Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
AMYLMETACRESOL, 2, 4-DICHLOROBENZYL ALCOHOL, ASCORBIC ACID
Reckitt Benckiser Ireland Ltd
R02AA03
AMYLMETACRESOL, 2, 4-DICHLOROBENZYL ALCOHOL, ASCORBIC ACID
0.6/1.2/100 Milligram
Lozenges
Product not subject to medical prescription
Antiseptics
Authorised
2013-07-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils with Vitamin C Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Vitamin C 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2, 4-Dichlorobenzyl Alcohol and 100 mg Vitamin C (as Ascorbic Acid and Sodium Ascorbate). Excipients: Each lozenge also contains 968.5 mg glucose, 1437.9 mg sucrose, 0.162 mg sunset yellow FCF (E110) and 0.016 mg Ponceau 4R (E124). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge An orange flavoured and coloured circular lozenge. Embossed on both sides with strepsils brand icon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mouth and throat infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest effective dose should be used for the shortest duration necessary to relieve symptoms up. It is recommended that the product should be used for a maximum of 3 days. Adults: One lozenge every 2-3 hours. Do not take more than 12 lozenges in 24 hours. Paediatric population - Children over 6 years of age: As above for adults Children under 6 years of age: Not suitable for children under 6 years (see section 4.4) Elderly: There is no need for dosage reduction in the elderly. Method of administration: For oromucosal administration. To be dissolved slowly in the mouth. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _ Διαβάστε το πλήρες έγγραφο