Skip to Content

BUPRENORPHINE 0.4MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE HYDROCHLORIDE / BUPRENORPHINE HYDROCHLORIDE / BUPRENORPHINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Also tell your doctor immediately if you
experience uncommon side effects (may
affect up to 1 in 10 people), such as:
• severe fatigue, loss of appetite or yellowing
of skin and eyes. These may be symptoms
of liver damage such as death of the cells of
the liver (necrosis of the liver).

5 H
 ow to store Buprenorphine

Tablets

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton, blister and label
after EXP. The expiry date refers to the last day
of that month.
Blister packs: Do not store above 25°C. Store
in the original package in order to protect
from moisture.

Misusing this medicine by injecting it can
cause withdrawal symptoms, infections, other
skin reactions and potentially serious liver
problems - see ‘Warnings and precautions’.
After the first dose of Buprenorphine tablets,
you may have some opiate withdrawal
symptoms, see section 3 ‘How to take’.
Very common side effects (may affect more
than 1 in 10 people)
• not being able to sleep
• a general feeling of weakness
• withdrawal syndrome.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6 C
 ontents of the pack and other

Common side effects (may affect up to 1 in
10 people)
• headache
• fainting
• dizziness
• anxiety
• nervousness
• constipation
• nausea
• vomiting
• diarrhoea
• stomach pain
• tearing disorder
• runny nose
• drowsiness
• drop in blood pressure on changing position
from sitting or lying down to standing
• sweating
• back pain
• chills
• abnormal electrocardiogram.
Uncommon side effects (may affect up to 1 in
100 people)
• hallucinations
• severe difficulty in breathing (respiratory
depression)

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.

continued top of next column
50900306 AAAJ0473

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Buprenorphine Tablets
0.4, 2 & 8mg x 7’s (UK)
JDE No.:

information

What Buprenorphine tablets contain

• The active substance is buprenorphine (as
buprenorphine hydrochloride).
Each tablet contains 0.4mg, 2mg or 8mg of
buprenorphine.
• The other ingredients are magnesium
stearate, sodium citrate, povidone,
anhydrous citric acid, pregelatinised
starch (maize), and lactose monohydrate.
Buprenorphine 2mg and Buprenorphine
8mg sublingual tablets also contain
crospovidone, mannitol and sunset yellow
(E110).

What Buprenorphine tablets look like
and contents of the pack

Buprenorphine 0.4mg sublingual tablets are
uncoated, white or almost white, 6mm round
and flat with “B” on one side.
Buprenorphine 2mg sublingual tablets are
uncoated, light orange, 5x8mm oval and
biconvex with “B” on one side.
Buprenorphine 8mg sublingual tablets are
uncoated, light orange, 7.35x13.35mm oval
and biconvex with “B” on one side.
Pack size 7 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78
220 Hafnarfjörõur, Iceland
Manufacturer
Actavis hf., Reykjavíkurvegur 78
IS-220 Hafnarfjörõur, Iceland
Actavis, Barnstaple, EX32 8NS, UK.

Buprenorphine 0.4mg, 2mg and 8mg
Sublingual Tablets
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep this leaflet. You may need to read
it again.
• I f you have any further questions, ask
your doctor or pharmacist.
•  This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
•  I f you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
•  The full name of this medicine is
Buprenorphine 0.4mg, 2mg and 8mg
Sublingual Tablets but within the leaflet
it will be referred to as Buprenorphine
tablets.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Do not take Buprenorphine tablets if
you

• are allergic to buprenorphine or any of the
other ingredients of this medicine (listed in
section 6)
• have serious breathing problems
• have serious problems with your liver
• are intoxicated due to alcohol or have
delirium tremens (the “shakes” and
hallucinations).

Warnings and precautions

Misuse and abuse

Misuse, especially by injection and at high
dose is dangerous and could be fatal.

and what they are used for

If you would like a
leaflet with larger
text, please contact
01271 385257.

Buprenorphine is a medicinal product used in
opioid (narcotic) dependence.
Buprenorphine tablets are used as a part of a
medical, social and psychological treatment
programme for patients addicted to opiate
(narcotic) drugs. A sublingual tablet is a tablet
that is placed under your tongue and allowed
to dissolve.

