SUBOXONE 8 MG SUBLINGUAL TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HCL DIHYDRATE

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HCL DIHYDRATE

Units in package:

28 Tablet Tablets

Manufactured by:

RECKITT BENCKISER HEALTHCARE (UK) LIMITED

Patient Information leaflet

Not Applicable

Summary of Product characteristics

Page 1 of 18
1. NAME OF THE MEDICINAL PRODUCT
SUBOXONE
® SUBLINGUAL TABLET
2MG/0.5MG & 8MG/2MG
SUBOXONE sublingual tablets contain buprenorphine (as hydrochloride)
and naloxone (as
hydrochloride dihydrate) at a ratio of 4:1 buprenorphine: naloxone
(ratio of free bases).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SUBOXONE 2 mg/0.5 mg sublingual tablet contains 2 mg
buprenorphine (as
hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Each SUBOXONE 8 mg/2 mg sublingual tablet contains 8 mg buprenorphine
(as hydrochloride)
and 2 mg naloxone (as hydrochloride dihydrate).
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Sublingual tablet
SUBOXONE 2mg/0.5mg sublingual tablets are white, hexagonal, and
biconvex, embossed with
“N2”.
SUBOXONE 8mg/2mg sublingual tablets are white, hexagonal, and
biconvex, and embossed
with “N8”.
The sublingual formulation is not designed to be split or broken.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of medical, social and
psychological treatment. The intention of the naloxone component is to
deter intravenous
misuse. Treatment is intended for use in adults and adolescents over
15 years of age who have
agreed to be treated for addiction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Administration is sublingual.
Treatment must be under the supervision of a physician experienced in
the management of
opiate dependence/addiction.
Each SUBOXONE sublingual tablet contains buprenorphine and naloxone.
Method of administration
Physicians must warn patients that the sublingual route is the only
effective and safe route of
administration for this medicinal product (see SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE).
SUBOXONE sublingual tablets are to be placed under the tongue until
dissolved, which usually
requires 5 to 10 minutes. Patients should not swallow or consume food
or drink until the tablet is
completely dissolved. The dose is made up from SUBOXONE 2 mg/0.5 mg
and SUBO