Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Lidocaine Hydrochloride Ph. Eur.
Reckitt Benckiser Ireland Ltd
R02AA; R02AA03
Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Lidocaine Hydrochloride Ph. Eur.
0.6 mg/1.2 mg/10 milligram(s)
Lozenge
Product not subject to medical prescription
Antiseptics; dichlorobenzyl alcohol
Marketed
1995-10-03
PACKAGE LEAFLET: INFORMATION FOR THE USER STREPSILS +PLUS ANAESTHETIC LOZENGES Amylmetacresol 0.6 mg 2,4-Dichlorobenzyl alcohol 1.2 mg Lidocaine hydrochloride 10 mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. . WHAT IS IN THIS LEAFLET: 1. What Strepsils +Plus Anaesthetic Lozenges are and what they are used for 2. What you need to know before you take Strepsils +Plus Anaesthetic Lozenges 3. How to use Strepsils +Plus Anaesthetic Lozenges 4. Possible side effects 5. How to store Strepsils +Plus Anaesthetic Lozenges 6. Further information 1. WHAT STREPSILS +PLUS ANAESTHETIC LOZENGES ARE AND WHAT THEY ARE USED FOR Strepsils +Plus Anaesthetic Lozenges contain the active ingredients amylmetacresol, 2,4-dichlorobenzyl alcohol and lidocaine hydrochloride 10mg. Amylmetacresol and 2,4-dichlorobenzyl alcohol have antiseptic properties to kill bacteria which cause mouth and throat infections. Lidocaine is a local anaesthetic to rapidly numb the pain of a painful sore throat. Strepsils +Plus Anaesthetic Lozenges can be used in adults and children over 12 years of age for the symptomatic relief of throat infections, including severe sore throat. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STREPSILS +PLUS ANAESTHETIC LOZENGES DO NOT USE STREPSILS +PLUS ANAESTHETIC LOZENGES if you are allergic (hypersensitive) to any of the ingredients listed in section 6 if you are under 12 years of age if you are pregnant or breastfeeding, unless under the supervision of your Lees het volledige document
Health Products Regulatory Authority 01 March 2022 CRN00C5NT Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils +Plus Anaesthetic Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Lidocaine Hydrochloride 10mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2, 4-Dichlorobenzyl Alcohol and 10 mg Lidocaine Hydrochloride. Excipients with known effects: Glucose 0.98 g (980 mg)/lozenge. Sucrose 1.52 g (1523 mg)/lozenge. Wheat Starch (containing gluten) 19.60 µg/lozenge present in liquid glucose. Sulphites - Sulphur Dioxide (E220) 0.125 ppm/lozenge present in liquid glucose. Star Anise oil contains Anisyl alcohol, d-limonene and linalool. Peppermint oil contains d-Limonene. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge Pale, blue-green circular lozenges, embossed on both sides with Strepsils brand icon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strepsils +Plus anaesthetic Lozenges are indicated for the symptomatic relief of mouth and throat infections including severe sore throat. Strepsils +Plus Anaesthetic Lozenges is indicated in adults and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. ADULTS One lozenge to be sucked slowly every two hours as required. No more than 8 lozenges to be sucked in any 24 hours. PAEDIATRIC POPULATION Children over 12 years: As above for adults. CHILDREN UNDER 12 YEARS: Not recommended for children under 12 years (see section 4.4) ELDERLY There is no need for dosage reduction in the elderly. Health Products Regulatory Authority 01 March 2022 CRN00C5NT Page 2 of 5 METHOD OF ADMINISTRATION For oromucosal administration. To be dissolved slowly in the mouth. 4.3 CONTRAINDICATIONS Strepsils +Plus anaesthetic Lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the active ingredients or to Lees het volledige document