Potters Cough Remover
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Cough Remover
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains:-12 mg Lobelia Herb (Lobelia inflata L.)
6.5 mg Ipecacuanha Root (Cephaelis Ipecacuanha (Brot.))
0.1 ml of extract (as liquid extract) from White Horehound Herb (Marrubium vulgare L.) (1:1) (equivalent to 100 mg White Horehound leaf)
Extraction Solvent: Water
0.075 ml of extract (as liquid extract) from Elecampane Root (Inula helenium L.) (1:1) (equivalent to 75 mg Elecampane root)
Extraction Solvent: Water
0.075 ml of extract (as liquid extract) from Hyssop Herb (Hyssopus officinalis L.) (1:1) (equivalent to 75 mg Hyssop herb)
Extraction Solvent: Water
Excipients:
5 ml of oral liquid contains 0.75 ml ethanol and 1.15 g sucrose. (See section 4.4 ‘Special warnings and precautions for use’.)
For full list of excipients, See section 6.1
3 PHARMACEUTICAL FORM
Oral liquid.
A dark brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of coughs, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults, the elderly, children and adolescents over 12 years: Take two 5ml teaspoonful after meals three or four times a day.
Duration of use:
Do not use for more than 7 days.
Not recommended for children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or persist for more than 7 days, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients. Obstruction of the bile duct, cholangitis, liver disease, ileus
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.
If symptoms worsen or persist for more than 7 days, a doctor or a qualified healthcare practitioner should be consulted.
Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.
Patients with active peptic ulcer, gallstones and any other biliary disorders should consult a doctor before using Marrubium (White horehound) preparations.
This medicinal product contains 15% v/v ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 ml beer, 12.5 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.
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 fertility have not been carried out.
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.
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
Lobelia can cause nausea, vomiting, diarrhoea, coughing, tremors and dizziness. The frequency is not known
Allergic reactions including contact dermatitis may occur after ingesting Elecampane and White Horehound. The frequency is not known.
If other 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
The Lobelia and Ipecacuanha are likely to produce emesis.
Symptomatic and supportive measures should be taken as appropriate.
Large doses of Elecampane may cause vomiting ,diarrhoea, spasms and symptoms of paralysis.
Overdose of Lobelia could produce nausea vomiting, diarrhoea, profuse diaphoresis, paresis, hypotension and coma. High doses could be cardioactive
Older herbal texts state that doses of over 5 g unprocessed drug daily may produce symptoms of nausea, vomiting, dizziness, visual disturbances, reduced pulse rate and increased perspiration.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (12 g in 100 ml; 24 g in 200 ml: equivalent to 0.5 and 1 large glass 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
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Tincture Capsicum, Strong (capsaicin, ethanol, water)
Star Anise Oil
Myrrh Tincture (myrrh, ethanol, water)
Treacle
Syrup (sucrose)
Block Juice (spray dried liquorice powder)
Avicel CL (microcrystalline cellulose, carboxymethylcellulose)
Strawberry Flavouring (natural)
Water
6.3
6.4
6.5
Nature and contents of container
Glass bottle with child-resistant safety cap contained in cardboard carton: 60 ml, 100 ml, 150 ml, 200 ml or 250 ml.
Not all pack sizes may be marketed.
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MARKETING AUTHORISATION HOLDER
Vifor Pharma UK Ltd 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
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11/04/2013
10 DATE OF REVISION OF THE TEXT
04/09/2015