Some people have died from respiratory
failure (inability to breathe) because they
misused buprenorphine or took it in
combination with other central nervous
system depressants such as alcohol,
benzodiazepines (medicines used to treat
anxiety or sleep disorders) or other opioids.
Cases of acute hepatic injury (liver problems)
have been reported in a context of misuse,
especially by intravenous route and at a high
dose. These injuries could be due to special

continued top of next column

page 4

continued over page

page 1

Buprenorphine 0.4mg, 2mg & 8mg 7 Tablets PIL - UK

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
12/05/16
Technologist: R.Wrey

you take Buprenorphine tablets

Tell your doctor if you have any of the
following illnesses before treatment or
develop them during treatment, as your
doctor may need to reduce your dose of
Buprenorphine tablets or you may need extra
treatment to control them:
• asthma or other breathing problems
• l iver or kidney problems. If you suffer from
serious liver insufficiency you must not
take buprenorphine
• head injuries or brain disease
• low blood pressure
• enlarged prostate gland, which can make
it difficult to pass water
•d
 ifficulties passing water because of
narrowing of the urethral (urethral stenosis).

1 What Buprenorphine tablets are

50900306

Pharmacode: 3697

2 What you need to know before

What is in this leaflet:
1 What Buprenorphine tablets are
and what they are used for
2 What you need to know before
you take Buprenorphine tablets
3 How to take Buprenorphine
tablets
4 Possible side effects
5 How to store Buprenorphine
tablets
6 Contents of the pack and other
information

This leaflet was last revised in August 2016

Actavis, Barnstaple, EX32 8NS, UK

Treatment is prescribed and monitored
by physicians who are specialists in the
treatment of drug dependence.
Treatment with Buprenorphine tablets is
intended for use in adults and adolescents
over 15 years of age.

item no: AAAJ0473

dimensions: 296 x 210

print proof no: 4

pharmacode:

origination date: 19.05.16

min pt size: 8

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 26.08.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Free Area
2.
3.

conditions such as viral infections (chronic C
hepatitis), alcohol abuse, anorexia, or when
taken with certain other medicines (for
example: antiretroviral nucleoside analogues,
acetylsalicylic acid (aspirin), amiodarone,
isoniazid and valproate). If you have
symptoms of severe tiredness, no appetite,
itching or if your skin or eyes look yellow, tell
your doctor immediately, so that you can
receive the proper treatment.
This medicine can cause:
• withdrawal symptoms if you take it less than
six hours after you use a narcotic (morphine,
heroin or other related products) or less than
24 hours after you use methadone
• 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
• sudden drop in blood pressure, causing you
to feel dizzy if you get up too quickly from
sitting or lying down
• drug dependency
• a positive reaction to “anti-doping” tests
(athletes should be aware).
Buprenorphine tablets may mask pain
reflecting some diseases. Do not forget
to inform your physician if you take this
medicine.

Discontinuation of treatment may lead to
withdrawal syndrome.

Children and adolescents

Buprenorphine tablets should not be used
in children and adolescents below the age
of 15 years due to lack of data on safety and
efficacy.

Other medicines and Buprenorphine
tablets

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Before taking Buprenorphine tablets, you
must tell your doctor if you are taking any of
the following medicines:
• benzodiazepines and other medicines used
to treat anxiety or sleep disorders. If your
physician prescribes benzodiazepines, you
must not take more than the prescribed
dose. Taking Buprenorphine tablets with
benzodiazepines may cause death due to
respiratory failure
• other medicines with sedative properties
including sedating antihistamines,
certain antidepressants and clonidine (a
treatment for high blood pressure, migraine,
menopausal flushing)
• strong pain killers (opioid analgesics)
and cough medicines containing opioidrelated substances such as methadone,
dextropropoxyphene, codeine,
continued top of next column

Buprenorphine Tablets
0.4, 2 & 8mg x 7’s (UK)
JDE No.:

Buprenorphine tablets with alcohol

Do not drink alcohol when you are
being treated with buprenorphine.
Alcohol increases the sedative effects of
buprenorphine, which can make driving and
operating machinery dangerous.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for
advice before taking this medicine.

