SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

A.Vogel 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 product contains 69.5 v/v % ethanol (alcohol).

This corresponds to:

•    248 mg alcohol equivalent to 6.2 ml beer or 2.58 ml wine (15 drops)

•    341 mg alcohol equivalent to 8.4 ml beer or 3.5 ml wine (20 drops)

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

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

Brown glass PELD dropper bottles (Type III glass) with a tamper-proof screw cap.

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

Bioforce (UK) 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

15/04/2014