País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE TARTARE
Sanofi-Aventis Ireland Limited
10 Milligram
Tablets
1977-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vallergan 10 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg Alimemazine Tartrate. EXCIPIENTS Lactose monohydrate 33.87 mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Dark blue, biconvex tablets with bevelled edges, impressed “V” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of urticaria, pruritus (including that associated with obstructive jaundice) and senile pruritus. 2. In short term sedation and pre-anaesthetic medication in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR USE IN ADULTS AND CHILDREN OVER 7 YEARS OF AGE. The route of administration is oral. Recommended dosage: Urticaria and Pruritus _Adults:_ The usual total daily dosage is 30 to 40 mg in divided doses. _Children:_ The usual total daily dosage is 7.5 to 20 mg in divided doses. Dosing may be repeated as needed during the day not to exceed 4 daily doses. Evening dosing is preferable due to the pronounced sedative effect of alimemazine. For sedation _Children:_ _Aged 7 to 12 years:_ 60 to 90 mg daily in divided doses. _Aged 3 to 6 years_ Give Vallergan Syrup or Vallergan Forte Syrup. _Pre-anaesthetic medication (children aged 2-7 years):_ Give Vallergan Syrup or Vallergan Forte Syrup. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/04/2012_ _CRN 2114730_ _page number: 1_ 4.3 CONTRAINDICATIONS • Use in patients hypersensitive to the active ingredient or any of the excipients • Children under 7 years of age (tablets). • Use in patients with hepatic or renal dysfunction, epilepsy, Parkinson’s disease, hypothyroidism, phaeochr Llegiu el document complet