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BUPRENORPHINE 8 MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
®

Subutex 2 mg Sublingual Tablets
®
Subutex 8 mg Sublingual Tablets
(buprenorphine hydrochloride)
Read all of this leaflet carefully before you start
taking this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Your medicine is called by any of the above names,
but will be referred to as Subutex Sublingual Tablets.
The other strength 0.4 mg is also available.
In this leaflet:
1. What Subutex Sublingual Tablets are and what
they are used for
2. Before you take Subutex Sublingual Tablets
3. How to take Subutex Sublingual Tablets
4. Possible side effects
5. How to store Subutex Sublingual Tablets
6. Further information
1. WHAT SUBUTEX SUBLINGUAL TABLETS ARE
AND WHAT THEY ARE USED FOR
Subutex Sublingual Tablets contain buprenorphine
hydrochloride, which is a medicine called an
‘opioid analgesic’ (strong pain reliever). Subutex is
used to help patients addicted to opiate (narcotic)
drugs, such as morphine and heroin by acting as a
substitute for these drugs. Over a period of time
patients can withdraw from the narcotics that they were
addicted to.
2. BEFORE YOU TAKE SUBUTEX SUBLINGUAL
TABLETS
Do not take Subutex
− If you are a child under the age of 16 years.
− If you are allergic to buprenorphine or to any of the
other ingredients in this medicine.
− If you have serious breathing problems.
− If you have serious problems with your liver.
− If you are intoxicated due to alcohol or have delirium
tremens (confusion and shaking due to stopping
drinking alcohol) and hallucinations (seeing and
hearing things that are not there).
− If you are breast-feeding a baby.
Take special care with Subutex

− medicines for high blood pressure
− treatment for a mental problem.
You should tell your doctor if you are taking any of
the following medicines as he may need to give
you a lower dose of Subutex:
− Ketoconazole (a medicine used to treat fungal
infections which can increase the levels of
Subutex in your blood if both are taken at the same
time)
− gestodene (found in contraceptives)
− troleandomycin (an antibiotic)
− ritonavir, indinavir1and1saquinavir (the1HIV
protease inhibitors)
Also tell your doctor or pharmacist if you are taking
any of the following medicines:
− phenobarbital, carbamazepine or phenytoin
(used in treatment of epilepsy)
− rifampicin (used for infections)
− phenprocoumon (to thin your blood).
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Subutex with food and drink
Do not drink alcohol or take medicines that contain
alcohol whilst you are being treated with Subutex.
Pregnancy and breast-feeding
You should not take Subutex if you are pregnant
unless your doctor has told you to. You must not
breast-feed your baby if you are taking Subutex.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
This medicine can cause drowsiness, which may
be made worse if you also drink alcohol or take
tranquillisers or anti-anxiety drugs. If you are drowsy,
do not drive or operate machinery.
The medicine can affect your ability to drive as it may
make you sleepy or dizzy.
− Do not drive while taking this medicine until you
know how it affects you.
− It is an offence to drive if this medicine affects your
ability to drive.
− However, you would not be committing an offence
if:
− The medicine has been prescribed to treat a
medical or dental problem and
− You have taken it according to the
instructions given by the prescriber or in the
information provided with the medicine and
− It was not affecting your ability to drive safely

If you have:
− asthma or other breathing problems.
− problems with your kidneys.

Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.

Tell your doctor before taking Subutex.

Important information about some of the
ingredients of Subutex

Subutex contains buprenorphine which can become
addictive if used continually for a long period of time.
Drug dependence may occur as a result of taking this
medicine.
Taking other medicines
You should not take benzodiazepines (medicines used
to treat anxiety or sleep disorders) whilst you are
taking Subutex, unless they are prescribed by your
doctor.
Subutex may make you feel sleepy and taking any of
the following medicines may make this worse.
Tell your doctor if you are already taking:
− strong pain killers and cough medicines that contain
opioid-related substances
− antidepressants, including monoamine oxidase
inhibitors
− antihistamines that make you feel drowsy
− sedatives (to help you sleep)
− medicines for anxiety

Subutex Sublingual Tablets contain lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
Athletes should be aware that this medicine may cause
a positive reaction to “anti-doping” tests.
3. HOW TO TAKE SUBUTEX SUBLINGUAL
TABLETS
You must place the tablet under your tongue and allow
it to dissolve, which will take 5 to 10 minutes. This is
the only way to take the tablets. Do not chew or
swallow them whole, as they will not work.
Your doctor will tell you how many tablets to take and
you should always follow this advice.

