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SUBUTEX 2 MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE

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Side effects reported with Subutex
Very common side effects:
Drug withdrawal syndrome, headache,
hyperhidrosis (sweating), insomnia
(inability to sleep), nausea (feeling sick),
pain
Common side effects:
Abdominal pain, agitation, anxiety, joint
pain, weakness, back pain, bone pain,
bronchitis, chest pain, chills, constipation,
cough, decreased appetite, depression,
diarrhoea, dizziness, dry mouth, painful
period, indigestion, shortness of breath,
flatulence, gastrointestinal disorder,
hostility, increase in muscle tension,
infection, influenza, nervousness, tearing
(watery eyes) disorder, swollen glands
(lymph nodes), malaise, migraine, muscle
spasms, muscle pain, dilation of the
pupil, neck pain, palpitations, paranoia,
burning or tingling in hands and feet,
swelling (hands and feet), sore throat and
painful swallowing, fever, rash,
somnolence, syncope (fainting),
thinking abnormal, tooth disorder, tremor;
flushing, vomiting (being sick), yawning.
Frequency not known:
Drug dependence, drug withdrawal
syndrome in newborn, hallucinations
(sensing things that are not real), drop in
blood pressure on changing position from
sitting or lying down to standing, difficulty
in urinating.
Misusing this medicine by injecting it can
cause withdrawal symptoms, infections,
other skin reactions and potentially
serious liver problems.
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.
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
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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.

Subutex® 2 mg
Sublingual Tablets
Subutex® 8 mg
Sublingual Tablets

FURTHER INFORMATION

What Subutex contains
 Each 2 mg tablet contains 2 mg
buprenorphine (as hydrochloride)
as the active ingredient.
Each 8 mg tablet contains 8mg
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.
What Subutex looks like and contents
of the pack
The Subutex 2 mg is a white to creamy
white, oval tablet. Flat with bevelled edges,
and marked with “B2” on one side and plain
on the reverse.
The Subutex 8 mg is a white to creamy
white, oval tablet. Flat with bevelled edges,
and marked with “B8” on one side and plain
on the reverse.
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
Cross Healthcare Ltd., Unit 2a Bandeath
Industrial Estate, Throsk, Stirling, FK7 7NP.
POM

PL:30984/0233
Subutex®121mg1Sublingual1Tablets1

CD

PL: 30984/0234
Subutex®181mg1Sublingual1Tablets1

(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.
The other strength 0.4 mg is also available.

Take special care with Subutex
Tell your doctor before you start taking
Subutex If you have:

asthma or other breathing problems

any liver disease such as hepatitis

low blood pressure

recently suffered head injury or brain
disease

a urinary disorder (especially linked to
enlarged prostate in men)

any kidney disease

thyroid problems

adrenocortical disorder (e.g. Addison’s
disease)
Important things to be aware of:




In this leaflet:
1.
2.
3.
4.
5.
6.

What Subutex is and what it is used for
Before you take Subutex
How to take Subutex
Possible side effects
How to store Subutex
Further information

1. WHAT SUBUTEX IS AND WHAT IT IS
USED FOR
Subutex is used to treat dependence on
opiate (narcotic) drugs, such as
morphine and heroin in drug addicts
who have agreed to be treated for their
addiction.
Subutex is used in adults and
adolescents over 16 years of age who
are also receiving medical, social and
psychological support.

This leaflet was last approved in
15.09.2016

2. BEFORE YOU TAKE SUBUTEX

Subutex® is a registered trade mark of
Indivior UK Ltd.








Do not take Subutex:









If you are a child under the age of
16 years.
If you are allergic (hypersensitive) to
buprenorphine or to any of the other
ingredients of this medicine (listed in
section 6).
If you have serious breathing
problems.
If you have serious problems with
your liver.
If you are intoxicated due to alcohol or
have trembling, sweating, anxiety
confusion or hallucinations caused by
alcohol.
If you are breast feeding a baby.



