Subutex 8mg sublingual tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Buprenorphine hydrochloride

可用日期:

Pilsco Ltd

ATC代码:

N07BC01

INN（国际名称）:

Buprenorphine hydrochloride

剂量:

8mg

药物剂型:

Sublingual tablet

给药途径:

Sublingual

类:

Schedule 3 (CD No Register)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04100300; GTIN: 05060669871323

资料单张

PIL0212.5
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBUTEX
®
8 MG
SUBLINGUAL TABLETS
(buprenorphine hydrochloride)
The name of this product is Subutex 8 mg Sublingual Tablets but
will be referred to as Subutex throughout this leaflet.
This leaflet contains information about other strengths of Subutex
that are available.
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 Subutex is and what it is used for
2.
What you need to know before you take Subutex
3.
How to take Subutex
4.
Possible side effects
5.
How to store Subutex
6. Contents of the pack and other information
THIS MEDICINE CONTAINS BUPRENORPHINE WHICH IS AN OPIOID,
WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS
IF YOU STOP TAKING IT SUDDENLY.
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.
This medicine contains buprenorphine which belongs to a class of
medicines called opioids.
This medicine has been prescribed to you and should not be given
to anyone else. Opioids can cause addiction and you may get
withdrawal symptoms if you stop taking it suddenly. Your prescriber
should have explained how long you will be taking it for and when it
is appropriate to stop, how to do this safely.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SUBUTEX
DO NOT TA

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Subutex 8mg sublingual tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect: lactose
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sublingual tablet
Uncoated oval white flat bevelled edged tablet, nominal dimensions 14
mm x 7 mm, debossed
with “B8” 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Subutex sublingual tablets is intended for use in
adults and children
aged 16 years or over who have agreed to be treated for opioid
dependence.
_Precautions to be taken before dosing _
Prior to treatment induction, physicians should be aware of the
partial agonist profile
of buprenorphine to the opiate receptors, which may precipitate a
withdrawal
syndrome in opioid-dependent patients, and consideration should be
given to the
types of opioid dependence (i.e. long- or short-acting opioid), the
time since last
opioid use and the degree of opioid dependence. To avoid precipitating
withdrawal,
induction with Subutex should be undertaken when objective and clear
signs of
withdrawal are evident e.g. a score higher than 12 on the Clinical
Opioid Withdrawal
Scale (COWS).
•
FOR PATIENTS DEPENDENT ON HEROIN OR SHORT-ACTING OPIOIDS, the first
dose of
buprenorphine should be started when objective signs of withdrawal
appear, but
not less than 6 hours after the patient last used opioids.
•
FOR PATIENTS RECEIVING METHADONE: before beginning Subutex therapy,
the dose
of methadone should be reduced to a maximum of 30mg/day. Subutex may
precipitate symptoms of withdrawal in patients dependent on methadone.
The
first dose of buprenorphine should be started only when objective
signs of
withdrawal appear and generally not less than 24 hours afte