Buprenorphine 8mg sublingual tablets sugar free

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Buprenorphine hydrochloride

Disponible depuis:

Thornton & Ross Ltd

Code ATC:

N07BC01

DCI (Dénomination commune internationale):

Buprenorphine hydrochloride

Dosage:

8mg

forme pharmaceutique:

Sublingual tablet

Mode d'administration:

Sublingual

classe:

Schedule 3 (CD No Register)

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04100300

Notice patient

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
630791
11845 & 11846
Removal of 0.4mg and alignment
of SmPC with reference product
(safety)
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
7's
24368803
160 x 480mm
9
02.02.2016
Process Black
PANTONE 485 C
Keyline (Does not print)
Buprenorphine 2mg and 8mg
Sublingual Tablets
Dax
Frutiger
Helvetica LT
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
630791
11845 & 11846
Removal of 0.4mg and alignment
of SmPC with reference product
(safety)
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
7's
24368803
160 x 480mm
9
02.02.2016
Process Black
PANTONE 485 C
Keyline (Does not print)
Buprenorphine 2mg and 8mg
Sublingual Tablets
Dax
Frutiger
Helvetica LT
BUPRENORPHINE 2MG, 8MG 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 please ask your doctor or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it onto
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 Buprenorphine 2mg and 8mg Sublingual tablets are and what they
are used for
2. What you need to know before you take Buprenorphine 2mg and 8mg
Sublingual tablets
3. How to take the tablets
4. Possible side effects
5. How to store the tablets
6. Contents of the pack and other information
1. WHAT BUPRENORPHINE 2MG AND 8MG SUBLINGUAL TABLETS ARE AND WHAT THEY
ARE USED FOR
Buprenorphine 2mg and 8mg Subling

Résumé des caractéristiques du produit

OBJECT 1
BUPRENORPHINE 8.0MG SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 03-Mar-2016 | Thornton &
Ross Ltd
1. Name of the medicinal product
Buprenorphine 8mg Sublingual Tablets
2. Qualitative and quantitative composition
Each tablet contains buprenorphine hydrochloride 8.64mg equivalent to
buprenorphine 8mg.
Excipient 191.36mg of lactose monohydrate per tablet.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Sublingual tablet
White, oval shaped, biconvex uncoated tablets with '8' embossed 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 with Buprenorphine Sublingual Tablets is intended for use in
adults and children age 16 years
or over who have agreed to be treated for addiction.
When initiating treatment the physician should be aware of the partial
agonist profile of buprenorphine
and that it can precipitate withdrawal in opioid dependent patients.
Buprenorphine binds to the µ and κ
opiate receptors.
Administration is sublingual. Physicians must advise patients that the
sublingual route is the only
effective and safe route of administration for this drug. The tablet
should be kept under the tongue until
dissolved which usually occurs within 5 to 10 minutes.
INDUCTION THERAPY: the initial dose is from 0.8mg to 4mg, administered
as a single daily dose.
. FOR OPIOID-DEPENDENT DRUG ADDICTS WHO HAVE NOT UNDERGONE WITHDRAWAL:
one dose of Buprenorphine
Tablets administered sublingually at least 4 hours after the last use
of the opioid, or when the first signs of
craving appear.
. FOR PATIENTS RECEIVING METHADONE: before beginning Buprenorphine
therapy, the dose of methadone
should be reduced to a maximum of 30mg/day. Buprenorphine may
precipitate symptoms of withdrawal
in patients dependent upon methadone.
TITRATION TO A MAINTENANCE DOSE:
The dosage should be individually titrated to each patien