SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Elixir of Echinacea Plus Napiers Elixir of Echinacea Complex

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains: -0.64 ml of extract (as liquid extract) from Echinacea angustifolia (Echinacea angustifolia (D.C.)) (1:1) (equivalent to 0.64 g Echinacea angustifolia root)

Extraction solvent: Ethanol 45% v/v 0.175 ml of extract (as liquid extract) from Wild Indigo (Baptisia tinctoria R.Br.) (1:1) (equivalent to 0.175 g Wild Indigo root)

Extraction solvent: Ethanol 60% v/v 0.16 ml of extract (as liquid extract) from Fumitory (Fumaria officinalis L.) (1:1) (equivalent to 0.16 g Fumitory herb)

Extraction solvent: Water

Excipients:

5ml of oral liquid contains approximately 0.888 ml ethanol, 0.55 g sucrose, 0.095 ml glucose and also contains sorbitol. (See Section 4.4 “Special warnings and precautions for use”.)

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral liquid.

A dark brown liquid.

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve:

•    the symptoms of the common cold and flu type infections

•    minor skin conditions based on traditional use only.

4.2 Posology and method of administration

For oral use.

Start at the first signs of a common cold

Adults, the elderly, children and adolescents over 12 years: One 5ml teaspoonful three times a day.

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

Duration of use:

Do not use this product for more than 10 days.

If the symptoms worsen or persist for longer than 10 days during the use of the medicinal product or you get a high fever, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients, other plants of the Asteraceae (Compositae) family or any of the excipients.

Because of its immunostimulating activity, Echinacea 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. onocological cytostatic therapy, history of organ or bone marrow transplant) and 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.

If the symptoms worsen or do not improve or high fever occurs during the use of the product or if symptoms persist for more than 10 days, a doctor or a qualified health care practitioner should be consulted.

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

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

This medicinal product contains 19 % v/v ethanol (alcohol). Each 5 ml corresponds to 760 mg alcohol equivalent to 19 ml beer or 7.9 ml wine.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

This medicinal product contains sucrose, glucose and sorbitol.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose 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.

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during 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 fertility have not been performed.

4.7 Effects on ability to drive and use machines

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section 4.4 ‘Special warnings and precautions for use’.)

4.8 Undesirable effects

Hypersensitive reactions (skin reactions rash, urticaria, Stevens-Johnson Syndrome, angiodema of the skin, Quincke’s oedema, bronchospasm with obstruction, asthma and analphylactic shock) have been reported.

Echinacea can trigger 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 of these reactions is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

4.9 Overdose

No cases of overdose have been reported.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (15.2 g in 100ml; 30.4 g in 200ml: equivalent to 0.4 and 0.8 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

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 carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethanol

Anise Oil Coriander Oil Lemon Oil Orange Oil

Elixir Saccharin (saccharin sodium, water, 90 % ethanol)

Colour Solution (caramel, glycerin, 90 % ethanol, water)

Glycerin

Fluid Extract Glycyrrhizae Special (water, glucose liquid, caramel, 90 % ethanol, liquorice liquid extract, sorbitol)

Syrup (sucrose)

Water

6.2 Incompatibilities

None known.

DATE OF REVISION OF THE TEXT

04/08/2012