Buprenorphine 8 mg Sublingual Tablets/ Natzon 8mg Sublingual Tablets

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

BUPRENORPHINE HYDROCHLORIDE

Հասանելի է:

Aspire Pharma (Malta) Limited Trident Park, Notabile Gardens No. 2, Level 3, Mdina Road Central Business District Birkirkara CBD2010 , Malta

ATC կոդը:

N07BC01

INN (Միջազգային անվանումը):

BUPRENORPHINE HYDROCHLORIDE 8 mg

Դեղագործական ձեւ:

SUBLINGUAL TABLET

Կազմը:

BUPRENORPHINE HYDROCHLORIDE 8 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

OTHER NERVOUS SYSTEM DRUGS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2019-03-25

Տեղեկատվական թերթիկ

Page 1 of 16
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPRENORPHINE 2 MG AND 8 MG SUBLINGUAL TABLETS
THIS MEDICINE CONTAINS BUPRENORPHINE WHICH IS AN OPIOID, WHICH CAN
CAUSE ADDICTION. YOU CAN
GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY.
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 Buprenorphine Sublingual Tablets are and what they are used for
2.
What you need to know before you take Buprenorphine Sublingual Tablets
3.
How to take Buprenorphine Sublingual Tablets
4.
Possible side effects
5.
How to store Buprenorphine Sublingual Tablets
6.
Contents of the pack and other information
1. WHAT BUPRENORPHINE SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED
FOR
This medicine has been prescribed for you for substitution
(replacement) treatment in patients who
are addicted to opioid drugs such as heroin and morphine.
It contains the buprenorphine which belongs to a class of medicines
called opioids, which are ‘pain
relievers’.
This medicine has been prescribed/provided 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.
Buprenorphine Sublingual Tablets are used in adults and adolescents
over 16 years of age who are
also receiving medical, social and psychological support.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL
TABLETS
DO NOT TAKE BUPRENORPH

Ապրանքի հատկությունները

Page
1
of
15
1.
NAME OF THE MEDICINAL PRODUCT
Buprenorphine 8 mg Sublingual Tablets
Natzon 8 mg Sublingual Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg of buprenorphine (as buprenorphine
hydrochloride).
Excipient: Each tablet contains 80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sublingual tablet.
Off-white to brownish, oval, biplane tablets marked 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 Buprenorphine 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, physician 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 patient 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 buprenorphine
therapy, the dose of
methadone should be reduced to a maximum of 30mg/day. Buprenorphine
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