To avoid sudden withdrawal symptoms, treatment with
Subutex should be given when there are already clear
signs of withdrawal symptoms.
Adults and children over the age of 16 years:
when beginning treatment the dose is between
0.8 to 4 mg, taken once a day.
For drug addicts who have not had any withdrawal
treatment: one dose of Subutex should be taken at
least 6 hours after the last use of the opioid (narcotic
such as morphine or heroin), or when the first signs of
craving appear. If you take it less than six hours after
you use a narcotic you may get withdrawal symptoms.
For patients taking methadone: before beginning
treatment, your doctor should reduce your dose of
methadone to not more than 30mg a day. Subutex
may cause withdrawal symptoms in patients who are
dependent on methadone if used within 24 hours of the
last dose of methadone.
During your treatment, your doctor may increase your
dose of Subutex, to a maximum single daily dose of
32mg, depending upon your response. Once you have
been stable for a while, your doctor will gradually
reduce your dose and it may be possible to stop it
altogether. Do not suddenly stop taking the tablets, as
this may cause withdrawal symptoms.
If you take more Subutex than you should
Get medical help at once.
If you forget to take Subutex
You should tell your doctor and follow his or her
instructions. Do not take a double dose to make up for
the forgotten dose.
If you stop taking Subutex
Do not suddenly stop taking the tablets, as this may
cause withdrawal symptoms.
How to remove the tablet from the blister pack:

Other side effects that may occur with Subutex are:
− constipation
− headaches
− feeling and or being sick.
− sweating.
− fainting and dizziness,
− drowsiness or difficulty in sleeping,
− lack of energy or feeling weak,
− feeling faint or dizzy after standing up from a sitting
or lying position.
− hallucinations (sensing things that are not real)
− difficulty in urinating
It is possible that taking this medicine can lead to drug
dependence.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE SUBUTEX SUBLINGUAL
TABLETS
Keep all medicines out of the sight and reach of
children.
Do not store above 30ºC.
Store in the original package.
Do not use after the expiry date printed on the carton
and blister pack.
If your medicine becomes discoloured or shows any
signs of deterioration, consult your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Subutex tablets contain
− Each 2 mg tablet contains 2 mg buprenorphine (as
hydrochloride) as the active ingredient.
Each 8 mg tablet contains 8 mg buprenorphine (as
hydrochloride) as the active ingredient.
− Your medicine also contains: lactose monohydrate,
mannitol E421, maize starch, povidone, citric acid
(E472c), sodium citrate E331 and magnesium
stearate.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Subutex can cause side effects,
although not everybody gets them.
Tell your doctor immediately if you experience any of
the following symptoms after taking this medicine.
Although they are rare, these symptoms can be
serious.
− sudden wheezing, difficulty breathing, swelling of the
eyelids, face, tongue, lips, throat or hands; rash or
itching especially those covering your whole body.
These may be signs of an allergic reaction.
− if you start to breathe more slowly or weakly than
expected (respiratory depression).
− if you start to feel faint, as this may be a sign of low
blood pressure.
Some cases of severe liver problems have been
reported during treatment, although they may
not necessarily have been caused by Subutex.
If you develop severe fatigue (tiredness), have no
appetite or if your skin or eyes look yellow, tell
your doctor immediately.

What Subutex tablets look like and contents of the
pack
The Subutex 2 mg is a white to creamy white, oval
tablet. Flat with bevelled edges. Engraved with sword
logo midline on short axis on one side and "B2" on the
other.
The Subutex 8 mg is a white to creamy white, oval
tablet. Flat with bevelled edges. Engraved with sword
logo midline on short axis on one side and "B8" on the
other.
Subutex 2 mg and 8 mg Sublingual Tablets are in
packs of 7 or 28 tablets.
Manufacturer
Reckitt Benckiser Healthcare (UK) Ltd.,
Dansom Lane, Hull, HU8 7DS, UK.
Procured from within the EU.
Product Licence Holder: S.C.A.C. Ltd., Unit 2a
Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP,
and repackaged by Doncaster Pharmaceuticals Ltd.,
Doncaster, DN3 1QR.
CD

POM
®

Subutex 121mg1Sublingual1Tablets PL: 30984/0233
®

Subutex 181mg1Sublingual1Tablets PL: 30984/0234
This leaflet was last approved in 21.11.2014
®

