sainsbury’s echinacea cold and flu relief, thr 20894 … · sainsbury’s echinacea cold and flu...

MHRA PAR; ECHINACEA COLD AND FLU RELIEF AND MAX STRENGTH ECHINACEA COLD AND FLU RELIEF, 20894/0062-3

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SAINSBURY’S ECHINACEA COLD AND FLU RELIEF

TESCO ECHINACEA COLD AND FLU RELIEF MORRISONS ECHINACEA COLD AND FLU RELIEF SUPERDRUG ECHINACEA COLD AND FLU RELIEF

WILKO ECHINACEA COLD AND FLU RELIEF CO-OP ECHINACEA COLD AND FLU RELIEF

GERARD HOUSE ECHINACEA COLD AND FLU RELIEF HERBALSTORE ECHINACEA COLD AND FLU RELIEF

WAITROSE ECHINACEA COLD AND FLU RELIEF

SAINSBURY’S MAX STRENGTH ECHINACEA COLD AND FLU RELIEF

TESCO MAX STRENGTH ECHINACEA COLD AND FLU RELIEF MORRISONS MAX STRENGTH ECHINACEA COLD AND FLU RELIEF SUPERDRUG MAX STRENGTH ECHINACEA COLD AND FLU RELIEF

WILKO MAX STRENGTH ECHINACEA COLD AND FLU RELIEF CO-OP MAX STRENGTH ECHINACEA COLD AND FLU RELIEF

GERARD HOUSE MAX STRENGTH ECHINACEA COLD AND FLU RELIEF

WAITROSE MAX STRENGTH ECHINACEA COLD AND FLU RELIEF THR 20894/0062-3

UKPAR

TABLE OF CONTENTS

Lay summary

Page 2

Scientific discussion

Page 4

Steps taken for assessment

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Summary of product characteristics

Page 15

Product information leaflet

Page 23

Labelling Page 27


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SAINSBURY’S ECHINACEA COLD AND FLU RELIEF TESCO ECHINACEA COLD AND FLU RELIEF

MORRISONS ECHINACEA COLD AND FLU RELIEF SUPERDRUG ECHINACEA COLD AND FLU RELIEF









LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Brunel Healthcare Manufacturing Limited a Traditional Herbal Registration Certificate for the traditional herbal medicinal products Sainsbury’s Echinacea Cold and Flu Relief, Tesco Echinacea Cold and Flu Relief, Morrisons Echinacea Cold and Flu Relief, Superdrug Echinacea Cold and Flu Relief, Wilko Echinacea Cold and Flu Relief, Co-op Echinacea Cold and Flu Relief, Gerard House Echinacea Cold and Flu Relief, HERBALSTORE Echinacea Cold and Flu Relief and Waitrose Echinacea Cold and Flu Relief (Herbal Registration number: THR 20894/0062) and Sainsbury’s Max Strength Echinacea Cold and Flu Relief, Tesco Max Strength Echinacea Cold and Flu Relief, Morrisons Max Strength Echinacea Cold and Flu Relief, Superdrug Max Strength Echinacea Cold and Flu Relief, Wilko Max Strength Echinacea Cold and Flu Relief, Co-op Max Strength Echinacea Cold and Flu Relief, Gerard House Max Strength Echinacea Cold and Flu Relief and Waitrose Max Strength Echinacea Cold and Flu Relief (THR 20894/0063). These products will be referred to as Echinacea Cold and Flu Relief or Max Strength Echinacea Cold and Flu Relief throughout the remainder of this report. Echinacea Cold and Flu Relief and Max Strength Echinacea Cold and Flu Relief are available without prescription and can be bought from pharmacies and other outlets.


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These products contain Echinacea purpurea root extract as the active ingredient. These products are traditional herbal medicines used to relieve the symptoms of the common cold and influenza type infections based on traditional use only. These registrations are based exclusively upon the longstanding use of Echinacea purpurea root as a traditional herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration scheme to prove scientifically that a product works. No new or unexpected safety concerns arose from these applications and it was, therefore, decided that Traditional Herbal Registration Certificates could be granted.


