SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Thompson and Capper Echinacea Cold-n-Flu-Eze

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 105mg of extract (as dry extract) from Echinacea purpurea root (equivalent to 630mg - 840mg of Echinacea purpurea (L.) Moench, root).

Extract Solvent Ethanol 75% v/v For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film coated Tablet

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. This is based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Start at first signs of a common cold.

Adults, the elderly and children over 12 years:

Take 1 tablet twice a day.

Swallow the tablets whole with some water or other liquid.

Do not chew the tablets.

Do not take this product for more than ten days.

If symptoms worsen or persist for more than ten days or you get a high fever, consult your doctor or qualified healthcare practitioner.

Not recommended for use in children under 12 years (see section 4.4 special warnings and precautions for use)

4.3 Contraindications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.

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

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens or high fever occurs during the use of the product or if symptoms persist for more than 10 days, consult a doctor or qualified healthcare practitioner.

There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor or qualified healthcare practitioner before using Echinacea.

This product is not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

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 (skin rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma and anaphylactic shock) have been reported.

Echinacea can trigger allergic reactions in atopic patients.

Association with autoimmune diseases (encephalitis disseminata, 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 or a pharmacist should be consulted.

4.9 Overdose

No case of overdose has been reported.

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Not required as per Article 16 c (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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract

Maltodextrin

Colloidal anhydrous silica

Tablet Core

Maltodextrin

Microcrystalline cellulose Sodium croscarmellose Stearic Acid Magnesium Stearate Colloidal Anhydrous Silica

Tablet Coating

Hypromellose

Glycerol

6.2 Incompatibilities

None known.

6.3 Shelf life

18 months

6.4 Special precautions for storage

Do not store above 25 °C. Store in the original packaging.

6.5 Nature and contents of container

Tablets are packed into PVC/PVDC blister strips of 15 tablets in the following pack sizes; 30, 60, 90 Tablets and packed into a Carton

Not all pack sizes may be marketed

6.6 Special precautions for disposal

No special requirements.

MARKETING AUTHORISATION HOLDER

Thompson and Capper Limited

Hardwick Road

Atmore

Runcorn

Cheshire

WA7 1PH

03/10/2011