Buprenorphine 8mg sublingual tablets sugar free

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Buprenorphine hydrochloride

Διαθέσιμο από:

Accord-UK Ltd

Φαρμακολογική κατηγορία (ATC):

N07BC01

INN (Διεθνής Όνομα):

Buprenorphine hydrochloride

Δοσολογία:

8mg

Φαρμακοτεχνική μορφή:

Sublingual tablet

Οδός χορήγησης:

Sublingual

Kατηγορία:

Schedule 3 (CD No Register)

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04100300; GTIN: 5012617019547

Φύλλο οδηγιών χρήσης

Actavis BST - Packing Technical
[e-mail]
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Buprenorphine
0.4, 2 & 8mg x 7’s (UK)
296x210 (Reel Fed)
50929811
Leaflet for Blisters
3879
R.Wrey
04/04/17
296x210 Leaflet Reel Fed Bi Fold Profile (BST)
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BUPRENORPHINE 0.4MG, 2MG AND 8MG PIL, UK
Black
Profile
BBBA0656
C.Grant
05/04/17
296x210
8pt
Actavis UK
N/A
01
page 4
page 1
50929811 BBBA0656
page 4
page 1
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

Αρχείο Π.Χ.Π.

OBJECT 1
BUPRENORPHINE 8MG SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 01-Mar-2016 | Accord-UK Ltd
1. Name of the medicinal product
Buprenorphine 8mg Sublingual Tablets
2. Qualitative and quantitative composition
Each sublingual tablet contains 8 mg of buprenorphine (as
buprenorphine hydrochloride).
Excipients with known effect: Each tablet contains 175.6 mg of lactose
monohydrate and 0.76 mg of
sunset yellow (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet.
Uncoated, light orange, 7.35x13.35 mm oval, biconvex tablets with
“B“ 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
TREATMENT MUST BE UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN
THE MANAGEMENT OF OPIATE
DEPENDENCE/ADDICTION.
Treatment with buprenorphine sublingual tablets is intended for use in
adults and adolescents aged over
15 years who have agreed to be treated for addiction.
When initiating buprenorphine treatment, the physician should be aware
of the partial agonist profile of
buprenorphine and that it can precipitate withdrawal symptoms in
opioid-dependent patients.
Buprenorphine binds to the µ (mu) and κ (kappa) opiate receptors.
_Adults:_
Baseline liver function tests and documentation of viral hepatitis
status is recommended prior to
commencing therapy. Patients who are positive for viral hepatitis, on
concomitant medicinal products (see
section 4.5) and/or have existing liver dysfunction are at risk of
accelerated liver injury. Regular
monitoring of liver function is recommended (see section 4.4).
Induction
Prior to treatment induction, consideration should be given to the
type 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 buprenorphine should be
undertaken when obje