Ropaccord Tablets

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Ropinirole hydrochloride; ropinirole

Saatavilla:

Accord Healthcare Pty Ltd

luokka:

Medicine Registered

Pakkausseloste

ROPACCORD TABLETS
CONSUMER MEDICINE INFORMATION
Version 2
-2010-
1
ROPACCORD TABLETS 0.5 MG & 2 MG
Ropinirole (as Hydrochloride) Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before
you
use
Ropaccord
Tablets.
This
leaflet
answers
some
common
questions
about
Ropaccord Tablets. It does not
contain
all
of
the
available
information.
It does not take the place of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and
benefits.
Your
doctor
has
weighed the expected benefits of
you taking Ropaccord Tablets
against the risks this medicine
could have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT ROPACCORD
TABLETS IS USED FOR?
The name of your medicine is
Ropaccord Tablets; it is also
known as ropinirole.
Ropaccord Tablets is used to
treat restless legs syndrome.
Restless legs syndrome is a
condition in which a sense of
uneasiness,
restlessness,
and
itching
often
accompanied
by
twitching and pain is felt in the
legs and sometimes arms when
sitting or lying down, especially in
bed at night. The only relief is
walking or moving the affected
limbs,
which
often
leads
to
problems sleeping at night time.
Restless
legs
syndrome
is
thought to be due to a deficiency
in
the
body
of
a
naturally
occurring
body
chemical:
dopamine.
Ropaccord Tablets belongs to a
group
of
medicines
called
nonergoline, dopamine agonists.
Ropaccord
Tablets
works
by
having a similar effect on the
body as dopamine, therefore it
makes
up
for
the
dopamine
shortage
in
restless
legs
syndrome. This in turn relieves
the discomfort and reduces the
involuntary limb movements that
disrupt night time sleep.
Your doctor may have prescribed
Ropaccord Tablets for another
reason.
Ropaccord Tablets tablets are
not addictive.
BE

Valmisteyhteenveto

Product Information:   
Ropaccord Tablets 0.5mg & 2mg [Ropinirole (as Hydrochloride)
Tablets 0.5mg & 2mg]                       
          Ver 2.0 
-2012-                                   

                   1 

PRODUCT INFORMATION 
ROPACCORD TABLETS 0.5 MG 
(ROPINIROLE (AS HYDROCHLORIDE) TABLETS 0.5 MG) 

ROPACCORD TABLETS 2 MG 
(ROPINIROLE (AS HYDROCHLORIDE) TABLETS 2 MG) 

NAME OF THE MEDICINE 
Ropinirole (as Hydrochloride) 

_Chemical name:_ 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2_H_-indol-2-one hydrochloride. 

Molecular formula: C
16
H
24
N
2
O.HCl. Molecular weight: 296.8 (260.38 free base)

_ _
_CAS:_ 91374-20-8  

DESCRIPTION

Ropinirole Hydrochloride is a white to pale
greenish yellow powder. It is highly soluble in 
water (133 mg/mL). 
ACTIONS: Dopamine receptor agonist. 
EXCIPIENTS: lactose, cellulose microcrystalline, croscarmellose
sodium, magnesium stearate, 
hypromellose, OPADRY complete film
coating system 03B82930 YELLOW (0.5 mg) (ARTG 
12851) and OPADRY complete film coating system 03B54094
PINK (2 mg) (ARTG 12850). 

PHARMACOLOGY

Ropinirole Hydrochloride is a potent, non-ergoline D
2
/D
3
-dopamine agonist. 
Studies with human cloned receptors _in vitro _show that ropinirole
binds with high affinity to 
cloned human D
2, 
D
3 
and D
4
 receptors. Neither ropinirole hydrochloride nor its
metabolites 
bind with high affinity to dopamine D
1 
receptors. Ropinirole hydrochloride also has very low 
affinity for 5HT
1
, 5HT
2
, benzodiazepine, GABA, muscarinic, alpha or beta-adrenoceptors. 
Ropinirole hydrochloride is a potent dopamine agonist _in
vitro _and  _in vivo. _The 
pathophysiology of Restless Legs Syndr