Misuse, abuse and diversion
This medicine can be a target for
people who abuse prescription
medicines, and should be kept in a
safe place to protect it from theft. Do
not give this medicine to anyone else.
It can cause death or otherwise harm
them.
Breathing problems
Some people have died from
respiratory failure (inability to breathe)
because they misused this medicine
or took it in combination with other
central nervous system depressants,
such as alcohol, benzodiazepines
(tranquilisers), or other opioids.
Dependence
This product can cause dependence.
Withdrawal symptoms
This product can cause withdrawal
symptoms if you take it less than
6 hours after you use a short-acting
opioid (e.g. morphine, heroin) or less
than 24 hours after you use a
long-acting opioid such as
methadone.
Subutex can also cause withdrawal
symptoms if you stop taking it
abruptly.
Liver damage
Liver damage has been reported after
taking Subutex, especially when the
medicine is misused. This could also
be due to viral infections (chronic
hepatitis C), alcohol abuse, anorexia
or use of other medicines with the
ability to harm your liver (see section 4).
Regular blood tests may be conducted
by your doctor to monitor the
condition of your liver. Tell your
doctor if you have any liver problems
before you start treatment with
Subutex.
Blood pressure
This product may cause your blood
pressure to drop suddenly, causing
you to feel dizzy if you get up too
quickly from sitting or lying down.



Diagnosis of unrelated medical
conditions
This medicine may mask pain
symptoms that could assist in the
diagnosis of some diseases. Do not
forget to advise your doctor if you
take this medicine.

Taking other medicines
Some medicines may increase the side
effects of Subutex and may sometimes
cause very serious reactions. Do not
take any other medicines whilst taking
Subutex without first talking to your
doctor, especially:

Benzodiazepines (used to treat anxiety
or sleep disorders) such as diazepam,
temazepam, alprazolam. Your doctor
will prescribe the correct dose for you.
Taking the wrong dose of
benzodiazepines may cause death due
to respiratory failure (inability to
breathe).

Other medicines that may make you
feel sleepy which are used to treat
illnesses such as anxiety,
sleeplessness, convulsions / seizures,
pain. These types of medicines will
reduce your alertness levels making it
difficult for you to drive and use
machines. They may also cause central
nervous system depression, which is
very serious. Below is a list of
examples of these types of medicines:
 other opioid containing medicines
such as methadone, certain pain
killers and cough suppressants.
 antidepressants (used to treat
depression) such as isocarboxazide,
phenelzine, selegiline,
tranylcypromine, and valproate may
increase the effects of this medicine.
 sedative H1 receptor antagonists
(used to treat allergic reactions)
such as diphenhydramine and
chlorphenamine.
 barbiturates (used to cause sleep or
sedation) such as phenobarbital,
secobarbital.
 tranquilisers (used to cause sleep or
sedation) such as chloral hydrate.

Naltrexone may prevent Subutex from
working. If you take naltrexone whilst
you are taking Subutex you may
experience a sudden onset of
prolonged and intense withdrawal
symptoms.

Clonidine (used to treat high blood
pressure) may extend the effects of this
medicine.

Anti-retrovirals (used to treat AIDS)
such as ritonavir, nelfinavir, indinavir
may increase the effects of this
medicine.

Some antifungal agents (used to treat
fungal infections) such as ketoconazole
and itraconazole and certain antibiotics
(macrolide) may extend the effects of this
medicine.



