ZYRTEC-D

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CETIRIZINE DIHYDROCHLORIDE (CORE'S SECOND LAYER); PSEUDOEPHEDRINE HYDROCHLORIDE (CORE'S FIRST LAYER)

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R01BA52

Dosage:

5 MG

Pharmaceutical form:

TABLET, FILM COATED

Composition:

CETIRIZINE DIHYDROCHLORIDE (CORE'S SECOND LAYER) 5 MG; PSEUDOEPHEDRINE HYDROCHLORIDE (CORE'S FIRST LAYER) 120 MG

Administration route:

ORAL

Prescription type:

Pharmacy Only

Manufactured by:

UCB FARCHIM SA

Authorization status:

ACTIVE

Authorization date:

2005-07-04

Patient Information leaflet

1
ZYRTEC-D
NAME OF THE MEDICINAL PRODUCT
Zyrtec-D
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
Zyrtec-D is indicated for the treatment of symptoms associated with
seasonal and perennial allergic
rhinitis with nasal congestion, and hypersecretion, nose and/or eye
itching and watery eyes.
It should be administered when both the anti-allergic properties of
cetirizine dihydrochloride and the
nasal decongestant activity of pseudoephedrine hydrochloride are
desired.
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 to 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
Zyrtec-D
is contraindicated in children under 12 years of age (see Sections
_Contraindications; _
_Warnings and Precautions_
).
ELDERLY
2
Zyrtec-D
should be used with caution in patients over 50 years of age. The dose
should be reduced to
one tablet daily for patients ≥ 77 years old.
RENAL IMPAIRMENT
The dose should be reduced to one tablet daily in patients with mild
to moderate renal insufficiency.
Zyrtec-D
is contraindicated in severe renal insufficiency (see
_ _
Section
_ Contraindications_
).
_ _

Summary of Product characteristics

1
ZYRTEC-D
NAME OF THE MEDICINAL PRODUCT
Zyrtec-D
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
Zyrtec-D is indicated for the treatment of symptoms associated with
seasonal and perennial allergic
rhinitis with nasal congestion, and hypersecretion, nose and/or eye
itching and watery eyes.
It should be administered when both the anti-allergic properties of
cetirizine dihydrochloride and the
nasal decongestant activity of pseudoephedrine hydrochloride are
desired.
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 to 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
Zyrtec-D
is contraindicated in children under 12 years of age (see Sections
_Contraindications; _
_Warnings and Precautions_
).
ELDERLY
2
Zyrtec-D
should be used with caution in patients over 50 years of age. The dose
should be reduced to
one tablet daily for patients ≥ 77 years old.
RENAL IMPAIRMENT
The dose should be reduced to one tablet daily in patients with mild
to moderate renal insufficiency.
Zyrtec-D
is contraindicated in severe renal insufficiency (see
_ _
Section
_ Contraindications_
).
_ _