Subutex 8mg sublingual tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Buprenorphine hydrochloride

Διαθέσιμο από:

Waymade Healthcare Plc

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

Φύλλο οδηγιών χρήσης

Package leaflet: Information for the user
SUBUTEX
®
2MG SUBLINGUAL TABLETS
SUBUTEX
®
8MG SUBLINGUAL TABLETS
(buprenorphine hydrochloride)
Your medicine is known by one of the above names, but will be referred
to
as Subutex throughout this leaflet. Subutex is also available in 0.4mg
strength.
PATIENT INFORMATION LEAFLET
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 get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
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 lin

Αρχείο Π.Χ.Π.

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