Some medicines may decrease the
effect of Subutex. These include
medicines used to treat epilepsy (such
as carbamazepine and phenytoin) and
medicines used to treat tuberculosis
(rifampicin).
To get the greatest benefit from taking
Subutex, you must tell your doctor
about all the medicines you are taking,
including alcohol, medicines containing
alcohol, street drugs, and any
prescription medicine you are taking
that has not been prescribed for you by
your doctor.
Taking Subutex with food and drink
Alcohol may increase drowsiness and
may increase the risk of respiratory
failure (inability to breathe) if taken with
Subutex. Do not take Subutex together
with alcohol. Do not swallow or
consume food or drink until the tablet is
completely dissolved.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend
to become pregnant.
When taken during pregnancy,
particularly late pregnancy, medicines
like Subutex may cause drug withdrawal
symptoms including problems with
breathing in your new born baby.
These symptoms may occur several
days after birth.
Do not breast feed your baby whilst
taking this medicine as Subutex passes
into breast milk.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
If you feel drowsy or dizzy while taking
these tablets do not use 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:
o The medicine has been
prescribed to treat a medical or dental
problem and
o You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
o 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 Subutex
Subutex 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.

3. HOW TO TAKE SUBUTEX

If you stop taking Subutex

You must place the tablet under your
tongue (sublingual) 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.

Do not change the treatment in any way
or stop treatment without the agreement
of the doctor who is treating you.
Stopping treatment suddenly may cause
withdrawal symptoms.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

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.

How to remove the tablet from the
blister pack

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
If you or someone else takes too much
of this medicine, you must go or be
taken immediately to an emergency
centre or hospital as overdose with
Subutex may cause serious and
life-threatening breathing problems.
If you forget to take Subutex
Tell your doctor as soon as
possible if you miss a dose and
follow his or her instructions.
Do not take a double dose to make
up for the forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Subutex can cause
side effects, although not everybody
gets them.
Tell your doctor immediately or seek
urgent medical attention if you
experience side effects such as:

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 a
life-threatening 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.
Also tell your doctor immediately if you
experience side effects such as:

severe fatigue (tiredness), have no
appetite or if your skin or eyes look
yellow. These may be symptoms of
liver damage.
The frequency of possible side effects
listed below is defined using the
following convention:

very common (affects more than
1 user in 10)

common (affects 1 to 10 users in 100)

not known (frequency cannot be
estimated from the available data).

Side effects reported with
Buprenorphine
Very common side effects:
Drug withdrawal syndrome, headache,
hyperhidrosis (sweating), insomnia
(inability to sleep), nausea (feeling sick),
pain
Common side effects:
Abdominal pain, agitation, anxiety, joint
pain, weakness, back pain, bone pain,
bronchitis, chest pain, chills, constipation,
cough, decreased appetite, depression,
diarrhoea, dizziness, dry mouth, painful
period, indigestion, shortness of breath,
flatulence, gastrointestinal disorder,
hostility, increase in muscle tension,
infection, influenza, nervousness, tearing
(watery eyes) disorder, swollen glands
(lymph nodes), malaise, migraine, muscle
spasms, muscle pain, dilation of the
pupil, neck pain, palpitations, paranoia,
burning or tingling in hands and feet,
swelling (hands and feet), sore throat and
painful swallowing, fever, rash,
somnolence, syncope (fainting),
thinking abnormal, tooth disorder, tremor;
flushing, vomiting (being sick), yawning.
Frequency not known:
Drug dependence, drug withdrawal
syndrome in newborn, hallucinations
(sensing things that are not real), drop in
blood pressure on changing position from
sitting or lying down to standing, difficulty
in urinating.
Misusing this medicine by injecting it can
cause withdrawal symptoms, infections,
other skin reactions and potentially
serious liver problems.
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.
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
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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.

Buprenorphine 2 mg
Sublingual Tablets
Buprenorphine 8 mg
Sublingual Tablets

FURTHER INFORMATION

What Buprenorphine contains
 Each 2 mg tablet contains 2 mg
buprenorphine (as hydrochloride)
as the active ingredient.
Each 8 mg tablet contains 8mg
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.
What Buprenorphine look like
and contents of the pack
The Buprenorphine 2 mg is a white to creamy
white, oval tablet. Flat with bevelled edges,
and marked with “B2” on one side and plain
on the reverse.
The Buprenorphine 8 mg is a white to creamy
white, oval tablet. Flat with bevelled edges,
and marked with “B8” on one side and plain
on the reverse.
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
Cross Healthcare Ltd., Unit 2a Bandeath
Industrial Estate, Throsk, Stirling, FK7 7NP.
POM

PL:30984/0233
Buprenorphine®121mg1
Sublingual1Tablets1

CD

PL: 30984/0234
Buprenorphine®181mg1
Sublingual1Tablets1

This leaflet was last approved in
15.09.2016

(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. The other strength 0.4 mg is
also available.

