Krajina: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland
R02AA03
AMYLMETACRESOL 0.6 mg ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg
LOZENGE
AMYLMETACRESOL 0.6 mg ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg
OTC
THROAT PREPARATIONS
Authorised
2006-02-28
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON) 1. NAME OF THE MEDICINAL PRODUCT Strepsils Orange with Vitamin C Lozenges 2. STATEMENT OF ACTIVE SUBSTANCE(S) Active Ingredients: Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl Alcohol 1.2mg and Vitamin C (as Sodium Ascorbate / Ascorbic Acid) 100mg. 3. LIST OF EXCIPIENTS Each lozenge contains 0.97 g glucose and 1.44 g sucrose which should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Each lozenge contains no more than 19.36 micrograms of gluten (from wheat starch) and is regarded as 'gluten-free' and very unlikely to cause problems if you have coeliac disease. If you have a wheat allergy (different from coeliac disease) you should not take this medicine. Each lozenge contains 3 mg propylene glycol. Contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Contains sulphur dioxide (E220) which may rarely cause severe skin reactions and bronchospasm. The orange flavour contains citral, citronellol, d-Limonene, geraniol and linalool, which may cause allergic reactions. The Azo colouring agents Ponceau 4R (E124) and Sunset Yellow (E110) may cause allergic reactions. Also contains Tartaric Acid and Menthol. 4. PHARMACEUTICAL FORM AND CONTENTS Lozenge 24 lozenges 36 lozenges Strepsils Orange with Vitamin C Lozenges provide fast, soothing and effective relief from the discomfort of sore throats. Each lozenge contains a combination of 2 anti-bacterials to help kill the bacteria which can cause sore throats and mouth infections. 100mg Vitamin C to help boost levels of Vitamin C which is beneficial during an infection. 5. METHOD AND ROUTE(S) OF ADMINISTRATION 6. SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN 7. OTHER SPECIAL WARNINGS: IF NECESSARY Remember young children can choke on lozenges. Like all medicines, this medicine can Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Strepsils Orange 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 with known effects: Glucose 0.97 g (968 mg)/lozenge. Sucrose 1.44 g (1438 mg)/lozenge. Propylene glycol 3 mg/lozenge. Wheat Starch (containing gluten present in liquid glucose) 19.36 micrograms/lozenge. Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.124 ppm/lozenge. Orange flavour fragrances containing citral, citronellol, d-Limonene, geraniol and linalool. Colouring agents Ponceau 4R (E124) and Sunset yellow (E110). For the 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. 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 POPULATIONS: 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. 4.4 SPECIAL WARNINGS AND SP Prečítajte si celý dokument