The risk of serious side effects is greater if you
use opioids, alcohol, sedatives and hypnotics
especially benzodiazepines.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

dextromethorphan and noscapine
• barbiturates and other medicines used for
the treatment of sleep disorders, anxiety or
relievment of convulsions
• monoamine oxidase inhibitors (a type of
antidepressant)
• antipsychotic drugs
• gestodene (an oral contraception)
• medicines to treat HIV / AIDS (protease
inhibitors) including indinavir, ritonavir,
nelfinavir and saquinavir
• anti-epileptic (anticonvulsant) medicines
including phenobarbital, carbamazepine
and phenytoin
• antibiotic medicines including rifampicin,
erythromycin and troleandomycin
• antifungal medicines including
ketoconazole and itraconazole.

Pregnancy

Before taking Buprenorphine tablets tell
your doctor if you are pregnant or trying to
become pregnant. If you become pregnant
during treatment with Buprenorphine tablets
tell your doctor straight away.
Buprenorphine tablets should only be used
in pregnancy if the benefits outweigh the
possible risks.
Neonatal withdrawal symptoms, including
respiratory suppression have been reported
after treatment of mothers in the last part
of the pregnancy. Your doctor will decide if
you should be treated with Buprenorphine
tablets.

Breast-feeding

Since this product will pass into your milk
and may adversely affect the breast-fed child,
you should discontinue breast-feeding while
taking Buprenorphine tablets.

Driving and using machines

Buprenorphine may cause drowsiness. If you
feel tired, 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
continued over page

the information provided with the medicine
and
- I t 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.

Buprenorphine tablets contains
lactose and sunset yellow

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

If you have the impression that the effect of
Buprenorphine tablets are too strong or too
weak, talk to your doctor or pharmacist.

Buprenorphine 2mg and Buprenorphine 8mg
sublingual tablets also contain the colouring
agent sunset yellow (E110), which may cause
allergic reactions.

If you take more Buprenorphine
tablets than you should

In case of overdose of Buprenorphine tablets,
you must go or be taken immediately to an
emergency centre or hospital for treatment.
Immediately advise your doctor or your
pharmacist. Symptoms of an overdose can
include breathing difficulties, slow breathing
or heart symptoms. Toxic poisoning has been
observed after misuse (overdose or wrong
administration) and in worst case it can result
in stop of breathing, heart failure and/or liver
damage.

3 How to take Buprenorphine

tablets

Method of administration

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The tablets are administered sublingually. This
means that you must place the tablet under
your tongue and allow it to dissolve. This is
the only way the tablets should be taken.
Do not chew or crush the tablets or swallow
them whole, as they will not work properly
and you may get withdrawal symptoms.

If you forget to take Buprenorphine
tablets

Contact your doctor if you forget to take
Buprenorphine tablets. Do not take a double
dose to make up for a forgotten dose unless
your doctor instructs you to do so.

Take the dose once a day, unless otherwise is
prescribed by your doctor.
Your doctor will determine the best dose
for you. During your treatment, the doctor
may adjust the dose, depending upon your
response. To get the greatest benefit from
taking Buprenorphine tablets, 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
have not been prescribed to you by your
doctor.

If you stop taking Buprenorphine
tablets

Do not suddenly stop taking Buprenorphine
tablets as this may cause withdrawal
symptoms (sweating, disquiet and
restlessness). Do not stop the treatment
yourself, but ask your doctor how to end the
treatment.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

After the first dose of Buprenorphine tablets,
it is possible that you may have some opiate
withdrawal symptoms, see section 4 ‘Possible
side effects’.

4 Possible side effects

Reduced kidney or liver function

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Tell your doctor immediately or seek
urgent medical help if you experience very
rare (may affect up to 1 in 10,000 people)
allergic reactions, such as:
• difficulty in breathing, wheezing and
swelling of eyes, lips, throat, tongue or
hands.
• skin rash, hives and itching.

If you have problems with your kidneys or
liver your dose may have to be reduced.
Talk to your doctor. If you suffer from
serious liver insufficiency you must not take
Buprenorphine tablets.

Treatment duration

The length of treatment will be determined
individually by your doctor.
After a time of successful treatment, the
doctor may reduce the dose gradually to a

continued top of next column

page 2

continued over page

page 3

Buprenorphine 0.4mg, 2mg & 8mg 7 Tablets PIL - UK

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
12/05/16
Technologist: R.Wrey

The effectiveness of this treatment depends
on the dose, in combination with the
associated medical, psychological and social
treatment.