Take special care with Buprenorphine
Tell your doctor before you start taking
Buprenorphine If you have:

asthma or other breathing problems

any liver disease such as hepatitis

low blood pressure

recently suffered head injury or brain
disease

a urinary disorder (especially linked to
enlarged prostate in men)

any kidney disease

thyroid problems

adrenocortical disorder (e.g. Addison’s
disease)
Important things to be aware of:




In this leaflet:
1. What Buprenorphine is and what it is
used for
2. Before you take Buprenorphine
3. How to take Buprenorphine
4. Possible side effects
5. How to store Buprenorphine
6. Further information




1. WHAT BUPRENORPHINE IS AND
WHAT IT IS USED FOR
Buprenorphine is used to treat dependence
on opiate (narcotic) drugs, such as
morphine and heroin in drug addicts
who have agreed to be treated for their
addiction.
Buprenorphine is used in adults and
adolescents over 16 years of age who
are also receiving medical, social and
psychological support.



2. BEFORE YOU TAKE BUPRENORPHINE
Do not take Buprenorphine:









If you are a child under the age of
16 years.
If you are allergic (hypersensitive) to
buprenorphine or to any of the other
ingredients of this medicine (listed in
section 6).
If you have serious breathing
problems.
If you have serious problems with
your liver.
If you are intoxicated due to alcohol or
have trembling, sweating, anxiety
confusion or hallucinations caused by
alcohol.
If you are breast feeding a baby.



Misuse, abuse and diversion
This medicine can be a target for
people who abuse prescription
medicines, and should be kept in a
safe place to protect it from theft. Do
not give this medicine to anyone else.
It can cause death or otherwise harm
them.
Breathing problems
Some people have died from
respiratory failure (inability to breathe)
because they misused this medicine
or took it in combination with other
central nervous system depressants,
such as alcohol, benzodiazepines
(tranquilisers), or other opioids.
Dependence
This product can cause dependence.
Withdrawal symptoms
This product can cause withdrawal
symptoms if you take it less than
6 hours after you use a short-acting
opioid (e.g. morphine, heroin) or less
than 24 hours after you use a
long-acting opioid such as methadone.
Buprenorphine can also cause
withdrawal symptoms if you stop taking
it abruptly.
Liver damage
Liver damage has been reported after
taking Buprenorphine, especially when
the medicine is misused. This could also
be due to viral infections (chronic
hepatitis C), alcohol abuse, anorexia
or use of other medicines with the
ability to harm your liver (see section 4).
Regular blood tests may be conducted
by your doctor to monitor the
condition of your liver. Tell your
doctor if you have any liver problems
before you start treatment with
Buprenorphine.
Blood pressure
This product may cause your blood
pressure to drop suddenly, causing
you to feel dizzy if you get up too
quickly from sitting or lying down.



Diagnosis of unrelated medical
conditions
This medicine may mask pain
symptoms that could assist in the
diagnosis of some diseases. Do not
forget to advise your doctor if you
take this medicine.

Taking other medicines
Some medicines may increase the side
effects of Buprenorphine and may
sometimes cause very serious reactions. Do
not take any other medicines whilst taking
Buprenorphine without first talking to your
doctor, especially:

Benzodiazepines (used to treat anxiety
or sleep disorders) such as diazepam,
temazepam, alprazolam. Your doctor
will prescribe the correct dose for you.
Taking the wrong dose of
benzodiazepines may cause death due
to respiratory failure (inability to
breathe).

