Skip to Content

SUBUTEX 2 MG SUBLINGUAL TABLETS

Active substance(s): BUPRENORPHINE / BUPRENORPHINE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

5. HOW TO STORE SUBUTEX
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original
package in order to protect from moisture.
Do not use after the expiry date which is stated
on the carton and blister label after ‘EXP’. The
expiry date refers to the last day of that month.
Should your tablets become discoloured or
show any other signs of deterioration, contact
your pharmacist who will advise you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Subutex contains
2 mg: Each sublingual tablet contains 2 mg of
buprenorphine (as hydrochloride).
8 mg: Each sublingual tablet contains 8 mg of
buprenorphine (as hydrochloride).
The other ingredients are lactose monohydrate,
mannitol, maize starch, povidone K30, citric
acid anhydrous, sodium citrate and magnesium
stearate.
What Subutex looks like and contents of the
pack
Subutex 2 mg Sublingual Tablets are uncoated
oval white tablets of 10 mm x 5 mm, debossed
with “B2” on one side and plain on the reverse.
Subutex 8 mg Sublingual Tablets are uncoated
oval white tablets of 14 mm x 7 mm, debossed
with “B8” on one side and plain on the reverse.
The sublingual tablets come in blister packs
containing 7 tablets.
Manufactured by:
Reckitt Benckiser Healthcare (UK) Ltd, Dansom
Lane, Hull, East Yorkshire, HU8 7DS, United
Kingdom.
Procured from within the EU by the Product
Licence Holder:
Expono Ltd, Cornwall Road, Smethwick, B66
2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0182 - Subutex® 2 mg Sublingual
Tablets
PL 22961/0183 - Subutex® 8 mg Sublingual
Tablets
POM
CD
Revision Date: 30.01.2017
Subutex® is a registered trademark of Indivior
UK Limited.

To request a copy of this leaflet in
large print, audio CD or Braille
please call 0121 565 3101.

Ref: 756

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Subutex® 2 mg Sublingual Tablets
Subutex® 8 mg 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.
Your medicine will be known by either of the above
names but will be referred to as Subutex throughout
this leaflet. Please note that the leaflet also contains
information about another strength, 0.4 mg.
In this leaflet:
1. What Subutex is and what it is used for
2. Before you take Subutex
3. How to take Subutex
4. Possible side effects
5. How to store Subutex
6. Further information
1. WHAT SUBUTEX IS AND WHAT IT IS
USED FOR
Subutex is used to treat dependence on opiate
(narcotic) drugs, such as morphine and heroin
in drug addicts who have agreed to be treated
for their addiction.
Subutex is used in adults and adolescents over
16 years of age who are also receiving
medical, social and psychological support.
2. BEFORE YOU TAKE SUBUTEX
Do not take Subutex:
• If you are a child under the age of 16 years.
• If you are allergic (hypersensitive) to
buprenorphine or to any of the other ingredients
of this medicine (listed in section 6).
• If you have serious breathing problems.
• If you have serious problems with your liver.
• If you are intoxicated due to alcohol or have
trembling, sweating, anxiety, confusion or
hallucinations caused by alcohol.
• If you are breast feeding a baby.
Take special care with Subutex
Tell your doctor before you start taking Subutex
if you have:
• asthma or other breathing problems
• any liver disease such as hepatitis
• low blood pressure
• recently suffered head injury or brain disease
• a urinary disorder (especially linked to
enlarged prostate in men)
• any kidney disease
• thyroid problems
• adrenocortical disorder (e.g. Addison’s disease)

