Buprenorphine (as hydrochloride) + Naloxone (as hydrochloride dihydrate)
Consumer Medicine Information
What is in this leaflet?
This leaflet answers some common questions about SUBOXONE SUBLINGUAL 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 SUBLINGUAL 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 SUBLINGUAL FILM, ask your doctor.
Keep this leaflet.
You may want to read it again.
What is SUBOXONE SUBLINGUAL FILM used for?
SUBOXONE SUBLINGUAL 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 SUBLINGUAL FILM is used to help such patients to regain control over their
SUBOXONE SUBLINGUAL FILMS contain the active ingredients buprenorphine (as hydrochloride)
and naloxone (as 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) as prescribed, naloxone has no effect, as it is very poorly absorbed.
However, if SUBOXONE SUBLINGUAL 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 SUBLINGUAL FILM
to discourage misuse by injection, as it can cause very bad withdrawal symptoms.
SUBOXONE SUBLINGUAL FILM should be used exactly as prescribed by your doctor.
Ask your doctor if you have any questions about why SUBOXONE SUBLINGUAL FILM has been
prescribed for you.
Before you take SUBOXONE SUBLINGUAL FILM
SUBOXONE SUBLINGUAL FILM is not suitable for everyone.
When you must not take SUBOXONE SUBLINGUAL 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 SUBLINGUAL FILM if you are pregnant. If you become pregnant
while taking SUBOXONE SUBLINGUAL FILM, tell your doctor.
Do not take SUBOXONE SUBLINGUAL FILM if you are breastfeeding.
Do not take SUBOXONE SUBLINGUAL FILM if the package is torn, shows signs of tampering
or the films do not look quite right.
Before you start to use SUBOXONE SUBLINGUAL 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 SUBLINGUAL
asthma or other breathing problems
problems with excess alcohol use
problems with drowsiness
Adrenal gland problems (e.g. Addison's disease)
Kyphoscoliosis (hunchback disease)
low blood pressure
if you have head injuries or in a condition where you have increased pressure within
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
Whilst you are being treated with SUBOXONE SUBLINGUAL FILM, do not use benzodiazepines
unless they have been prescribed by your doctor.
SUBOXONE SUBLINGUAL FILM may cause fatal respiratory failure if children accidently
Keep this medicine out of reach and sight of children.
As SUBOXONE SUBLINGUAL 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 SUBOXONE SUBLINGUAL 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 SUBLINGUAL 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 SUBLINGUAL FILM is not intended for occasional use and should be taken only
SUBOXONE SUBLINGUAL 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 SUBLINGUAL 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"
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 SUBLINGUAL FILM.
A number of medicines may alter the effects of SUBOXONE SUBLINGUAL 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)
certain medicines for high blood pressure
other opioid medicines
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 SUBLINGUAL 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 SUBLINGUAL FILM. You should
not use benzodiazepines whilst you are taking SUBOXONE SUBLINGUAL FILM unless they
are prescribed by your doctor.
How to Take SUBOXONE SUBLINGUAL FILM
Do not take SUBOXONE SUBLINGUAL FILM to treat any condition other than the one prescribed
for by your doctor.
Do not give SUBOXONE SUBLINGUAL 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 SUBLINGUAL FILM should
be held between 2 fingers by the outside edges of the film. The films are taken sublingually.
This means that you place the film under your tongue 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 and
try not to have them overlap. If you are taking more than 2 films, place the next
films under your tongue 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 SUBLINGUAL 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 SUBLINGUAL FILM is only for adults and children over the age of 16 years.
Your doctor will tell you how much SUBOXONE SUBLINGUAL FILM to take and you should
always follow medical advice.
Each SUBOXONE SUBLINGUAL FILM contains buprenorphine and naloxone. SUBOXONE SUBLINGUAL
FILM 2/0.5 containing 2mg buprenorphine and 0.5mg naloxone is referred to as 'the
2mg film', SUBOXONE SUBLINGUAL FILM 4/1 containing 4mg buprenorphine and 1mg naloxone
is referred to as 'the 4mg film', SUBOXONE SUBLINGUAL FILM 8/2 containing 8mg buprenorphine
and 2mg naloxone is referred to as 'the 8mg film' and SUBOXONE SUBLINGUAL 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 mg SUBOXONE SUBLINGUAL 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 SUBLINGUAL 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 SUBLINGUAL
FILM, your doctor will probably reduce your dose of methadone to a maximum of 30 mg/day.
The first dose of SUBOXONE SUBLINGUAL FILM should preferably be taken when the first
signs of craving appear and at least 24 hours after your last dose of methadone.
SUBOXONE SUBLINGUAL 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 SUBLINGUAL 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 SUBLINGUAL FILM
If you miss a dose of SUBOXONE SUBLINGUAL 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 SUBLINGUAL FILM.
If you take too much SUBOXONE SUBLINGUAL FILM (overdose)
If you think that you or anyone else may have taken too much SUBOXONE SUBLINGUAL 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
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much SUBOXONE, some of the symptoms which may or may not occur are
listed in the Side effects section of this leaflet.
Like all medicines, SUBOXONE SUBLINGUAL 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
Many of the common side effects reported with the use of SUBOXONE SUBLINGUAL FILM
were related to opioid withdrawal symptoms, such as:
difficulty sleeping, anxiety, nervousness
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.
Other side effects which have occurred are:
depression, abnormal thinking
reduced sex drive
nausea, vomiting, constipation, wind, indigestion, decreased weight
flushing, swelling of the legs and arms
rash and itching
redness in mouth, inflammation of the tongue
dizziness or fainting when standing up
If you think you are experiencing any of the above side effects, you should tell your
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 SUBLINGUAL FILM
If you stop taking SUBOXONE SUBLINGUAL 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.
SUBOXONE SUBLINGUAL 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 SUBLINGUAL
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 SUBLINGUAL FILM
after the expiry date that is shown on the pack.
What SUBOXONE SUBLINGUAL FILM Looks Like.
SUBOXONE SUBLINGUAL 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.
Each SUBOXONE SUBLINGUAL FILM 2/0.5 contains 2mg buprenorphine (as hydrochloride)
+ 0.5mg naloxone (as hydrochloride dihydrate) as active ingredients. Each SUBOXONE
SUBLINGUAL FILM 4/1 contains 4mg buprenorphine (as hydrochloride) + 1mg naloxone (as
hydrochloride dihydrate) as active ingredients. Each SUBOXONE SUBLINGUAL FILM 8/2
contains 8mg buprenorphine (as hydrochloride) + 2mg naloxone (as hydrochloride dihydrate)
as active ingredients. Each SUBOXONE SUBLINGUAL FILM 12/3 contains 12mg buprenorphine
(as hydrochloride) + 1mg naloxone (as hydrochloride dihydrate) as active ingredients.
SUBOXONE SUBLINGUAL 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 a white printing ink.
Each pack of SUBOXONE SUBLINGUAL FILM 2/0.5 is labelled with AUST R 163443
Each pack of SUBOXONE SUBLINGUAL FILM 4/1 is labelled with AUST R 211117*
Each pack of SUBOXONE SUBLINGUAL FILM 8/2 is labelled with AUST R 163444
Each pack of SUBOXONE SUBLINGUAL FILM 12/3 is labelled with AUST R 211120*
*Not currently supplied.
Indivior Pty Ltd
78 Waterloo Road
Macquarie Park NSW 2113
For adverse event reporting please contact:
Indivior Pty Ltd
Date of Preparation: