Suboxone 2/0.5

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Buprenorphine hydrochloride 2.16mg equivalent to 2 mg buprenorphine; Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5 mg naloxone

Διαθέσιμο από:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Διεθνής Όνομα):

Buprenorphine hydrochloride 2.16 mg (equivalent to 2 mg buprenorphine)

Δοσολογία:

2mg/0.5mg

Φαρμακοτεχνική μορφή:

Sublingual tablet

Σύνθεση:

Active: Buprenorphine hydrochloride 2.16mg equivalent to 2 mg buprenorphine Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5 mg naloxone Excipient: Acesulfame potassium Citric acid Lactose monohydrate Lemon flavour PHS-020484 Magnesium stearate Maize starch Mannitol Povidone Sodium citrate dihydrate

Μονάδες σε πακέτο:

Blister pack, PVC/PVdC-Al - 7 tablets, 7 tablets

Kατηγορία:

Class C4 Controlled Drug

Τρόπος διάθεσης:

Class C4 Controlled Drug

Κατασκευάζεται από:

Indivior UK Limited

Θεραπευτικές ενδείξεις:

Treatment of opiate dependence, within a framework of medical, social and psychological treatment. Naloxone is included in SUBOXONE to deter intravenous misuse of the product.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, Paper/Aluminium/Nylon/Aluminium/PVC - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Paper/Aluminium/Nylon/Aluminium/PVC - 28 tablets - 36 months from date of manufacture stored at or below 30°C

Ημερομηνία της άδειας:

2000-04-04

Φύλλο οδηγιών χρήσης

Page 1 of 5
SUBOXONE
® SUBLINGUAL TABLETS
_Buprenorphine Hydrochloride + Naloxone Hydrochloride Dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
SUBOXONE. It does not
contain all the available
information.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking SUBOXONE against
the benefits you may gain and
he/she believes it will help in
your treatment.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING SUBOXONE,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET. You may
want to read it again.
WHAT IS SUBOXONE USED
FOR?
SUBOXONE is used as part
of a medical, social and
psychological treatment
program for patients
dependent on opioids like
heroin, morphine, oxycodone
or codeine. SUBOXONE is
used to help such patients to
regain control over their lives.
SUBOXONE tablets contain
the active ingredients
buprenorphine hydrochloride
and naloxone hydrochloride
dihydrate. Buprenorphine
acts as a substitute for opioids
like heroin and it helps
withdrawal from opioid over a
period of time. When taken
sublingually (under the
tongue) as prescribed,
naloxone has no effect, as it is
very poorly absorbed.
However, if SUBOXONE is
injected, naloxone will act to
block the effects of other
opioids like heroin,
methadone or morphine,
leading to bad withdrawal
symptoms. Therefore,
naloxone is included in
SUBOXONE to discourage
misuse by injection, as it can
cause very bad withdrawal
symptoms.
SUBOXONE should be used
exactly as prescribed by your
doctor.
Ask your doctor if you have
any questions about why
SUBOXONE has been
prescribed for you.
BEFORE YOU TAKE
SUBOXONE
SUBOXONE is not suitable for
everyone.
_WHEN YOU MUST NOT TAKE _
_SUBOXONE _
•
If you are under the age of
16 years.
•
If you are allergic to
buprenorphine or to
naloxone or to any of the
other ingredients in this
medicine (see Product
Description below).
•
If you have serious
breathing problems.
•
If you have serious
problems with your liver,
or if your doctor detects
the development of
•
su

Αρχείο Π.Χ.Π.

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SUBOXONE 2 mg/0.5 mg sublingual tablet
SUBOXONE 8 mg/2 mg sublingual tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet of SUBOXONE 2 mg/0.5 mg contains 2 mg
buprenorphine (as hydrochloride)
and 0.5 mg naloxone (as hydrochloride dihydrate).
Each sublingual tablet of SUBOXONE 8 mg/2mg contains 8 mg
buprenorphine (as hydrochloride)
and 2 mg naloxone (as hydrochloride dihydrate).
Excipients with known effect: The sublingual tablets contain lactose
(as monohydrate): 42 mg in each
SUBOXONE 2 mg/0.5 mg and 168 mg in each SUBOXONE 8 mg/2 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
SUBOXONE 2 mg/0.5 mg: white, hexagonal, biconvex tablets debossed with
a “N2”.
SUBOXONE 8 mg/2 mg: white, hexagonal, biconvex tablets debossed with a
“N8”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of opioid dependence, within a framework of medical, social
and psychological treatment.
Naloxone is included in SUBOXONE to deter intravenous misuse of the
product.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with SUBOXONE sublingual tablets is intended for adults and
children aged 16 years or
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Although SUBOXONE is indicated for the treatment of opioid dependence
it still poses risks of
hazardous and harmful use which can lead to overdose and death.
Monitor the patient’s ongoing risk of
hazardous and harmful use regularly during opioid substitution therapy
with SUBOXONE (see section
4.4. Special Warnings and Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life‐threatening or fatal respiratory depression may occur
with the use of SUBOXONE. Be
aware of situations which increase the risk of respiratory depression,
and monitor patients closely,
especially on initiation or following a dose increase (see section 4.4
Special Warnings and Precautions
for Use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS,