Echinacin Juice Madaus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Echinacin Juice MADAUS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of oral liquid contains 0.117 g of dried pressed juice from Echinacea purpurea fresh herb) [31.5 - 53.6 : 1] equivalent to 3.7 - 6.3 g Echinacea purpurea (L.) Moench).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution (yellow to brown, viscous liquid)
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: one 5 ml teaspoonful to be taken 3 times a day.
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)
Contraindications
4.3
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.
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 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.
Undesirable effects
4.8
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
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
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.
6.1 List of excipients
Xylitol Xanthan gum Potassium sorbate Citric acid Orange aroma Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
3 years.
Shelf life after first opening: 6 months
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original container
6.5 Nature and contents of container
Glass bottles containing 100 ml.
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 25843/0009
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/08/2012
10 DATE OF REVISION OF THE TEXT
08/08/2012