Tasmar
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
25-11-2022
Vara einkenni
(SPC)
25-11-2022
Opinber matsskýrsla
(PAR)
28-07-2014
Virkt innihaldsefni:
tolcapone
Fáanlegur frá:
Viatris Healthcare Limited
ATC númer:
N04BX01
INN (Alþjóðlegt nafn):
tolcapone
Meðferðarhópur:
Anti-Parkinson drugs, Other dopaminergic agents
Lækningarsvæði:
Parkinson Disease
Ábendingar:
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.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.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.
Vörulýsing:
Revision: 24
Leyfisstaða:
Authorised
Leyfisdagur:
1997-08-27
Upplýsingar fylgiseðill
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tasmar 100 mg film-coated tablets
tolcapone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Tasmar is and what it is used for
2.
What do you need to know before you take Tasmar
3.
How to take Tasmar
4.
Possible side effects
5.
How to store Tasmar
6.
Contents of the pack and other information
1.
WHAT TASMAR IS AND WHAT IT IS USED FOR
For the treatment of Parkinson’s disease, Tasmar is used together
with the medicinal product levodopa
(as levodopa/benserazide or levodopa/carbidopa).
Tasmar is used when all other alternative medicines cannot stabilise
your Parkinson’s disease.
For the treatment of your Parkinson’s disease you already take
levodopa.
A natural protein (enzyme) in your body, the (COMT) Catechol-
_O_
-methyltransferase breaks down the
levodopa. Tasmar blocks this enzyme and thus slows the breakdown of
levodopa. This means when it
is taken together with levodopa (as levodopa/benserazide or
levodopa/carbidopa) you should have an
improvement in the symptoms of your Parkinson’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TASMAR
DO NOT TAKE TASMAR:
-
if you have liver disease or increased liver enzymes
-
if you have severe involuntary movement (dyskinesia)
-
if you have a previous history of severe symptoms of muscle
stiffening, fever or mental
confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex)
and/or if you have
damage of skeletal muscle tissue (non-traumatic rhabdomyolysis) or
fever (hyperthe
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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
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