Other medicines that may make you
feel sleepy which are used to treat
illnesses such as anxiety,
sleeplessness, convulsions / seizures,
pain. These types of medicines will
reduce your alertness levels making it
difficult for you to drive and use
machines. They may also cause central
nervous system depression, which is
very serious. Below is a list of
examples of these types of medicines:
 other opioid containing medicines
such as methadone, certain pain
killers and cough suppressants.
 antidepressants (used to treat
depression) such as isocarboxazide,
phenelzine, selegiline,
tranylcypromine, and valproate may
increase the effects of this medicine.
 sedative H1 receptor antagonists
(used to treat allergic reactions)
such as diphenhydramine and
chlorphenamine.
 barbiturates (used to cause sleep or
sedation) such as phenobarbital,
secobarbital.
 tranquilisers (used to cause sleep or
sedation) such as chloral hydrate.

Naltrexone may prevent Buprenorphine
from working. If you take naltrexone
whilst you are taking Buprenorphine you
may experience a sudden onset of
prolonged and intense withdrawal
symptoms.

Clonidine (used to treat high blood
pressure) may extend the effects of this
medicine.

Anti-retrovirals (used to treat AIDS)
such as ritonavir, nelfinavir, indinavir
may increase the effects of this
medicine.

Some antifungal agents (used to treat
fungal infections) such as ketoconazole
and itraconazole and certain antibiotics
(macrolide) may extend the effects of this
medicine.



Some medicines may decrease the
effect of Buprenorphine. These include
medicines used to treat epilepsy (such
as carbamazepine and phenytoin) and
medicines used to treat tuberculosis
(rifampicin).
To get the greatest benefit from taking
Buprenorphine, you must tell your doctor
about all the medicines you are taking,
including alcohol, medicines containing
alcohol, street drugs, and any
prescription medicine you are taking
that has not been prescribed for you by
your doctor.
Taking Buprenorphine with food and drink
Alcohol may increase drowsiness and
may increase the risk of respiratory
failure (inability to breathe) if taken with
Buprenorphine. Do not take Buprenorphine
together with alcohol. Do not swallow or
consume food or drink until the tablet is
completely dissolved.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend
to become pregnant.
When taken during pregnancy,
particularly late pregnancy, medicines
like Buprenorphine may cause drug
withdrawal symptoms including problems
with breathing in your new born baby.
These symptoms may occur several
days after birth.
Do not breast feed your baby whilst
taking this medicine as Buprenorphine passes
into breast milk.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
If you feel drowsy or dizzy while taking
these tablets do not use 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:
o The medicine has been
prescribed to treat a medical or dental
problem and
o You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
o 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
Buprenorphine 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.

3. HOW TO TAKE BUPRENORPHINE

If you stop taking Buprenorphine

You must place the tablet under your
tongue (sublingual) 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.

Do not change the treatment in any way
or stop treatment without the agreement
of the doctor who is treating you.
Stopping treatment suddenly may cause
withdrawal symptoms.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

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 should be
given when there are already clear signs
of withdrawal symptoms.

How to remove the tablet from the
blister pack

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 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
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,
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 than
you should
If you or someone else takes too much
of this medicine, you must go or be
taken immediately to an emergency
centre or hospital as overdose with
Buprenorphine may cause serious and
life-threatening breathing problems.
If you forget to take Buprenorphine
Tell your doctor as soon as
possible if you miss a dose and
follow his or her instructions.
Do not take a double dose to make
up for the forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Buprenorphine can cause
side effects, although not everybody
gets them.
Tell your doctor immediately or seek
urgent medical attention if you
experience side effects such as:

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 a
life-threatening 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.
Also tell your doctor immediately if you
experience side effects such as:

severe fatigue (tiredness), have no
appetite or if your skin or eyes look
yellow. These may be symptoms of
liver damage.
The frequency of possible side effects
listed below is defined using the
following convention:

very common (affects more than
1 user in 10)

common (affects 1 to 10 users in 100)

not known (frequency cannot be
estimated from the available data).

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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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