Država: Malta
Jezik: engleski
Izvor: Medicines Authority
HYDROXYZINE HYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
N05BB01
HYDROXYZINE HYDROCHLORIDE 2 mg/ml
SYRUP
HYDROXYZINE HYDROCHLORIDE 2 mg/ml
POM
PSYCHOLEPTICS
Withdrawn
2005-09-23
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument