Summary of medicine characteristics - ENGLISH HERBAL MEDICINES ECHINACEA COLD-N-FLU TINCTURE, POTTERS ECHINACEA TINCTURE
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTEnglish Herbal Medicines Echinacea Cold-n-Flu Tincture
Potter’s Echinacea Tincture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml of oral liquid contains 1.7 ml of tincture from fresh Echinacea purpurea (L.)
Moench root * (1:2). Extraction solvent: Ethanol 45% v/v
* certified organically produced herbal ingredient
Each 2.5 ml of oral liquid also contains approximately 0.9 ml ethanol (alcohol). See Section
4.4 „Special warnings and precautions for use“
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral Liquid.
Medium to dark brown liquid
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 2.5ml spoon (half a 5 ml spoonful) three times a day.
Shake the bottle well before use in order to disperse any sediment.
Not suitable for children below the age of 12 years (see section 4.4 Special warnings and precautions for use.’)
Start at the 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 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).
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 the product or if symptoms persist for more than 10 days, consult a doctor or qualified healthcare practitioner.
Not recommended for children under 12 years because data are not sufficient and medical advice should be sought.
There is a possible risk of allergic reactions in sensitive individuals. Those patients should consult their doctor before using Echinacea.
There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.
This product contains approximately 35% v/v ethanol (alcohol), i.e. up to 0.69 g per 2.5 ml dose, equivalent to 6.1 ml beer or 2.6 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
4.5 Interaction with other medicinal products and other forms of interaction
Contains alcohol, and should therefore be avoided in patients taking other medications known to interact with alcohol (e.g. metronidazole).
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 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.
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 of this product on the ability to drive or use machinery have been performed. This product contains alcohol (see Section 2).
4.8 Undesirable effects
Hypersensitivity reactions (rash, urticaria, swelling of the face) may occur. Cases of severe hypersensitivity reactions such as Stevens-Johnson Syndrome, angioedema of the skin, Quincke oedema, bronchospasm with airway obstruction, asthma and anaphylactic shock) have been reported.
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 qualified healthcare
practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration 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.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (13.8 g in 50 ml; 27.6 g in 100 ml and 55.2 g in 200 ml: equivalent to approximately 0.6, 1.2 or 2.4 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Water
Star Anise Oil
Capsicum tincture (capsicum, ethanol, water)
Lemon Oil
Elderberry juice concentrate
Clove Oil
Ceylon Cinnamon Bark Oil
Glycerol
Liquorice Liquid Extract (liquorice root, ethanol, water and sorbitol)
Peppermint Oil
Xanthan Gum
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container.
6.5 Nature and contents of container
6.5 Nature and contents of containerAmber glass bottle with HDPE screw-cap: 50ml, 100ml and 200ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal No special requirements.
7 MARKETING AUTHORISATION HOLDER
English Herbal Medicines Ltd
Town Park Farm
Brooke
Rutland
LE15 8DG.
8 MARKETING AUTHORISATION NUMBER(S) THR 35008/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/06/2017