REPREVE ropinirole (as hydrochloride) 1 mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

ropinirole hydrochloride, Quantity: 1.14 mg (Equivalent: ropinirole, Qty 1 mg)

Доступно од:

Arrotex Pharmaceuticals Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Пут администрације:

Oral

Јединице у пакету:

28 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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

Резиме производа:

Visual Identification: Green, pentagon shaped tablet with 'RI' over '1' 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

Статус ауторизације:

Licence status A

Датум одобрења:

2017-11-07

Карактеристике производа

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