Natzon 8mg sublingual tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Buprenorphine hydrochloride

Предлага се от:

Morningside Healthcare Ltd

АТС код:

N07BC01

INN (Международно Name):

Buprenorphine hydrochloride

дозиране:

8mg

Лекарствена форма:

Sublingual tablet

Начин на приложение:

Sublingual

Клас:

Schedule 3 (CD No Register)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04100300; GTIN: 5055132709425

Листовка

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 Buprenorphine Sublingual

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
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 ge