Apo-Risperidone Tablets 2 mg

Երկիր: Մալայզիա

Լեզու: անգլերեն

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

Ակտիվ բաղադրիչ:

RISPERIDONE

Հասանելի է:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Միջազգային անվանումը):

RISPERIDONE

Միավորները փաթեթում:

60Tablet Tablets; 60 Tablet Tablets; 100 Tablet Tablets

Պատրաստված է:

APOTEX INC

Տեղեկատվական թերթիկ

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
APO-RISPERIDONE TABLETS
_ _
Risperidone (1mg, 2mg)
1
WHAT IS IN THIS LEAFLET
1. What Apo-Risperidone is used for
2. How Apo-Risperidone works
3. Before you use Apo-Risperidone
4. How to use Apo-Risperidone
5. While you are using it
6. Side effects
7. Storage and disposal of Apo-
Risperidone
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT APO-RISPERIDONE IS USED FOR
For
the
treatment
of
schizophrenia
symptoms and other types of related
mental illness.
HOW APO-RISPERIDONE WORKS
Apo-Risperidone helps to readjust the
chemical imbalance in the brain.
BEFORE YOU USE APO-RISPERIDONE
_- When you must not use it _
Do not take / give Apo-Risperidone if
an allergic reaction to the medicine or
any of the ingredients of the product
has occurred.
Symptoms of an allergic reaction may
include: itching, skin rash, swelling
of the face, lips or tongue, shortness
of breath.
If
you
experience
any
of
these
symptoms
/
if
these
symptoms
are
experienced
by
the
person
you
are
caring for, your doctor / the treating
physician
should
be
contacted
immediately.
_- Before you start to use it _
Before you use Apo-Risperidone, talk
to your_ _doctor or pharmacist if you /
the person you are caring for:

have/has
a
history
of
stroke,
mini-strokes,

are/is
smoking,
have/has
a
history of or are at risk of sleep
apnoea or high blood pressure;

have/has diabetes or at risk of
having
diabetes
(e.g
being
overweight or a family history of
diabetes).
Your
doctor
should
check
your
blood
sugar
before
you start taking Apo-Risperidone
and regularly during treatment;

are/is
pregnant
or
planning
to
become pregnant;

are/is breast-feeding;

have/has
ever
had
seizures;
have/has a history of kidney or
liver problems;

have/has a history of problems
with
your
heart
and/or
blood
vessels;

have/has Parkinson’s disease;

drink/drinks alcoholic beverages
or use/uses drugs;

suffer/suffers from dementia;
_Pregnancy and Breast-feeding _

Ապրանքի հատկությունները

APO-RISPERIDONE TABLETS 1 MG AND 2MG
NAME AND STRENGTH OF ACTIVE SUBSTANCE
1 mg: Each tablet contains 1.0 mg risperidone
2 mg: Each tablet contains 2.0 mg risperidone
PRODUCT DESCRIPTION
1 mg: White, capsule shaped, biconvex, film-coated
tablets.
Engraved
“APO”
on
one
side,
“RI”
European bisect “1” on the other side.
2 mg: Peach, capsule shaped, biconvex, film-coated
tablets.
Engraved
“APO”
on
one
side,
“RI”
European bisect “2” on the other side.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Risperidone is a novel antipsychotic belonging to a
new
class
of
antipsychotic
agents,
the
benzisoxazole-derivatives. Risperidone is a selective
monoaminergic antagonist with a high affinity for
both
serotonergic
5-HT
2
and
dopaminergic
D
2
receptors.
Risperidone
binds
also
to
alpha
1
-
adrenergic receptors and, with lower affinity, to H
1
-
histaminergic
and
alpha
2
-adrenergic
receptors.
Risperidone
has
no
affinity
for
cholinergic
receptors.
Although
risperidone
is
a
potent
D
2
antagonist,
that
is
considered
to
improve
the
positive symptoms of schizophrenia, it causes less
depression
of
motor
activity
and
induction
of
catalepsy
than
classical
neuroleptics.
Balanced
central
serotonin
and dopamine
antagonism
may
reduce the tendency to cause extrapyramidal side
effects, and extend the therapeutic activity to the
negative and affective symptoms of schizophrenia.
Pharmacokinetic properties
Risperidone
is
completely
absorbed
after
oral
administration, reaching peak plasma concentrations
within
1
to
2
hours.
Food
does
not
affect
the
absorption of risperidone from the stomach. The
effect of food particles in the mouth on absorption
has not been studied.
The
most
important
route
of
metabolism
of
risperidone is hydroxylation by cytochrome
CYP 2D6 to 9-hydroxy-risperidone which has a
similar pharmacological activity to risperidone. This
hydroxylation
is
subject
to
debrisoquine-type
genetic polymorphism but this does not affect the
active antipsychotic fraction since this consists of
risperidone
and
its