Skip to Content

BUPRENORPHINE 2MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Subutex® 2mg Sublingual Tablets
(buprenorphine hydrochloride)
PATIENT INFORMATION LEAFLET
Subutex Sublingual Tablets are available in the following strengths: 0.4mg, 2mg and 8mg.
This leaflet only applies to Subutex 2mg Sublingual Tablets which will be referred to as Subutex
throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.





In
1.
2.
3.
4.
5.
6.
1.

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.

this leaflet:
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
WHAT SUBUTEX IS AND WHAT IT IS USED FOR

Subutex contains 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

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

If you have:

asthma or other breathing problems.

problems with your kidneys.
Tell your doctor before taking 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
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, 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 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
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 contains lactose monohydrate. 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

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 4mg, taken once a day.

Page 1 of 2

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.

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

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

Get medical help at once.

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

If you forget to take Subutex

Reporting of side effects

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:

If you get any side effects talk to your doctor or pharmacist. 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.









6.

HOW TO STORE SUBUTEX

Do not use after the expiry date printed on the pack.
Do not store above 30°C.
Store in the original package to protect from moisture.
As with all medicines, keep out of the sight and reach of children.
If your tablets appear discoloured, or show any other signs of deterioration, take them back to
your pharmacist who will advise you.
Take any unused medicine back to your pharmacist for safe disposal.
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.

FURTHER INFORMATION

What Subutex contains
1 – Remove just one section from the blister pack, tearing it along the
perforated line.

Each sublingual tablet contains 2.16mg buprenorphine hydrochloride, equivalent to 2mg buprenorphine
base as the active ingredient, along with the following inactive ingredients: lactose monohydrate,
mannitol, maize starch, povidone K30, citric acid, sodium citrate and magnesium stearate.

What Subutex looks like and contents of the pack

Subutex are uncoated, white, oval tablets with the markings ‘B2’ on one side and company logo on the
reverse.
The sublingual tablets are available in packs containing 7 tablets.
2 – Starting from the edge where the seal is lifted, pull back the foil on the
back to remove the tablet.

Manufacturer

Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd., Hull, United Kingdom.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

4.

POSSIBLE SIDE EFFECTS

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Like all medicines, Subutex can cause side effects, although not everybody gets them.

PL No: 08929/0427

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.

Leaflet revision and issue date (Ref): 16.10.14

POM

Subutex® is a registered trademark of Reckitt Benckiser Healthcare (UK) Limited.

Page 2 of 2

Buprenorphine 2mg Sublingual Tablets
(Buprenorphine hydrochloride)
PATIENT INFORMATION LEAFLET
Buprenorphine Sublingual Tablets are available in the following strengths: 0.4mg, 2mg and 8mg.
This leaflet only applies to Buprenorphine 2mg Sublingual Tablets which will be referred to as
Buprenorphine Tablets throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.





In
1.
2.
3.
4.
5.
6.
1.

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.

this leaflet:
What Buprenorphine Tablets are and what these are used for
Before you take Buprenorphine Tablets
How to take Buprenorphine Tablets
Possible side effects
How to store Buprenorphine Tablets
Further information
WHAT BUPRENORPHINE TABLETS ARE AND WHAT THESE ARE USED
FOR

Buprenorphine Tablets contains Buprenorphine hydrochloride, which is a medicine called an ‘opioid
analgesic’ (strong pain reliever). Buprenorphine 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 BUPRENORPHINE TABLETS

Do not take Buprenorphine 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 Tablets
If you have:

asthma or other breathing problems.

problems with your kidneys.
Tell your doctor before taking Buprenorphine Tablets.

Buprenorphine 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 Tablets, unless they are prescribed by your doctor.
Buprenorphine Tablets 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 Tablets:

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, 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 Tablets with food and drink

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

Pregnancy and breast-feeding

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

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 Tablets
Buprenorphine Tablets contains lactose monohydrate. 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 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 Tablets should be given when
there are already clear signs of withdrawal symptoms.

Page 1 of 2

Adults and children over the age of 16 years:




For drug addicts who have not had any withdrawal treatment:

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

For patients taking methadone:

Other side effects that may occur with Buprenorphine 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

When beginning treatment the dose is between 0.8 to 4mg, taken once a day.
One dose of Buprenorphine 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.
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 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 Tablets than you should
Get medical help at once.

If you forget to take Buprenorphine Tablets

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

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 Tablets

Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms.

How to remove the tablet from the blister pack:

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. 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.









6.
1 – Remove just one section from the blister pack, tearing it along the
perforated line.

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.

HOW TO STORE BUPRENORPHINE TABLETS

Do not use after the expiry date printed on the pack.
Do not store above 30°C.
Store in the original package to protect from moisture.
As with all medicines, keep out of the sight and reach of children.
If your tablets appear discoloured, or show any other signs of deterioration, take them back to
your pharmacist who will advise you.
Take any unused medicine back to your pharmacist for safe disposal.
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.

FURTHER INFORMATION

What Buprenorphine Tablets contains

Each sublingual tablet contains 2.16mg Buprenorphine hydrochloride, equivalent to 2mg
Buprenorphine base as the active ingredient, along with the following inactive ingredients:
lactose monohydrate, mannitol, maize starch, povidone K30, citric acid, sodium citrate and
magnesium stearate.

What Buprenorphine Tablets looks like and contents of the pack
2 – Starting from the edge where the seal is lifted, pull back the foil on the
back to remove the tablet.

Buprenorphine Tablets are uncoated, white, oval tablets with the markings ‘B2’ on one side and
company logo on the reverse.
The sublingual tablets are available in packs containing 7 tablets.

Manufacturer

Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd., Hull, United Kingdom.

4.

POSSIBLE SIDE EFFECTS

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Like all medicines, Buprenorphine Tablets can cause side effects, although not everybody gets them.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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.

PL No: 08929/0427

POM

Leaflet revision and issue date (Ref): 16.10.14

Page 2 of 2

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.

Hide