Important things to be aware of:
• Misuse, abuse and diversion
This medicine can be a target for people who
abuse prescription medicines, and should be
kept in a safe place to protect it from theft.
Do not give this medicine to anyone else.
It can cause death or otherwise harm them.
• Breathing problems
Some people have died from respiratory
failure (inability to breathe) because they
misused this medicine or took it in
combination with other central nervous
system depressants, such as alcohol,
benzodiazepines (tranquilisers), or other
opioids.
• Dependence
This product can cause dependence.
• Withdrawal symptoms
This product can cause withdrawal
symptoms if you take it less than 6 hours
after you use a short-acting opioid (e.g.
morphine, heroin) or less than 24 hours after
you use a long-acting opioid such as
methadone.
Subutex can also cause withdrawal
symptoms if you stop taking it abruptly.
• Liver damage
Liver damage has been reported after taking
Subutex, especially when the medicine is
misused. This could also be due to viral
infections (chronic hepatitis C), alcohol
abuse, anorexia or use of other medicines
with the ability to harm your liver (see
section 4).
Regular blood tests may be conducted by
your doctor to monitor the condition of
your liver. Tell your doctor if you have any
liver problems before you start treatment
with Subutex.
• Blood pressure
This product may cause your blood pressure
to drop suddenly, causing you to feel dizzy if
you get up too quickly from sitting or lying
down.
• Diagnosis of unrelated medical
conditions
This medicine may mask pain symptoms that
could assist in the diagnosis of some
diseases. Do not forget to advise your doctor
if you take this medicine.
Taking other medicines
Some medicines may increase the side effects
of Subutex and may sometimes cause very
serious reactions. Do not take any other
medicines whilst taking Subutex without first
talking to your doctor, especially:
• Benzodiazepines (used to treat anxiety or
sleep disorders) such as diazepam,
temazepam, alprazolam. Your doctor will
prescribe the correct dose for you.
Taking the wrong dose of
benzodiazepines may cause death due to
respiratory failure (inability to breathe).
• Other medicines that may make you
feel sleepy which are used to treat
illnesses such as anxiety,

sleeplessness, convulsions / seizures, pain.
These types of medicines will reduce your
alertness levels making it difficult for you to
drive and use machines. They may also
cause central nervous system depression,
which is very serious. Below is a list of
examples of these types of medicines:
- other opioid containing medicines such as
methadone, certain pain killers and cough
suppressants.
- antidepressants (used to treat depression)
such as isocarboxazide, phenelzine,
selegeline, tranylcypromine, and valproate
may increase the effects of this medicine.
- sedative H1 receptor antagonists (used to
treat allergic reactions) such as
diphenhydramine and chlorphenamine.
- barbiturates (used to cause sleep or
sedation) such as phenobarbital,
secobarbital.
- tranquilisers (used to cause sleep or
sedation) such as chloral hydrate.
• Naltrexone may prevent Subutex from
working. If you take naltrexone whilst you are
taking Subutex you may experience a
sudden onset of prolonged and intense
withdrawal symptoms.
• Clonidine (used to treat high blood pressure)
may extend the effects of this medicine.
• Anti-retrovirals (used to treat AIDS) such as
ritonavir, nelfinavir, indinavir may increase
the effects of this medicine.
• Some antifungal agents (used to treat fungal
infections) such as ketoconazole and
itraconazole and certain antibiotics
(macrolide) may extend the effects of this
medicine.
• Some medicines may decrease the effect of
Subutex. These include medicines used to
treat epilepsy (such as carbamazepine and
phenytoin) and medicines used to treat
tuberculosis (rifampicin).
To get the greatest benefit from taking Subutex,
you must tell your doctor about all the
medicines you are taking, including alcohol,
medicines containing alcohol, street drugs, and
any prescription medicine you are taking that
has not been prescribed for you by your doctor.
Taking Subutex with food and drink
Alcohol may increase drowsiness and may
increase the risk of respiratory failure (inability
to breathe) if taken with Subutex. Do not take
Subutex together with alcohol. Do not
swallow or consume food or drink until the
tablet is completely dissolved.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend to
become pregnant.
When taken during pregnancy, particularly late
pregnancy, medicines like Subutex may cause
drug withdrawal symptoms including problems
with breathing in your new born baby.

