RESPIDON 1mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-03-2020
Ciri produk Ciri produk (SPC)
05-04-2020

Bahan aktif:

RISPERIDONE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

RISPERIDONE

Unit dalam pakej:

60 Tablet Tablets; 20Tablet Tablets; 100 Tablet Tablets; 60 Tablet Tablets; 10 Tablet Tablets; 20 Tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICAL LIMITED

Risalah maklumat

                                RESPIDON TABLET
_ _
Risperidone (1mg, 2mg, 3mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Respidon used for
2.
How Respidon works
3.
Before you use Respidon
4.
How to use Respidon
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Respidon
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT RESPIDON IS USED FOR
It is used to treat psychotic conditions
which affect the way you think, feel
and/or act. These are associated with
symptoms
such
as
confusion,
hallucinations (e.g. hearing, seeing or
sensing
things
which
are
not
there),
delusions,
unusual
suspiciousness
(paranoia),
emotional
and
social
withdrawal.
People
with
the
above
mentioned
conditions also feel depressed, guilty,
anxious or tense. For both sudden and
long-lasting disorders Risperidone may
be used.
Ask your doctor if you are still unsure
why
you
have
been
prescribed
this
medicine.
HOW RESPIDON WORKS
Risperidone
rebalances
of
certain
natural substances in the brain (such as
dopamine
and
serotonin)
to
improve
thinking, mood, and behaviour.
BEFORE YOU USE RESPIDON
-
_When you must not use it _
Do not take Respidon if you:
•
Are allergic to Risperidone or any
of the ingredients. These allergic
reactions
include
rash,
itching,
swollen face or lips, or shortness of
breath.
•
Have bone-marrow depression.
•
Have phaeochromocytoma (tumor
of the adrenal glands).
It is not to be used for individual in
coma that is caused by the medicine
Central Nervous System depressants.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Respidon
if
you
are
pregnant, trying to get pregnant or think
you
may
be
pregnant.
Only
take
Respidon
during
pregnancy
if
the
benefit justifies the potential risk to the
baby.
Do not take Respidon if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Before taking Risperidone tablets tell
your doctor or pharmacist if you:
•
Are having an eye surgery.
•

                                
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                                _METHOD OF ADMINISTRATION_
Oral use:
RESPIDON tablets should be swallowed with a drink of water, with or
without food. They should not be chewed or crushed.
CONTRAINDICATIONS:
Risperidone
is
contraindicated
in
patients
with
a
known
hypersensitivity
to
RESPIDON
or
any
other
ingredients
of
the
RESPIDON tablet. It is also contraindicated in patient with coma
caused by CNS depressents, bone-marrow depression and avoided
in phaeochromocytoma.
WARNING AND PRECAUTION:
HYPERGLYCEMIA AND DIABETES MELLITUS
Hyperglycaemia,
in
some
cases
extreme
and
associated
with
ketoacidosis or hyperosmolar coma or death, has been reported in
patients treated with atypical antipsychotics. Assessment of the
relationship
between
atypical
antipsychotic
use
and
glucose
abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia
and the increasing incidence of diabetes mellitus in the general
population.
Given
these
confounders,
the
relationship
between
atypical
antipsychotic
use
and
hyperglycaemia-related
adverse
events
is
not
completely
understood.
However,
epidemiological
studies
suggest
an
increased
risk
of
treatment-emergent
hyperglycaemia-related adverse events in patients treated with the
atypical
antipsychotics.
Precise
risk
estimates
for
hyperglycaemia-related
adverse
events
in
patients
treated
with
atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are
started on atypical antipsychotics should be monitored regularly for
worsening of glucose control. Patients with risk factors for diabetes
mellitus (e.g., obesity, family history of diabetes) who are starting
treatment with atypical antipsychotics should undergo fasting blood
glucose testing at the beginning of treatment and periodically during
treatment. Any patient treated with atypical antipsychotics should be
monitored for symptoms of hyperglycaemia including polydipsia,
polyuria;
polyphagia,
and
weakness.
Patients
who
develop
symptoms
of
hyperglycaemia
du
                                
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