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Echinacin Liquidum Madaus

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Echinacin Liquidum MADAUS

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2.5    ml (2.49 g) of oral solution contains 1.99 g of pressed juice from Echinacea purpurea fresh herb [1.7-2.5 : 1] ( equivalent to 3.4 - 5 g Echinacea purpurea (L.) Moench)

1 ml of oral solution contains 179 mg ethanol (alcohol) equivalent to 4 ml of beer or

1.6    ml of wine

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution (clear or slightly to moderately turbid brownish solution)

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 use only.

Start at first signs of a common cold.

Adults, the elderly and children over 12 years:    2.5 ml of oral solution 3

times daily.

The solution can be swallowed undiluted or diluted with a little water. Duration of use:

Do not take this product for more than ten days.

If symptoms worsen or persist for more than ten days or high fever occurs, a doctor or qualified healthcare practitioner should be consulted.

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, e.g. daisies, marigolds, artichokes.

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 symptoms worsen or persist for more than ten days or high fever occurs, 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 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.

This medicinal product contains 22 % v/v ethanol (alcohol), i.e. up to 447.5 mg per

2.5 ml dose, equivalent to 10 ml beer, 4 ml wine per dose.

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.

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 therefore be avoided in patients taking medications known to interact with alcohol (e.g. metronidazole).

4.6


Pregnancy and lactation

Safety during pregnancy and lactation has not been established. 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.

No studies have been performed on fertility.

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.

This product contains alcohol (see Section 4.4).

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 cases of overdose have been reported.

Overdose of this product may result in alcohol intoxication: 50 ml of oral solution contains 8.95 g of alcohol, 100 ml of oral solution contain 17.9 g of alcohol, 150 ml of oral solution contain 26.85 g of alcohol (equivalent to 80 ml, 160 ml and 240 ml respectively of wine or 200 ml, 400 ml and 600 ml respectively of beer) and should be treated accordingly.

Pharmacodynamic properties

5.1


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

Echinacea purpurea showed no toxicity in single-dose toxicity (rodents), repeated-dose toxicity (rodents) and genotoxicity studies.

Tests on reproductive toxicity and on carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Ethanol Purified water

6.2    Incompatibilities

None known

6.3    Shelf life

3 years.

Shelf life after first opening: 3 months

6.4    Special precautions for storage

Do not store above 25°C.

Store in the original container.

Nature and contents of container

6.5


Amber glass bottles (Ph. Eur. Type III) containing 100 ml of brownish solution.

6.6 Special precautions for disposal

No special requirements for disposal.

7    MARKETING AUTHORISATION HOLDER

MADAUS GmbH 51101 Cologne Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 25843/0010

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/08/2012

10    DATE OF REVISION OF THE TEXT

08/08/2012