ZIRIN Softgel Capsules 10mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

cetirizine dihydochloride

Boleh didapati daripada:

MEGA LIFESCIENCES SDN. BHD.

INN (Nama Antarabangsa):

cetirizine dihydochloride

Unit dalam pakej:

10 Capsules; 50 Capsules

Dikeluarkan oleh:

Mega Lifesciences Public Company Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
ZIRIN (CAPSULE)
Cetirizine dihydrochloride (10mg)
WHAT IS IN THIS LEAFLET
1.
What
ZIRIN
Capsules
are
and
what they are used for
2.
How ZIRIN Capsules works
3.
Before you use ZIRIN Capsules
4.
How to use ZIRIN Capsules
5.
While
you
are
using
ZIRIN
Capsules
6.
Side effects
7.
Storage
and
disposal
of
ZIRIN
Capsules
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
WHAT
ZIRIN
CAPSULE
ARE
AND
WHAT
THEY
ARE
USED
FOR
The
active
ingredient
in
ZIRIN
Capsule is cetirizine dihydrochloride,
which belongs to a group of medicines
called antihistamines. ZIRIN Capsule
are
used
for
symptomatic
relief
of
seasonal
allergic
rhinitis,
perennial
allergic rhinitis, and chronic idiopathic
urticaria in adults and children over 12
years of age.
HOW ZIRIN CAPSULE WORKS
Cetirizine dihydrochloride, the active
ingredient
of
ZIRIN
is
an
antihistamine. It blocks the effects of a
substance
called
histamine
which
occurs
naturally
in
the
body.
Histamine
is
involved
in
allergic
reactions.
Antihistamines like ZIRIN relieve the
unpleasant symptoms and discomfort
associated with these conditions, such
as
sneezing,
irritated,
runny
and
blocked
up
nose,
itchy,
red
and
watering eyes and skin rashes.
BEFORE
YOU
USE
ZIRIN
CAPSULE
_When you must not use it _
•
You
are
allergic
(hypersensitive)
to cetirizine dihydrochloride
•
You
are
allergic
(hypersensitive)
to any of the other ingredients of
ZIRIN
•
You are breast-feeding
•
You
have
severe
kidney
failure
(creatinine clearance less than 10
ml/min).
•
You
have
problems
of
urinary
retention.
If any of the above applies to you talk
to your pharmacist.
_Before you start to use it _
Check
with
your
pharmacist
before
taking ZIRIN if
•
You
have
problems
with
your
kidneys
•
You have predisposition factors of
urinary retention (eg: spinal cord
lesion,
prostatic
hyperplasia)
as
cetirizine
increases
the
risk
of
urinary retention.
•
You suffer from epilepsy or are at
risk of convulsions.
•
If you are pregnan

Ciri produk

_PAGE 2/2 _
Drug Interactions
:
Due to the pharmacokinetic, pharmacodynamics and tolerance profile of
cetirizine, no interactions are expected with this antihistamine.
Neither pharmacodynamic nor significant pharmacokinetic interaction
was reported in drug-drug interactions studies performed, notably
with pseudoephedrine or theophylline (400 mg/day),
_Alcohol and other CNS depressants _
In sensitive patients, the concurrent use of alcohol or other CNS
depressants may cause additional reductions in alertness and
impairment of
performance, although cetirizine does not potentiate the effect of
alcohol (0.5 g/L blood levels).
Pregnancy 8- Lactation
_PREGNANCY _
Caution should be exercised when prescribing to pregnant women. For
cetirizine prospectively collected data on pregnancy outcomes do not
suggest potential for maternal or foetal/embryonic toxicity above
background rates.
Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryonal/fetal development, parturition or
postnatal development.
_LACTATION _
Caution should be exercised when prescribing cetirizine to lactating
women. Cetirizine is excreted in human milk at concentrations
representing 25% to 90% of those measured in plasma, depending on
sampling time after administration.
SIDE EFFECTS :
_BLOOD AND LYMPHATIC DISORDERS: _
Thrombocytopenia
_IMMUNE SYSTEM DISORDERS: _
hypersensitivity, anaphylactic shock
_METABOLISM AND NUTRITION DISORDERS: _
increased appetite
_PSYCHIATRIC DISORDERS: _
agitation, aggression, confusion, depression, hallucination, insomnia
Tics, suicidal ideation, nightmare
_NERVOUS SYSTEM DISORDERS: _
paraesthesia, convulsions, dysgeusia, dyskinesia, dystonia, syncope,
tremor, amnesia, memory impairment
_EYE DISORDERS: _
accommodation disorder, blurred vision, oculogyration
_EAR AND LABYRINTH DISORDERS: _
vertigo
_CARDIAC DISORDERS: _
tachycardia
_GASTROINTESTINAL DISORDERS: _
diarrhoea
_HEPATOBILIARY DISORDERS: _
hepatic function abnormal (transaminases increased, blood bilirubin
increased, blood, a