Summary of medicine characteristics - ENGLISH HERBAL MEDICINES PMS RELIEF TINCTURE
1 NAME OF THE MEDICINAL PRODUCT
English Herbal Medicines PMS Relief Tincture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral liquid contains 1 ml of tincture from Agnus castus fruit* (Vitex agnus-castus L.) (1:5). Extraction solvent: Ethanol 60% v/v.
*Certified_orgamcally produced herbal ingredient.
Each 1 ml (36 drops) of oral liquid also contains approximately 473mg Ethanol (alcohol) equivalent to 12 ml of beer or 5 ml of wine.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution Dark brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve premenstrual symptoms such as irritability, mood swings, breast tenderness, bloating and menstrual cramps, based on traditional use only
4.2 Posology and method of administration
For oral use only.
Shake bottle before use.
Adults:
For women experiencing premenstrual symptoms:
Take 40 drops (1.1ml), in a glass of water, once a day in the morning.
As treatment effects may not be apparent immediately, this product may need to be taken up to 3 months continuously.
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 a continued use of the product over three monthly cycles, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients in the product.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Patients who suffer or who have suffered from an estrogen-sensitive cancer should consult their doctor before using Vitex agnus-castus.
Patients who are using dopamine agonists, dopamine antagonists, estrogens and antiestrogens should consult their doctor before using Vitex agnus-castus (see Section 4.5 ‘Interactions with other medicinal products and other forms of interaction’)
If the symptoms worsen or persist after a continued use of the product over three monthly cycles, a doctor or a qualified healthcare practitioner should be consulted.
Vitex agnus-castus fruits are thought to act on the pituitary-hypothalamic axis and therefore patients with a history of a pituitary disorder should consult a doctor before using this product.
In cases of prolactin secreting tumours of the pituitary gland, the intake of Vitex agnus-castus fruits can mask symptoms of the tumour.
This product contains approximately 60 % v/v ethanol (alcohol), i.e. up to 520 mg per 1.1 ml dose, equivalent to 13 ml beer or 5.5 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
The use of this product in children or adolescents under 18 years of age has not been established due to a lack of adequate data and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
Contains alcohol, and should therefore be avoided in patients taking other medications known to interact with alcohol (e.g. metronidazole).
Because of the possible dopaminergenic and oestrogenic effects of Vitex agnus-castus fruits, interactions with dopamine agonists, dopamine antagonists, oestrogens and antioestrogens cannot be excluded.
4.6 Fertility, pregnancy and lactation
There is no indication for the use during pregnancy.
Data from reproductive studies suggest that extracts of Vitex agnus-castus fruits may affect lactation. The use during lactation is not recommended.
Because of the potential for Vitex agnus-castus to have hormone-like activity, this product should not be used by women trying to become pregnant.
Studies on the effects on fertility have not been carried out.
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. This product contains alcohol (see Section 2).
4.8 Undesirable effects
Severe allergic reactions with face swelling, dyspnoea and swallowing difficulties have been reported.
Allergic skin reactions (rash and urticaria), headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), acne, menstrual disorders have also been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration 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
4.9 OverdoseNo case of overdose has been reported. Management of an overdose should be symptomatic and supportive.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (23.7 g in 50ml and 47.3 g in 100ml: equivalent to 1.5 or 3 large glasses 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
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
Limited data from reproductive studies suggest that extracts of Vitex agnus castus, fructus influence lactation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original packaging.
6.5 Nature and contents of container
50ml or 100ml amber glass bottle, with 1 ml graduated glass pipette, butyl-rubber bulb and HDPE plastic cap. Plastic cap includes a tamper-evident collar that shears on first opening.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.