Public Assessment Report Hexylresorcinol 2.4mg Lozenges

Public Assessment Report

Hexylresorcinol 2.4mg Lozenges (Hexylresorcinol)

UK Licence No.: PL 00094/0253-0255

Ernest Jackson & Company Limited

UKPAR Hexylresorcinol 2.4mg Lozenges

PL 00094/0253-0255

Lay Summary Hexylresorcinol 2.4mg Lozenges (Hexylresorcinol) This is a summary of the Public Assessment Report (PAR) for Hexylresorcinol 2.4mg Lozenges (PL 00094/0253-0255). It explains how Hexylresorcinol 2.4mg Lozenges were assessed and their authorisation recommended, as well as the conditions of use. It is not intended to provide practical advice on how to use these products. For practical information about using Hexylresorcinol 2.4mg Lozenges, patients should read the package leaflets or contact their doctor or pharmacist. What are Hexylresorcinol 2.4mg Lozenges and what are they used for? This medicine is the same as Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour (PL 00094/0036, PL 00094/0038 and PL 00094/0018), authorised to the same Marketing Authorisation Holder (Ernest Jackson & Co. Ltd; PL 00094/0253-0255). Hexylresorcinol 2.4mg Lozenges are recommended for relief of sore throats and associated pain. This medicine also acts as an anaesthetic to bring soothing relief of pain and discomfort. How do Hexylresorcinol 2.4mg Lozenges work? Hexylresorcinol 2.4mg Lozenges contain the active substance hexylresorcinol, which is an antiseptic which combats the bacteria that cause sore throats. How are Hexylresorcinol 2.4mg Lozenges used? Hexylresorcinol 2.4mg Lozenges are taken by mouth. In adults, the elderly and children 6 years and over, one lozenge must be dissolved slowly in the mouth every 3 hours or as required. Patients must not take more than 12 lozenges in 24 hours. This medicine is not recommended for children under the age of 6. Hexylresorcinol 2.4mg Lozenges can be obtained without a prescription and are available on the General Sales List (GSL). For further information on how Hexylresorcinol 2.4mg Lozenges are used, please see the Summaries of Product Characteristics or the package leaflets available on the MHRA website. What benefits of Hexylresorcinol 2.4mg Lozenges have been shown in studies? As Hexylresorcinol 2.4mg Lozenges (PL 00094/0253-0255) are considered to be identical to Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour (PL 00094/0036, PL 00094/0038 and PL 00094/0018), their benefits and risks are taken as being the same as those for the reference products. 2


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What are the possible side effects from Hexylresorcinol 2.4mg Lozenges? Like all medicines, this medicine can cause side effects, although not everybody gets them. For the full list of all side effects reported with Hexylresorcinol 2.4mg Lozenges, see section 4 of the package leaflets. For the full list of restrictions, see the package leaflets. Why are Hexylresorcinol 2.4mg Lozenges approved? No new or unexpected safety concerns arose from these applications. It was, therefore, considered that the benefits of Hexylresorcinol 2.4mg Lozenges outweigh the risks, and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of Hexylresorcinol 2.4mg Lozenges? A Risk Management Plan (RMP) has been developed to ensure that Hexylresorcinol 2.4mg Lozenges are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics and the package leaflets for Hexylresorcinol 2.4mg Lozenges, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Hexylresorcinol 2.4mg Lozenges Marketing Authorisations were granted in the UK on 16 March 2017. The full PAR for Hexylresorcinol 2.4mg Lozenges follows this summary. This summary was last updated in March 2017.

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Table of Contents I II III IV V VI

Introduction Quality aspects Non-clinical aspects Clinical aspects User consultation Overall conclusion, benefit/risk assessment and recommendation

Table of content of the PAR update

Page 5 Page 6 Page 8 Page 8 Page 9 Page 10

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I

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Introduction

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Ernest Jackson & Company Limited Marketing Authorisations for the medicinal products Hexylresorcinol 2.4mg Lozenges (PL 00094/0253-0255) on 16 March 2017. These products can be obtained without a prescription and are available on the General Sales List (GSL). Hexylresorcinol 2.4mg Lozenges are used as an antiseptic, demulcent and local anaesthetic for the relief of sore throat and its associated pain. These applications were submitted as abridged simple applications, according to Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour, which were first authorised to Ernest Jackson & Co. Ltd (PL 00094/0036, PL 00094/0038 and PL 00094/0018) on 29 July 1999, 29 March 2000 and 22 November 1993 respectively. Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated. The product base has a demulcent action. No new data were submitted nor were they necessary for these simple applications, as the data are identical to those of the previously granted cross-reference products. The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture and assembly of these products. A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with these applications, and these are satisfactory.

