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BUPRENORPHINE 8MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE / BUPRENORPHINE HYDROCHLORIDE

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S514 LEAFLET Subutex 20150723

PACKAGE LEAFLET: INFORMATION FOR THE USER

SUBUTEX 2mg SUBLINGUAL TABLETS
SUBUTEX 8mg SUBLINGUAL TABLETS
(buprenorphine hydrochloride)
Your medicine is called Subutex 2mg Sublingual Tablets and
Subutex 8mg Sublingual Tablets but will be referred to as Subutex
Sublingual Tablets throughout the remainder of the leaflet.
Information regarding other strength Subutex 0.4mg Sublingual
Tablets is also present in the below leaflet.
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.

In this leaflet:
1. What Subutex Sublingual Tablets are and what they are used
for
2. Before you take Subutex Sublingual Tablets

Tell your doctor if you are already taking:


strong pain killers and cough medicines that contain opioidrelated 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 Subutex Sublingual Tablets:


Ketoconazole ( a medicine used to treat fungal infections which
can increase the levels of Subutex Sublingual Tablets in your
blood if both are taken at the same time)



gestodene (found in contraceptives)



troleandomycin (an antibiotic)



ritonavir, indinavir and saquinavir (the HIV 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 Sublingual Tablets with food and drink

3. How to take Subutex Sublingual Tablets

Do not drink alcohol or take medicines that contain alcohol whilst
you are being treated with Subutex Sublingual Tablets.

4. Possible side effects

Pregnancy and breast-feeding

5. How to store Subutex Sublingual Tablets

You should not take Subutex Sublingual Tablets if you are pregnant
unless your doctor has told you to. You must not breast-feed your
baby if you are taking 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 Sublingual Tablets are 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 Sublingual Tablets

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:



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.

o

The medicine has been prescribed to treat a medical or
dental problem and



If you have serious breathing problems.

o



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).

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

 If you are breast-feeding a baby.
Take special care with Subutex Sublingual Tablets
If you have:


asthma or other breathing problems.



problems with your kidneys.

Tell your doctor before taking Subutex Sublingual Tablets.
Subutex Sublingual Tablets contain 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 Sublingual
Tablets, unless they are prescribed by your doctor.
Subutex Sublingual Tablets may make you feel sleepy and taking
any of the following medicines may make this worse.

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 Sublingual Tablets
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.

Other side effects that may occur with Subutex Sublingual Tablets
are:

To avoid sudden withdrawal symptoms, treatment with Subutex
Sublingual Tablets should be given when there are already clear
signs of withdrawal symptoms.



constipation



headaches



feeling and or being sick.



sweating.

For drug addicts who have not had any withdrawal treatment:
one dose of Subutex 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.



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.

For patients taking methadone: before beginning treatment, your
doctor should reduce your dose of methadone to not more than
30mg a day. Subutex Sublingual Tablets may cause withdrawal
symptoms in patients who are dependent on methadone if used
within 24 hours of the last dose of methadone



hallucinations (sensing things that are not real)



difficulty in urinating

Adults and children over the age of 16 years: when beginning
treatment the dose is between 0.8 to 4mg, taken once a day.

During your treatment, your doctor may increase your dose of
Subutex 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.

It is possible that taking this medicine can lead to drug dependence.
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 take more Subutex Sublingual Tablets than you should

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.

Get medical help at once.
If you forget to take Subutex Sublingual Tablets

By reporting side effects, you can help provide more information on
the safety of this medicine.

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 Sublingual Tablets

5. HOW TO STORE SUBUTEX SUBLINGUAL TABLETS

Do not suddenly stop taking the tablets, as this may cause
withdrawal symptoms.
How to remove the tablet from the blister pack:

1- Remove just one section from the
blister pack, tearing it along the
perforated line.
2 – Starting from the edge where the
seal is lifted, pull back the foil on the
back to remove the tablet.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Subutex Sublingual Tablets should not be stored above 30°C.
They should be stored in the original package.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the gel, please take it back
to the pharmacist for safe disposal. Only keep the gel if your
doctor tells you to.



If the medicines becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.

6. FURTHER INFORMATION
What Subutex Sublingual Tablets contain


Each Subutex Sublingual 2mg Tablets contains 2.16mg
buprenorphine hydrochloride equivalent to 2mg buprenorphine.



Each Subutex 8mg Sublingual Tablets contain 8.64mg
buprenorphine hydrochloride equivalent to 8mg buprenorphine.



Subutex Sublingual Tablets also contain the following inactive
ingredient: lactose monohydrate, mannitol (E421), maize
starch, povidone K30, citric acid, sodium citrate and magnesium
stearate.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Subutex 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

What Subutex Sublingual Tablets look like and contents of the
pack



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.

Product Licence holder

Some cases of severe liver problems have been reported during
treatment, although they may not necessarily have been caused by
Subutex Sublingual Tablets. If you develop severe fatigue
(tiredness), have no appetite or if your skin or eyes look
yellow, tell your doctor immediately.



Subutex Sublingual 2mg Tablets are oval white tablets marked
‘B2’ on one side with a sword logo on the other.



Subutex Sublingual Tablets are oval white tablets marked ‘B8’
on one side with a sword logo on the other.



Subutex Sublingual Tablets are available as blister packs of 7
tablets.

