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BUPRENORPHINE 8MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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

Ref:11823/080514/1/F

(buprenorphine hydrochloride)
Patient Information 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.
Your medicine is called Subutex 2mg Sublingual Tablets / Subutex 8mg
Sublingual Tablets but it will referred to Subutex through out this leaflet.
In this leaflet:
1 What Subutex is and what it is used for
2

Before you take Subutex

3

How to take Subutex

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.

4

Possible side effects

5

How to store Subutex

6

Further information

Taking Subutex with food and drink
Do not drink alcohol or take medicines that contain alcohol whilst you are
being treated with Subutex.

What Subutex is and what it is used for

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.

1

Subutex 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

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 dependance 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 can 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
* antihstamines that make you feel drowsy
* sedatives (to help you sleep)
* medicines for anxiety
* medicines for high blood pressure
* treatment for a mental problem.

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 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

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.
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.
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.

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

Ref: 11823/080514/1/B

(buprenorphine hydrochloride)
Patient Information Leaflet (continued)
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 in 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.

5

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 30°C.
Protect from moisture
Store in the original package.
Do not use this medicine after the expiry date shown on the carton or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal.
Only keep this medicine, if your doctor tells you to. If your medicine
becomes discoloured or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do.

*
*
*
*
*
*

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
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, 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.
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.
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.

How to store Subutex

6

Further information

What this medicine contains:
Each sublingual tablet contains buprenorphine hydrochloride, equivalent to
either 2mg or 8mg buprenorphine base as the active ingredient.
Subutex also has the following inactive ingredients: lactose monohydrate,
mannitol, maize starch, povidone K30, citric acid, sodium citrate and
magnesium stearate.
What this medicine looks like and contents of the pack:
Subutex 2mg Sublingual Tablets are white oval shaped tablets with B2 on
one side and the company logo (sword) on the other side.
Subutex 8mg Sublingual Tablets are white oval shaped tablets with B8 on
one side and the company logo (sword) on the other side.
Subutex 2mg and 8mg Tablets are available in boxes of 7 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by SCHERING-PLOUGH, 2 rue Louis
Pasteur 14200 Hérouville-Saint-Clair, France and is procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1182
PL 15184/1183

Subutex 2mg Sublingual Tablets
Subutex 8mg Sublingual Tablets

Subutex is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.
Revision date: 08/05/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 11823/080514/2/F

Buprenorphine 2mg Sublingual Tablets / Buprenorphine 8mg Sublingual Tablets
(buprenorphine hydrochloride)
Patient Information 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.
Your medicine is called Buprenorphine 2mg Sublingual Tablets /
Buprenorphine 8mg Sublingual Tablets but it will referred to Buprenorphine
Tablets through out this leaflet.
In this leaflet:
1 What Buprenorphine Tablets is and what is it used for?
2 Before you take Buprenorphine Tablets
3 How to take Buprenorphine Tablets
4 Possible side effects
5 How to store Buprenorphine Tablets
6 Further information

1

What Buprenorphine Tablets is and what it is used
for

Buprenorphine Tablets contain buprenorphine hydrochloride, which is a
medicine called an ‘opioid analgesic’ (strong pain reliever). Buprenorphine
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 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 dependance 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 can 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
* antihstamines 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 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 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 medicine
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 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 Tablets

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

Ref: 118283/080514/2/B

Buprenorphine 2mg Sublingual Tablets / Buprenorphine 8mg Sublingual Tablets
(buprenorphine hydrochloride)
Patient Information Leaflet (continued)
For drug addicts who have not had any withdrawal treatment: 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.
For patients taking methadone: before beginning treatment, your doctor
should reduce your dose of methadone to not more than 30mg a day.
Buprenorphine Tablets may cause withdrawal symptoms in patients who are
dependent on methadone if used within in 24 hours of the last dose of
methadone.

*
*

hallucinations (sensing things that are not real)
difficulty in urinating

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.

5

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
You should tell your doctor and follow his or her instructions. Do not take a
double dose to make up for the forgotten dose.
6
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

4

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 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 medicines. 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
Tablets.
If you develop severe fatigue (tiredness), have no appetite or if your skin or
eyes look yellow, tell your doctor immediately.
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

How to store Buprenorphine Tablets
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not store above 30°C.
Protect from moisture
Store in the original package.
Do not use this medicine after the expiry date shown on the carton or
blister strip. If your doctor tells you to stop taking this medicine, return
any unused medicine to your pharmacist for safe disposal.
Only keep this medicine, if your doctor tells you to. If your medicine
becomes discoloured or shows any other signs of deterioration, consult
your pharmacist who will tell you what to do.

Further information

What this medicine contains:
Each sublingual tablet contains buprenorphine hydrochloride, equivalent to
either 2mg or 8mg buprenorphine base as the active ingredient.
Buprenorphine also has the following inactive ingredients: lactose
monohydrate, mannitol, maize starch, povidone K30, citric acid, sodium
citrate and magnesium stearate.
What this medicine looks like and contents of the pack:
Buprenorphine 2mg Sublingual Tablets are white oval shaped tablets with
B2 on one side and the company logo (sword) on the other side.
Buprenorphine 8mg Sublingual Tablets are white oval shaped tablets with
B8 on one side and the company logo (sword) on the other side.
Buprenorphine 2mg and 8mg Tablets are available in boxes of 7 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by SCHERING-PLOUGH, 2 rue Louis
Pasteur 14200 Hérouville-Saint-Clair, France and is procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1182 Buprenorphine 2mg Sublingual Tablets
PL 15184/1183 Buprenorphine 8mg Sublingual Tablets

Revision date: 08/05/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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