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II

Quality aspects

II.1

Introduction

PL 00094/0253-0255

These are abridged simple, piggyback (informed consent) applications for Hexylresorcinol 2.4mg Lozenges (PL 00094/0253-0255), submitted under Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour, which were first authorised to Ernest Jackson & Co. Ltd (PL 00094/0036, PL 00094/0038 and PL 00094/0018) on 29 July 1999, 29 March 2000 and 22 November 1993 respectively. The current applications are considered valid. II.2. Drug Substance Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross-reference products. II.3. Medicinal Product Name The proposed product name for these applications is Hexylresorcinol 2.4mg Lozenges. The products have been named in line with current requirements. Strength, pharmaceutical form, route of administration, container and pack size Each lozenge contains 2.4 mg hexylresorcinol, as active ingredient. The route of administration is oral. Honey and Lemon Flavour 510167E The finished product is packed in blister strips of polyvinylchloride (PVC) coated with polyvinylidenechloride (PVdC) sealed with hard temper aluminium foil, and packed in a carton or overwrap containing 6, 8, 10 or 12 lozenges per blister strip. The pack sizes are: Carton (blister strips per carton): 6, 8, 10, 12, 16, 20, 24, 30 or 36 lozenges Overwrap (blister strips per overwrap): 6, 8, 10 or 12 lozenges. Not all pack sizes may be marketed. The proposed shelf-life is 36 months with storage conditions ‘Do not store above 25°C’ and ‘Store in the original packaging’. Cherry Flavour 500880E The finished product is packaged in blister strips of PVC coated with PVdC and sealed with hard temper aluminium foil in a carton or laminate flowrap. The pack sizes are 6, 8, 10, 12, 16, 24, 30, 32 or 36 lozenges. Not all pack sizes may be marketed. The proposed shelf-life is 36 months with storage conditions ‘Do not store above 25°C’ and ‘Store in the original package’. Blackcurrant Flavour 545071E

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The finished product is packaged in blister packs of PVC coated with PVdC and sealed with hard temper aluminium foil packed in a carton or flow wrapped flexible laminate pack. The pack sizes are 8 (1x8), 12 (1x12) 16 (2x8), 24 (2x12) or 36 (3x12) lozenges. Not all pack sizes may be marketed. The proposed shelf-life is 24 months with storage conditions ‘Do not store above 25°C’ and ‘Store in the original package’. The proposed packaging, shelf-lives and storage conditions are consistent with the details registered for the cross-reference products. Legal status These products are available on the General Sales List (GSL). Marketing Authorisation Holder/Contact Persons/Company Ernest Jackson & Co Ltd, High Street, Crediton, Devon, EX17 3AP, UK The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory Curriculum Vitae (CV) has been provided. Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. Qualitative and quantitative composition The proposed compositions are consistent with the details registered for the cross-reference products. Manufacturing process The proposed manufacturing processes are consistent with the details registered for the cross-reference products and the maximum batch size is stated. Finished product/shelf-life specification The proposed finished product specifications are in line with the details registered for the cross-reference products. Bioequivalence No bioequivalence data are required to support these simple abridged applications as the proposed products are manufactured to the same formula utilising the same processes as the cross-reference products, Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour (PL 00094/0036, PL 00094/0038 and PL 00094/0018). Expert Report The applicant cross-refers to the data for Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour (PL 00094/0036, PL 00094/0038 and PL 00094/0018), to which these applications are claimed to be

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identical. This is acceptable. The applicant has included expert reports of the applications. Signed declarations and copies of the experts’ CVs are enclosed for the quality, non-clinical and clinical experts. All are considered to have sufficient experience for their responsibilities. II.4 Discussion on chemical, pharmaceutical and biological aspects The quality data for these applications are consistent with those approved for Halls Sore Throat Relief Dual Action Honey & Lemon Flavour 2.4mg Lozenges/Boots Sore Throat Relief Double Action 2.4 mg Lozenges Cherry Flavour/Mac Dual Action Blackcurrant Flavour (PL 00094/0036, PL 00094/0038 and PL 00094/0018) and, as such, have been judged to be satisfactory. The grant of Marketing Authorisations is recommended.

III

Non-clinical aspects

As these are abridged simple applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new non-clinical data has been supplied and none are required. A suitable justification has been provided for not submitting an environmental risk assessment. The grant of Marketing Authorisations is recommended.

IV

Clinical aspects

As these are abridged simple applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new clinical data have been supplied and none are required. The Marketing Authorisation Holder has provided details of a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that they have the services of a qualified person responsible for pharmacovigilance, and have the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. The grant of Marketing Authorisations is recommended. Risk Management Plan (RMP) The applicant has submitted an RMP, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Hexylresorcinol 2.4mg Lozenges.

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A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, is listed below:

The applicant proposes only routine risk minimisation measures, which are detailed in the SmPCs. These are considered sufficient. No additional risk minimisation measures are considered necessary.

V

User consultation

The package leaflets are identical to the leaflets for the reference products.

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VI Overall conclusion, benefit/risk assessment and recommendation The quality of the products is acceptable, and no new non-clinical or clinical concerns have been identified. The applicant’s products are identical to the reference products. The benefit-risk assessment is, therefore, considered to be positive.

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Summary of Product Characteristics, Patient Information Leaflet & Labels In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPCs and PIL for this product are available on the MHRA website. The current approved labelling text is listed below:

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Table of content of the PAR update Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II variations, PSURs, commitments) Date submitted

Application type

Scope

Outcome

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Public Assessment Report Hexylresorcinol 2.4mg Lozenges

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