Buprenorphine 8mg sublingual tablets sugar free

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Buprenorphine hydrochloride

Dostupné z:

Sun Pharma UK Ltd

ATC kód:

N07BC01

INN (Medzinárodný Name):

Buprenorphine hydrochloride

Dávkovanie:

8mg

Forma lieku:

Sublingual tablet

Spôsob podávania:

Sublingual

Trieda:

Schedule 3 (CD No Register)

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04100300; GTIN: 8718309122454

Príbalový leták

V010
1
PACKAGE LEAFLET
V010
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PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPRENORPHINE 2 MG SUBLINGUAL TABLETS
BUPRENORPHINE 8 MG SUBLINGUAL TABLETS
Buprenorphine
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 is and what it is used for
2.
What you need to know before you take Buprenorphine
3.
How to take Buprenorphine
4.
Possible side effects
5.
How to store Buprenorphine
6.
Contents of the pack and other information
1.
WHAT BUPRENORPHINE IS AND WHAT IT IS USED FOR
Buprenorphine belongs to a group of medicines called opioid analgesics
(also known as ‘opiates’ or ‘narcotics’).
Opioid analgesics, such as morphine or diamorphine (heroin), are often
subject to abuse, which can lead to dependence
(addiction). If you are addicted to these drugs, you need a regular
dose to feel ‘normal’, otherwise you will develop
withdrawal symptoms within a day or so of the last dose. Withdrawal
symptoms include sweating, feeling hot and
cold, runny eyes and nose, feeling or being sick, diarrhoea, stomach
cramps, poor sleep and just feeling awful.
Buprenorphine is used as a substitution (replacement) treatment in
patients who are addicted to opioid drugs such as
heroin and morphine. The tablets prevent or reduce the unpleasant
withdrawal symptoms experienced when addicts
stop using opioid drugs.
Treatment with Buprenorphine may form one aspect of a specialist
support programme aimed at resolving opioid
addiction.
Treatment with Buprenorphine is intended for use in adults and
adolescents a

Súhrn charakteristických

OBJECT 1
BUPRENORPHINE 8 MG SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 27-Apr-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Buprenorphine 8 mg sublingual tablets
2. Qualitative and quantitative composition
Buprenorphine 8mg: each tablet contains 8.62mg buprenorphine
hydrochloride equivalent to 8mg
buprenorphine.
Excipients with known effect:
Each tablet contains 119.40mg of lactose monohydrate and 1.00mg of
butylhydroxyanisole (E320).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet.
8 mg tablet: White to off-white, round, biconvex uncoated sublingual
tablet debossed with “8” on one
side and plain on the other 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 is intended for use in adults and adolescents aged 16 years
or older who have agreed to be
treated for addiction.
_Induction therapy_
Baseline liver function tests and documentation of viral hepatitis
status is recommended prior to
commencing therapy. Patients who are positive for viral hepatitis, on
concomitant medication (see section
4.5) and/or have existing liver dysfunction are at risk of accelerated
liver injury. Regular monitoring of
liver function is recommended (see section 4.4).
_Induction_
Prior to treatment induction, consideration should be given to the
type 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 Buprenorphine should be
undertaken when objective and clear
signs of withdrawal are evident.
The initial dose is from 0.8mg to 4mg, administered as a single daily
dose. 0.4mg dose strength of
Buprenorphine is not available. If low dose is required, the patient
should use tablets (0.4mg) of another
brand.
- for opioid-dependent