Buprenorphine tablets contain lactose (a
type of sugar). If you have been told by your
doctor that you have intolerance to some
sugars, contact your doctor before taking this
medicinal product.

50900306

Pharmacode: 3697

lower maintenance dose. Depending on your
condition, the dose of Buprenorphine tablets
may continue to be reduced under careful
medical supervision, until eventually it may
be stopped.
Do not change the treatment in any way or
stop treatment without the agreement of the
doctor who is treating you.

item no: AAAJ0473

dimensions: 296 x 210

print proof no: 4

pharmacode:

origination date: 19.05.16

min pt size: 8

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 26.08.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Free Area
2.
3.

Buprenorphine 0.4mg, 2mg and 8mg
Sublingual Tablets
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
•  If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
•  The full name of this medicine is Buprenorphine 0.4mg, 2mg
and 8mg Sublingual Tablets but within the leaflet it will be
referred to as Buprenorphine tablets.

What is in this leaflet:
1 What Buprenorphine tablets are and what they are
used for
2 What you need to know before you take
Buprenorphine tablets
3 How to take Buprenorphine tablets
4 Possible side effects
5 How to store Buprenorphine tablets
6 Contents of the pack and other information

1 What Buprenorphine tablets are and what they are
used for

Buprenorphine is a medicinal product used in opioid (narcotic)
dependence.
Buprenorphine tablets are used as a part of a medical, social and
psychological treatment programme for patients addicted to opiate
(narcotic) drugs. A sublingual tablet is a tablet that is placed under your
tongue and allowed to dissolve.
Treatment is prescribed and monitored by physicians who are
specialists in the treatment of drug dependence.
Treatment with Buprenorphine tablets is intended for use in adults and
adolescents over 15 years of age.

2 What you need to know before you take
Buprenorphine tablets

Do not take Buprenorphine tablets if you

• are allergic to buprenorphine or any of the other ingredients of this
medicine (listed in section 6)
• have serious breathing problems
• have serious problems with your liver
• are intoxicated due to alcohol or have delirium tremens (the “shakes”
and hallucinations).

Warnings and precautions

Tell your doctor if you have any of the following illnesses before
treatment or develop them during treatment, as your doctor may need
to reduce your dose of Buprenorphine tablets or you may need extra
treatment to control them:
• asthma or other breathing problems
• l iver or kidney problems. If you suffer from serious liver
insufficiency you must not take buprenorphine
• head injuries or brain disease
• low blood pressure
• enlarged prostate gland, which can make it difficult to pass water
•d
 ifficulties passing water because of narrowing of the urethral
(urethral stenosis).

Misuse and abuse

Misuse, especially by injection and at high dose is dangerous and
could be fatal.
Some people have died from respiratory failure (inability to breathe)
because they misused buprenorphine or took it in combination
with other central nervous system depressants such as alcohol,
benzodiazepines (medicines used to treat anxiety or sleep disorders) or
other opioids.
Cases of acute hepatic injury (liver problems) have been reported
in a context of misuse, especially by intravenous route and at a high
dose. These injuries could be due to special conditions such as viral
infections (chronic C hepatitis), alcohol abuse, anorexia, or when taken
with certain other medicines (for example: antiretroviral nucleoside
analogues, acetylsalicylic acid (aspirin), amiodarone, isoniazid and
valproate). If you have symptoms of severe tiredness, no appetite,
itching or if your skin or eyes look yellow, tell your doctor immediately,
so that you can receive the proper treatment.
continued top of next column

AAAH8305

This medicine can cause:
•w
 ithdrawal symptoms if you take it less than six hours after you use a
narcotic (morphine, heroin or other related products) or less than 24
hours after you use methadone
•d
 rowsiness, 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
• s udden drop in blood pressure, causing you to feel dizzy if you get up
too quickly from sitting or lying down
• drug dependency
• a positive reaction to “anti-doping” tests (athletes should be aware).
Buprenorphine tablets may mask pain reflecting some diseases. Do not
forget to inform your physician if you take this medicine.
The risk of serious side effects is greater if you use opioids, alcohol,
sedatives and hypnotics especially benzodiazepines.
Discontinuation of treatment may lead to withdrawal syndrome.

