Tasmar

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Tolcapone 100mg

Sẵn có từ:

iNova Pharmaceuticals (New Zealand) Limited

INN (Tên quốc tế):

Tolcapone 100 mg

Liều dùng:

100 mg

Dạng dược phẩm:

Film coated tablet

Thành phần:

Active: Tolcapone 100mg Excipient: Calcium hydrogen phosphate Ethylcellulose Hypromellose Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified talc   Sodium laurilsulfate Sodium starch glycolate Titanium dioxide Triacetin

Các đơn vị trong gói:

Blister pack, Al/PE/PVC/PVDC (not marketed), 10 tablets

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Piramal Enterprises Limited

Chỉ dẫn điều trị:

Tasmar is indicated for use in combination with levodopa/benserazide and levodopa/carbidopa in Parkinson's disease, including both fluctuating and non-fluctuating patients.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, Al/PE/PVC/PVDC - 10 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, Al/PE/PVC/PVDC - 30 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, Al/PE/PVC/PVDC - 60 tablets - 60 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Ngày ủy quyền:

1996-07-22

Tờ rơi thông tin

CONSUMER MEDICINE INFORMATION (CMI)
_ _
TASMAR
®
_TOLCAPONE 100 MG TABLETS _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TASMAR tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking TASMAR
tablets against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TASMAR IS USED FOR
TASMAR contains the active ingredient tolcapone.
TASMAR is used in the treatment of Parkinson’s disease.
TASMAR belongs to a group of medicines called
catechol-O-methyltransferase (COMT) inhibitors.
COMT inhibitors work together with the medicines levodopa/benserazide
(Madopar
®
) or
levodopa/carbidopa (Sinemet
®
, Sindopa
®
) to manage your Parkinson’s disease symptoms. COMT is
an enzyme that occurs naturally in your body and breaks down levodopa
(the medicine used to treat
Parkinson’s disease). TASMAR blocks COMT and slows the breakdown of
levodopa. This means
that when it is taken together with levadopa (as levodopa/benserazide
or levodopa/carbidopa) the
medicine you take is more effective.
You should have an improvement in your Parkinson’s disease symptoms
and you may need to take
less levodopa/benserazide (Madopar
®
) or levodopa/carbidopa (Sinemet
®
, Sindopa
®
) when taking
TASMAR. Your doctor will stop TASMAR treatment if after 3 weeks you do
not improve enough to
justify the risks of continuing treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TASMAR HAS BEEN
PRESCRIBED FOR YOU.
Your doctor however, may have prescribed TASMAR for another purpose.
BEFORE YOU TAKE TASMAR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TASMAR IF YOU HAVE OR HAVE EVER HAD:
1.
An allergic reaction to TASMAR or any ingredients listed at the end of
this leaflet
2.
Galactose intolerance
Tasmar contains lactose
3.
Live

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
TASMAR®
TASMAR
Page 1 of 14
1 PRODUCT NAME
TASMAR 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg tolcapone.
Excipients with known effect
Lactose monohydrate
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
TASMAR 100 mg is a pale to light yellow, hexagonal, biconvex
film-coated tablet with "TASMAR 100"
engraved on one side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
TASMAR is indicated for use in combination with levodopa/benserazide
and levodopa/carbidopa in
Parkinson's disease, including both fluctuating and non-fluctuating
patients.
4.2
Dose and method of administration
Children
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 impaired renal function
No dose adjustment of TASMAR is recommended for patients with mild to
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 information on the tolerability of tolcapone in these
populations is available (see section
5.2).
Patients with hepatic impairment
TASMAR is contraindicated for patients with liver disease or increased
liver enzymes (see section
4.3).
Method of administration
The administration of TASMAR is restricted to prescription and
supervision by physicians
experienced in the management of advanced Parkinson's disease.
NEW ZEALAND DATA SHEET
TASMAR®
TASMAR
Page 2 of 14
TASMAR is administered orally three times daily. The first dose of the
day of TASMAR should
be taken together with the first dose of the day of a levodopa
preparation, and the
subsequent doses should be given approximately 6 and 12 hours later.
TASMAR may be taken with or without food (see section 5.2).