These symptoms may occur several days after
birth.
Do not breast feed your baby whilst taking this
medicine as Subutex passes into breast milk.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
If you feel drowsy or dizzy while taking these
tablets do not use machinery.
The medicine can affect your ability to drive as
it may make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
• However, you would not be committing an
offence if:
o The medicine has been prescribed to treat
a medical or dental problem and
o You have taken it according to the
instructions given by the prescriber or in
the information provided with the medicine
and
o It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.
Important information about some of the
ingredients of Subutex
Subutex contains lactose. If you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this medicine.
3. HOW TO TAKE SUBUTEX
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.
For patients taking methadone:
before beginning treatment, your doctor
should reduce your dose of methadone
to not more than 30mg a day. Subutex
may cause withdrawal symptoms in patients

who are dependent on methadone if used
within 24 hours of the last dose of methadone.
During your treatment, your doctor may
increase your dose of Subutex, to a maximum
single daily dose of 32mg, depending upon
your response. Once you have been stable for
a while, your doctor will gradually reduce your
dose and it may be possible to stop it
altogether. Do not suddenly stop taking the
tablets, as this may cause withdrawal
symptoms.
If you take more Subutex than you should
If you or someone else takes too much of this
medicine, you must go or be taken immediately
to an emergency centre or hospital as overdose
with Subutex may cause serious and
life-threatening breathing problems.
If you forget to take Subutex
Tell your doctor as soon as possible if you miss
a dose and follow his or her instructions. Do
not take a double dose to make up for the
forgotten dose.
If you stop taking Subutex
Do not change the treatment in any way or stop
treatment without the agreement of the doctor
who is treating you. Stopping treatment
suddenly may cause withdrawal symptoms.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Subutex can cause side
effects, although not everybody gets them.
Tell your doctor immediately or seek urgent
medical attention if you experience side
effects such as:





sudden wheezing, difficulty breathing,
swelling of the eyelids, face, tongue, lips,
throat or hands; rash or itching especially
those covering your whole body. These may
be signs of a life-threatening allergic
reaction.
if you start to breathe more slowly or weakly
than expected (respiratory depression).



if you start to feel faint, as this may be a sign
of low blood pressure.
Also tell your doctor immediately if you
experience side effects such as:
• severe fatigue (tiredness), have no appetite
or if your skin or eyes look yellow. These
may be symptoms of liver damage.
The frequency of possible side effects listed
below is defined using the following convention:
• very common (affects more than
1 user in 10)
• common (affects 1 to 10 users in 100)
• not known (frequency cannot be estimated
from the available data).
Side effects reported with Subutex
Very common side effects:
Drug withdrawal syndrome, headache,
hyperhidrosis (sweating), insomnia (inability
to sleep), nausea (feeling sick), pain.
Common side effects:
Abdominal pain, agitation, anxiety, joint
pain, weakness, back pain, bone pain,
bronchitis, chest pain, chills, constipation,
cough, decreased appetite, depression,
diarrhoea, dizziness, dry mouth, painful
period, indigestion, shortness of breath,
flatulence, gastrointestinal disorder, hostility,
increase in muscle tension, infection,
influenza, nervousness, tearing (watery
eyes) disorder, swollen glands (lymph
nodes), malaise, migraine, muscle spasms,
muscle pain, dilation of the pupil, neck pain,
palpitations, paranoia, burning or tingling in
hands and feet, swelling (hands and feet),
sore throat and painful swallowing, fever,
rash, somnolence, syncope (fainting),
thinking abnormal, tooth disorder, tremor;
flushing, vomiting (being sick), yawning.
Frequency not known:
Drug dependence, drug withdrawal
syndrome in newborn, hallucinations
(sensing things that are not real), drop in
blood pressure on changing position from
sitting or lying down to standing, difficulty in
urinating.
Misusing this medicine by injecting it can
cause withdrawal symptoms, infections,
other skin reactions and potentially serious
liver problems.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.
Ref: 756

+ 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