Atarax

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROXYZINE HYDROCHLORIDE

Available from:

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

ATC code:

N05BB01

INN (International Name):

HYDROXYZINE HYDROCHLORIDE 25 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROXYZINE HYDROCHLORIDE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2005-09-23

Patient Information leaflet

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

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ATARAX
®
(Hydroxyzine dihydrochloride)
25 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of hydroxyzine dihydrochloride
For the full list of excipients, see section 6.1.
_ _
3. PHARMACEUTICAL FORM
White, oblong film-coated tablets
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
Posology
Atarax should be used at the lowest effective dose and for the
shortest possible duration.
In adults and children over 40 kg in weight, the maximum daily dose is
100 mg per day.
_ _
_In the symptomatic treatment of anxiety _: 50 to 100 mg/day : i.e. 2
to 4 tablets per day, or 2 to 4 tablets in the
evening when going to bed if anxiety is particularly manifest in
insomnia.
_ _
_In the symptomatic treatment of pruritus of allergic origin_: 25 to
100 mg/day: 4 tablets per day.
_Older people _
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.
In the elderly, the maximum daily dose is 50 mg per day (see section
4.4).
_Patients with renal impairment _
If a very brief effect is desired, the dose can be reduced to half.
Dosage should be reduced in patients with
moderate or severe renal function impairment due to decreased
excretion of its metabolite cetirizine.
_Patients with hepatic impairment _
Page 2 of 9
In patients with hepatic failure, the recommended daily dose should be
reduced by 33%.
_Paediatric population_ (Children from the age of 30 months):
In children up to 40 kg in