Cetyrol 10mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

100 Tablets; 7 Tablets; 20 Tablets; 50 Tablets; 20 Tablets; 50 Tablets; 100 Tablets; 7 Tablets

Dikeluarkan oleh:

Salutas pharma GmbH

Risalah maklumat

CETYROL FILM COATED
TABLETS
Cetirizine dihydrochloride (10mg)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is CETYROL used for
2.
How CETYROL works
3.
Before you use CETYROL
4.
How to use CETYROL
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
CETYROL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
10. Date of Revision
WHAT IS CETYROL USED FOR
In adults and children aged 6 years
and above, Cetyrol is used for the
relief of symptoms associated with
seasonal and perennial (symptoms
that are present throughout the year)
allergies including sneezing; itchy
nose and throat; stuffy and runny
nose; and tearing, red, or itchy eyes.
It is also used for the relief of
symptoms associated with allergic
skin conditions e.g., chronic
idiopathic urticaria (hives with no
known cause that last for an extended
period of time) such as itchy skin and
hives.
HOW CETYROL WORKS
Cetirizine dihydrochloride is the
active ingredient of Cetyrol, an anti-
allergic medication. Cetirizine works
by blocking the actions of one of the
body's natural chemicals known as
histamine
_._
Histamine is responsible
for many of the symptoms caused by
allergies.
BEFORE YOU USE CETYROL
-
_When you must not use it _
•
if you are known to be
hypersensitive to the active
substance of Cetirizine
dihydrochloride, to any of its
excipients (other constituents),
to hydroxyzine or to piperazine
derivatives (closely related
active substances of other
medicines).
•
if you have a severe kidney
disease (severe renal failure with
creatinine clearance below 10
ml/min);
•
if you have hereditary problems
of galactose intolerance, the
Lapp lactase deficiency or
glucose-galactose malabsorption
_PREGNANCY AND BREAST-FEEDING _
Ask your doctor for advice before
taking any medicine.
As with other medicines, use of
Cetyrol should be avoided in
pregnant women. Accidental use of
the drug by a pregnant woman
should not produce any harmful
effects on the foetus. Nevertheless,
the administrati

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
CETYROL 10 MG FILM COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Appearance: white, oblong with notch on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults and children of 6 years and above: symptomatic treatment of
seasonal rhinitis, perennial
allergic rhinitis and urticaria of allergic origin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
In children 6 years old or above: 10 mg daily, either 5 mg twice daily
or 10 mg once daily.
In adults, the recommended dose is 10 mg once daily.
Elderly patients
Data do not suggest that the dose needs to be reduced in elderly
subjects provided that the renal
function is normal.
Patients with moderate to severe renal impairment
Dosing adjustments for adult patients with impaired renal function
GROUP
CREATININE CLEARANCE (ML/MIN)
DOSAGE AND FREQUENCY
Normal
≥80
10 mg once daily
Mild
50 – 79
10 mg once daily
Moderate
30 – 49
5 mg once daily
Severe
<30
5 mg once every 2 days
End-stage renal disease –
Patients undergoing dialysis
<10
Contra-indicated
In paediatric patients suffering from renal impairment, the dose will
have to be adjusted on an
individual basis taking into account the renal clearance of the
patient, his age and his body weight.
Patients with hepatic impairment
No dose adjustment is needed in patients with solely hepatic
impairment.
Patients with hepatic impairment and renal impairment
Dose adjustment is recommended (see patients with moderate to severe
renal impairment above).
METHOD OF ADMINISTRATION
The tablets need to be swallowed with a glass of liquid.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance, to any of the excipients, to
hydroxyzine or to any
piperazine derivatives.
•
Patients with severe renal impairment at less than 10 ml/min
creatinine clearance.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
At