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SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 5

Pharmaceutical assessment

Page 6

Non-clinical assessment

Page 10

Clinical assessment

Page 11

Overall conclusions and risk assessment Page 13


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INTRODUCTION

The MHRA granted a Traditional Herbal Registration Certificates for the traditional herbal remedies Echinacea Cold and Flu Relief and Max Strength Echinacea Cold and Flu Relief on 17 March 2010. These products are on the general sales list (GSL). These applications were submitted according to Article 16.c of Directive 2001/83 EC, as amended, as part of the Traditional Herbal Medicines Registration Scheme. Echinacea Cold and Flu Relief contains 71.5mg of extract (dry extract) from Echinacea purpurea root (6-7:1) (equivalent to 429 mg - 500mg of Echinacea purpurea root). Max Strength Echinacea Cold and Flu Relief contains 143.0 mg of extract (dry extract) from Echinacea purpurea root (6-7:1) (equivalent to 858 mg – 1000 mg of Echinacea purpurea root). Both products are used to relieve the symptoms of the common cold and influenza type infections based on traditional use only. The data supplied by the Applicant demonstrate 30 years of traditional use of Echinacea purpurea root in the European Community. A satisfactory review of the available safety data on Echinacea purpurea root has also been provided, together with an Expert Safety Report supporting the proposed products.


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PHARMACEUTICAL ASSESSMENT

HERBAL SUBSTANCE: ECHINACEA

Name: Echinacea purpurea (L) Moench Family: Asteraceae/Compositae Common name: Echinacea Parts of the plant used: Root Echinacea purpurea is a perennial plant of 60-100 cm in height (although it can be cultivated up to 150 cm). The leaves, which have more or less serrated edges, are broad and oval, with an intense green upper side and are rather coarsely hirsute on both sides. The inflorescence is a single flower head terminating stem comprised of approximately 20 radial collar like flowers of a purplish violet colour, which first remain vertical and then horizontal, and have numerous cone-shaped flowers in the central part in the shape of a wide brimmed hat or hedgehog of about 3 cm in height by 3-5 cm wide. Manufacture The plant is cultivated in Europe and harvested during winter. The roots are stored in a cool dry place. The supplier of the Echinacea purpurea has provided confirmation that the herbal substance is cultivated under GACP controlled conditions. The lowest effective doses of herbicides and pesticides are used. The manufacturing process is clearly defined and the controls necessary are carried out to verify correct manufacture of the herbal substance. Control of Herbal Substance An appropriate specification based on the Ph Eur monograph is applied and is acceptable. The specification is supported by the batch data provided. Container Closure System Satisfactory details of the container closure system are provided and confirmation has been given that all components of the container closure system comply with Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs. Stability Confirmation is given that the herbal substance will be tested prior to being used to make the herbal preparation. A shelf-life for the herbal substance is not appropriate because it is only a precursor of the active substance, the herbal preparation. The actual guideline requires stability testing data for the herbal preparation and the herbal product in the application documents and not for the herbal substance. HERBAL PREPARATION General information


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The herbal preparation is a dry quantified extract of Echinacea at 4-6% in phenolic acids derived from dihydroxycinnamic acid, expressed as caffeic acid, chicoric acid, chlorogenic acid and caftaric acid. Manufacture Manufacture of the extract is a standard procedure. A satisfactory description of the manufacturing process of the herbal substance and flow diagram has been provided. There are no critical steps identified as the manufacture of the herbal preparation is considered a standard procedure. Certificates of analysis for all materials used in the manufacture of the herbal preparation have been provided. Control of Herbal Preparation A satisfactory specification with appropriate tests and limits has been provided for the herbal preparation. Satisfactory analytical procedures are used to control the quality of the herbal preparation. Analytical procedures have been validated as appropriate. Container Closure System The container closure system used to store the dry extract complies with Directive 2002/72/EC. Stability Batches were packed in the final container closure system and stored under ICH real time and accelerated conditions. The data support the storage conditions used. HERBAL PRODUCT Description and Composition of the Herbal Product Both products are film coated tablets; Echinacea Cold and Flu Relief tablets are pale green, circular and biconvex and Max Strength Echinacea Cold and Flu Relief tablets are pale yellow, oval and biconvex. Echinacea Cold and Flu Relief tablets and Max Strength Echinacea Cold and Flu Relief tablets contain 71.5mg and 143.0 mg dry extract from Echinacea purpurea root (6-7:1), respectively. Manufacture A copy of the manufacturing licence for the finished product manufacturing site is provided. The site complies with GMP standards. A flow diagram summarising the manufacturing process and in-process controls has been provided. A number of in-process control tests are performed during manufacture. All are considered adequate. Control of Excipients Both products contain maltodextrin, colloidal anhydrous silica, calcium hydrogen phosphate dehydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose and purified talc.


