ZYRTEC 10MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

CETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

0.01 gm 50 Units Units

Dikeluarkan oleh:

UCB FARCHIM S.A.

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ZYRTEC FILM-COATED TABLET/ORAL
SOLUTION/ORAL DROPS
Cetirizine dihydrochloride (10mg, 1mg/ml, 10mg/ml)
1
WHAT IS IN THIS LEAFLET
1.
What ZYRTEC is used for
2.
How ZYRTEC works
3.
Before you use ZYRTEC
4.
How to use ZYRTEC
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of ZYRTEC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZYRTEC IS USED FOR
Zyrtec is used to treat adults and
children aged 2 and over who have hay
fever (seasonal allergic rhinitis), year
round allergies such as dust or pet
allergies (perennial allergic rhinitis)
and urticaria (swelling, redness and
itchiness of the skin).
HOW ZYRTEC WORKS
Cetirizine dihydrochloride, the active
ingredient of Zyrtec 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 Zyrtec 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 ZYRTEC
-
_When you must not use it _
Do not take Zyrtec if:
•
You are allergic (hypersensitive) to
cetirizine dihydrochloride
•
You are allergic (hypersensitive) to
any of the other ingredients of Zyrtec
•
You are breast-feeding
•
You have severe kidney failure
(Glomerular Filtration Rate below 15
ml/min).
•
You have problems of urinary
retention.
•
For Zyrtec oral solution: You have
fructose intolerance.
•
For Zyrtec tablets: You have
hereditary problems of galactose
intolerance, the Lapp lactase
deficiency or glucose- galactose
malabsorption
If any of the above applies to you talk
to your pharmacist.
-
_Before you start to use it _
Check with your pharmacist before
taking Zyrtec if:
•
You have problems with your
kidneys
•
You have predisposition factors of
urinary retention (eg: spinal cord
lesion, prostatic hyperplasia) as
cetirizine i

Ciri produk

[GSK logo]  
Zyrtec 
Cetirizine dihydrochloride 
NAME OF THE MEDICINAL PRODUCT
Cetirizine dihydrochloride, 10 mg, film-coated tablet
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetirizine dihydrochloride, 10 mg, film-coated tablet
Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Each 1 ml contains 1 mg of cetirizine dihydrochloride.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Each 1 ml contains 10 mg of cetirizine dihydrochloride.
Excipients
Cetirizine dihydrochloride, 10 mg, film-coated tablet
Microcrystalline cellulose, Lactose monohydrate, Colloidal anhydrous silica, Magnesium
stearate, Opadry Y-1-7000 which consists of, Hydroxypropylmethylcellulose (E464),
Titanium dioxide (E171), Macrogol 400.
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Sorbitol solution at 70 % (non crystallizing), Glycerol (85%), Propylene glycol, Sodium
saccharinate, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Banana flavour
54.330/A , Sodium Acetate, Glacial Acetic Acid, Purified water.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Glycerol (85%), Propylene glycol, Sodium saccharinate, Methyl parahydroxybenzoate, Propyl
parahydroxybenzoate, Sodium acetate, Glacial acetic acid, Purified water.
PHARMACEUTICAL FORM
Cetirizine dihydrochloride, 10 mg, film-coated tablet
White, oblong, film-coated tablet, with a bisect line and Y-Y logo.
Cetirizine dihydrochloride, 1 mg/ml, oral solution
Banana flavoured clear colourless liquid.
Cetirizine dihydrochloride, 10 mg/ml, oral drops, solution
Clear and colourless liquid.