Suboxone

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

buprenorphine, naloxone

Tilgængelig fra:

Indivior Europe Limited

ATC-kode:

N07BC51

INN (International Name):

buprenorphine, naloxone

Terapeutisk gruppe:

Other nervous system drugs

Terapeutisk område:

Opioid-Related Disorders

Terapeutiske indikationer:

Substitution treatment for opioid-drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Produkt oversigt:

Revision: 22

Autorisation status:

Authorised

Autorisation dato:

2006-09-26

Indlægsseddel

63
B. PACKAGE LEAFLET
64
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBOXONE 2 MG/0.5 MG SUBLINGUAL TABLETS
SUBOXONE 8 MG/2 MG SUBLINGUAL TABLETS
SUBOXONE 16 MG/4 MG SUBLINGUAL TABLETS
buprenorphine / naloxone
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.
WHAT IS IN THIS LEAFLET
1.
What Suboxone is and what it is used for
2.
What you need to know before you take Suboxone
3.
How to take Suboxone
4.
Possible side effects
5
How to store Suboxone
6.
Contents of the pack and other information
1.
WHAT SUBOXONE IS AND WHAT IT IS USED FOR
Suboxone is used to treat dependence on opioid (narcotic) drugs such
as heroin or morphine in drug
addicts who have agreed to be treated for their addiction. Suboxone is
used in adults and adolescents
over 15 years of age, who are also receiving medical, social and
psychological support.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUBOXONE
DO NOT TAKE SUBOXONE
•
if you are allergic to buprenorphine, naloxone or 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 taking naltrexone or nalmefene for the treatment of alcohol
or opioid dependence.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING SUBOXONE IF YOU HAVE:
•
ast
hma or other breathing problems
•
problems with your liver such as hepatitis
•
low blood pressure
•
recently suf

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Suboxone 2 mg/0.5 mg sublingual tablets
Suboxone 8 mg/2 mg sublingual tablets
Suboxone 16 mg/4 mg sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Suboxone 2 mg/0.5 mg sublingual tablets
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride)
and 0.5 mg naloxone (as
hydrochloride dihydrate).
Excipients with known effect:
Each sublingual tablet contains 42 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
Suboxone 8 mg/2 mg sublingual tablets
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride)
and 2 mg naloxone (as
hydrochloride dihydrate).
Excipients with known effect:
Each sublingual tablet contains 168 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
Suboxone 16 mg/4 mg sublingual tablets
Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride)
and 4 mg naloxone (as
hydrochloride dihydrate).
Excipients with known effect:
Each sublingual tablet contains 156.64 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Suboxone 2 mg/0.5 mg sublingual tablets
White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on
one side.
Suboxone 8 mg/2 mg sublingual tablets
White hexagonal biconvex tablets of 11
mm with “N8” debossed on one side.
Suboxone 16 mg/4 mg sublingual tablets
White round biconvex tablets of 10.5 mm with “N16” debossed on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug
_ _
dependence, within a framework of medical, social and
psychological treatment. The intention of the naloxone component is to
deter intravenous misuse.
Suboxone is indicated in adults and adolescents over 15 years of age
who have agreed to be treated for
addiction.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be under the supervision of a physician experienced in
the management of opiate
depe