This information is intended for use by health professionals

1. Name of the medicinal product

PremEeze Agnus Castus Capsules.

Care Agnus Castus PMS Relief Capsules

2. Qualitative and quantitative composition

Each capsule contains 400mg of Agnus Castus Fruit (Vitex agnus castus L.)

For list of excipients see section 6.1

3. Pharmaceutical form

Hard capsules

Clear size 0 hard capsules with brown powder fill.

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, base on traditional use only.

4.2 Posology and method of administration

For oral use only. For women experiencing premenstrual symptoms.

Take 1 capsule 2 times a day (morning and night) swallowed with water.

As treatment effects may not be apparent immediately, the product may need to be taken for up to three months continuously. Maximum daily dose: 2 capsules.

If symptoms persist, worsen, or do not improve after 3 months use, a doctor or qualified healthcare practitioner should be consulted.

Women suffering from a pituitary disorder should not take this product. (see section 4.3).

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 or hypromellose.

Patients with a pituitary disorder.

Pregnancy or lactation.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Patients who suffer from 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 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 the symptoms persist, or worsen during the use of the product, or do not improve after 3 months of using the product, 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 with 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.

4.5 Interaction with other medicinal products and other forms of interaction

Because of the possible dopaminergic 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 in pregnancy.

Data from reproductive studies suggest that extracts of the 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.

No studies on the effect on fertility have 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.

4.8 Undesirable effects

Severe allergic reactions with face swelling, dypsnoea 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 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 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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.

4.9 Overdose

No case of overdose has been reported.

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 mutagenicity and carcinogenicity have not been performed.

Limited data from reproductive studies suggest that extracts of the fruits influence lactation. Adequate tests on reproductive toxicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Hypromellose (capsule shell)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 Months

6.4 Special precautions for storage

Store below 25°C.

Store in the original container.

6.5 Nature and contents of container

Ph Eur type III glass bottles with polypropylene screw cap incorporating an induction heat seal liner. Printed outer carton containing Patient Information Leaflet.

Pack sizes: 30, 60, 90, 120 hard capsules. Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Natures Aid Ltd

St Georges Park

Kirkham

Preston PR4 2DQ

Tel: 01772 686231

Fax: 01772 671688

email: sales@naturesaid.co.uk

8. Marketing authorisation number(s)

THR 33336/0009

9. Date of first authorisation/renewal of the authorisation

19/08/2014

10. Date of revision of the text

08/02/2018