Subutex is a registered trade mark of Reckitt
Benckiser Healthcare (UK) Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Buprenorphine 2 mg Sublingual Tablets
Buprenorphine 8 mg Sublingual Tablets
(buprenorphine hydrochloride)
Read all of this leaflet carefully before you start
taking this medicine.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
− If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Your medicine is called by any of the above names, but will
be referred to as Buprenorphine Sublingual Tablets. The
other strength 0.4 mg is also available.
In this leaflet:
1. What Buprenorphine Sublingual Tablets are and what
they are used for
2. Before you take Buprenorphine Sublingual Tablets
3. How to take Buprenorphine Sublingual Tablets
4. Possible side effects
5. How to store Buprenorphine Sublingual Tablets
6. Further information
1. WHAT BUPRENORPHINE SUBLINGUAL TABLETS
ARE AND WHAT THEY ARE USED FOR
Buprenorphine Sublingual Tablets contain buprenorphine,
which is a medicine called an ‘opioid analgesic’ (strong
pain reliever). Buprenorphine Sublingual Tablets is used to
help patients addicted to opiate (narcotic) drugs, such as
morphine and heroin by acting as a substitute for these
drugs. Over a period of time patients can withdraw from
the narcotics that they were addicted to.
2. BEFORE YOU TAKE BUPRENORPHINE
SUBLINGUAL TABLETS
Do not take Buprenorphine Sublingual Tablets
− If you are a child under the age of 16 years.
− If you are allergic to buprenorphine or to any of the other
ingredients in this medicine.
− If you have serious breathing problems.
− If you have serious problems with your liver.
− If you are intoxicated due to alcohol or have delirium
tremens (confusion and shaking due to stopping drinking
alcohol) and hallucinations (seeing and hearing things
that are not there).
− If you are breast-feeding a baby.
Take special care with Buprenorphine Sublingual
Tablets
If you have:
− asthma or other breathing problems.
− problems with your kidneys.
Tell your doctor before taking Buprenorphine Sublingual
Tablets.
Buprenorphine Sublingual Tablets contains buprenorphine
which can become addictive if used continually for a long
period of time. Drug dependence may occur as a result of
taking this medicine.
Taking other medicines
You should not take benzodiazepines (medicines used to
treat anxiety or sleep disorders) whilst you are taking
Buprenorphine, unless they are prescribed by your doctor.
Buprenorphine may make you feel sleepy and taking any
of the following medicines may make this worse.
Tell your doctor if you are already taking:
− strong pain killers and cough medicines that contain
opioid-related substances
− antidepressants, including monoamine oxidase inhibitors
− antihistamines that make you feel drowsy
− sedatives (to help you sleep)
− medicines for anxiety
− medicines for high blood pressure
− treatment for a mental problem.

You should tell your doctor if you are taking any of the
following medicines as he may need to give you a
lower dose of Buprenorphine:
− Ketoconazole (a medicine used to treat fungal infections
which can increase the levels of Buprenorphine in your
blood if both are taken at the same time)
− gestodene (found in contraceptives)
− troleandomycin (an antibiotic)
− ritonavir, indinavir1and1saquinavir (the1HIV protease
inhibitors)
Also tell your doctor or pharmacist if you are taking any
of the following medicines:
− phenobarbital, carbamazepine or phenytoin
(used in treatment of epilepsy)
− rifampicin (used for infections)
− phenprocoumon (to thin your blood).
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Buprenorphine with food and drink
Do not drink alcohol or take medicines that contain alcohol
whilst you are being treated with Buprenorphine.
Pregnancy and breast-feeding
You should not take Buprenorphine if you are pregnant
unless your doctor has told you to. You must not breastfeed your baby if you are taking Buprenorphine.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
This medicine can cause drowsiness, which may
be made worse if you also drink alcohol or take
tranquillisers or anti-anxiety drugs. If you are drowsy, do
not drive or operate machinery.
The medicine can affect your ability to drive as it may
make you sleepy or dizzy.
− Do not drive while taking this medicine until you know
how it affects you.
− It is an offence to drive if this medicine affects your
ability to drive.
− However, you would not be committing an offence if:
− The medicine has been prescribed to treat a
medical or dental problem and
− You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
− It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Important information about some of the ingredients of
Buprenorphine Sublingual Tablets
Buprenorphine Sublingual Tablets contain lactose. If you
have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
medicine.
Athletes should be aware that this medicine may cause a
positive reaction to “anti-doping” tests.
3. HOW TO TAKE BUPRENORPHINE SUBLINGUAL
TABLETS
You must place the tablet under your tongue and allow it to
dissolve, which will take 5 to 10 minutes. This is the only
way to take the tablets. Do not chew or swallow them
whole, as they will not work.
Your doctor will tell you how many tablets to take and you
should always follow this advice.
To avoid sudden withdrawal symptoms, treatment with
Buprenorphine Sublingual Tablets should be given when
there are already clear signs of withdrawal symptoms.

