CONTRAVE Prolonged-Release Tablet Naltrexone Hydrochloride 8mg Bupropion Hydrochloride 90mg

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

Bupropion; Naltrexone

Dostupno od:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (International ime):

Bupropion; Naltrexone

Jedinice u paketu:

120 Tablets

Proizveden od:

PATHEON WHITBY INC

Uputa o lijeku

2
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CONTRAVE
® PROLONGED-RELEASE
TABLET 8MG/90MG
Naltrexone hydrochloride / Bupropion hydrochloride (8mg/90mg)
_______________________________________________________________________________________________________
_WHAT IS IN THIS LEAFLET _
_ _
1.
_What Contrave® Prolonged- _
_Release Tablet 8mg/90mg is _
_used for _
2.
_How Contrave® Prolonged- _
_Release _
_Tablet _
_8mg/90mg _
_works _
3.
_Before _
_you _
_use _
Contrave® Prolonged-
Release
Tablet
8mg/90mg
4.
How
to
use
_Contrave® _
_Prolonged- _
_Release _
_Tablet _
_8mg/90m_
g
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
_Contrave® Prolonged-Release _
_Tablet 8mg/90mg _
8.
Product description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of revision
WHAT
CONTRAVE®
PROLONGED-
RELEASE TABLET 8MG/90MG IS USED
FOR
_Contrave® _
_Prolonged-Release _
_Tablet 8mg/90mg_
is used in obese
or
overweight
adults
to
manage
weight
together
with
a
reduced
calorie diet and physical exercise.
HOW
CONTRAVE®
PROLONGED-
RELEASE TABLET 8MG/90MG WORKS
_Contrave® _
_Prolonged-Release _
_Tablet 8mg/90mg_
works on areas
on the brain involved in the control
of food intake and energy use.
BEFORE
YOU
USE
CONTRAVE®
PROLONGED-RELEASE
TABLET
8MG/90MG
_-When you must not use it _
_ _
Do not use this medicine if you
have an allergy to:
•
any medicine containing
Naltrexone hydrochloride
and
Bupropion
hydrochloride
•
any of the ingredients listed
at the end of this leaflet.
Some
of
the
symptoms
of
an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling
of
the
face,
lips,
tongue
or other
parts
of
the
body
•
rash,
itching
or
hives
on
the
skin.
Do not take this medicine if you:
•
have
high
blood
pressure
that is not controlled with
medicines
•
have ever had a seizure
•
have a brain tumour
•
are usually a heavy drinker
and
have
just
suddenly
stopped
drinking
a
lot
of
alcohol, or are going to stop
while
you
are
taking
this
medicine
•
have

Svojstava lijeka

CONTRAVE
®
PROLONGED-RELEASE TABLET 8MG/90MG
1.
PRODUCT DESCRIPTION
Prolonged-release tablet. Blue, biconvex, round tablet of 12-12.2 mm
diameter debossed with “NB-890” on
one side.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2
mg of naltrexone, and 90 mg bupropion
hydrochloride, equivalent to 78 mg of bupropion.
List of excipients:
Tablet core:
Cysteine hydrochloride
Microcrystalline cellulose
Hydroxypropyl cellulose
Magnesium stearate
Lactose anhydrous
Lactose monohydrate
Crospovidone type A
Indigo carmine aluminium lake (E132)
Hypromellose
Edetate disodium
Colloidal silicon dioxide
Film-coating:
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol (3350)
Talc
Indigo carmine aluminium lake (E132)
3.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiobesity preparations excluding diet
products, centrally acting antiobesity
products, ATC code: A08AA62.
Mechanism of action and pharmacodynamic effects
The exact neurochemical appetite suppressant effects of
naltrexone/bupropion are not fully understood. The
medicinal product has two components: naltrexone, a mu-opioid
antagonist, and bupropion, a weak inhibitor
of neuronal dopamine and norepinephrine reuptake. These components
affect two principal areas of the brain,
specifically the arcuate nucleus of the hypothalamus and the
mesolimbic dopaminergic reward system.
In the arcuate nucleus of the hypothalamus, bupropion stimulates
pro-opiomelanocortin (POMC) neurons that
release alpha-melanocyte stimulating hormone (α-MSH), which in turn
binds to and stimulates melanocortin
4 receptors (MC4-R). When α-MSH is released, POMC neurons
simultaneously release β-endorphin, an
endogenous agonist of the mu-opioid receptors. Binding of β-endorphin
to mu-opioid receptors on POMC
neurons mediates a negative feedback loop on POMC neurons leading to a
decrease in the release of α-MSH.
Blocking this inhibitory feedback loop with naltrexone is proposed to
facilitate a more potent and longer-
lasting a