Public Assessment Report - GOV.UK

1 1 Public Assessment Report Decentralised Procedure Dextromethorphan hydrobromide 10mg/5ml syrup Procedure No: UK/H/5042/001/DC UK Licence No: PL 14598/0098 Boehringer Ingelheim International GmbH Dextromethorphan hydrobromide 10mg/5ml syrup UK/H/5042/001/DC 2 LAY SUMMARY Dextromethorphan hydrobromide 10mg/5ml syrup This is a summary of the Public Assessment Report (PAR) for Dextromethorphan hydrobromide 10mg/5ml syrup (PL 14598/0098, formerly PL 23022/0103; UK/H/5042/001/DC). It explains how the application for Dextromethorphan hydrobromide 10mg/5ml syrup was assessed and its authorisation recommended, as well as the conditions of use.

2 It is not intended to provide practical advice on how to use Dextromethorphan hydrobromide 10mg/5ml syrup. The product may be referred to as Dextromethorphan hydrobromide syrup in this Report . For practical information about using Dextromethorphan hydrobromide syrup, patients should read the package leaflet or contact their doctor or pharmacist. What is Dextromethorphan hydrobromide syrup and what is it used for? Dextromethorphan hydrobromide syrup is a medicine with well-established use . This means that the medicinal use of the active substance of Dextromethorphan hydrobromide syrup is well established in the European Union for at least ten years, with recognised efficacy and an acceptable level of safety.

3 Dextromethorphan hydrobromide syrup is used to help relieve dry, irritating coughs in adults and children aged 12 years and over. How does Dextromethorphan hydrobromide syrup work? Dextromethorphan hydrobromide syrup contains the active ingredient dextromethorphan hydrobromide which belongs to a group of medicines called cough suppressants that help provide relief from dry cough. How is Dextromethorphan hydrobromide syrup used? Dextromethorphan hydrobromide syrup is available as a syrup containing 10 mg of dextromethorphan hydrobromide monohydrate per 5 ml of syrup. This medicine should be taken by mouth (orally).

4 Dextromethorphan hydrobromide syrup should always be taken exactly as advised by the patient s doctor or pharmacist. If unsure, the patient should check with his/her doctor or pharmacist. The recommended dose is: Adults and children aged 12 years and over. 15 ml of syrup up to 3 times daily, every 6 - 8 h as required. The patient should not take more than the maximum total daily dose of 45 ml of syrup (3 intakes). The measuring device included in the package should be used. Please read section 3 of the package leaflet (PL) for detailed information on dosing recommendations, the route of administration, and the duration of treatment.

5 Dextromethorphan hydrobromide syrup can only be obtained with a prescription. What benefits of Dextromethorphan hydrobromide syrup have been shown in studies? As dextromethorphan hydrobromide is a well-known substance, and its use in providing relief from dry, irritating coughs in adults and children aged 12 years and over is well established, the applicant Dextromethorphan hydrobromide 10mg/5ml syrup UK/H/5042/001/DC 3 presented data from the scientific literature. The literature confirmed the efficacy and safety of dextromethorphan hydrobromide in providing relief from dry, irritating coughs in adults and children aged 12 years and over.

6 What are the possible side effects from Dextromethorphan hydrobromide syrup? Like all medicines, Dextromethorphan hydrobromide syrup can cause side effects, although not everybody gets them. For the full list of all side effects reported with Dextromethorphan hydrobromide syrup, see section 4 of the package leaflet or the Summary of Product Characteristics available on the MHRA website. Also, for the full list of restrictions, see the package leaflet. Why is Dextromethorphan hydrobromide syrup approved? The use of Dextromethorphan hydrobromide syrup in providing relief from dry, irritating coughs in adults and children aged 12 years and over is well-established in medical practice and documented in the scientific literature.

7 No new or unexpected safety concerns arose from this application. It was, therefore, considered that the benefits of Dextromethorphan hydrobromide syrup outweigh the risks and the grant of a Marketing Authorisation was recommended. What measures are being taken to ensure the safe and effective use of Dextromethorphan hydrobromide syrup? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Dextromethorphan hydrobromide syrup, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored.

8 Furthermore, new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Dextromethorphan hydrobromide syrup. The Czech Republic, Estonia, Poland, the Slovak Republic and the UK agreed that a Marketing Authorisation for Dextromethorphan hydrobromide 10mg/5ml syrup could be granted on 26 April 2013. A Marketing Authorisation for Dextromethorphan hydrobromide 10mg/5ml syrup was granted in the UK on 15 May 2013 to PharOS Pharmaceutical Oriented Services Ltd. Subsequent to a Change of Ownership (COA) procedure, Dextromethorphan hydrobromide 10mg/5ml syrup (PL 14598/0098; UK/H/5042/001/DC) was granted to Boehringer Ingelheim International GmbH on 20 March 2014.

9 The full PAR for Dextromethorphan hydrobromide syrup follows this summary. For more information about treatment with Dextromethorphan hydrobromide syrup, read the package leaflet, or contact your doctor or pharmacist. This summary was last updated in November 2015. Dextromethorphan hydrobromide 10mg/5ml syrup UK/H/5042/001/DC 4 SCIENTIFIC DISCUSSION TABLE OF CONTENTS I Introduction Page 5 II Quality aspects Page 6 III Non-clinical aspects Page 9 IV Clinical aspects Page 10 V User consultation Page 11 VI Overall conclusion, benefit/risk Assessment and recommendation Page 11 Annex 1 - Table of content of the PAR update for MRP and DCP Page 12 Dextromethorphan hydrobromide 10mg/5ml syrup UK/H/5042/001/DC 5 Scientific discussion I INTRODUCTION Based on the review of the data on quality, safety and efficacy.

10 The member states considered that the application for Dextromethorphan hydrobromide 10mg/5ml syrup (PL 23022/0103; UK/H/5042/001/DC) could be approved. The product is a prescription-only medicine (POM) and it is indicated in adults and children 12 years and older for symptomatic treatment of irritable cough (non-productive/dry cough). The application was submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) and the Czech Republic, Estonia, Poland and the Slovak Republic as Concerned Member States (CMS). The application was submitted under Article 10a of Directive 2001/83/EC, as amended, claiming to be an application for a product containing an active substance of well-established use.