Zyrtec-D Tablet

Country: Malaysia

Language: English

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

Active ingredient:

CETIRIZINE DIHYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

CETIRIZINE DIHYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Units in package:

400 Tablets; 00400Tablet Tablets; 000010Tablet Tablets; 10 Tablets

Manufactured by:

UCB FARCHIM S.A.

Patient Information leaflet

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
ZYRTEC-D TABLET
Cetirizine dihydrochloride/psedoephedrine hydrochloride (5 mg/120 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZYRTEC-D is used for
2.
How ZYRTEC-D works
3.
Before you use ZYRTEC-D
4.
How to use
ZYRTEC-D
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of ZYRTEC-D
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZYRTEC-D IS USED FOR
Zyrtec-D is indicated for the treatment
of symptoms such as blocked nose,
sneezing, runny nose, itchy nose or itchy
eyes, which occur in seasonal allergic
rhinitis (hay fever) or perennial allergic
rhinitis (house-dust allergy).
Zyrtec-D is indicated for adults and
children above 12 years.
HOW ZYRTEC-D WORKS
Zyrtec-D tablets contain two active
substances: cetirizine dihydrochloride
which is an antihistamine and
pseudoephedrine hydrochloride which is
a decongestant.
Zyrtec-D is a medicine that is used to
relieve allergic symptoms, especially
when the anti-allergy properties of
cetirizine are combined with the effects
of pseudoephedrine in reducing swelling
of the mucous membranes inside the
nose.
BEFORE YOU USE ZYRTEC-D
-
_When you must not use it _
Do not take Zyrtec-D:
•
if you are allergic to cetirizine,
ephedrine or any of the other
ingredients of this medicine or to any
piperazine derivative (closely related
active substances of other medicines).
•
if you have high blood pressure or
coronary heart disease.
•
if you suffer from impaired kidney
function, impaired thyroid function or
a tumour called a
phaeochromocytoma, if you have
serious disturbances of heart rhythm,
increased intraocular pressure (inside
the eye) or urination problems.
•
if you are taking medication for high
blood pressure such as beta-blockers,
sympathomimetics (medicines that
reduce swelling), dihydroergotamine
(for problems with the circulation) or
amphetamines (stimulants).
•
if you are receiving treatment with
MAO inhibitors (antidepressants) or
have taken these

Summary of Product characteristics

Page 1 of 15
CONFIDENTIAL
[GSK logo]
ZYRTEC-D
CETIRIZINE DIHYDROCHLORIDE/PSEUDOEPHEDRINE HYDROCHLORIDE, 5MG/120 MG,
PROLONGED-RELEASE TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg cetirizine dihydrochloride in an immediate
release form and
120 mg pseudoephedrine hydrochloride in a prolonged-release form.
EXCIPIENTS
Hypromellose, Microcrystalline cellulose, Colloidal anhydrous silica,
Magnesium
stearate, Lactose monohydrate, Croscarmellose sodium, Titanium dioxide
(E171),
Macrogol 400
PHARMACEUTICAL FORM
Prolonged release tablet is white to off-white, round, biconvex
film-coated tablet having a
circular logo on one side.
CLINICAL INFORMATION
INDICATIONS
Cetirizine/pseudoephedrine is indicated for symptomatic treatment of
acute rhinitis with
nasal congestion and hypersecretion, nose and/or eye itching and
watery eyes.
It should be administered when both the anti-allergenic properties of
cetirizine
dihydrochloride and the nasal decongestant activity of pseudoephedrine
hydrochloride
are desired.
Page 2 of 15
CONFIDENTIAL
DOSAGE AND ADMINISTRATION
The tablet should be swallowed whole with some liquid, and must not be
broken, chewed
or crushed. It may be taken with or without food.
After consultation with the doctor, duration of treatment should not
exceed the period of
acute symptoms and should not exceed 2 - 3 weeks. After improvement of
nasal
symptoms, treatment should be continued only with cetirizine, where
appropriate.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN AGED 12 YEARS AND OLDER
One tablet twice daily (morning and evening).
CHILDREN UNDER 12 YEARS OF AGE
Cetirizine/pseudoephedrine is contraindicated in children under 12
years of age (
_see _
_Sections: Contraindications; Warnings and Precautions_
).
ELDERLY
No data.
RENAL IMPAIRMENT
The dose should be reduced to one tablet daily in patients with
moderate renal
insufficiency. Cetirizine/pseudoephedrine is contraindicated in severe
renal insufficiency
(
_see Section Contraindications_
)
_. _
HEPATIC IMPAIRMENT
The do