Tasmar 100mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Tolcapone

Sẵn có từ:

Meda Pharmaceuticals Ltd

Mã ATC:

N04BX01

INN (Tên quốc tế):

Tolcapone

Liều dùng:

100mg

Dạng dược phẩm:

Tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 04090100; GTIN: 5060022635906

Tờ rơi thông tin

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 medici-
nal 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 (Hyperthermia).
-
if you are hypers

Đặc tính sản phẩm

OBJECT 1
TASMAR 100 MG TABLETS
Summary of Product Characteristics Updated 16-Dec-2014 | Meda
Pharmaceuticals
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 tablet contains 7.5 mg lactose.
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-methyl transferase 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 patients_
No dose adjustment of Tasmar is recommended for elderly patients.
_Patients with hepatic impairment (see section 4.3)_
Tasmar is contraindicated for patients with liver disease or increased
liver enzymes.
_Patients with 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
< 3