SUNIZINE SYRUP 5MG5ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

CETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

3.8 L; 3.6 L; 1 L; 120 ml; 100 ml; 60 ml; 120 ml; 60 ml; 100 ml

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

SUNIZINE SYRUP
®
Cetirizine hydrochloride (5mg/5ml)
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Sunizine Syrup is used for
2. How Sunizine Syrup works
3. Before you use Sunizine Syrup
4. How to use Sunizine Syrup
5. While you are using it
6. Side effects
7. Storage & disposal of Sunizine Syrup
8. Product description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SUNIZINE SYRUP IS USED FOR
Sunizine Syrup is used for the symptomatic
treatment of seasonal rhinitis (inflammation
of the mucous membrane inside the nose),
perennial
(throughout
the
year)
allergic
rhinitis and urticaria (a red, raised, itchy rash)
of allergic origin in adults and children of 3
years or above.
HOW SUNIZINE SYRUP WORKS
The
active
ingredient
this
medicine
is
cetirizine. It belongs to a group of medicines
called ‘antihistamines. It works by blocking a
certain
natural
substance
(histamine)
that
your body makes during an allergic reaction.
BEFORE YOU USE SUNIZINE SYRUP
_- When you must not use it _
Do not use Sunizine Syrup if you:

are hypersensitive to cetirizine or any other
ingredients in this product.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant, planning
to
become
pregnant
or
breastfeeding.
Cetirizine should not be used during the first
3 months of pregnancy. Cetirizine is contra-
indicated
during
breast-feeding
as
it
is
excreted in breast milk.
_ _
_- Before you start to use it _
Inform your doctor if you have any kidney
problem before taking Sunizine Syrup.
_- Taking other medicines _
There are no known interactions with other
drugs.
Nevertheless,
cetirizine
should
be
used with caution if sedatives are also being
taken.
HOW TO USE SUNIZINE SYRUP
_- How much to use_
You should take Sunizine Syrup exactly as
advised by your doctor or pharmacist.
The
amount you take each day
will
depend
on
your
condition.
Do not take more or less
than what your doctor prescribes.
Adults: 10ml (10mg) syrup once daily.
Children 6- 12 years of age: 10ml (10mg)
syrup onc

Ciri produk

Each 5ml cantains :
Cetirizine HCl
5mg
PHARMACOLOGY:
In experimental animals, cetirizine has been shown to be an anti-H1
agent devoid of
any significant anticholinergic or antiserotonin effects. At
pharmacological active doses,
it induces neither sedation nor behavioural changes. This may be
explained by the fact
that cetirizine does not cross the blood-brain barrier.
It was shown in human pharmacology studies that cetirizine will
inhibit certain effects
produced by exogenous histamine. This activity appears rapidly.
Cetirizine also inhibits
the effects produced by endogenous histamine released in vivo by an
agent eg 48/80.
Finally,
it
inhibits
the
cutaneous
reaction
induced
by
VIP
(Vasoactive
Intestinal
Polypeptide) and substance P, neuropeptides that are believed to take
part in the
allergic reaction.
Cetirizine markedly reduces bronchial hyper-reactivity to histamine in
the asthmatic
patient. It also reduces the allergic reaction induced by specific
allergens. These effects
are obtained without central effects being demonstrated either by
psychometric test or
by a quantified EEG.
PHARMACOKINETICS:
Peak blood levels of the order of 0.3 mg/ml are reached between 30 and
60 minutes
after administration of a 10 mg dose of cetirizine. Its plasma
half-life is approximately 11
hours. Absorption is very consistent from one subject to the next. Its
renal clearance is
30 ml/minute and the excretion half-life is approximately 9 hours.
Cetirizine is strongly
bound to plasma proteins.
INDICATIONS:
Adults and children of 3 years or above: Symptomatic treatment of
seasonal rhinitis,
perennial allergic rhinitis and urticaria of allergic origin.
SIDE EFFECTS / ADVERSE REACTIONS:
There have been occasional reports of mild and transient subjective
side effects such
as headache, dizziness, drowsiness, agitation, dry mouth and
gastrointestinal
discomfort. In objective tests of psychomotor function, the incidence
of sedation with
cetirizine was similar to that of placebo. Occasionally, symptoms of
hypersensitivity
have been reported