Summary of Product Characteristics (SmPC) - Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of concentrate contains:
1140 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench herb (1:12-
- 13) and 60 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench root (1:11-12).
Extraction solvent: Ethanol 65% V/V
Excipients with known effect:
5 ml of concentrate contains 4.12 g of sucrose and a maximum of 33 mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution
Dark red to dark violet viscous liquid with an aromatic, fruity, elderberry-like odour and an aromatic, fruity, sweet, slightly sour taste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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 and children over 12 years:
Days 1-3: Take 5 ml diluted in hot water five times daily
Days 4-10: Take 5 ml diluted in hot water three times daily
Shake the bottle before use.
Dilute in hot water before use.
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 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 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 the stated dose.
Not recommended for use in children under 12 years of age because data is not sufficient and medical advice should be sought.
If 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 product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains 33 mg of alcohol (ethanol) in each 5 ml dose. The amount in each dose (5 ml) of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
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 extracts on pregnancy or on the health of the foetus/new-born child. Data concerning the immune system of the new-born 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 effect 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 disseminate, 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 of adverse reactions 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 balance 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.
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 required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
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 on 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
Sucrose
Purified water
Concentrated elderberry juice
Citric acid monohydrate
Modified starch
Medium-chain triglycerides
Potassium sorbate
Ethanol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months unopened.
After opening:
Use within 1 month of opening.
6.4 Special precautions for storage
Store below 25°C. After opening, store in the refrigerator (below 8°C).
6.5 Nature and contents of container
Amber glass bottle with white pilfer-proof PE-HD screw cap, white PE-LD spout and a PP measuring device.
A measuring spoon with a 5 ml measure is supplied with this pack.
Pack size: 100 ml
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
A.Vogel Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
enquiries@avogel.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0031
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/10/2014
10 DATE OF REVISION OF THE TEXT
25/10/2023