DOPICAR

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

CARBIDOPA; LEVODOPA

Հասանելի է:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC կոդը:

N04BA01

Դեղագործական ձեւ:

TABLETS

Կազմը:

LEVODOPA 250 MG; CARBIDOPA 25 MG

Կառավարման երթուղին:

PER OS

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Թերապեւտիկ խումբ:

LEVODOPA

Թերապեւտիկ տարածք:

LEVODOPA

Թերապեւտիկ ցուցումներ:

For the relief of symptoms associated with parkinson's disease.

Հաստատման ամսաթիվը:

2014-10-31

Տեղեկատվական թերթիկ

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
DOPICAR
® TABLETS
COMPOSITION
Each tablet contains:
Carbidopa 25 mg
Levodopa 250 mg
For the list of inactive ingredients in the preparation,
see section 6 – “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THIS MEDICINE. THIS LEAFLET CONTAINS
CONCISE INFORMATION ABOUT THE MEDICINE. IF YOU
HAVE FURTHER QUESTIONS, REFER TO THE DOCTOR OR
PHARMACIST.
THIS MEDICINE HAS BEEN PRESCRIBED FOR THE
TREATMENT OF YOUR AILMENT. DO NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM EVEN IF IT SEEMS TO YOU
THAT THEIR AILMENT IS SIMILAR.
This medicine is not intended for children under
18 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of Parkinson’s disease.
THERAPEUTIC GROUP
Levodopa: Dopamine derivative.
Carbidopa: Inhibitor of the enzyme dopa-
decarboxylase.
2.
BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active
ingredients (carbidopa or levodopa) or to any of
the other ingredients of the medicine (see section
6 – “Further information”).
You are pregnant or breastfeeding.
You are suffering, or have suffered in the past,
from an undiagnosed skin lesion or from skin
cancer.
You are concomitantly using preparations from
the monoamine oxidase inhibitor (MAOI) group
to treat depression; stop using these medicines
at least two weeks before starting use of Dopicar
(also see “If you are taking other medicines”
section).
You have narrow-angle glaucoma.
You have a severe mental disorder.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE
∙ During long-term treatment period with this
medicine, blood tests, heart, liver and kidney
function tests should be performed.
∙ If you are sensitive to any food or medicine,
inform the doctor before taking this medicine.
∙ Avoid sudden transitioning from a lying or sitting
to standing position (also see in the side effects
section).
∙

Ապրանքի հատկությունները

DOPICAR Tablets 16. 4. 2015, RH
."רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
לירפא רשואמ ןולע
2015
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: April 2015.
PHYSICIANS’ PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Dopicar Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Levodopa 250 mg
Carbidopa 25 mg
3. PHARMACEUTICAL FORM
Tablets.
Blue slightly spotted white, round flat tablet with bevelled edges,
engraved ‘TEVA’ on one side
and quadrisected on the other.
For the full list of excipients see 6.1.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with Parkinson’s disease
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken orally.
The optimum daily dosage of Dopicar' must be determined by careful
titration in each patient.
Dopicar Tablets are available in a ratio of 1:10 of carbidopa to
levodopa to provide facility for
fine dosage titration for each patient.
Most patients can be maintained on 3-6 tablets of Dopicar a day, given
in divided doses.
The maximum dosage should not exceed 8 tablets of Dopicar a day, since
experience with total
daily dosages of carbidopa greater than 200 mg is limited. If further
titration of dosage is desired,
levodopa should be added to the treatment regimen.
GENERAL CONSIDERATIONS
Studies show that the peripheral dopa-decarboxylase is fully inhibited
(saturated) by carbidopa at
doses between 70 and 100 mg a day. Patients receiving less than this
amount of carbidopa are
more likely to experience nausea and vomiting. Patients who require
only low doses of levodopa
(e.g.
less
than
700
mg
when
given
as
Dopicar),
will
receive
doses
of
carbidopa
which
theoretically do not saturate peripheral dopa decarboxylase.
Standard antiparkinsonian drugs, other than levodopa alone, may be
continued while Dopicar is
being administered, although their dosa