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1. Potters Lightning Cough Remedy
2. Potters Lightning Cough Remedy

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Lightning Cough Remedy

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains: -

0.25 ml of extract (as liquid extract) from Liquorice Root (Glycyrrhiza glabra L.) (1:1)

Excipients:

5 ml of oral liquid contains 0.5 ml ethanol. (See section 4.4 ‘Special warnings and precautions for use’.)

Also contains small amounts of sorbitol and 3.74 ml maltitol For full list of excipients see Section 6.1

3    PHARMACEUTICAL FORM

Oral Liquid.

A dark reddish 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 three or four times a day.

Not recommended for children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’).

Duration of use:

Do not take for more than 7 days.

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.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

Patients taking liquorice medication should not take other liquorice containing products as serious adverse events may occur such as water retention, hypokalemia, hypertension, cardiac rhythm disorders.

Liquorice medication is not recommended to be used in patients affected by hypertension, kidney diseases, liver or cardiovascular disorders or hypokalemia, as they are more sensitive to the adverse effects of liquorice. Concomitant use with diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance is not recommended (see section 4.5).

If symptoms worsen or persist for more than 7 days,a doctor or a qualified health care practitioner should be consulted.

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.

This product contains sorbitol and maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicinal product contains 10% v/v ethanol (alcohol), i.e. up to 0.8 g per dose, equivalent to 20 ml beer, 8.3 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.

4.5 Interaction with other medicinal products and other forms of interaction

Liquorice root may counteract antihypertensive action of prescribed medications.

Not to be used concomitantly with diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or other medications which may aggravate electrolyte imbalance (see section with 4.4).

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

Studies in animals have shown reproductive toxicity (see section 5.3 ‘Preclinical safety data’).

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use 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 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

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

Cases of overdose have been reported with prolonged use (more than 4 weeks) and/or intake of high amount of liquorice, with symptoms such as water retention, hypokalaemia, hypertension, cardiac rhythm disorders, hypertensive encephalopathy.

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 0.33 and 0.67 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

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.

A study has shown that 18P-glycyrrhetinic acid4 crosses through the placental barrier and can be detected in the rat foetuses. Following feeding of dams with 100 mg 18P-glycyrrhetinic acid/kg/day commencing on the 13th day of gestation, on the 17th, 19th and 21st days of gestation the maternal plasma 18P-glycyrrhetinic acid concentrations were approximately 100 pg/ml, whereas the foetal concentrations were 5, 18 and 32 p/ml, respectively.

In developmental toxicity studies, glycyrrhizin (ammonium salt) exhibited some embryotoxicity to the developing rat foetus, but the foetal effects were considered as minor. These effects were shown at the dose of 100 and 250 mg/kg of ammonium glycyrrhizin from 7th to 20th day of pregnancy (soft-tissue abnormalities, mostly renal, and external haemorrhages) and at the dose of 1000 mg/kg of 18P-glycyrrhetinic acid from the 13th day of gestation (significant reduction in lamellar body content of lungs and reduced number alveolar lamellar body and surfactant clusters, but no apparent increase in malformation or foetal death rate).

Another study suggested that 100 mg/kg of liquorice extract repeated for 7 days may also aggravate body weight loss and malformations of foetuses, induced by intrauterine exposure to cyclophosphamide.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol Aniseed Oil

Liquid Maltitol (hydrogenated glucose syrup)

Sorbitol E420

Water

10 DATE OF REVISION OF THE TEXT

28/09/2015