Presmedic Cetirizine 10mg Tablet

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

CETIRIZINE HYDROCHLORIDE

Fáanlegur frá:

Hovid Pharmacy Sdn. Bhd.

INN (Alþjóðlegt nafn):

CETIRIZINE HYDROCHLORIDE

Einingar í pakka:

10 x 10 Tablets

Framleitt af:

HOVID BERHAD

Upplýsingar fylgiseðill

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PRESMEDIC CETIRIZINE 10MG TABLET
Cetirizine Hydrochloride (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Presmedic Cetirizine 10mg is
used for
2.
How Presmedic Cetirizine 10mg
works
3.
Before you use Presmedic
Cetirizine 10mg
4.
How to use Presmedic Cetirizine
10mg
5.
While you are using Presmedic
Cetirizine 10mg
6.
Side effects
7.
Storage and Disposal of Presmedic
Cetirizine 10mg
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT PRESMEDIC CETIRIZINE 10MG IS
USED FOR
Presmedic Cetirizine 10mg is used for
adults and children of 2 years and
above to treat seasonal allergic rhinitis
(pollen allergic), perennial allergic
rhinitis (hay fever) and urticaria (hives)
of allergic origin.
HOW PRESMEDIC CETIRIZINE 10MG
WORKS
Presmedic Cetirizine 10mg contains
Cetirizine Hydrochloride which is an
antihistamine agent. Antihistamine can
help to relieve the symptoms of some
allergies and itchy skin rashes.
BEFORE YOU USE PRESMEDIC CETIRIZINE
10MG
_- When you must not use it _
Do not take this medicine if:
•
You have ever had an allergic
reaction to antihistamines or to any
of the other ingredients (listed in
later part of this leaflet).
•
You have severe kidney problems.
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 if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription, as they
may interact with Presmedic Cetirizine
10mg.
_ _
_- Taking other medicines_
Consumption of alcohol at the same
time may reduce the alertness and
impairment of performance.
Other interactions not stated may occur.
Talk to your doctor or pharmacist if
you have any other concerns.
HOW TO USE PRESMEDIC CETIRIZINE
10MG
_- How much to use_
Swallow Presmedic Cetirizine 10mg
with water at the recommended dose as
follows:
•
_Adult: _
10 mg (1 tablet) once daily.
A 5 mg starting dose (hal

Vara einkenni

MEDDRA SOC
ADVERSE REACTION
FREQUENCY
Blood and
lympha�c
disorders
Thrombocytopenia
Very rare
Metabolism and
nutri�on
disorders
Increased appe�te
Not known
Agita�on
Uncommon
Aggression, confusion,
depression, hallucina�ons,
insomnia
Rare
Tic
Very rare
Suicidal idea�on, nightmare
Not known
Psychiatric
disorders
Nervous system
disorders
Paraesthesia
Uncommon
Convulsions, movement
disorders
Rare
Dysgeusia, syncope, tremor,
dystonia, dyskinesia
Very rare
Amnesia, memory
impairment
Unknown
Eye disorders
Accommoda�on
disorder,
blurred vision, oculogyra�on
Very rare
Skin and
subcutaneous
�ssue disorders
Pruritus, rash
Uncommon
Ur�caria
Rare
Angioneuro�c
oedema,
fixed drug erup�on
Very rare
Acute generalized
exanthematous pustulosis
(AGEP)
Unknown
Ear and labyrinth
disorders
Ver�go
Not known
Cardiac disorders
Tachycardia
Rare
Gastro-intes�nal
disorders
Diarrhoea
Uncommon
Hepatobiliary
disorders
Hepa�c func�on abnormal
(increased transaminases,
alkaline phosphates, γ -GT
and bilirubin)
Rare
Hepa��s
Unknown
VICETxx-0
694
DESCRIPTION
Oblong, white to off-white film-coated tablet, bevel-edged, shallow
convex and scored on one face.
COMPOSITION
Each tablet contains Cetirizine HC
_l_
10 mg.
PHARMACODYNAMICS
Cetirizine, a human metabolite of hydroxyzine, is a potent and
selective
antagonist of peripheral H1-receptors. In vitro receptor binding
studies
have
shown
no
measurable
affinity
for
receptors
other
than
H1-receptors. In addition to its anti-H1 effect, cetirizine was shown
to
display anti-allergic activities at a dose of 10 mg once or twice
daily, it
inhibits the late phase recruitment of eosinophils, in the skin and
conjunctiva of atopic subjects submitted to allergen challenge.
At
the
recommended
dosage,
cetirizine
has
demonstrated
that
it
improves the quality of life of patients with perennial and seasonal
allergic rhinitis.
PHARMACOKINETICS
Peak blood levels in the order of 0.3μg/ml are reached within about
one
hour after the oral administration of cetirizine.
The terminal half-li