Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
HYDROXYZINE HYDROCHLORIDE
UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium
N05BB01
HYDROXYZINE HYDROCHLORIDE 25 mg
FILM-COATED TABLET
HYDROXYZINE HYDROCHLORIDE 25 mg
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Withdrawn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 Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο