APPESE 2 ropinirole (as hydrochloride) 2 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ropinirole hydrochloride, Quantity: 2.28 mg (Equivalent: ropinirole, Qty 2 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Ropinirole hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.

Product summary:

Visual Identification: Pink, pentagon shaped tablet with 'RI' over '2' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-08-04

Patient Information leaflet

APPESE- Consumer Medicine Information
Page 1 of 4
APPESE
ropinirole (as hydrochloride)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APPESE.
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 benefits and
risks. Your doctor has weighed the
risks of you taking APPESE against
the benefits they expect it will have
for you.
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT APPESE IS USED FOR
APPESE 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 dopamine, a naturally
occurring body chemical.
APPESE belongs to a group of
medicines called non-ergoline,
dopamine agonists. APPESE 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.
APPESE is not recommended for
use in children or adolescents
(under the age of 18), as there
have been no studies of its effects
in this age group).
This medicine is available only with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE APPESE IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
ROPINIROLE
OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
DO NOT TAKE IT IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
It may affect your developing baby
if you take it du

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APPESE
(ROPINIROLE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Ropinirole hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Appese tablets come in four strengths and contain either 0.25 mg, 0.5
mg, 1 mg or 2 mg of ropinirole
(as hydrochloride).
Excipients of known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_APPESE 0.25*_
White to off-white, pentagon shaped tablet with ‘RI’ over ‘25’
on one side and plain
on the other side. Each tablet contains 0.25mg ropinirole (as
hydrochloride).
_APPESE 0.5 _
Yellow, pentagon shaped tablet with ‘RI’ over ‘50’ on one side
and plain on the other
side. Each tablet contains 0.5mg ropinirole (as hydrochloride)._ _
_APPESE 1* _
Green, pentagon shaped tablet with ‘RI’ over ‘1’ on one side
and plain on the other
side. Each tablet contains 1mg ropinirole (as hydrochloride).
_APPESE 2 _
Pink, pentagon shaped tablet with ‘RI’ over ‘2’ on one side
and plain on the other
side. Each tablet contains 2mg ropinirole (as hydrochloride).
*Not currently marketed
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of primary restless legs syndrome, including the reduction
of associated periodic limb
movement and episodes of nocturnal arousal.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Individual dose titration against efficacy and tolerability is
recommended. Ropinirole should be
taken once-daily before bedtime, however the dose can be taken up to
three hours before retiring.
_TREATMENT INITIATION (WEEK 1) _
The recommended initial dose is 0.25 mg once daily for two days. If
this dose is well tolerated the
dose may be increased to 0.5 mg once daily for the remainder of week
1.
2
_THERAPEUTIC REGIMEN (WEEK 2 ONWARDS) _
Following treatment initiation, the daily dose can be increased
according to the regimen shown in
Table 1 until optimal therapeutic response is achieved.
Table 1
WEEK
DOSE
(MG)/ONCE DAILY
2
3
4
5
6
7
1
1.5
2
2.5
3
4
First signs of