Atarax syrup

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

HYDROXYZINE HYDROCHLORIDE

متاح من:

UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium

ATC رمز:

N05BB01

INN (الاسم الدولي):

HYDROXYZINE HYDROCHLORIDE 2 mg/ml

الشكل الصيدلاني:

SYRUP

تركيب:

HYDROXYZINE HYDROCHLORIDE 2 mg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

PSYCHOLEPTICS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2005-09-23

نشرة المعلومات

Atarax
®
Hydroxyzine dihydrochloride
NAME OF THE MEDICINAL PRODUCT
Atarax 25 mg film-coated tablets (Hydroxyzine dihydrochloride)
Atarax 2mg/ml syrup (Hydroxyzine dihydrochloride)
COMPOSITION
Film-coated tablet at 25 mg:
Hydroxyzine dihydrochloride 25 mg − Colloidal anhydrous silica −
microcrystalline
cellulose − Lactose − Magnesium Stearate − Opadry Y-1-7000
(Titanium Dioxyde −
Hydroxypropylmethylcellulose − Macrogol 400)
Syrup at 0.2 %:
Hydroxyzine dihydrochloride 2 mg− Ethanol − Sucrose − Sodium
Benzoate −
Levomenthol − Hazelnut flavour (DB02692) − water q.s. for 1 ml
PHARMACEUTICAL FORM
Box of 25 film-coated 25 mg tablets
Bottle of 200 ml 2mg/ml Syrup
PHARMACOTHERAPEUTIC GROUP
Anxiolytic - Antihistaminic
MARKETING AUTHORISATION HOLDER
UCB Pharma SA
Allée de la Recherche 60, B-1070 Brussels - Belgium
MANUFACTURER
Manufacturer Syrup:
NextPharma SAS,
Route de Meulan, 17, 78520 Limay · France
Manufacturer film-coated tablets:
UCB Pharma SA
Chemin du Foriest, B-1420 Braine-l’Alleud - Belgium
INDICATED IN
Due to its sedative, tranquillizing and antihistaminic properties,
Atarax is indicated:
- in the symptomatic treatment of anxiety,
- in the symptomatic treatment of pruritus of allergic origin.
CONTRAINDICATIONS
Hypersensitivity to one of the constituents of the drug, to
cetirizine, to other piperazine
derivatives, aminophylline or ethylenediamine.
Intermittent acute porphyria.
Pregnancy and lactation.
Patients with an abnormal ECG (electrocardiogram) showing a heart
rhythm problem
called “QT interval prolongation”.
Patients with a cardiovascular disease or patients with a very low
heart rate.
Patients with low salt levels in the body (e.g. low level of potassium
or of magnesium)
Patients taking certain medicines for heart rhythm problems or
medicines that may affect
the heart rhythm (see “Other medicines and X”)
Patients with anyone in their close family who has died suddenly of
heart problems
Atarax 2 mg/ml syrup includes 0.75g of sucrose per ml. Patients with
rare heredita

خصائص المنتج

Page 1 of 8 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. TRADE NAME OF THE MEDICINAL PRODUCT 

ATARAX syrup 
®  
(Hydroxyzine dihydrochloride)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
_ _
_Syrup 2 mg/ml_: Hydroxyzine dihydrochloride 2 mg - Levomenthol –
Sodium benzoate - Sucrose - 
Ethanol. – Hazelnut flavour (containing a.o. propylene glycol,
vanillin, ethyl vanillin, fenugreek seed 
extract, lovage oil) - purified water q.s. ad 1 ml. 

3. PHARMACEUTICAL FORM  

Clear, colourless solution 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Atarax is indicated for its sedative, tranquillising and
antihistaminic properties in: 
- the symptomatic treatment of anxiety, 
- the symptomatic treatment of pruritus of allergic origin. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Adults 
_ _
_In the symptomatic treatment of anxiety_: 50 to 100 mg/day: i.e.
from 5 teaspoons of syrup to 10 
teaspoons per day in the evening when going to bed if
anxiety is particularly manifest in insomnia. 
_ _
_In the symptomatic treatment of pruritus of allergic origin_: 30 to
100 mg/day: from 3 teaspoons of syrup 
to 10 teaspoons per day. 

The maximum single dose in adults should not exceed 200 mg whereas
the maximum daily dose should 
not exceed 300 mg. 

Children of 30 months to 15 years: 

For pruritus of allergic origin, the dose is calculated on the basis
of body weight and is 1 mg/kg/day with 
a maximum of 2 mg/kg/day. 
The syrup form is preferably used: 1 teaspoon = 10 mg. 

Page 2 of 8 
As the response to Atarax is very variable, it is advised,
particularly in elderly people, to start the 
treatment at low doses and to gradually increase the dose to find
the right dose, adjusted according to the 
response of the patient to the therapy. 
In the elderly, it is advised to start with half the recommended
dose due to a prolonged action. 

If a very brief effect is desired, the dose can be reduced to ha