CARZEPIN TABLET 200MG

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

CARBAMAZEPINE

Commercializzato da:

HOVID BERHAD

INN (Nome Internazionale):

CARBAMAZEPINE

Confezione:

500 Tablets; 1000 Tablets; 100 Tablets; 100 Tablets

Prodotto da:

HOVID BERHAD

Foglio illustrativo

_Consumer Medication Information Leaflet (RiMUP) _
CARZEPIN TABLET
Carbamazepine (200 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Carzepin is used for
2.
How Carzepin works
3.
Before you use Carzepin
4.
How to use Carzepin
5.
While you are using Carzepin
6.
Side effects
7.
Storage and disposal of Carzepin
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CARZEPIN IS USED FOR
Treatment of:
•
partial
seizure
with
complex
symptomatology (starts in one part
of the brain and affects other parts
of the brain that involve alertness
and awareness)
•
generalized
tonic-clonic
seizures
(epilepsy)
•
painful condition of the face called
trigeminal neuralgia
•
painful condition of the ear, throat,
tonsils
and
tongue
called
glossopharyngeal neuralgia
HOW CARZEPIN WORKS
The
active
ingredient
in
Carzepin
Tablet,
carbamazepine,
is
an
anticonvulsant agent, which can affect
the body in several different ways. The
exact mechanism how it works is still
unknown but it is believed to stabilize
and limit the spread of the brain nerve
activities.
BEFORE YOU USE CARZEPIN
_- When you must not use it _
Do not take this medicine:
•
if you are allergic (hypersensitive)
to carbamazepine or similar drugs
or
any
of
the
other
ingredients
listed
at
the
end
of
the
leaflet.
Some
of
the
symptoms
of
an
allergic
reaction
may
include
shortness
of breath, wheezing
or
difficulty breathing, swelling of the
face, lips, tongue or other parts of
the body, rash, itching or hives on
the skin
•
if
you
have
any
heart
problem
called atrioventricular (AV) heart
block
•
if you have history of bone marrow
depression
•
if you have blood disorders such as
porphyria
•
if you are breastfeeding
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
_ _
Tell your doctor/pharmacist if:
•
you
have
allergies
to
tricyclic
antidepressants
•
you ever had allergic reactions to
other medicine
•
you have heart problem
•
you have liver prob

Scheda tecnica

CARZEPIN TABLET 200MG
VICAR13-var (MY)
DESCRIPTION
Round,
10.0
mm
in
diameter,
white
uncoated
tablet,
bevel-edged, flat faces, "HOVID" embossed on one face and
scored on the other.
COMPOSITION
Carbamazepine 200 mg/tablet
PHARMACODYNAMICS
In animal studies, carbamazepine raises the threshold for
electrically
and
chemically
induced
convulsions.
After-discharge
activity
is
reduced,
especially
in
the
amygdaloid nucleus and hippocampus, and the cortico-
thalamic threshold is raised. The motor cortex is relatively
unaffected. Decreased post-tetanic potentiation has been
demonstrated in the rabbit spinal cord, and has decreased
synaptic transmission in the spinal trigeminal nuclei in cats.
Decreased appreciation of induced pain has been shown in
guinea pigs and rabbits. Carbamazepine will convert ECG
patterns
to
normal
in
digoxin-induced
tachycardia
by
prolongation of A-V Conduction and reduction of Purkinje cell
automaticity. In human studies, suppression of spike foci has
not been demonstrated. Anticonvulsant and anti-neuralgic
effects are believed to result primarily from depression of
synaptic transmission.
PHARMACOKINETICS
ABSORPTION
Carbamazepine
is
almost
entirely
absorped
from
the
gastro-intestinal
tract,
the
major
proportion
of
the
administered
dose
being
recoverable
in
the
urine. The
absorption from carbamazepine tablets is slow but virtually
complete.
BLOOD CONCENTRATION
After an oral dose of 6mg/kg, peak serum concentrations are
about 4ug/ml at 7 hours and 6.5ug/ml at 3 hours. During
therapy with about 12.5mg/kg daily for 6 months, mean
plasma concentrations for carbamazepine and its 10, 11
-epoxide metabolite are about 5 and 1ug/ml respectively.
Therapeutic concentrations are in the range 3 to 6ug/ml.
Side-effects are suffered by 50% of subjects with blood
concentrations in the range of 8.5 to 10ug/ml.
HALF-LIFE
Plasma half-life is 21 to 53 hours. In infants the half-life is
reduced to 8 to 27 hours. After chronic treatment the plasma
half-life is significantly reduced.
DISTRIBUTION
Carbamazepine enters the