Adults and children over the age of 16 years:
when beginning treatment the dose is between
0.8 to 4 mg, taken once a day.
For drug addicts who have not had any withdrawal
treatment: one dose of Buprenorphine Sublingual Tablets
should be taken at least 6 hours after the last use of the
opioid (narcotic such as morphine or heroin), or when the
first signs of craving appear. If you take it less than six
hours after you use a narcotic you may get withdrawal
symptoms.
For patients taking methadone: before beginning
treatment, your doctor should reduce your dose of
methadone to not more than 30mg a day. Buprenorphine
Sublingual Tablets may cause withdrawal symptoms in
patients who are dependent on methadone if used within
24 hours of the last dose of methadone.
During your treatment, your doctor may increase your dose
of Buprenorphine Sublingual Tablets, to a maximum single
daily dose of 32mg, depending upon your response. Once
you have been stable for a while, your doctor will gradually
reduce your dose and it may be possible to stop it
altogether. Do not suddenly stop taking the tablets, as this
may cause withdrawal symptoms.
If you take more Buprenorphine Sublingual Tablets
than you should
Get medical help at once.
If you forget to take Buprenorphine Sublingual Tablets
You should tell your doctor and follow his or her
instructions. Do not take a double dose to make up for the
forgotten dose.
If you stop taking Buprenorphine Sublingual Tablets
Do not suddenly stop taking the tablets, as this may cause
withdrawal symptoms.
How to remove the tablet from the blister pack:

Other side effects that may occur with Buprenorphine
Sublingual Tablets are:
− constipation
− headaches
− feeling and or being sick.
− sweating.
− fainting and dizziness,
− drowsiness or difficulty in sleeping,
− lack of energy or feeling weak,
− feeling faint or dizzy after standing up from a sitting or
lying position.
− hallucinations (sensing things that are not real)
− difficulty in urinating
It is possible that taking this medicine can lead to drug
dependence.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE BUPRENORPHINE SUBLINGUAL
TABLETS
Keep all medicines out of the sight and reach of children.
Do not store above 30ºC.
Store in the original package.
Do not use after the expiry date printed on the carton and
blister pack.
If your medicine becomes discoloured or shows any signs
of deterioration, consult your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Buprenorphine Sublingual Tablets tablets
contain
− Each 2 mg tablet contains 2 mg buprenorphine (as
hydrochloride) as the active ingredient.
− Each 8 mg tablet contains 8 mg buprenorphine (as
hydrochloride) as the active ingredient.
− Your medicine also contains: lactose monohydrate,
mannitol E421, maize starch, povidone, citric acid
(E472c), sodium citrate E331 and magnesium stearate.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Buprenorphine Sublingual Tablets can
cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the
following symptoms after taking this medicine.
Although they are rare, these symptoms can be serious.
− sudden wheezing, difficulty breathing, swelling of the
eyelids, face, tongue, lips, throat or hands; rash or
itching especially those covering your whole body. These
may be signs of an allergic reaction.
− if you start to breathe more slowly or weakly than
expected (respiratory depression).
− if you start to feel faint, as this may be a sign of low
blood pressure.
Some cases of severe liver problems have been reported
during treatment, although they may not necessarily have
been caused by Buprenorphine Sublingual Tablets.
If you develop severe fatigue (tiredness), have no
appetite or if your skin or eyes look yellow, tell your
doctor immediately.

What Buprenorphine Sublingual Tablets look like and
contents of the pack
The Buprenorphine 2 mg is a white to creamy white, oval
tablet. Flat with bevelled edges. Engraved with sword logo
midline on short axis on one side and "B2" on the other.
The Buprenorphine 8 mg is a white to creamy white, oval
tablet. Flat with bevelled edges. Engraved with sword logo
midline on short axis on one side and "B8" on the other.
Buprenorphine 2 mg and 8 mg Sublingual Tablets are in
packs of 7 or 28 tablets.
Manufacturer
Reckitt Benckiser Healthcare (UK) Ltd.,
Dansom Lane, Hull, HU8 7DS, UK.
Procured from within the EU.
Product Licence Holder: S.C.A.C. Ltd., Unit 2a Bandeath
Industrial Estate, Throsk, Stirling, FK7 7NP, and
repackaged by Doncaster Pharmaceuticals Ltd.,
Doncaster, DN3 1QR.
POM

CD

PL: 30984/0233
Buprenorphine 2 mg Sublingual Tablets
PL: 30984/0234
Buprenorphine 8 mg Sublingual Tablets
This leaflet was last approved in 21.11.2014

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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