Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Amylmetacresol; 2,4 DICHLOROBENZYL ALCOHOL
McDermott Laboratories Ltd., T/A Gerard Laboratories
R02AA; R02AA03
Amylmetacresol; 2,4 DICHLOROBENZYL ALCOHOL
0.60/1.2 milligram(s)
Lozenge
Antiseptics; dichlorobenzyl alcohol
Not marketed
2021-02-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMYLMETACRESOL/2,4-DICHLOROBENZYL ALCOHOL MYLAN 0.6 MG/1.2 MG MINT LOZENGES amylmetacresol 2,4-dichlorobenzyl alcohol 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 have 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. 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 Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan is and what it is used for 2. What you need to know before you take Amylmetacresol/2, 4-Dichlorobenzyl alcohol Mylan 3. How to take Amylmetacresol/2, 4-Dichlorobenzyl alcohol Mylan 4. Possible side effects 5. How to store Amylmetacresol/2, 4-Dichlorobenzyl alcohol Mylan 6. Contents of the pack and other information 1. WHAT AMYLMETACRESOL/2,4-DICHLOROBENZYL ALCOHOL MYLAN IS AND WHAT IT IS USED FOR Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan contains amylmetacresol and 2,4-dichlorobenzyl alcohol. These ingredients are both mid antiseptics and are are used for the symptomatic relief of mouth and throat infections. The action of sucking the lozenge allows the active ingredients to work in the area of the discomfort and also helps lubricate and soothe the painful area. This helps relieve the soreness and discomfort of mouth and throat. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMYLMETACRESOL/2, 4-DICHLOROBENZYL ALCOHOL MYLAN This medicine is recommended for adults, children (over 6 years old) and the elderly. Children under 6 years old should not use this product. DO NOT TAKE AMYLMETACRESOL/2, 4-DICHLOROBENZYL ALCO Citiți documentul complet
Health Products Regulatory Authority 01 March 2021 CRN008K7J Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan 0.6 mg/1.2 mg mint lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 0.6 mg amylmetacresol and 1.2 mg 2,4-dichlorobenzyl alcohol. Excipients with known effect Each lozenge contains 1.83 g of isomalt (E953) and 0.46 g of maltitol liquid (E965). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lozenge A green, round, mint flavoured lozenge with a diameter of 19 mm ± 1 mm. 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 every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours. _Paediatric population_ _ _ _Children over 6 years of age_ One lozenge every 2 or 3 hours, as needed up to a maximum of 4 lozenges in 24 hours, with a minimum of 2 hours between the lozenges. _Children under 6 years of age_ Amylmetacresol/2, 4-Dichlorobenzyl alcohol Mylan should not be used in 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. Do not swallow, chew or bite. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Health Products Regulatory Authority 01 March 2021 CRN008K7J Page 2 of 4 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product is not recommended for young children due to a risk of choking (see section 4.2). Patients should be advised to consult the doctor if symptoms persist or if anything unusual happens. Excipients This medicinal product contains is Citiți documentul complet