Summary of Product Characteristics (SmPC) - A Vogel Agnus Castus oral drops
1 NAME OF THE MEDICINAL PRODUCT
A.Vogel Premenstrual Relief PMS Agnus castus oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml (33 drops) contains:
895 mg of tincture from Agnus castus fruits (Vitex agnus-castus L.) (1:10)
Extraction solvent: Ethanol 69.5% v/v
1 ml contains approximately 555mg of ethanol (alcohol) equivalent to 13.9 ml beer or 5.79 ml wine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
Clear, yellow-brown liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to help 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.
Adults: For the temporary relief of symptoms associated with premenstrual syndrome in women. Take 15-20 drops in a little water twice daily
As treatment effects may not be apparent immediately, the product may need to be taken up to 3 months continuously.
Maximum daily dose: 40 drops
Duration of use:
If the symptoms persist or worsen or do not improve after 3 months, a doctor or a qualified healthcare practitioner should be consulted.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to Agnus castus fruit or to any of the excipients.
Patients with a pituitary disorder
Pregnancy and lactation
4.4 Special warnings and precautions for use
Do not exceed stated dose.
Patients who suffer or suffered from an oestrogen-sensitive cancer should consult their doctor before using the product.
Patients who are using dopamine agonists, dopamine antagonists, oestrogens and antioestrogens should consult their doctor before using the product (see section 4.5 ‘Interactions with other medicinal products and other forms of interaction’).
The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.
If symptoms persist or worsen or do not improve after 3 months during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Agnus castus fruits are thought to act on the pituitary-hypothalamic axis and therefore patients with a history of pituitary disorder should consult a doctor before using this product. In cases of prolactin secreting tumours of the pituitary gland the intake of Agnus castus fruits can mask symptoms of the tumour.
This medicine contains approximately 277 – 369 mg of alcohol (ethanol) in each 15 – 20 drops, respectively.
The amount in 15 – 20 drops of this medicine is equivalent to less than 7 – 9 ml beer or 3 – 4 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
4.5 Interaction with other medicinal products and other forms of interaction
Because of the possible dopaminergic and oestrogenic effects of Agnus castus fruits, interactions with dopamine agonists, dopamine antagonists, oestrogens and anti-oestrogens cannot be excluded.
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
There is no indication for the use during pregnancy.
Data from reproductive studies suggest that extracts of Agnus castus fruits may affect lactation. The use during lactation is not recommended.
Due to the potential for Agnus castus fruits to have hormone-like actions, use should be avoided by women who are trying to get pregnant.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
This product contains alcohol (See Section 4.4 for details of alcohol content).
4.8 Undesirable effects
Severe allergic reactions with face swelling, dyspnoea and swallowing difficulties. Allergic skin reactions (rash and urticaria), headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), acne, menstrual disorders have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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
No case of overdose has been reported with Agnus castus fruits.
Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (27.75 g in 50 ml equivalent to 1 or 2 small 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
Limited data from reproductive studies suggest that extracts of Agnus castus fruits influence lactation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
From tincture:
Ethanol
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened:
4 years
In-use:
3 months
6.4 Special precautions for storage
Store in the original packaging.
6.5 Nature and contents of container
Amber glass dropper bottles (Type III glass) with a two part dropper (PE-LD)/dispenser cap (PP) and ring (PE-HD).
Amber glass dropper bottles (Type III glass Ph.Eur.) with a child-resistant closure (polypropylene cap with high density polyethylene child-resistant mechanism or high density polyethylene cap with high density polyethylene child-resistant mechanism) fitted with a drop inset dispenser (low density polyethylene).
Pack sizes: 50 ml
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
A.Vogel Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
enquiries@avogel.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0029
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/04/2014
10 DATE OF REVISION OF THE TEXT
20/08/2024