Espranor 2 mg oral lyophilisate

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

BUPRENORPHINE HYDROCHLORIDE

Tillgänglig från:

Martindale Pharmaceuticals Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC-kod:

N07BC01

INN (International namn):

BUPRENORPHINE HYDROCHLORIDE 2 mg

Läkemedelsform:

ORAL LYOPHILISATE

Sammansättning:

BUPRENORPHINE HYDROCHLORIDE 2 mg

Receptbelagda typ:

POM

Terapiområde:

OTHER NERVOUS SYSTEM DRUGS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2016-01-28

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ESPRANOR 2 MG ORAL LYOPHILISATE
ESPRANOR 8 MG ORAL LYOPHILISATE
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
Section 4.
WHAT IS IN THIS LEAFLET:
1.
What Espranor is and what it is used for
2.
What you need to know before you take Espranor
3.
How to take Espranor
4.
Possible side effects
5.
How to store Espranor
6.
Contents of the pack and other information
1.
WHAT ESPRANOR IS AND WHAT IT IS USED FOR
Espranor oral lyophilisate is a freeze-dried wafer which dissolves
rapidly on the tongue.
Espranor is used in adults and adolescent over 15 years of age, as
part of a medical,
social and psychological treatment programme for addiction.
Espranor contains buprenorphine, an opioid (narcotic) analgesic. When
it is used for the
treatment of patients addicted to opiate (narcotic) drugs, such as
morphine or heroin, it
acts as a substitute for these drugs and therefore aids the patient in
withdrawing from
them over a period of time.
If treatment is stopped abruptly, withdrawal symptoms can occur.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESPRANOR
Espranor is not interchangeable with other oral buprenorphine products
and the dose of
Espranor may differ from the dose of other buprenorphine products
Do not take Espranor if:
•
You are allergic (hypersensitive) to buprenorphine or any of the other
ingredients in
Espranor (see section 6)
•
You have severe breathing problems
•
You have severe liver problems
•
You are alcohol dependent or suffer from acute alc

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Espranor 2 mg oral lyophilisate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate contains 2 mg of buprenorphine (as
hydrochloride).
Excipient with known effect:
Each oral lyophilisate contains 0.50 mg aspartame.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral lyophilisate.
White to off-white circular oral lyophilisate with a diameter of 10.3
mm, debossed
with ‘M2’ 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.
Treatment with Espranor oral lyophilisate is intended for use in
adults and
adolescents aged 15 years or over who have agreed to be treated for
addiction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TREATMENT SHOULD BE UNDER THE SUPERVISION OF A CLINICIAN EXPERIENCED
IN THE
MANAGEMENT OF OPIATE DEPENDENCE/ADDICTION
.
Espranor is
NOT INTERCHANGEABLE WITH OTHER BUPRENORPHINE PRODUCTS
. Different
buprenorphine products have different bioavailability. Therefore, the
dose in mg can
differ between products. Once the appropriate dose has been identified
for a patient
with a certain product (brand), the product cannot readily be
exchanged with another
product.
The route of administration for Espranor is
ON THE TONGUE
, not under it.
Administration is oromucosal. The oral lyophilisate should be taken
from the blister
unit with dry fingers, and placed whole on the tongue until dispersed,
which usually
occurs within 15 seconds, and then absorbed through the oromucosa.
Swallowing
should be avoided for 2 minutes. The oral lyophilisate should be taken
immediately
after opening the blister. Patients should not consume food or drink
for 5 minutes
after administration.
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Physicians must advise patients that the oromucosal route of
administration is the
only effective and safe route of administration for this medicinal
product. If the oral
lyophilisate, o