Tasmar
Country: Unjoni Ewropea
Lingwa: Malti
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
25-11-2022
Karatteristiċi tal-prodott
(SPC)
25-11-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-07-2014
Ingredjent attiv:
tolcapone
Disponibbli minn:
Viatris Healthcare Limited
Kodiċi ATC:
N04BX01
INN (Isem Internazzjonali):
tolcapone
Grupp terapewtiku:
Kontra l-marda ta ' Parkinson id-drogi, aġenti dopaminerġiċi Oħra
Żona terapewtika:
Marda ta 'Parkinson
Indikazzjonijiet terapewtiċi:
Tasmar hija indikata fil kombinazzjoni ma ' ticlopidine hydrochloride / benserazide jew ticlopidine hydrochloride / carbidopa għall-użu fil-pazjenti ma ticlopidine hydrochloride-responsivi idiopathic Parkinson's marda u oxxillazzjonijiet vetturi bil-mutur, li naqas milli jirrispondi għal jew huma intolerant ta ' xulxin inibituri ta ' catechol-O-methyltransferase (COMT). Minħabba r-riskju ta potenzjalment fatali, ħsara fil-fwied akut, Tasmar ma għandhomx jiġu kkunsidrati bħala l-ewwel linja ta 'trattament miżjud ma' levodopa / benserazide jew levodopa / carbidopa. Peress li Tasmar għandu jiġi użat biss flimkien ma 'levodopa / benserazide u b'levodopa / carbidopa, l-tagħrif preskritt individwalment għal dawn l-sustanzi ta' levodopa hija applikabbli għall-użu tagħhom flimkien ma ' Tasmar.
Sommarju tal-prodott:
Revision: 24
L-istatus ta 'awtorizzazzjoni:
Awtorizzat
Data ta 'l-awtorizzazzjoni:
1997-08-27
Fuljett ta 'informazzjoni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tasmar 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg tolcapone.
Excipients with known effect
Each film-coated tablet contains 7.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pale to light yellow, hexagonal, biconvex, film-coated tablet.
“TASMAR” and “100” are engraved on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tasmar is indicated in combination with levodopa/benserazide or
levodopa/carbidopa for use in
patients with levodopa-responsive idiopathic Parkinson’s disease and
motor fluctuations, who failed to
respond to or are intolerant of other catechol-
_O_
-methyltransferase (COMT) inhibitors (see section 5.1).
Because of the risk of potentially fatal, acute liver injury, Tasmar
should not be considered as a first-
line adjunct therapy to levodopa/benserazide or levodopa/carbidopa
(see sections 4.4 and 4.8).
Since Tasmar should be used only in combination with
levodopa/benserazide and levodopa/carbidopa,
the prescribing information for these levodopa preparations is also
applicable to their concomitant use
with Tasmar.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
Tasmar is not recommended for use in children below the age of 18 due
to insufficient data on safety
or efficacy. There is no relevant indication for use in children and
adolescents.
_Elderly _
No dose adjustment of Tasmar is recommended for elderly patients.
_Hepatic impairment (see section 4.3) _
Tasmar is contraindicated for patients with liver disease or increased
liver enzymes.
_ _
_Renal impairment (see section 5.2) _
No dose adjustment of Tasmar is recommended for patients with mild or
moderate renal impairment
(creatinine clearance of 30 ml/min or greater). Patients with severe
renal impairment (creatinine
clearance <30 ml/min) should be treated with caution. No informatio
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tasmar 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg tolcapone.
Excipients with known effect
Each film-coated tablet contains 7.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pale to light yellow, hexagonal, biconvex, film-coated tablet.
“TASMAR” and “100” are engraved on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tasmar is indicated in combination with levodopa/benserazide or
levodopa/carbidopa for use in
patients with levodopa-responsive idiopathic Parkinson’s disease and
motor fluctuations, who failed to
respond to or are intolerant of other catechol-
_O_
-methyltransferase (COMT) inhibitors (see section 5.1).
Because of the risk of potentially fatal, acute liver injury, Tasmar
should not be considered as a first-
line adjunct therapy to levodopa/benserazide or levodopa/carbidopa
(see sections 4.4 and 4.8).
Since Tasmar should be used only in combination with
levodopa/benserazide and levodopa/carbidopa,
the prescribing information for these levodopa preparations is also
applicable to their concomitant use
with Tasmar.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
Tasmar is not recommended for use in children below the age of 18 due
to insufficient data on safety
or efficacy. There is no relevant indication for use in children and
adolescents.
_Elderly _
No dose adjustment of Tasmar is recommended for elderly patients.
_Hepatic impairment (see section 4.3) _
Tasmar is contraindicated for patients with liver disease or increased
liver enzymes.
_ _
_Renal impairment (see section 5.2) _
No dose adjustment of Tasmar is recommended for patients with mild or
moderate renal impairment
(creatinine clearance of 30 ml/min or greater). Patients with severe
renal impairment (creatinine
clearance <30 ml/min) should be treated with caution. No informatio
Aqra d-dokument sħiħ
