SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Echinaforce Chewable Cold & Flu Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains 380 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench herb (1:12) and 20 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench root (1:11).

Extraction solvent: Ethanol 65% v/v

Excipients:

One tablet contains 269.45 mg sorbitol and 2.1 mg of orange flavour (containing sucrose).

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Chewable Tablet.

Greenish, flat, round-shaped, speckled 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 based on traditional use only.

4.2    Posology and method of administration

Adults, elderly and children over 12 years:

2 tablets two to three times daily

Not recommended for use in children under 12 years of age (See section 4.4 Special warnings and precautions for use.’)

To be chewed.

For oral use only.

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 doctor or qualified healthcare practitioner should be consulted.

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), immunodeficiences (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).

This product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Refer to Section 2, Qualitative and Quantitative Composition for sorbitol.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

Not recommended for use in children under 12 years of age because data is not sufficient and medical advice should be sought.

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

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

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 carried out.

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 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 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.

Pharmacokinetic properties

No relevant pharmacokinetic data are available.

5.3 Preclinical safety data

Echinacea purpurea herb showed no toxicity in single-dose toxicity, repeated-dose toxicity and genotoxicity studies. Tests on reproductive toxicity and on carcinogenicity have not been performed.

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

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sorbitol

Betadex

Silica colloidal, anhydrous

Magnesium stearate

Orange flavour (containing sucrose)

6.2    Incompatibilities

None known.

6.4 Special precautions for storage

Store in the original container to protect from moisture.

Keep out of reach and sight of children.

6.5. Nature and contents of container

Amber glass bottles (type III conforming to Ph.Eur. standards) with coated aluminium foil sealing and aluminium pilfer proof closure fitted with a polyethylene liner.

Pack sizes:    40 tablets

80 tablets 120 tablets

Amber glass bottles (type III conforming to Ph.Eur. standards) with a stopper cap containing molecular sieve as desiccant.

Pack sizes:    40 tablets

80 tablets 120 tablets

Not all pack sizes, or packaging types, respectively, may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Bioforce (UK) Ltd,

2 Brewster Place,

Irvine

KA11 5DD, UK Telephone: 01294 277344 enquiries@avogel.co.uk

8    MARKETING AUTHORISATION NUMBER(S)

THR 13668/0015

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/01/2010

10    DATE OF REVISION OF THE TEXT

22/08/2012