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Echinacea Cold and Flu Relief tablets also contain mastercote green FA0511G (vegetable carbon black (E153), copper chlorophylin (E141) and titanium dioxide (E171)) and Max Strength Echinacea Cold and Flu Relief tablets contain mastercote yellow FA0117 (titanium dioxide (E171) and yellow iron oxide (E172)) All excipients are controlled in line with their respective Ph Eur monographs, with the exception of mastercote green FA0511G and mastercote yellow FA0117, which are controlled by appropriate in-house specifications. In the absence of an appropriate Ph Eur monograph this is acceptable. There are no excipients of human or animal origin used in the manufacture of the product. Certificates of Analysis have been provided from all excipients. Control of Herbal Product The finished product specifications for release and end of shelf life are detailed and the tests and limits used were found to be satisfactory for a product of this nature. Satisfactory details have been provided on all analytical procedures and these analytical procedures are valid. Satisfactory batch data have been provided to support the specifications. Reference Standards or Materials Certificates of analysis have been provided for all reference standards used. Container Closure System The finished products are packed in either PVD/PVDC blister packs with aluminium foil or HDPE tablet containers. Packs contain 30, 60, 120 or 180 tablets.

Specifications and certificates are provided from the manufacturers and the applicant has confirmed that all components of the final container closure system comply with Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs. Stability Data is provided for production scale batches of both product strengths. Batches were packed in the final packaging and tested under ICH conditions of real, intermediate and accelerated time. Based on the data provided, a shelf life of 24 months with the storage precautions “Do not store above 25° C. Store in the original container” is acceptable. PRODUCT LITERATURE All product literature (SPCs, PILs and labels) is satisfactory. The package leaflets were submitted to the MHRA along with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the package leaflets are well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that they contain.


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ADMINISTRATIVE The Quality Overall Summary has been written by a suitably qualified expert and is satisfactory. ASSESSOR’S OVERALL CONCLUSIONS ON QUALITY These products are satisfactory and Traditional Herbal Registrations can be granted.


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NON-CLINICAL ASSESSMENT Non-clinical aspects The Safety Expert Report submitted by the applicant lists relevant references to published work studying the toxicology of Echinacea purpurea. Non-clinical overview The applicant has submitted an adequate literature review with these applications. An Expert Safety Report was also provided, which included reviews of some non-clinical data. The overview submitted in support of these applications is satisfactory. Due to a shortage of published data on Echinacea purpurea it is not possible to assess if the safety package for the phytochemical constituents of Echinacea purpurea is acceptable to the standards of today’s GLP and safety testing requirements. However, the information supplied demonstrating traditional use is acceptable and thus the lack of provision of a complete standard safety package may be acceptable and in compliance with guideline EMEA/HMPC/32116/05. In view of the absence of results of genotoxicity testing, the applicant has provided assurance that results will be provided before the renewal of the registrations. Summary of product characteristics The Summaries of Product Characteristics for these products are satisfactory. Environmental risk assessment An environmental risk assessment is not required for herbal medicinal products according to guidance CPMP/SWP/4447/00. Conclusion The information supplied demonstrating traditional use of Echinacea purpurea is acceptable. An adequate literature review for Echinacea purpurea has been carried out by the applicant and no new nonclinical data were submitted for assessment with this application. Granting of THRs is acceptable.


