things that
are not really there)
if you have a history of seizures
Some people have died from respiratory failure (inability to breathe) when using benzodiazepines
(medicines used to treat anxiety or sleeping problems) at the same time as SUBOXONE
FILM.
Whilst you are being treated with SUBOXONE FILM, do not use benzodiazepines unless
they have been prescribed by your doctor.
SUBOXONE FILM may cause fatal respiratory failure if children accidently ingest it.
Keep this medicine out of reach and sight of children.
As SUBOXONE FILM contains naloxone, it is highly likely to produce strong opioid withdrawal
symptoms if misused as an injection while you are still experiencing the effects of
other opioids.
When taken sublingually or buccally, SUBOXONE FILM can cause withdrawal symptoms if
you take it less than six hours after you use a short acting opioid (such as morphine
or heroin) or less than 24 hours after a long acting opioid (such as methadone).
SUBOXONE FILM can cause drug dependence. This means that you can get withdrawal symptoms
if you stop using the medicine too quickly. Withdrawal symptoms may be delayed in
some cases.
SUBOXONE FILM is not intended for occasional use and should be taken only as prescribed.
SUBOXONE FILM may cause drowsiness, which may be made worse if you also drink alcohol
or take sedatives or anti-anxiety medicines. If you are drowsy, do not drive or operate
machinery.
SUBOXONE FILM may cause your blood pressure to drop suddenly, causing you to feel
dizzy if you get up too quickly from sitting or lying down.
Athletes should be aware that this medicine may cause a positive reaction to "anti-doping"
tests.
The safety and effectiveness in patients over 65 years of age have not been established.
Your doctor may ask you to have additional blood tests to see if this medication is
right for you.
Taking Other Medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop, before
you begin treatment with SUBOXONE FILM.
A number of medicines may alter the effects of SUBOXONE FILM. These include:
certain medicines for treating HIV/AIDS
certain medicines for treating fungal and bacterial infections
strong pain killers
cough medicines containing opioid-related substances
certain antidepressants including monoamine oxidase inhibitors
certain medicines used to treat fits or epilepsy (anti-convulsants)
sedating antihistamines
sedatives, alcohol
anti-anxiety medicines
certain medicines for high blood pressure
antipsychotic medicines
other opioid medicines
naltrexone
Tell your doctor if you are scheduled to have surgery using a general anaesthetic.
Do not drink alcohol or take medicines that contain alcohol whilst you are being treated
with SUBOXONE FILM.
Alcohol and certain other medicines (as listed above) may increase the sedative effects
of buprenorphine, which can make driving and operating machinery hazardous.
Some people have died when using sedatives (benzodiazepines) or other depressants
or alcohol or other opioids at the same time as SUBOXONE FILM. You should not use
benzodiazepines whilst you are taking SUBOXONE FILM unless they are prescribed by
your doctor.
How to Take SUBOXONE FILM
Do not take SUBOXONE FILM to treat any condition other than the one prescribed for
by your doctor.
Do not give SUBOXONE FILM to anyone else, even if their symptoms seem the same as
yours. It may harm them.
Before touching the film, make sure your hands are dry. SUBOXONE FILM should be held
between 2 fingers by the outside edges of the film. The films are taken sublingually
and/or buccally. This means that you place the film under your tongue and/or inside
either cheek and allow it to dissolve, which may take between 4 and 8 minutes. This
is the only way the films should be taken. If you need to take two films, place them
on opposite sides under your tongue or inside your cheeks and try not to have them
overlap. If you are taking more than 2 films, place the next films under your tongue
or inside your cheeks after the first two have dissolved.
Do not swallow or consume food or drink until the films are completely dissolved.
The films will not work if you chew or swallow them whole. They are not designed to
be split or broken.
Do not inject SUBOXONE FILM; patients have died from injecting SUBOXONE. Additionally,
when injecting SUBOXONE and also taking benzodiazepines (medicines used to treat anxiety
or sleeping problems), people were even more likely to die.
How much to take
SUBOXONE FILM is only for adults and children over the age of 16 years. Your doctor
will tell you how much SUBOXONE FILM to take and you should always follow medical
advice.
Each SUBOXONE FILM contains buprenorphine and naloxone. SUBOXONE FILM 2/0.5 containing
2mg buprenorphine and 0.5mg naloxone is referred to as 'the 2mg film', SUBOXONE FILM
4/1 containing 4mg buprenorphine and 1mg naloxone is referred to as 'the 4mg film',
SUBOXONE FILM 8/2 containing 8mg buprenorphine and 2mg naloxone is referred to as
'the 8mg film' and SUBOXONE FILM 12/3 containing 12mg buprenorphine and 3mg naloxone
is referred to as 'the 12mg film'.
On the first day the usual starting dose is 4-8 mg SUBOXONE FILM with an additional
4 mg depending on your needs as determined by your treating doctor.
For patients who are still using short acting opioids such as heroin, morphine, oxycodone
or codeine: when starting treatment the dose of SUBOXONE FILM should be taken when
the first signs of craving appear or at least 6 hours after your last use of opioid
or when the first signs of craving appear.
For patients receiving methadone: before beginning treatment with SUBOXONE FILM, your
doctor will probably reduce your dose of methadone to the minimum daily dose that
you can tolerate. The first dose of SUBOXONE FILM should preferably be taken when
the first signs of craving appear and at least 24 hours after your last dose of methadone.
