ATARAX SYRUP 10 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROXYZINE HCl

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N05BB01

Dosage:

10 mg/5 ml

Pharmaceutical form:

SYRUP

Composition:

HYDROXYZINE HCl 10 mg/5 ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

NEXTPHARMA SAS

Authorization status:

ACTIVE

Authorization date:

1988-04-30

Patient Information leaflet

CONFIDENTIAL 

ATARAX™ 
HYDROXYZINE HYDROCHLORIDE 
ATARAX
™
 10 MG FILM-COATED TABLET 
ATARAX
™
 25 MG FILM-COATED TABLET 
ATARAX™ 2 MG/ML SYRUP

QUALITATIVE AND QUANTITATIVE COMPOSITION 

_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
Each film-coated
tablet contains 10 mg of hydroxyzine hydrochloride. 

_Hydroxyzine hydrochloride, 25 mg, film-coated tablet _
Each film-coated tablet contains 25
mg of hydroxyzine hydrochloride. 

_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Each ml of syrup contains 2 mg of hydroxyzine hydrochloride. 

EXCIPIENTS 

_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
Lactose, Starch, Calcium stearate, Talc, PVP, Eudragit, PEG,
Titanium dioxide 
_ _
_Hydroxyzine hydrochloride, 25 mg, film-coated tablet  _
Lactose monohydrate,
Microcrystalline cellulose, Magnesium stearate,
Colloidal anhydrous 
silica, Titanium dioxide (E171), H.P.M.C. 2910 5cP, Macrogol 400,
Opadry Y-1-7000 
_ _
_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Ethyl alcohol, Sucrose, Sodium benzoate, Menthol,
Hazelnut flavour, Water 

PHARMACEUTICAL FORM 
_ _
_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
White, round, film-coated tablet. 
_ _
_Hydroxyzine hydrochloride, 25 mg, film-coated tablet _
White, oblong, film-coated tablet, with a bisect line. 
_ _
_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Clear, colourless solution. 

CLINICAL PHARMACOLOGY 

PHARMACODYNAMICS 

PHARMACOTHERAPEUTIC GROUP 
Anxiolytics; Diphenylmethane derivatives 
[http://www.whocc.no/atc_ddd_index/?code=N05BB]

ATC CODE 
N05BB01 
CONFIDENTIAL 

MECHANISM OF ACTION 
Hydroxyzine is a first generation antihistamine that
crosses the blood/brain barrier extensively 
and has a high affinity for histaminic receptors into
the brain, thereby producing sedative-
anxiolytic effects. 

PHARMACODYNAMIC EFFECTS 

Antihistaminic and bronchodilator act

Summary of Product characteristics

CONFIDENTIAL
ATARAX
HYDROXYZINE HYDROCHLORIDE
ATARAX 10 MG FILM-COATED TABLET
ATARAX 25 MG FILM-COATED TABLET
ATARAX 2 MG/ML SYRUP
[GSK LOGO]
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
Each film-coated tablet contains 10 mg of hydroxyzine hydrochloride.
_Hydroxyzine hydrochloride, 25 mg, film-coated tablet _
Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride.
_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Each ml of syrup contains 2 mg of hydroxyzine hydrochloride.
EXCIPIENTS
_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
Lactose, Starch, Calcium stearate, Talc, PVP, Eudragit, PEG, Titanium
dioxide
_ _
_Hydroxyzine hydrochloride, 25 mg, film-coated tablet _
Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate,
Colloidal anhydrous
silica, Titanium dioxide (E171), H.P.M.C. 2910 5cP, Macrogol 400,
Opadry Y-1-7000
_ _
_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Ethyl alcohol, Sucrose, Sodium benzoate, Menthol, Hazelnut flavour,
Water
PHARMACEUTICAL FORM
_ _
_Hydroxyzine hydrochloride, 10 mg, film-coated tablet _
White, round, film-coated tablet.
_ _
_Hydroxyzine hydrochloride, 25 mg, film-coated tablet _
White, oblong, film-coated tablet, with a bisect line.
_ _
_Hydroxyzine hydrochloride, 10 mg/5 ml, syrup _
Clear, colourless solution.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
PHARMACOTHERAPEUTIC GROUP
Anxiolytics; Diphenylmethane derivatives
ATC CODE
N05BB01
CONFIDENTIAL
MECHANISM OF ACTION
Hydroxyzine is a first generation antihistamine that crosses the
blood/brain barrier extensively
and has a high affinity for histaminic receptors into the brain,
thereby producing sedative-
anxiolytic effects.
PHARMACODYNAMIC EFFECTS
Antihistaminic and bronchodilator activities have been demonstrated
experimentally and
confirmed clinically. Pharmacological and clinical studies indicate
that hydroxyzine at
therapeutic dosage does not increase gastric secretion or acidity and
in most cases has mild
antisecretory activity.
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