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CLINICAL ASSESSMENT

LEGAL STATUS Echinacea purpurea is currently on Schedule 1 of the General Sales List for internal use. PROPOSED INDICATION The applicant has proposed the following for both products: ‘A traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections based on traditional use only’. This indication is appropriate. POSOLOGY AND METHOD OF ADMINISTRATION The applicant has submitted the following for Echinacea Cold Flu Relief: ‘For oral administration. Swallow the tablets whole with water. Adults, elderly and children over 12 years: 1-2 tablets, twice a day. Not recommended for children under 12 years of age’ The applicant has submitted the following for Max Strength Echinacea Cold and Flu Relief: ‘For oral administration. Swallow the tablets whole with water. Adults, elderly and children over 12 years: 1 tablet, three times a day, if required. Not recommended for children under 12 years of age.’ Both posologies are acceptable. EFFICACY No clinical efficacy data is required for registration of Traditional Herbal Medicinal Products (THMP). EVIDENCE OF TRADITIONAL USE Article 16 c 1 (c) requires the Applicant to provide bibliographic or expert evidence showing that the medicinal product in question, or a corresponding product, has been in medicinal use throughout a period of at least 30 years, including at least 15 years within the European Community. The Applicant has provided a bibliographic review as evidence of the use of Echinacea purpurea within the EU for a period exceeding 30 years. The information provided is considered to satisfy the requirement to demonstrate use for at least 30 years of which at least 15 years have been in an EU Member State. The requirements of the Directive are therefore addressed for this aspect. SAFETY REVIEW Article 16 c 1 (d) requires the Applicant to provide a bibliographic review of the


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safety data together with a safety expert report. A safety review has been provided as well as an expert report written by a suitably qualified professional who is a pharmacologist and medical herbalist. The Safety Review and expert report are satisfactory. SUMMARY OF PRODUCT CHARACTERISTICS The SPCs for these products are satisfactory. PATIENT INFORMATION LEAFLET The PILs for these products are satisfactory. LABELLING All labelling is satisfactory. DISCUSSION These are applications for registration under the Traditional Herbal Medicinal Products Directive. The data supplied by the Applicant are sufficient to demonstrate 30 years’ of traditional use within the European Community of corresponding products and satisfactory safety data have been provided supporting the proposed products. RECOMMENDATIONS Traditional Herbal Registrations may be granted.


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OVERALL CONCLUSION AND RISK ASSESSMENT

QUALITY The quality data submitted with these applications are satisfactory. PRECLINICAL No new preclinical data were submitted and none are required for an application of this type. EFFICACY AND SAFETY No clinical efficacy data are required for registration of Traditional Herbal Medicinal Products (THMP). The Applicant has provided a bibliographic review which shows ample evidence for the use of Echinacea purpurea within the EU for a period exceeding 30 years. A satisfactory review of the safety data has been provided. The SPC, PIL and labelling are satisfactory. RISK ASSESSMENT The quality of the products is acceptable and no new preclinical or clinical safety concerns have been identified.


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STEPS TAKEN FOR ASSESSMENT

1 The MHRA received the Traditional Herbal Registration application on 25 March 2008

2 Following standard checks and communication with the applicant the MHRA considered the application valid on 18 April 2008

3 Following assessment of the application the MHRA requested further information relating to the quality and clinical dossier on 23 June 2008, 30 September 2008, 29 April 2009, 30 June 2009 and 26 October 2009.

4 The applicant responded to the MHRA’s requests, providing further information on the dossier on 06 April 2009, 30 June 2009, 01 September 2009 and 20 January 2010

5 A THR was granted on 23 March 2010.


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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sainsbury’s Echinacea Cold and Flu Relief Tesco Echinacea Cold and Flu Relief Morrisons Echinacea Cold and Flu Relief Superdrug Echinacea Cold and Flu Relief Wilko Echinacea Cold and Flu Relief Co-op Echinacea Cold and Flu Relief Gerard House Echinacea Cold and Flu Relief HERBALSTORE Echinacea Cold and Flu Relief Waitrose Echinacea Cold and Flu Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains: 71.5mg of extract (dry extract) from Echinacea purpurea root (6-7:1) (equivalent to 429 mg - 500mg of Echinacea purpurea (L.) Moench, root) Extraction solvent: Ethanol 30% v/v. For full list of excipients, see 6.1

3 PHARMACEUTICAL FORM

Film coated tablet. Pale green circular biconvex

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections based on traditional use only.

