Potters Cold & Flu Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter's Cold & Flu Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains: -
0.1 ml of extract (as liquid extract) from Elder Flower (Sambucus nigra L.) (1:1) (equivalent to 0.1 g Elder Flower)
Extraction Solvent: Water
0.1 ml of extract (as liquid extract) from Hemlock Spruce (Pinus canadensis L.) (1:1) (equivalent to 0.1 g Hemlock Spruce)
Extraction Solvent: Ethanol 45% v/v
0.05 ml of extract (as liquid extract) from Bayberry Bark (Myrica cerifera L.) (1:1) (equivalent to 0.05 g Bayberry Bark)
Extraction Solvent: Ethanol 45% v/v
Excipients:
5 ml of oral liquid contains ethanol, sucrose and glucose (dextrose). (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.
A reddish brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve of the symptoms of colds and flu, chills and sore throats, based on traditional use only.
4.2 Posology and method of administration
For oral use.
Start at the first signs of a common cold.
Adults, the elderly, children and adolescents over 12 years: Two 5ml teaspoonfuls in a third of a cup of warm or hot water, three times a day.
The use in children under 12 years is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Duration of use:
Not to be taken for more than 1 week.
If the symptoms persist or worsen for more than 7 days during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the symptoms persist or worsen for more than 7 days during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
The use in children under 12 years is not recommended because data are insufficient and medical advice should be sought.
If symptoms worsen or when dyspnoea, fever or purulent sputum occurs during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
This medicinal product contains 8% v/v ethanol (alcohol), i.e. up to 640 mg per dose, equivalent to 16 ml beer, 6.7 ml wine per dose.
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicinal product contains sucrose and glucose (dextrose).
Patients with rare hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.
Studies on the effect 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 and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section
4.4 ‘Special warnings and precautions for use’.)
4.8 Undesirable effects
None known.
If adverse reactions occur, a doctor or a qualified health care 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 cases have been reported with this product.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (8 g in 100 ml; 16 g in 200 ml: equivalent to 0.4 and 0.8 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 Peppermint Oil Cassia Oil Pimento Oil Clove Oil
Stronger Capsicum Tincture (96% ethanol, water, capsicum)
Strong Ginger Tincture (90% ethanol, ginger root)
Capsicum Oleoresin (red chilli pepper, mono & diglicerides of fatty acids (E471), castor oil)
Syrup (sucrose)
Acacia Powder Beetroot Powder (E162)
Caramel
Viscarin (carrageenan, glucose (dextrose))
Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 25oC. Keep in the original container.
6.5 Nature and contents of container
Glass bottle with child-resistant safety cap contained in cardboard carton: 75 ml, 100 ml, 135 ml, 150 ml, 200 ml or 250 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
MARKETING AUTHORISATION NUMBER(S)
THR 44893/0005
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/05/2012
10
DATE OF REVISION OF THE TEXT
28/09/2015