SUBUTEX buprenorphine 2mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine hydrochloride, Quantity: 2.16 mg (Equivalent: buprenorphine, Qty 2 mg)

Available from:

Indivior Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; mannitol; maize starch; povidone; citric acid; sodium citrate dihydrate; magnesium stearate

Administration route:

Sublingual

Units in package:

28 tablets, 7 Tablets

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Treatment of opiate dependence, including maintenance and detoxification, within a framework of medical, social and psychological treatment.

Product summary:

Visual Identification: Oval, flat, white to creamy white, glossy tablet with bevelled edges, debossed on one side with "B2".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-11-02

Patient Information leaflet

SUBUTEX
®
_Buprenorphine Hydrochloride_
CONSUMER MEDICINE INFORMATION
WARNINGS:
Hazardous and harmful use
Although SUBUTEX is indicated for the treatment of opioid dependence,
it still poses risks of hazardous and harmful use
which can lead to overdose and death. The doctor will monitor your
ongoing risk during treatment with SUBUTEX.
Life threatening respiratory depression
Serious, life-threatening respiratory depression may occur with the
use of SUBUTEX. Talk to your doctor about situations
which may increase the risk of respiratory depression.
Concomitant use of medicines affecting the central nervous system,
including alcohol
Use of SUBUTEX with anti-anxiety medicines, sedatives, antihistamines,
some antidepressants, antipsychotics, cannabis
and alcohol may result in profound sedation, respiratory depression,
coma and death.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SUBUTEX. It does
not contain all the available
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SUBUTEX
against the benefits you may gain and
he/she believes it will help in your
treatment.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING SUBUTEX, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT IS SUBUTEX
USED FOR?
SUBUTEX is used as part of a
medical, social and psychological
treatment program for patients
dependent on opioids like heroin,
morphine, oxycodone or codeine.
SUBUTEX is used to help patients
overcome this medical condition.
SUBUTEX tablets contain the active
ingredient buprenorphine
hydrochloride. It acts as a substitute
for opioids like heroin, morphine,
oxycodone or codeine and it helps
withdrawal from opioids over a
period of time.
SUBUTEX should be used exactly as
prescribed by your doctor.
Ask your doctor if you have any
questions about why SUBUTEX has
been prescribed for you.
BEFORE YOU TAKE
SUBUTEX
SUBUTEX is not suitable for
everyone.
_WHEN YOU MUST NOT TAKE_
_SUBUTEX_
•
If you are under the age of 16
years.
•
If you are allergi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SUBUTEX (BUPRENORPHINE)
1
NAME OF THE MEDICINE
SUBUTEX sublingual tablets contain buprenorphine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUBUTEX is available in three dosage strengths, 0.4 mg, 2 mg and 8 mg
buprenorphine (as
hydrochloride).
_Excipients with known effect_
SUBUTEX contains lactose monohydrate and mannitol.
Buprenorphine hydrochloride is a white powder, weakly acidic with
limited solubility in water
(19.5 mg/mL at 37
°
C, pH 4.1). Chemically, buprenorphine is 21-Cyclopropyl-7
α
-
[
(S)–1-
hydroxy1,2,2-trimethylpropyl
]
-6,14-_endo_–ethano-6,7,8,14-tetrahydrooripavine hydrochloride.
Buprenorphine hydrochloride has the molecular formula C
29
H
41
NO
4
HCl and the molecular
weight is 504.09.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
SUBUTEX is an uncoated tablet intended for sublingual administration.
SUBUTEX is supplied as white, oval tablets containing 0.4 mg, 2 mg and
8 mg buprenorphine.
Tablets are debossed with either “04”, “B2” or “B8”
respectively for SUBUTEX 0.4 mg, SUBUTEX
2 mg and SUBUTEX 8 mg.
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Although SUBUTEX 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 SUBUTEX
(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 SUBUTEX. 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, INCLUDING _
_ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
ant