Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Amylmetacresol; 2, 4-dichlorobenzyl alcohol
Reckitt Benckiser Ireland Ltd
R02AA; R02AA03
Amylmetacresol; 2, 4-dichlorobenzyl alcohol
0.6 mg/1.2 milligram(s)
Lozenge
Product not subject to medical prescription
Antiseptics; dichlorobenzyl alcohol
Marketed
2009-07-24
PLEASE NOTE: This is a peel and reveal leaflet which was submitted with the Renewal application back in 2013, incorporating a label and a patient information leaflet This artworks only applies to the Tetra pack - small, round tube containing 10 lozenges, which is not currently marketed. PATIENT INFORMATION LEAFLET STREPSILS WARM LOZENGE 2,4-Dichlorobenzyl alcohol 1.2mg Amylmetacresol 0.6mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Strepsils Warm carefully to get the best results from it Keep this leaflet. You may need to read it again. Ask you pharmacist if you need more information or advice. You must talk to a doctor if your symptoms worsen or do not improve after 3 days. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Strepsils Warm Lozenges are and what they are uses for 2. What you need to know before you take Strepsils Warm Lozenges 3. How to take Strepsils Warm Lozenges 4. Possible side effects 5. How to store Strepsils Warm Lozenges 6. Contents of the pack and other information 1. WHAT STREPSILS WARM LOZENGES ARE AND WHAT THEY ARE USED FOR Strepsils Warm Lozenges contains two antiseptic ingredients for use in throat preparations and are used for the symptomatic relief of mouth and throat infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STREPSILS WARM LOZENGES This product is recommended for adults, children (over 12 years old) and the elderly. Children under 12 years old should not use this product. DO NOT TAKE THIS PRODUCT IF YOU: Are allergic (hypersensitive to amylmetacresol, 2,4-dichlorobenzyl alcohol or any of the other ingredients shown in section 6 If you are under 12 years old IF you have rare hereditary problems with fructose intolerance, glucose-galactose malabsorption or su Přečtěte si celý dokument
Health Products Regulatory Authority 16 July 2021 CRN00C5NY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Warm Lozenges Amylmetacresol 0.6 mg 2, 4-Dichlorobenzyl alcohol 1.2 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains: Amylmetacresol 0.6 mg 2,4-Dichlorobenzyl alcohol 1.2 mg Excipients with known effects: Glucose 1.10 g (1102 mg)/lozenge. Sucrose 1.38 g (1384 mg)/lozenge. Wheat Starch (containing gluten present in liquid glucose) 22.04 micrograms/lozenge. Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.141 ppm/lozenge. Flavouring fragrances containing citral, cinnamol, citranellol, eugenol, farnesol, geraniol, isoeugenol and linalool. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Lozenge A circular, biplanar red to purple lozenge with a characteristic warm taste of plum and ginger, 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. ADULTS AND CHILDREN (OVER 12 YEARS): One lozenge to be dissolved slowly in the mouth every 2-3 hours or as directed by a physician. It is recommended that the product should be used for a maximum of 3 days. Do not take more than 12 lozenges in 24 hours. ELDERLY: There is no need for dosage reduction in the elderly. Not suitable for children under 12 years. METHOD OF ADMINISTRATION For oral administration. 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. Health Products Regulatory Authority 16 July 2021 CRN00C5NY Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Keep all medicines out of the sight Přečtěte si celý dokument