4.2 Posology and method of administration

For oral administration. Swallow the tablets whole with water.

Adults, elderly and children over 12 years: 1-2 tablets, twice a day. Not recommended for children under 12 years of age.

Start at first signs of common cold. Do not use the product for more than 10 days.

If symptoms worsen during the use of the product or persist for more than 10 days, a physician or a qualified healthcare practitioner should be consulted.


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4.3 Contraindications Hypersensitivity to Echinacea or to plants of the Asteraceae (Compositae) family. Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic diseases (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collangenoses, multiple sclerosis), immunodeficiencies (e.g.: HIV infection; AIDS), immunosuppression (e.g.: onocological cytostatic therapy; history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukaemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma). Children under 12 years of age.

4.4 Special warnings and precautions for use

Do not exceed the stated dose. If the condition worsens or high fever occurs whilst taking the product or if symptoms persist for more than 10 days, see a doctor, pharmacist or qualified healthcare practitioner. This medicinal product is not suitable for children under 12 years. There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

4.6 Pregnancy and lactation

In the absence of sufficient data the use in pregnancy and lactation is not recommended. Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma, and anaphylactic shock) may occur. Echinacea can trigger allergic reactions in atopic patients. Association with autoimmune diseases


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(encephalitis disseminate, erythema nodosum, immunothrombocytopenia, Evans Syndrome, Sjögren syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks). The frequency is not known. If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported. 5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed with Echinacea purpurea root.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients of the herbal preparation; Maltodextrin Colloidal Anhydrous Silica Tablet Core: Calcium Hydrogen Phosphate Dihydrate Microcrystalline Cellulose Croscarmellose Sodium Colloidal Anhydrous Silica Magnesium Stearate Film coating: Hypromellose Purified Talc Mastercote Green FA0511G, (Vegetable Carbon Black (E153), Copper Chlorophylin (E141), Titanium Dioxide (E171))

6.2 Incompatibilities

None applicable.


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6.3 Shelf life Shelf life of product as packaged for sale 24 months.

6.4 Special precautions for storage

Do not store above 25° C. Store in the original container. 6.5 Nature and contents of container

30, 60, 120 or 180 tablets in a PVC/PVDC blister pack with aluminium foil. 30, 60, 120 or 180 tablets in a HDPE tablet container/closure. Not all pack sizes may be marketed

6.6 Special precautions for disposal None.

7 MARKETING AUTHORISATION HOLDER

Brunel Healthcare Manufacturing Limited William Nadin Way Swadlincote Derbyshire DE11 0BB

8 MARKETING AUTHORISATION NUMBER(S)

THR 20894/0062

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 17/03/2010 10 DATE OF REVISION OF THE TEXT

17/03/2010

1 NAME OF THE MEDICINAL PRODUCT Sainsbury’s Max Strength Echinacea Cold and Flu Relief

Tesco Max Strength Echinacea Cold and Flu Relief Morrisons Max Strength Echinacea Cold and Flu Relief Superdrug Max Strength Echinacea Cold and Flu Relief Wilko Max Strength Echinacea Cold and Flu Relief

Co-op Max Strength Echinacea Cold and Flu Relief Gerard House Max Strength Echinacea Cold and Flu Relief Waitrose Max Strength Echinacea Cold and Flu Relief


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2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains: 143.0 mg of extract (dry extract) from Echinacea purpurea root (6-7:1) (equivalent to 858 mg – 1000 mg of Echinacea purpurea (L.) Moench, root)

Extraction solvent: Ethanol 30% v/v.

