ROPINIROLE ARW ropinirole (as hydrochloride) 0.25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ropinirole hydrochloride, Quantity: 0.285 mg (Equivalent: ropinirole, Qty 0.25 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Administration route:

Oral

Units in package:

12 Tablets, 2 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

REPREVE is indicated for the treatment of primary restless legs syndrome, including the reduction of associated periodic limb movement and episodes of nocturnal arousal.

Product summary:

Visual Identification: White, pentagonal film-coated, 'Tiltab' tablets with bevelled edges and a raised pentagonal flattened tilt feature offset on each face. Debossed 'SB' on one face and '4890' on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-10-05

Patient Information leaflet

REPREVE
®
1
REPREVE
®
_Ropinirole (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use REPREVE tablets.
This leaflet answers some common
questions about REPREVE 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
REPREVE 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 IS REPREVE
USED FOR?
The name of your medicine is
REPREVE; it is also known as
ropinirole.
REPREVE 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.
REPREVE belongs to a group of
medicines called non-ergoline,
dopamine agonists. REPREVE 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
REPREVE for another reason.
REPREVE tablets are not addictive.
BEFORE YOU TAKE
REPREVE
_DO NOT TAKE IF: _
You must not take REPREVE if:
•
you have ever had an allergic
reaction to ropinirole or any of
the ingredients listed toward the
end of this leaflet. (See
"Ingredients")
•
you are pregnant or intend to
become pregnant
•
you are breastfeeding or wish to
breastfeed
•
the expir

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
REPREVE
®
(ROPINIROLE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Ropinirole hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Repreve tablets come in four strengths and contain either 0.25 mg, 0.5
mg, 1 mg or 2 mg of
ropinirole (as hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_REPREVE 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).
_REPREVE 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)._ _
_REPREVE 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).
_REPREVE 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 a response can be anticipated after one