Summary of medicine characteristics - CARE ECHINACEA COLD & FLU RELIEF TABLETS,ECHINEEZE ECHINACEA TABLETS
1 NAME OF THE MEDICINAL PRODUCT
EchinEeze Echinacea Tablets
Care Echinacea Cold & Flu Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 70mg of extract (as dry extract) from Echinacea purpurea root (equivalent to 460 – 530mg of Echinacea purpurea(L.) Moench root.)
Extraction solvent: Ethanol 30% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige circular convex uncoated tablets.
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 administration.
Adults, elderly and children over 12 years: take one tablet three times a day.
This product is not intended for children below 12 years.
Start at first signs of common cold. Do not use the medicinal 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 a qualified healthcare practitionershould 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), immunodeficiencies (e.g.:HIV infection; AIDS), immunosuppression (e.g.: oncological cytostatic therapy; history of organ or bone marrow transplant), and diseases of the white blood cell system (e.g.: agranulocytosis, leukemias) allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).
Children under 12 years of age
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or high fever occurs during the use of this product, or if symptoms persist for more than 10 days, a doctor or qualified healthcare practitioner should be consulted.
This formulation is not suitable for children under 12 years of age.
Keep out of the sight and reach of children
There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea
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
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.
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, Sjögren 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 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 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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5.1
No relevant pharmacokinetic data are available.
5.2 Pharmacokinetic properties
No relevant pharmacokinetic data are available
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed with Echinacea purpurea root.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Herbal extract:
Maltodextrin
Silica, colloidal, hydrated.
Tablet core:
Calcium hydrogen phosphate dihydrate
Cellulose, microcrystalline
Silica, colloidal, hydrated. Crosscarmellose sodium Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
HDPE bottles
30 months
Glass bottles 36 months
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
6.5 Nature and contents of containerHDPE bottle with tamper evident closure and foam wad. Printed card outer carton containing Patient Information Leaflet.
or
Ph Eur type III glass bottles with polypropylene closure incorporating an induction heat seal liner. Printed card outer carton containing Patient Information Leaflet.
Pack sizes of 30, 60, 90, 120, and 180 tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Natures Aid Health Products
St Georges Park
Kirkham
Preston
Lancashire PR4 2DQ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 33336/0002