Children and adolescents

Buprenorphine tablets should not be used in children and adolescents
below the age of 15 years due to lack of data on safety and efficacy.

Other medicines and Buprenorphine tablets

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Before taking Buprenorphine tablets, you must tell your doctor if you
are taking any of the following medicines:
•b
 enzodiazepines and other medicines used to treat anxiety or sleep
disorders. If your physician prescribes benzodiazepines, you must not
take more than the prescribed dose. Taking Buprenorphine tablets
with benzodiazepines may cause death due to respiratory failure
•o
 ther medicines with sedative properties including sedating
antihistamines, certain antidepressants and clonidine (a treatment for
high blood pressure, migraine, menopausal flushing)
• strong pain killers (opioid analgesics) and cough medicines containing
opioid-related substances such as methadone, dextropropoxyphene,
codeine, dextromethorphan and noscapine
•b
 arbiturates and other medicines used for the treatment of sleep
disorders, anxiety or relievment of convulsions
• monoamine oxidase inhibitors (a type of antidepressant)
• antipsychotic drugs
• gestodene (an oral contraception)
•m
 edicines to treat HIV / AIDS (protease inhibitors) including indinavir,
ritonavir, nelfinavir and saquinavir
• a nti-epileptic (anticonvulsant) medicines including phenobarbital,
carbamazepine and phenytoin
• a ntibiotic medicines including rifampicin, erythromycin and
troleandomycin
• antifungal medicines including ketoconazole and itraconazole.

Buprenorphine tablets with alcohol

Do not drink alcohol when you are being treated with buprenorphine.
Alcohol increases the sedative effects of buprenorphine, which can
make driving and operating machinery dangerous.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.

Pregnancy

Before taking Buprenorphine tablets tell your doctor if you are
pregnant or trying to become pregnant. If you become pregnant
during treatment with Buprenorphine tablets tell your doctor straight
away.
Buprenorphine tablets should only be used in pregnancy if the benefits
outweigh the possible risks.
Neonatal withdrawal symptoms, including respiratory suppression
have been reported after treatment of mothers in the last part of
the pregnancy. Your doctor will decide if you should be treated with
Buprenorphine tablets.

Breast-feeding

Since this product will pass into your milk and may adversely affect the
breast-fed child, you should discontinue breast-feeding while taking
Buprenorphine tablets.

Driving and using machines

Buprenorphine may cause drowsiness. If you feel tired, do not drive or
operate machinery.
The medicine can affect your ability to drive as it may make you sleepy
or dizzy.
•D
 o 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.

continued over page

• 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.

Buprenorphine tablets contains lactose and sunset yellow
Buprenorphine tablets contain lactose (a type of sugar). If you have
been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.

Buprenorphine 2mg and Buprenorphine 8mg sublingual tablets also
contain the colouring agent sunset yellow (E110), which may cause
allergic reactions.

3 How to take Buprenorphine tablets
Method of administration

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
The tablets are administered sublingually. This means that you must
place the tablet under your tongue and allow it to dissolve. This is the
only way the tablets should be taken. Do not chew or crush the tablets
or swallow them whole, as they will not work properly and you may get
withdrawal symptoms.
Take the dose once a day, unless otherwise is prescribed by your doctor.
Your doctor will determine the best dose for you. During your
treatment, the doctor may adjust the dose, depending upon your
response. To get the greatest benefit from taking Buprenorphine
tablets, 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 have not been
prescribed to you by your doctor.
After the first dose of Buprenorphine tablets, it is possible that you may
have some opiate withdrawal symptoms, see section 4 ‘Possible side
effects’.

Reduced kidney or liver function

If you have problems with your kidneys or liver your dose may have
to be reduced. Talk to your doctor. If you suffer from serious liver
insufficiency you must not take Buprenorphine tablets.

