Natzon 0.4mg sublingual tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

N02AE01

INN (International Name):

Buprenorphine hydrochloride

Dosage:

400microgram

Pharmaceutical form:

Sublingual tablet

Administration route:

Sublingual

Class:

Schedule 3 (CD No Register)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5055132713460

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
This product can cause withdrawal symptoms if you take
it less than 6 hours after you use a short-acting opioid
(e.g. morphine, heroin) or less than 24 hours after you
use a long-acting opioid such as methadone.
2.
What you need to know before you take Natzon
Sublingual Tablets
5.
How to store Natzon Sublingual Tablets
1.
What Natzon Sublingual Tablets are and what they
are used for
3.
How to take Natzon Sublingual Tablets
Natzon belongs to a group of medicines called an opioid
(also known as "opiates" or "narcotics"). Opioids, 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.
Natzon Sublingual Tablets are 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 Natzon Sublingual Tablets may form one
aspect of a specialist support programme aimed at
resolving opioid addiction. This should be used in adults
and adolescents over 16 years of age who are also
receiving medical, social and psychological support.
WHAT IS IN THIS LEAFLET:
!
If you have any further questions, ask your doctor or
pharmacist.
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.
!
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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Natzon 0.4 mg Sublingual Tablets
Buprenorphine 0.4mg Sublingual Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.4 mg of buprenorphine (as buprenorphine
hydrochloride).
Excipient: Each tablet contains 4 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sublingual tablet.
Off-white to brownish, round, biplane tablets.
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
Treatment with this medicine is intended for use in adults and
adolescents
aged 16 years or over who have agreed to be treated for addiction.
When initiating buprenorphine treatment, the physician should be aware
of the
partial agonist profile of buprenorphine and that it can precipitate
withdrawal
in opioid-dependent patients. Buprenorphine binds to the
μ
and
κ
opiate
receptors.
Administration is sublingual. Physicians must advise patients that the
sublingual route is the only effective and safe route of
administration for this
drug. The tablet should be kept under the tongue until dissolved.
Adults
Initiation 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 Interaction with
other
medicinal products and other forms of interaction) and/or have
existing liver
dysfunction are at risk of accelerated liver injury. Regular
monitoring of liver
function is recommended (see section 4.4 Special warnings and
precautions
for use).
_Induction therapy _
The initial dose is from 0.8mg to 4mg, administered as a single daily
dose.
•
For opioid-dependent drug addicts who have not undergone withdrawal:
one dose of this medicine administered sublingually at least 4 hours
after
the last use of the opioid, or wh