ROPINIROLE TEVA 2 MG

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

ROPINIROLE AS HYDROCHLORIDE

Dostępny od:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Kod ATC:

N04BC04

Forma farmaceutyczna:

FILM COATED TABLETS

Skład:

ROPINIROLE AS HYDROCHLORIDE 2 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY

Grupa terapeutyczna:

ROPINIROLE

Dziedzina terapeutyczna:

ROPINIROLE

Wskazania:

Treatment of idiopathic Parkinson's disease : Ropinirole may be used alone in the treatment of idiopathic Parkinson's disease.Addition of ropinirole to levodopa may be used to control " on - off " fluctuations and permit a reduction in the total daily dose of levodopa.

Data autoryzacji:

2015-11-30

Charakterystyka produktu

_This leaflet format has been determined by the Ministry of Health and
the content thereof has been _
_checked and approved on_ October 2016
1. NAME OF THE MEDICINAL PRODUCT
ROPINIROLE TEVA
®
0.25 mg
ROPINIROLE TEVA
®
2 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet of ROPINIROLE TEVA
®
0.25 mg contains 0.285 mg ropinirole hydrochloride equivalent
to 0.25 mg ropinirole.
Each film coated tablet of ROPINIROLE TEVA
®
2 mg contains 2.28 mg ropinirole hydrochloride equivalent to 2
mg ropinirole.
Excipient(s) with known effect:
ROPINIROLE TEVA
®
0.25 mg: lactose monohydrate (110.615 mg)
ROPINIROLE TEVA
®
2 mg : lactose monohydrate -108.62 mg, Lecitin (soya) E322 ( 0.1575
mg)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets
ROPINIROLE TEVA 0.25 mg: White, round slightly arched tablet, debossed
"R 0.25" on one side and plain on
the other.
ROPINIROLE TEVA 2 mg : Pink, round slightly arched tablet. Debossed "R
2"on one side and plain on the
other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of idiopathic Parkinson's disease :
Ropinirole may be used alone in the treatment of idiopathic
Parkinson's disease.
Addition of ropinirole to levodopa may be used to control " on - off "
fluctuations and permit a
reduction in the total daily dose of levodopa.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
When switching treatment from another dopamine agonist to ropinirole,
the manufacturer's guidance on
discontinuation should be followed before initiating ropinirole.
Patients should be down-titrated if they experience disabling
somnolence at any dose level. For other adverse
events, down-titration followed by more gradual up-titration has been
shown to be beneficial.
POPULATIONS
:
ADULTS
Individual dose titration against efficacy and tolerability is
recommended.
Ropinirole should be taken three times a day, preferably with meals to
improve gastrointestinal tolerance.
_TREATMENT INITIATION: _
_ _
_ _The initial dose should be 0.25 mg three times dail