Lifeplan Echinacea Cold And Flu Relief Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lifeplan Echinacea Cold and Flu Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 140mg of extract (as dry extract) from (Echinacea purpurea root) (equivalent to 840mg - 1120mg of Echinacea purpurea (L.) Moench, root).
Extraction solvent: Ethanol 75% v/v For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige to light brown circular tablet.
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
Adults, elderly and children over 12 years: Take 1 tablet twice daily. Swallow the tablet whole with water.
Start at first signs of common cold. Do not use the medicinal product for more than 10 days.
The product is not recommended for children below 12 years. (See section 4.4 Special warning and precautions for use)
If the 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 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, leukaemia’s) allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).
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 product is not suitable for children under 12 years of age because data are not sufficient and medical advice should be sought.
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 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 on pregnancy or on the health of the fetus/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 the effects on fertility have not been performed.
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-Johson 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, Sjogren syndrome with renal tublar dysfunction) has been reported.
Leucopenia may occur on long-term use (more than 8 weeks)
The frequency is not known.
If other adverse reactions not mentioned above occurr, 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 Yellow Card Scheme, Website: 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 applicable -not required as per Article 16c (1) (a) (iii) of Directive
2001/83/EC as amended.
5.3 Preclinical safety data
Reverse mutation assays (Ames test) on bacteria indicated that Echinacea purpurea root extract contained in the product was not mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA98, TA 100 and TA102) mutation assays with or without metabolic activation.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Excipients in the Extract Maltodextrin
Silica colloidol anhydrous
Excipients in the tablet Microcystalline Cellulose Calcium hydrogen phosphate dihydrate Stearic acid
Crosscarmellose Sodium Magnesium Stearate
6.2 Incompatibilities
None Known
6.3 Shelf life
2 Years
6.4 Special precautions for storage
Do not store above 25°C Store in the original packaging.
6.5 Nature and contents of container
Amber glass bottle with polypropylene cap. Printed card outer carton containing Patient Information Leaflet.
Pack size of 60 tablets.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Lifeplan Products Ltd,
Elizabethan Way,
Lutterworth,
Leicestershire, LE17 4ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 20093/0002