País: Malta
Idioma: inglés
Fuente: Medicines Authority
AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL
Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland
R02AA20
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 Strawberry Sugar Free Lozenges 2. STATEMENT OF ACTIVE SUBSTANCE(S) Active Ingredients: Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl Alcohol 1.2mg 3. LIST OF EXCIPIENTS Each lozenge contains 1.83 g isomalt and 0.458 g maltitol liquid. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May have a mild laxative effect. Calorific value 2.34 kcal/g. Contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Contains 7.30 mg propylene glycol (present in strawberry flavour) in each lozenge. Fragranced with Benzyl Alcohol which may cause allergic reactions. Also contains Pink Antho (E163), Sodium Saccharin and Tartaric Acid. 4. PHARMACEUTICAL FORM AND CONTENTS Lozenge 16 lozenges Strepsils Strawberry Sugar Free 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. Strepsils Strawberry Sugar Free Lozenge are suitable for use by people with Diabetes. 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. 6. SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Reckitt Benckiser 0005 MA 096/01102 CCDS/Excipient Update 1.3.1 Outer Packaging Clean Strepsils SSF AMC DCBA 0333206 eCTD Page 1 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 medicine can cause side effects, although not everybody gets them. Side effects may include rash, stomach pain, feeling sick, oral discomfort, allergic reaction. If you are allergic to any ingredients listed, do not take this product. Consult your doctor if symptoms persist or anything unusual happens. Do not take for more than 3 days unless told to do so by yo Leer el documento completo
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Strepsils Strawberry Sugar Free Lozenges Amylmetacresol 600 micrograms 2,4-Dichlorobenzyl alcohol 1.2mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lozenge contains amylmetacresol 600 micrograms and 2,4-Dichlorobenzyl alcohol 1.2 mg. Excipients with known effects: Propylene Glycol 7.30 mg/lozenge. Isomalt (E 953) 1.83 g (1830 mg)/lozenge. Maltitol liquid (E 965) 0.458 g (458 mg)/lozenge. Benzyl Alcohol (present in Strawberry flavour) 0.0028 mg/lozenge. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Lozenge. Pink, circular lozenge with a characteristic strawberry taste, embossed on both sides with Strepsils brand icon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils Sugar Free are indicated for the symptomatic relief of mouth and throat infections including sore throat. 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 POPULATION: CHILDREN OVER 6 YEARS OF AGE: As above for adults. Page 2 of 7 CHILDREN UNDER 6 YEARS OF AGE: Page 3 of 7 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 Strepsils Strawberry Sugar Free Lozenges are contraindicated in persons who have previously shown hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product is not recommended for young children due to a risk of choking. Consult your doctor if symptoms persist or if anything unusual happens. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say Leer el documento completo