Napiers Oral Skin Soother Herbal Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Oral Skin Soother Herbal Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains:-
0.05ml of extract (as liquid extract) from Burdock root (Arctium lappa L.) (1:1) (equivalent to 50 mg Burdock root)
Extraction Solvent: Ethanol 21% v/v
0.10ml of extract (as liquid extract) from Burdock root (Arctium lappa L.) (1:1) (equivalent to 100 mg Burdock root)
Extraction Solvent: Ethanol 17% v/v
0.05ml of extract (as liquid extract) from Sarsaparilla root (Smilax aristolochiaefolia) (1:1) (equivalent to 50 mg Sarsaparilla)
Extraction Solvent: Ethanol 22% v/v
0.195ml of extract (as liquid extract) from Red Clover flower (Trifolium pratense) (1:1) (equivalent to 195 mg Red Clover)
Extraction Solvent: Ethanol 22% v/v
0.05ml of extract (as liquid extract) from Queen's Delight root (Stillingia sylvatica L.) (1:1) (equivalent to 50 mg Queen's Delight)
Extraction Solvent: Ethanol 22% v/v
0.10ml of extract (as liquid extract) from Cascara bark (Rhamnus purshiana L.) (1:1) (equivalent to 100 mg Cascara bark)
Extraction Solvent: Ethanol 13% v/v
0.05ml of extract (as liquid extract) from Poke root (Phytolacca decandra) (1:1) (equivalent to 50mg Poke Root)
Extraction Solvent: Ethanol 22% v/v
0.03ml of extract (as liquid extract) from Prickly Ash bark (Zanthoxylum americanum) (1:1) (equivalent to 0.03mg Prickly Ash bark)
Extract Solvent: Ethanol 22/% v/v
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral liquid.
Dark brown liquid with odour of sassafras.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of minor skin conditions causing skin irritation, including allergic conditions, dermatitis, mild acne and mild eczema based on traditional use.
4.2 Posology and method of administration
For oral use only.
Adults, Children over 12 and the Elderly: One 5ml teaspoonful three times a day.
The use in children and adolescents under 12 years of age is not recommended (See Section 4.4. Special warnings and precautions for use)
If symptoms worsen or persist for more than 2 weeks during the use of the medicinal product a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or to plants of the Asteraceae (Compositae) family or to any of the excipients.
Infected spots or inflamed spots associated with infection.
Do not exceed the stated dose.
If symptoms worsen or persist for more than 2 weeks consult a doctor or qualified healthcare practitioner.
If not treated adequately, acne may cause scarring. Do not use this product and consult your doctor or qualified healthcare practitioner if; you have widespread redness, oozing or infected skin sores, infected or inflamed spots, if the skin is broken, or if the affected area has suddenly become inflamed.
The use in children and adolescents under 12 years of age is not recommended because data are insufficient and medical advice should be sought.
This medicinal product contains 8.3 % v/v ethanol (alcohol), i.e. up to 332 mg per dose, equivalent to 8.3 ml beer, 3.46 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.
Contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption sucrose-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Contains Alcohol and should be avoided in patients taking medicines known to interact with alcohol e.g. metronidazole.
4.6 Fertility, Pregnancy and lactation
Safety 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 effects on fertility have not been performed.
4.7 Effects on ability to drive and use 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
Anaphylactic shock has been reported with Burdock root. This is rare and the frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
4.9 Overdose
No cases known.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (6.64 g in 100 ml; 16.6 g in 250 ml: equivalent to 0.4 or 1 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
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Ethanol Sucrose Caramel E150 Glycerin E422 Orange oil Water
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.
6.5 Nature and contents of container
100ml amber glass bottle with child-resistant polypropylene cap. 200ml amber glass bottle with child-resistant polypropylene cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
7 MARKETING AUTHORISATION HOLDER
Highland Herbs Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/12/2012
10 DATE OF REVISION OF THE TEXT
23/01/2015