SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sainsbury’s Echinacea Cold and Flu Relief Tesco Echinacea Cold and Flu Relief Superdrug Echinacea Cold and Flu Relief Wilko Echinacea Cold and Flu Relief Gerard House Echinacea Cold and Flu Relief Herbalstore Echinacea Cold and Flu Relief Waitrose Echinacea Cold and Flu Relief Boots Echinacea Tablets Numark Echinacea Cold & Flu Relief Asda 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.

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 Fertility, 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.

Studies on the effects on fertility have not been performed.

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, Sjogren 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

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

6.3    Shelf life

Shelf life of product as packaged for sale PVD/PVDC blister pack with aluminium foil 36 months.

HDPE tablet container/closure 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

12, 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

02/06/2015