Summary of Product Characteristics (SmPC) - Echinaforce tablets
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce (Echinacea Tablets)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 380 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench herb (1:7.5-14.6) and 20 mg of extract (as dry extract) from fresh Echinacea purpurea (L.) Moench root (1:7.1-12.5).
Extraction solvent: Ethanol 65% v/v.
Each tablet contains 230.3 mg lactose monohydrate.
For full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Tablets
Greenish, round-shaped, bi-convex, bevelled tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal remedy used for symptomatic relief of colds, influenza type infections and similar upper respiratory tract conditions.
4.2 Posology and method of administration
For oral use
Adults, elderly and children over 12 years: 2 tablets 2 or 3 times daily
Not recommended for use in children under 12 years of age (See section 4.4. Special warnings and precautions for use.’)
Start at first signs of common cold. Do not use this 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, to plants of the Asteraceae (Compositae) family or to any of the excipients.
Because of their immunostimulating activity, Echinacea extracts must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g. collangenoses, 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, leukaemias) and allergic diathesis (e.g. urticaria, atopic dermatitis, asthma).
4.4 Special warnings and precautions for use
Do not exceed stated dose.
If the condition worsens or high fever occurs during the use of the product or if symptoms persist for more than 10 days, consult a doctor or qualified healthcare practitioner.
Not recommended for use in children under 12 years of age because data is 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.
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 (see Section 2).
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
Data on a limited number (several hundreds) of exposed pregnancies indicate no adverse effects of Echinacea extracts 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.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended unless advised by a doctor.
Studies on fertility have not been carried out.
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
Hypersensitive 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, Sjorgen 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
Has stimulatory effect on the immune system with increasing number of circulating leucocytes giving an increased phagocytic response for invading organisms.
5.2 Pharmacokinetic properties
No direct references found in literature search.
5.3 Preclinical safety data
Used in folk medicine for many years without any reports of side effects.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potato starch
Magnesium stearate
Lactose monohydrate
6.2. Incompatibilities
None.
6.3. Shelf-Life
Unopened - 2 years.
6.4 Special precautions for storage
Store below 25ºC.
6.5 Nature and contents of container
- a)
Amber glass bottle (type III soda lime glass conforming to Eur. Ph. standards)
with Aluminium fluted tamper-proof cap and pharmaceutical standard Cotton wool plug.
- b)
Amber glass bottle (type III soda lime glass conforming to Eur. Ph. standards)
with polypropylene wadded closure and viscose ring seal.
Pack sizes: 42, 60 and 120 tablets
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
A.Vogel Ltd
2 Brewster Place,
Irvine
KA11 5DD, UK
Telephone: 01294 277344
enquiries@avogel.co.uk
8. MARKETING AUTHORISATION NUMBER
PL 13668/0001
9. DATE OF FIRST AUTHORISATION / ENEWAL OF AUTHORISATION
20th September 1996
No Data Held
10 DATE OF REVISION OF THE TEXT
04/02/2020