For full list of excipients, see 6.1

3 PHARMACEUTICAL FORM

Film coated tablet. Pale yellow oval biconvex

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections based on traditional use only.

4.2 Posology and method of administration

For oral administration. Swallow the tablets whole with water.

Adults, elderly and children over 12 years: 1 tablet, three times a day, if required.

Not recommended for children under 12 years of age. Start at first signs of common cold. Do not use the product for more than 10 days.

If symptoms worsen during the use of the product or persist for more than 10 days, a physician or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Echinacea or to plants of the Asteraceae (Compositae) family. Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic diseases (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collangenoses, multiple sclerosis), immunodeficiencies (e.g.: HIV infection; AIDS), immunosuppression (e.g.: onocological cytostatic therapy; history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukaemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).


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Children under 12 years of age. 4.4 Special warnings and precautions for use

Do not exceed the stated dose. If the condition worsens or high fever occurs whilst taking the product or if symptoms persist for more than 10 days, see a doctor, pharmacist qualified healthcare practitioner. This medicinal product is not suitable for children under 12 years. There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

4.6 Pregnancy and lactation

In the absence of sufficient data the use in pregnancy and lactation is not recommended. Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma, and anaphylactic shock) may occur. Echinacea can trigger allergic reactions in atopic patients. Association with autoimmune diseases (encephalitis disseminate, erythema nodosum, immunothrombocytopenia, Evans Syndrome, Sjögren syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks). The frequency is not known. If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.


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5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended 5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed with Echinacea purpurea root.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients of the herbal preparation; Maltodextrin Colloidal Anhydrous Silica Tablet core: Calcium Hydrogen Phosphate Dihydrate Microcrystalline Cellulose Croscarmellose Sodium Colloidal Anhydrous Silica Magnesium Stearate Film Coating: Hypromellose Purified Talc Mastercote Yellow FA0117 (Titanium Dioxide (E171), Yellow Iron Oxide (E172))

6.2 Incompatibilities

None applicable. 6.3 Shelf life

Shelf life of product as packaged for sale 24 months.

6.4 Special precautions for storage

Do not store above 25° C. Store in the original container. 6.5 Nature and contents of container

30, 60, 120 or 180 tablets in a PVC/PVDC blister pack with aluminium foil. 30, 60, 120 or 180 tablets in a HDPE tablet container/closure. Not all pack sizes may be marketed


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6.6 Special precautions for disposal

None. 7 MARKETING AUTHORISATION HOLDER

Brunel Healthcare Manufacturing Limited William Nadin Way Swadlincote Derbyshire DE11 0BB

8 MARKETING AUTHORISATION NUMBER(S) THR 20894/0063

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 17/03/2010 10 DATE OF REVISION OF THE TEXT

17/03/2010


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PATIENT INFORMATION LEAFLETS


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LABELLING Sainsbury’s Echinacea Cold and Flu Relief Blister:


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Carton:


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Tesco Echinacea Cold and Flu Relief Blister:


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Carton:


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Morrisons Echinacea Cold and Flu Relief Carton:


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Superdrug Echinacea Cold and Flu Relief Blister:


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Carton:


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Wilko Echinacea Cold and Flu Relief

Carton:


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Gerard House Echinacea Cold and Flu Relief


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HERBALSTORE Echinacea Cold and Flu Relief Blister:


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Carton:


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Sainsbury’s Max Strength Echinacea Cold and Flu Relief Blister:


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Carton:


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Tesco Max Strength Echinacea Cold and Flu Relief Blister:


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Carton:


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Morrisons Max Strength Echinacea Cold and Flu Relief


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Superdrug Max Strength Echinacea Cold and Flu Relief

Blister:


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Carton:


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Wilko Max Strength Echinacea Cold and Flu Relief Carton:

Co-op Max Strength Echinacea Cold and Flu Relief Carton:


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Gerard House Max Strength Echinacea Cold and Flu Relief Carton:

Waitrose Max Strength Echinacea Cold and Flu Relief Carton:

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