SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

5 ml of concentrate contains:

1140 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench herb (1:1213) and 60 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench root (1:11-12).

Extraction solvent: Ethanol 65% V/V Excipients with known effect:

5 ml of concentrate contains 3.22 g of sucrose and a maximum of 33 mg of ethanol. For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Concentrate for oral solution

Dark red to dark violet viscous liquid with an aromatic, fruity, elderberry-like odour and an aromatic, fruity, sweet, slightly sour taste.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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 use only.

Adults and children over 12 years:

Days 1-3:    Take 5 ml diluted in hot water five times daily

Days 4-10:    Take 5 ml diluted in hot water three times daily

Dilute in hot water before use.

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

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 extracts must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g. collangenoses, 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, leukaemias) and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).

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 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.

This product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

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 extracts on pregnancy or on the health of the foetus/new-born child. Data concerning the immune system of the new-born 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 effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Hypersensitive 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, Sjorgen Syndrome with renal tubular dysfunction) has been reported. Leucopenia may occur in long-term use (more than 8 weeks).

The frequency of adverse reactions is not known.

If other adverse reactions not mentioned above occur, a doctor or a 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 balance 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.

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

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

Sucrose Purified water

Concentrated elderberry juice

Citric acid monohydrate Modified starch Medium-chain triglycerides Potassium sorbate Ethanol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months unopened.

After opening:

Use within 1 month of opening.

6.4 Special precautions for storage

Store below 25°C. After opening, store in the refrigerator (below 8°C).

6.5 Nature and contents of container

Amber glass bottle with white pilfer-proof PE-HD screw cap, white PE-LD spout and a PP measuring device.

A measuring spoon with a 5 ml measure is supplied with this pack.

Pack size:    100 ml

Special precautions for disposal

No special requirements.