Neals Yard Remedies Stress & Sleep Herbal Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Herbal Stress and Sleep Aid
Neal’s Yard Remedies Stress and Sleep Herbal Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral liquid contains: -
0.812 ml of extract (as liquid extract) from Vervain herb (Verbena officinalis L.) (1:1) (equivalent to 812 mg of Vervain)
Extraction Solvent: Ethanol 21% v/v
0.188 ml of extract (as liquid extract) from Scullcap herb (Scutellaria lateriflora L.) (1:1) (equivalent to 188 mg of Scullcap)
Extraction Solvent: Ethanol 21% v/v
0.4 ml of tincture from dried Scullcap herb (Scutellaria lateriflora L.) (1:5) (equivalent to 80 mg of Scullcap)
Extraction Solvent: Ethanol 41% v/v
0.425ml of extract (as liquid extract) from Passion Flower herb (Passiflora incarnata L.) (1:1) (equivalent to 425 mg of Passion Flower)
Extraction Solvent: Ethanol 21% v/v
0.213ml of extract (as liquid extract) from Oat seed (Avena sativa L.) (1:1) (equivalent to 213 mg of Oat seed)
Extraction Solvent: Ethanol 21% v/v
5 ml of oral liquid contains approximately 0.7 ml of ethanol (alcohol) equivalent to14 ml of beer or 5.8 ml of wine.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral liquid.
A dark brown mobile liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For short term oral use only.
Adults and the elderly:
For temporary relief of mild anxiety:
One 5 ml teaspoonful in water three times day.
To aid sleep: One 5 ml teaspoonful in water at bed time. An extra 5 ml in water can be taken during the night if needed.
Not recommended for use in children or adolescents under 18 years (see section 4.4 ‘Special warnings and precautions for use’).
If the symptoms worsen or persist after 4 weeks of using of this medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients, or oat preparations or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Not recommended for use in children or adolescents under 18 years of age due to the lack of adequate data and medical advice should be sought.
Caution is advised when used in patients with coeliac disease because data on the protein content of Avena are not available.
This medicinal product contains approximately 14 % v/v ethanol (alcohol), i.e. up to 560 mg per dose, equivalent to 14 ml beer, 5.8 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.
If the symptoms worsen or persist after 4 weeks during the use of this medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.
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. In the absence of sufficient data, the use 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
May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.
This product contains alcohol (See Section 4.4 “Special warnings and precautions for use”.)
4.8 Undesirable effects
There has been one report of nausea and tachycardia (increased heart beat) and one report of hypersensitivity (vasculitis) in patients using Passion flower herb.
Other possible side effects include allergic skin reactions, such as itching, redness or blistering of the skin.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with this product.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (10 g in 100 ml; 20 g in 200 ml: equivalent to 0.4 or 0.8 glass of wine respectively or 0.98 or 1.9 glass 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid Extract Wild Thyme
Orange Oil
Lemon Oil
Coriander Oil
Aniseed Oil
90 % ethanol
Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Glass bottle with child-resistant safety cap placed in a cardboard carton: 100ml and 200ml.
6.6 Special precautions for disposal and other handling
Not special requirements.
7 MARKETING AUTHORISATION HOLDER
Highland Herbs Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/11/2012
10 DATE OF REVISION OF THE TEXT
23/05/2016