국가: 몰타
언어: 영어
출처: Medicines Authority
DICHLOROBENZYL ALCOHOL, AMYLMETACRESOL
Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland
R02AA03
2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg
LOZENGE
2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg
OTC
THROAT PREPARATIONS
Authorised
2006-02-28
PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON) 1. NAME OF THE MEDICINAL PRODUCT Strepsils Honey & Lemon Lozenges 2. STATEMENT OF ACTIVE SUBSTANCE(S) Active Ingredients: Amylmetacresol 0.6mg and 2,4-Dichlorobenzyl Alcohol 1.2mg. 3. LIST OF EXCIPIENTS Each lozenge contains 0.98 g glucose, 1.44 g sucrose and 100.9 mg invert sugars (honey) 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 19.52 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. 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 hypersensitivity reactions and bronchospasm. The lemon flavour contains citral, d-Limonene, geraniol and linalool, which may cause allergic reactions. Also contains Tartaric Acid, Peppermint Oil and Quinoline Yellow (E104). 4. PHARMACEUTICAL FORM AND CONTENTS Lozenge 24 lozenges 36 lozenges Strepsils Honey & Lemon 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. Natural honey with lemon for an extra soothing effect on the throat. 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Reckitt Benckiser 0004 MA 190/00504 CCDS/Excipient Update 1.3.1 Outer Packaging Clean Strepsils Honey and Lemon HZ2PZ eCTD Page 1 6. SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN KEEP 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 medic 전체 문서 읽기
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Strepsils Honey and Lemon Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains Amylmetacresol 600 micrograms and 2,4-Dichlorobenzyl alcohol 1.2mg Excipients with known effects: Glucose 0.98 g (976 mg)/lozenge. Sucrose 1.44 g (1441 mg)/lozenge. Invert Sugar (honey) 100.9 mg/lozenge. Wheat Starch (containing gluten present in liquid glucose) 19.52 micrograms/lozenge. Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.125 ppm/lozenge. Lemon flavour fragrance containing citral, d-Limonene, geraniol and linalool. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Lozenge A yellow circular lozenge with a taste of honey and lemon, embossed on both sides with Strepsils brand icon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mouth and throat infections. 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 to be dissolved slowly in the mouth every 2 – 3 hours. Do not take more than 12 lozenges in 24 hours. Page 2 of 6 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. 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 WARNING AND SPECIAL PRECAUTIONS FOR USE This product is not recommended for young child 전체 문서 읽기