Source: Υπουργείο Υγείας (CY) Revision Year: 2023 Publisher: UCB Pharma S.A., 60 ALLÉE DE LA RECHERCHE, BRUSSELS, 1070
ATARAX (Hydroxyzine dihydrochloride) 25 mg film-coated tablet.
ATARAX (Hydroxyzine dihydrochloride) 2 mg/ml syrup.
| Pharmaceutical Form |
|---|
|
Film-coated tablet: White, oblong, film-coated tablet with bisect line. The tablet can be divided into equal doses. Syrup: Clear, colourless solution. |
Each film-coated tablet contains 25 mg of hydroxyzine dihydrochloride (Rec. INN).
Each ml of syrup contains 2 mg of hydroxyzine dihydrochloride (Rec. INN).
Excipients with known effect:
Atarax 25 mg film-coated tablets:
Each 25 mg film-coated tablet contains 54.80 mg lactose monohydrate.
Atarax syrup:
Each ml of syrup contains 0.95 mg ethanol.
Each ml of syrup contains 750 mg sucrose.
Each ml of syrup contains 0.30 mg of sodium benzoate (0,048 mg sodium).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Hydroxyzine is a psycholeptic and anxiolytic agent (ataractic). Hydroxyzine dihydrochloride is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. |
| List of Excipients |
|---|
|
Film-coated tablet at 25 mg (by direct compression): Core: Lactose monohydrate Coat: Titanium dioxide (E171) Syrup: Ethanol |
Atarax 25 mg Film-coated tablets: The film-coated tablets are packed in thermoformed PVC/aluminium "blister" strips. Pack size of 25 tabs.
Atarax 2 mg/ml syrup: The syrup is filled in an amber glass bottle (type III – Ph. Eur.) closed by a polypropylene child-proof screw cap equipped with a polyethylene inner joint. A syringe is included for oral administration (Polyethylene/Polystyrene). Pack size of 200 mL.
Not all pack sizes may be marketed.
UCB Pharma S.A., 60 ALLÉE DE LA RECHERCHE, BRUSSELS, 1070
ATARAX 2 mg/ml syrup: 315
ATARAX 25 mg film-coated tablet: 313
Date of first authorization:
ATARAX 2 mg/ml syrup: 02 March 1971
ATARAX 25 mg film-coated tablet: 02 March 1971
Date of renewal of the authorization:
ATARAX 2 mg/ml syrup: 14 May 2010
ATARAX 25 mg film-coated tablet: 21 September 2010
| Drug | Countries | |
|---|---|---|
| ATARAX | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Japan, Malta, Mexico, Poland, Singapore, Tunisia, Turkey |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.