SUBUTEX

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

BUPRENORPHINE HYDROCHLORIDE

Предлага се от:

RB Pharmaceuticals Limited

АТС код:

N02AE01

INN (Международно Name):

BUPRENORPHINE HYDROCHLORIDE

дозиране:

8 Milligram

Лекарствена форма:

Tablet Sublingual

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

buprenorphine

Статус Оторизация:

Not Marketed

Дата Оторизация:

2002-08-16

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
Subutex 0.4mg, 2mg and 8mg sublingual tablets
buprenorphine
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 gets 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.
Contents of the pack and 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 opioid-dependent patients who have agreed to be treated for their
opioid dependence.
Subutex is used in adults and adolescents over 15 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 15 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
or are having an acute asthma attack.
•
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 have recently had a head injury or have a condition that causes
pressure to build up
in your head.
•
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
•
an enlarged prostate gland or have difficulty when passing urine
�

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Subutex 8 mg sublingual Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains buprenorphine hydrochloride equivalent to
buprenorphine base: 8 mg
Excipient(s) with known effect: Lactose monohydrate 191.76 mg/tablet
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sublingual tablet
8 mg: Uncoated oval white flat bevelled edged tablet, nominal
dimensions 14 mm x 7 mm, "B8" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Substitution treatment for major opioid drug dependence within a
comprehensive therapeutic monitoring 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 over 15 years of age who have
agreed to be treated for opioid dependence.
Treatment with Subutex sublingual tablets must be by physicians who
have specialist training in its use and all treated
patients must be on a central register according to Drug Misuse
Programme guidelines. These physicians can be
consultants, and/or Level I or Level II GPs who have received special
training. All patients will be reviewed and
reassessed regularly.
_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 withdra