Lanes Red Sage Catarrh Remedy
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lane’s Red Sage Catarrh Remedy
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains:-
0.2 ml of extract (as liquid extract) from Red Sage leaf (Salvia officinalis L.) (equivalent to 200mg Red Sage)
Extraction Solvent: Ethanol 21% v/v
0.55 ml of extract (as liquid extract) from Liquorice root (Glycyrrhiza glabra L.) DER (equivalent to 550 mg Liquorice root)
Extraction Solvent: Ethanol 18% v/v
5 ml of oral liquid contains approximately 0.4 ml of ethanol and 1.15mg of sucrose. (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.
Dark brown slightly viscous liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of colds, nasal congestion and sinusitis, and to relieve a chesty mucus cough, based on traditional use only.
4.2 Posology and method of administration
For oral use.
Adults and the elderly: Take one 5 ml teaspoonful three or four times a day, and during the night sipped slowly.
Maximum recommended daily dose: 20 ml (4 doses)
Adolescents and children over 12 years old: Take one 5 ml teaspoonful three times a day (six hours apart).
Maximum recommended daily dose : 15 ml (3 doses)
The use in children under 12 years is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
If the symptoms worsen or persist for more than 7 days during the use of this medicinal product, a doctor or a qualified health care 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 is not recommended in children under 12 years of age due to the lack of adequate data.
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 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 adverse effects of liquorice.
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 during the use of this medicinal product, a doctor or qualified health care practitioner should be consulted.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains approximately 18.1 % v/v ethanol (alcohol), i.e. up to 905 mg per dose, equivalent to 18.7 ml beer, 7.54 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
No studies have been carried out to determine if drug interactions occur with this product.
The intake of Sage leaf preparations might influence the effect of medicinal products acting via GABA receptor (e.g. barbiturates, benzodiazepines), even if not seen clinically. Therefore the concomitant use with such medicinal products is not recommended.
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.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronizadole).
4.6 Fertility, pregnancy and lactation
Studies in animals have shown reproductive toxicity with liquorice ( See Section 5.3 Preclinical safety data)
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.
Studies on the effect of this product on fertility have not been performed.
4.7 Effects on ability to drive and use machines
Sage leaf may impair ability to drive and use machines. Affected patients should not drive or operate machines.
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 qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with this product.
Overdose has been reported with a sense of heat, tachycardia, vertigo and epileptic form convulsions (seizures) after intake corresponding to more than 15 g of sage leaves (equivalent to 2.5 x 150ml bottles of this product).
Cases of overdose have been reported with prolonged use of liquorice (more than 4 weeks) and/or intake of high amounts of liquorice with symptoms such as water retention, hypokalaemia, hypertension, cardiac rhythm disorders, hypertensive encephalopathy.
Overdose of this products may result in alcohol intoxication; the amount of alcohol in a full bottle (18.1g in 100 ml, 27.15g in 150 ml: equivalent to 0.6 or 0.9 large glasses of wine respectively or 1.45 or 2.17 glasses of beer, 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.
Liquorice
A study has shown that 18P-glycyrrhetinic acid a constituent of liquorice, crosses through the placental barrier and can be detected in the rat foetuses. Following feeding of dams with 100mg 18P-glycyrrhetinic acd/kg/day commencing on the 13 th day of gestation, on the 17th, 19th and 21st days of gestation the maternal plasma 18P-glycyrrhetinic acid concentrations were approximately 100pg/ml, whereas the foetal concentrations were 5, 18 and 32p/ml respectively.
In development 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 (sot-tissue abnormalities, mostly renal and external haemorrhages) and at yhe 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 body and surfactant clusters, but no apparent increase in malformation of 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 cycloposphamide.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Garlic oil (Allium sativum L.)
Tragacanth Juniper Berry Oil Pumilio Pine Oil Menthol Sucrose (syrup)
Golden syrup Ethanol Water Talc
6.2 Incompatibilities
Not applicable.
6.3
Shelf life
Three years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle with hard polypropylene screw-cap: 100 ml, 150 ml and 300 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
Rickard Lane’s and W. H. Box Ltd 24 Tennant Street Edinburgh EH6 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2013 06/02/2013