Napiers Herbease Chesty Cough Lozenges
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Herbease Chesty Cough Lozenges Box's Herbals Cough & Chest Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains
50 mg of Senega root (Polygala senega L)
50 mg of extract (as dry extract) from Liquorice root (Glycyrrhiza glaba L.) (equivalent to 200mg of Liquorice root) (4:1)
Extraction Solvent: Water
10 mg of Ipecacuanha root (Cephaelis ipecacuanha (Brot.) A. Rich.)
50 mg of Marshmallow root (Althaea officinalis)
For a full list of excipients, see section 6.1.
Each lozenge contains approximately 826 mg of sucrose and 68 mg of glucose.
3 PHARMACEUTICAL FORM
Light yellow lozenges
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of sore throats and chesty coughs, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the Elderly: One or two lozenges to be sucked every four hours.
Maximum daily dose: 12 lozenges
The use in children and adolescents under 18 years of age is not recommended (see Section 4.4 ‘Special warnings and precautions for use’)
Duration of use:
If symptoms worsen or persist after 7 days, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescent under 18 years is not recommended because data are insufficient and medical advice should be sought.
If symptoms worsen or persist after 7 days, a doctor or qualified healthcare practitioner should be consulted.
If dyspnoea, fever or purulent sputum occurs, a doctor or qualified healthcare practitioner should be consulted.
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).
This medicinal product contains glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-glactose malabsorption or sucrose-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.
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).
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.
4.8 Undesirable effects
None reported.
If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with this product.
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
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.
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 100mg 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 lusters, 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
Menthol
Anise oil Lemon oil Peppermint oil Cubeb oil Acacia
Confectioner’s Sugar (sucrose & maize starch)
Liquid glucose
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in a cool dry place.
6.5 Nature and contents of container
Polyethylene Bag or Pouch: 36, 72 and 98 lozenges, packed in a cardboard carton.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Rickard Lane’s and W. H. Box Ltd 24 Tennant Street Edinburgh EH6 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0045
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 22/03/2013
10 DATE OF REVISION OF THE TEXT
22/03/2013