Treatment duration

The length of treatment will be determined individually by your doctor.
After a time of successful treatment, the doctor may reduce the dose
gradually to a lower maintenance dose. Depending on your condition,
the dose of Buprenorphine tablets may continue to be reduced under
careful medical supervision, until eventually it may be stopped.
Do not change the treatment in any way or stop treatment without the
agreement of the doctor who is treating you.
The effectiveness of this treatment depends on the dose, in
combination with the associated medical, psychological and social
treatment.
If you have the impression that the effect of Buprenorphine tablets are
too strong or too weak, talk to your doctor or pharmacist.

If you take more Buprenorphine tablets than you should

In case of overdose of Buprenorphine tablets, you must go or be
taken immediately to an emergency centre or hospital for treatment.
Immediately advise your doctor or your pharmacist. Symptoms of an
overdose can include breathing difficulties, slow breathing or heart
symptoms. Toxic poisoning has been observed after misuse (overdose
or wrong administration) and in worst case it can result in stop of
breathing, heart failure and/or liver damage.

Misusing this medicine by injecting it can cause withdrawal symptoms,
infections, other skin reactions and potentially serious liver problems see ‘Warnings and precautions’.
After the first dose of Buprenorphine tablets, you may have some
opiate withdrawal symptoms, see section 3 ‘How to take’.
Very common side effects (may affect more than 1 in 10 people)
• not being able to sleep
• a general feeling of weakness
• withdrawal syndrome.
Common side effects (may affect up to 1 in 10 people)
• headache
• fainting
• dizziness
• anxiety
• nervousness
• constipation
• nausea
• vomiting
• diarrhoea
• stomach pain
• tearing disorder
• runny nose
• drowsiness
• drop in blood pressure on changing position from sitting or lying
down to standing
• sweating
• back pain
• chills
• abnormal electrocardiogram.
Uncommon side effects (may affect up to 1 in 100 people)
• hallucinations
• severe difficulty in breathing (respiratory depression)

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 Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton, blister and label after EXP. The expiry date refers to the last day
of that month.
Blister packs: Do not store above 25°C. Store in the original package in
order to protect from moisture.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6 Contents of the pack and other information
What Buprenorphine tablets contain

• The active substance is buprenorphine (as buprenorphine
hydrochloride).
Each tablet contains 0.4mg, 2mg or 8mg of buprenorphine.
• The other ingredients are magnesium stearate, sodium citrate,
povidone, anhydrous citric acid, pregelatinised starch (maize), and
lactose monohydrate. Buprenorphine 2mg and Buprenorphine 8mg
sublingual tablets also contain crospovidone, mannitol and sunset
yellow (E110).

What Buprenorphine tablets look like and contents of the
pack

Contact your doctor if you forget to take Buprenorphine tablets. Do not
take a double dose to make up for a forgotten dose unless your doctor
instructs you to do so.

Buprenorphine 0.4mg sublingual tablets are uncoated, white or almost
white, 6mm round and flat with “B” on one side.
Buprenorphine 2mg sublingual tablets are uncoated, light orange,
5x8mm oval and biconvex with “B” on one side.
Buprenorphine 8mg sublingual tablets are uncoated, light orange,
7.35x13.35mm oval and biconvex with “B” on one side.

If you stop taking Buprenorphine tablets

Pack size 7 tablets.

If you forget to take Buprenorphine tablets

Do not suddenly stop taking Buprenorphine tablets as this may cause
withdrawal symptoms (sweating, disquiet and restlessness). Do
not stop the treatment yourself, but ask your doctor how to end the
treatment.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately or seek urgent medical help if you
experience very rare (may affect up to 1 in 10,000 people) allergic
reactions, such as:
• difficulty in breathing, wheezing and swelling of eyes, lips, throat,
tongue or hands.
• skin rash, hives and itching.

Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78
220 Hafnarfjörõur, Iceland
Manufacturer
Actavis hf., Reykjavíkurvegur 76-78, P.O.Box 420
IS-222 Hafnarfjordur, Iceland
This leaflet was last revised in January 2016

If you would like a leaflet
with larger text,
please contact
01271 385257.

Also tell your doctor immediately if you experience uncommon side
effects (may affect up to 1 in 10 people), such as:
• severe fatigue, loss of appetite or yellowing of skin and eyes. These
may be symptoms of liver damage such as death of the cells of the
liver (necrosis of the liver).
continued top of next column

AAAH8305

Actavis, Barnstaple, EX32 8NS, UK

Expand Transcript

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