SUBOXONE FILM may cause withdrawal symptoms if taken too soon after methadone or an
illicit opioid.
During your treatment, your doctor may increase your dose of SUBOXONE FILM up to a
maximum daily dose of 32mg, depending upon your response to treatment.
After a period of successful treatment, your doctor may gradually reduce your dose.
Depending on your condition, your dose may continue to be reduced under careful medical
supervision, until it is stopped altogether.
Do not suddenly stop taking the films, as this may cause withdrawal symptoms.
If you miss a dose of SUBOXONE FILM
If you miss a dose of SUBOXONE FILM, take it as soon as you remember. If you are unsure
consult your doctor.
In an emergency
Have family members or friends tell hospital or ambulance staff that you are dependent
on opioids (narcotics) and are being treated with SUBOXONE FILM.
If you take too much SUBOXONE FILM (overdose)
If you think that you or anyone else may have taken too much SUBOXONE FILM, immediately
telephone your doctor or National Poison Centre (in Australia telephone 13 11 26 or
in New Zealand telephone 0800 POISON or 0800 764 766), or go to Accident and Emergency
at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much SUBOXONE FILM, some of the symptoms which may or may not occur
are listed in the 'Side effects' section of this leaflet.
Side effects
Like all medicines, SUBOXONE FILM may have unwanted side effects which may need medical
treatment.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Many of the common side effects reported with the use of SUBOXONE FILM were related
to opioid withdrawal symptoms, such as:
difficulty sleeping, anxiety, nervousness
malaise, fatigue
pain in the abdomen, back, joints and muscles, leg cramps, muscle weakness
flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery
eyes and sweating
upset stomach and diarrhoea.
pain
headache
Other side effects which have occurred are:
headache, migraine
sleepiness, dizziness
abnormal vision
depression, abnormal thinking
reduced sex drive
chest pain
nausea, vomiting, constipation, wind, indigestion, decreased weight
hives
flushing, swelling of the legs and arms
difficulty urinating
rash and itching
toothache
respiratory infection
redness in mouth, inflammation of the tongue
sinus problems
dizziness or fainting when standing up
If you think you are experiencing any of the above side effects, you should tell your
doctor immediately.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital. You may need urgent medical attention.
There have been rare cases of life-threatening severe hypersensitivity reactions with
symptoms of severe difficulty in breathing, swelling of the face, lips, mouth or throat.
Some serious cases of severe liver problems have occurred during treatment with symptoms
of severe fatigue, no appetite, yellow skin or eyes, light coloured bowel motions
or dark coloured urine.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you feel unwell.
After Using SUBOXONE FILM
If you stop taking SUBOXONE FILM and restart your opioid use, you are at risk of being
more sensitive to opioids, which could be dangerous. You should talk to your doctor
if you commence using opioids again.
Storage
SUBOXONE FILM contains a narcotic that can be a target for people who abuse prescription
medicines or street drugs. Therefore, keep your medications in a safe place to protect
them from theft. Never give them to anyone else.
The films should be stored below 25°C in the original package. SUBOXONE FILM should
be protected from moisture and prolonged exposure to light. As with all medicines,
keep out of the reach of children. Do not use SUBOXONE FILM after the expiry date
that is shown on the pack.
Product Description
What SUBOXONE FILM Looks Like
SUBOXONE FILM is an orange, rectangular soluble film. A logo is printed on each film
to indicate the dosage strength: "N2" for the 2mg, "N4" for the 4mg, "N8" for the
8mg and "N12" for the 12mg.
Ingredients:
Each SUBOXONE FILM 2/0.5 contains 2mg buprenorphine (as hydrochloride) + 0.5mg naloxone
(as hydrochloride dihydrate) as active ingredients. Each SUBOXONE FILM 4/1 contains
4mg buprenorphine (as hydrochloride) + 1mg naloxone (as hydrochloride dihydrate) as
active ingredients. Each SUBOXONE FILM 8/2 contains 8mg buprenorphine (as hydrochloride)
+ 2mg naloxone (as hydrochloride dihydrate) as active ingredients. Each SUBOXONE FILM
12/3 contains 12mg buprenorphine (as hydrochloride) + 3mg naloxone (as hydrochloride
dihydrate) as active ingredients.
SUBOXONE FILM also contains the following inactive ingredients: acesulfame potassium,
citric acid, maltitol, hypromellose, polyethylene oxide, sodium citrate, Natural Lime
Flavour 3000180, Sunset Yellow FCF and OPACODE WB monogramming ink NS-78-18007 White.
Each pack of SUBOXONE FILM 2/0.5 is labelled with AUST R 163443
Each pack of SUBOXONE FILM 4/1 is labelled with AUST R 211117*
Each pack of SUBOXONE FILM 8/2 is labelled with AUST R 163444
Each pack of SUBOXONE FILM 12/3 is labelled with AUST R 211120*
*Not currently supplied.
Sponsor:
Indivior Pty Ltd
78 Waterloo Road
Macquarie Park NSW 2113
Australia
For adverse event reporting please contact:
Indivior Pty Ltd
+800-270-81901
Date of Preparation:
29 March 2021