AETOS CETIRIZINE TABLET 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CETIRIZINE HYDROCHLORIDE

Boleh didapati daripada:

ABIOTIDE SDN. BHD.

INN (Nama Antarabangsa):

CETIRIZINE HYDROCHLORIDE

Unit dalam pakej:

10 x 10 Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AETOS CETIRIZINE TABLET 10 MG
Cetirizine Hydrochloride (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Aetos Cetirizine 10mg is
used for
2.
How Aetos Cetirizine 10mg works
3.
Before you use Aetos Cetirizine
10mg
4.
How to use Aetos Cetirizine 10mg
5.
While you are using Aetos
Cetirizine 10mg
6.
Side effects
7.
Storage and Disposal of Aetos
Cetirizine 10mg
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT AETOS CETIRIZINE 10MG IS USED
FOR
Aetos 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 AETOS CETIRIZINE 10MG WORKS
Aetos 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 AETOS 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 Aetos 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 AETOS CETIRIZINE 10MG
_- How much to use_
Swallow Aetos Cetirizine 10mg with
water at the recommended dose as
follows:
•
_Adult: _
10 mg (1 tablet) once daily.
A 5 mg starting dose (half of the
tablet) may be proposed if this
leads to s

Ciri produk

AETOS CETIRIZINE TABLET 10 MG
VICETxx-0
MEDDRA SOC
ADVERSE REACTION
FREQUENCY
Blood and
lymphatic
disorders
Thrombocytopenia
Very rare
Metabolism and
nutrition
disorders
Increased appetite
Not known
Agitation
Uncommon
Aggression, confusion,
depression, hallucinations,
insomnia
Rare
Tic
Very rare
Suicidal ideation, 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
Accommodation
disorder,
blurred vision, oculogyration
Very rare
Skin and
subcutaneous
tissue disorders
Pruritus, rash
Uncommon
Urticaria
Rare
Angioneurotic
oedema,
fixed drug eruption
Very rare
Acute generalized
exanthematous pustulosis
(AGEP)
Unknown
Ear and labyrinth
disorders
Vertigo
Not known
Cardiac disorders
Tachycardia
Rare
Gastro-intestinal
disorders
Diarrhoea
Uncommon
Hepatobiliary
disorders
Hepatic function abnormal
(increased transaminases,
alkaline phosphates, γ -GT
and bilirubin)
Rare
Hepatitis
Unknown
DESCRIPTION
Oblong, white to off-white film-coated tablet, bevel-edged, shallow
convex
and scored on one face.
COMPOSITION
Each tablet contains Cetirizine Hydrochloride 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 t