Echinaforce Forte Cold & Flu Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce Forte Cold & Flu Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1,140 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench herb (1:12) and 60 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench root (1:11).
Extraction solvent: Ethanol 65% v/v
Excipients:
One tablet contains 683.4 mg lactose monohydrate and 7.5 mg of soya polysaccharide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Greenish, round-shaped, bi-convex, bevelled 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 administration
Adults, elderly and children over 12 years:
1 tablet two to three times daily
This tablet formulation is not intended for children below 12 years.
Start at first signs of common cold. Do not use the 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 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),
immunodeficiences (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).
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this product.
This product contains soya polysaccharide. If you are allergic to peanut or soya, do not take this product.
Refer to Section 2, Qualitative and Quantitative Composition for lactose and soya content.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the symptoms worsen or high fever occurs during the use of the product, or if symptoms persist for more than 10 days, 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 before using Echinacea.
This formulation is not suitable for children under 12 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
The product should not 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, Quinke 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 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 pharmacist should be consulted.
4.9 Overdose
No case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
No relevant pharmacodynamic data are available.
5.2 Pharmacokinetic properties
No relevant pharmacokinetic data are available.
5.3 Preclinical safety data
Echinacea purpurea herb showed no toxicity in single-dose toxicity, repeated-dose toxicity and genotoxicity studies; tests on reproductive toxicity and carcinogenicity have not been performed.
Tests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed with Echinacea purpurea root.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Pregelatinised starch Soya polysaccharide Magnesium stearate
6.2 Incompatibilities
Not known.
6.3 Shelf life
Unopened:
3 years
After first opening the container: 3 months
6.4 Special precautions for storage
This product does not require any special storage conditions.
Keep out of reach and sight of children.
6.5 Nature and contents of container
Amber glass bottles (type III conforming to Ph.Eur. standards) with coated aluminium foil sealing and aluminium pilfer proof closure fitted with a polyethylene liner.
Pack sizes: 30 tablets
40 tablets 120 tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bioforce (UK) Ltd,
2 Brewster Place,
Irvine
KA11 5DD, UK Telephone: 01294 277344 enquiries@avogel.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/06/2009
10 DATE OF REVISION OF THE TEXT
11/06/2009