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Subutex Sublingual Tablets are manufactured by Reckitt Benckiser
Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS.
POM

PL. 19488/0514 Subutex 2mg Sublingual Tablets
PL. 19488/0515 Subutex 8mg Sublingual Tablets

Leaflet revision date: 23 July 2015
Subutex is a registered trade mark of Reckitt Benckiser Healthcare
(UK) Ltd, UK.
S514 LEAFLET Subutex 20150723

S514 LEAFLET Buprenorphine 20150723

Buprenorphine Sublingual Tablets may make you feel sleepy and
taking any of the following medicines may make this worse.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tell your doctor if you are already taking:


strong pain killers and cough medicines that contain opioidrelated substances



antidepressants, including monoamine oxidase inhibitors



antihistamines that make you feel drowsy



sedatives (to help you sleep)

Your medicine is called Buprenorphine 2mg Sublingual Tablets and
Buprenorphine 8mg Sublingual Tablets but will be referred to as
Buprenorphine Sublingual Tablets throughout the remainder of the
leaflet.



medicines for anxiety



medicines for high blood pressure



treatment for a mental problem.

Information regarding other strength Buprenorphine 0.4mg
Sublingual Tablets is also present in the below leaflet.

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 Sublingual Tablets:

BUPRENORPHINE 2mg SUBLINGUAL TABLETS
BUPRENORPHINE 8mg 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.

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



Ketoconazole ( a medicine used to treat fungal infections which
can increase the levels of Buprenorphine Sublingual Tablets in
your blood if both are taken at the same time)



gestodene (found in contraceptives)



troleandomycin (an antibiotic)



ritonavir, indinavir and saquinavir (the HIV 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 Sublingual Tablets with food and drink

5. How to store Buprenorphine Sublingual Tablets

Do not drink alcohol or take medicines that contain alcohol whilst
you are being treated with Buprenorphine Sublingual Tablets.

6. Further information

Pregnancy and breast-feeding

1. WHAT BUPRENORPHINE SUBLINGUAL TABLETS ARE AND
WHAT THEY ARE USED FOR

You should not take Buprenorphine Sublingual Tablets if you are
pregnant unless your doctor has told you to. You must not breastfeed your baby if you are taking Buprenorphine Sublingual Tablets.

Buprenorphine Sublingual Tablets contain buprenorphine
hydrochloride, which is a medicine called an 'opioid analgesic'
(strong pain reliever). Buprenorphine Sublingual Tablets are 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.

Ask your doctor or pharmacist for advice before taking any
medicine.

2. BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL
TABLETS



Do not drive while taking this medicine until you know how it
affects you.

Do not take Buprenorphine Sublingual Tablets



It is an offence to drive if this medicine affects your ability to
drive.



However, you would not be committing an offence if:



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).

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.

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

 If you are breast-feeding a baby.
Take special care with Buprenorphine Sublingual Tablets

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

If you have:

Important information about some of the ingredients of
Buprenorphine Sublingual Tablets



asthma or other breathing problems.



problems with your kidneys.

Tell your doctor before taking Buprenorphine Sublingual Tablets.
Buprenorphine Sublingual Tablets contain 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
Sublingual Tablets, unless they are prescribed by your doctor.

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.

Other side effects that may occur with Buprenorphine Sublingual
Tablets are:


constipation



headaches



feeling and or being sick.

Your doctor will tell you how many tablets to take and you should
always follow this advice.



sweating.

To avoid sudden withdrawal symptoms, treatment with
Buprenorphine Sublingual Tablets should be given when there are
already clear signs of withdrawal symptoms.



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

Adults and children over the age of 16 years: when beginning
treatment the dose is between 0.8 to 4mg, 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:

It is possible that taking this medicine can lead to drug dependence.
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 SUBLINGUAL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Buprenorphine Sublingual Tablets should not be stored above
30°C. They should be stored in the original package.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the gel, please take it back
to the pharmacist for safe disposal. Only keep the gel if your
doctor tells you to.



If the medicines becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.

6. FURTHER INFORMATION
What Buprenorphine Sublingual Tablets contain
1- Remove just one section from the
blister pack, tearing it along the
perforated line.
2 – Starting from the edge where the
seal is lifted, pull back the foil on the
back to remove the tablet.

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.



Each Buprenorphine Sublingual 2mg Tablets contains 2.16mg
buprenorphine hydrochloride equivalent to 2mg buprenorphine.



Each Buprenorphine 8mg Sublingual Tablets contain 8.64mg
buprenorphine hydrochloride equivalent to 8mg buprenorphine.



Buprenorphine Sublingual Tablets also contain the following
inactive ingredient: lactose monohydrate, mannitol (E421),
maize starch, povidone K30, citric acid, sodium citrate and
magnesium stearate.

What Buprenorphine Sublingual Tablets look like and contents
of the pack


Buprenorphine Sublingual 2mg Tablets are oval white tablets
marked ‘B2’ on one side with a sword logo on the other.



Buprenorphine Sublingual Tablets are oval white tablets
marked ‘B8’ on one side with a sword logo on the other.



Buprenorphine Sublingual Tablets are available as blister packs
of 7 tablets.

Product Licence holder



if you start to breathe more slowly or weakly than expected
(respiratory depression).



Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

if you start to feel faint, as this may be a sign of low blood
pressure.

Buprenorphine Sublingual Tablets are manufactured by Reckitt
Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS.

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.

POM

PL. 19488/0514 Buprenorphine 2mg Sublingual Tablets

PL. 19488/0515 Buprenorphine 8mg Sublingual Tablets
Leaflet revision date: 23 July 2015
S514 LEAFLET Buprenorphine 20150723

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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