Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HYDROXYZINE HYDROCHLORIDE
UCB (Pharma) Ireland Limited
10 MG/5ml
Syrup
2001-07-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ucerax Syrup 10mg/5ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains hydroxyzine hydrochloride 10mg (2mg/ml). Also contains sucrose 3.75g/5ml. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Syrup. Clear, colourless to slightly yellowish syrup with an odour and taste of menthol and hazelnut flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ucerax is indicated to assist in the management of anxiety and tension states, psychomotor agitation and acute stress situations such as, for example, those accompanying minor surgical procedures or allergic states. Ucerax is indicated in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatosis, and in histamine-mediated pruritus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS _Anxiety_ 50 mg/day in 3 separate administrations of 12.5-12.5-25 mg. In more severe cases doses of up to 300 mg/day can be used. _Pruritus_ Starting dose of 25 mg before resting, to be followed if necessary with doses up to 25 mg 3 to 4 times daily. The maximum single dose in adults should not exceed 200mg whereas the maximum daily dose should not exceed 300 mg. CHILDREN _Children aged form 12 months to 6 years old_ 1 mg/kg/day up to 2.5 mg/kg/day in divided doses. _Children aged over 6 years old_ 1 mg/kg/day up to 2 mg/kg/day in divided doses. The dosage should be adjusted within the recommended dose range, according to patient’s response to treatment. In the elderly, it is advised to start with half the recommended dose due to a prolonged action. In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%. IRISH MEDICINES BOARD _____________________________________ Read the complete document