SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Agnus Castus PMS Relief Tablets GNC Live Well Agnus Castus PMS Relief Tablets Lifecycle Agnus Castus PMS Relief Tablets Nature’s Garden Agnus Castus PMS Relief Tablets Nature’s Bounty Agnus Castus PMS Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 3.9mg of extract (as dry extract) from Agnus Castus Fruit (Vitex agnus-castus L.) (equivalent to 23.4mg - 31.2mg of Agnus Castus Fruit).

Extraction solvent: Ethanol 75% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated tablets

Clear film coated, speckled, brown, round shaped tablet, plain on both sides

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to help relieve symptoms associated with premenstrual syndrome. such as irritability, mood swings, breast tenderness, bloating and menstrual cramps. This is based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults

For women experiencing premenstrual symptoms:

Take one tablet daily. Take the tablet at the same time each day (morning or evening). Swallow the whole tablet with water.

Do not exceed the stated dose.

Some women may need to take this product for up to 3 months for maximum benefit to occur

Duration of use:

If symptoms worsen or do not improve after a continued use over three months, a Doctor or a qualified Healthcare Practitioner should be consulted.

Not for use in children under 18 years (see section 4.4 Special warning and precautions for use)

4.3 Contraindications

Hypersensitivity to Agnus castus fruit or any of the excipients

4.4 Special warnings and precautions for use

Patients who suffer or who have suffered from an oestrogen-sensitive cancer should consult their doctor before using Vitex agnus-castus.

Patients who are using dopamine agonists, dopamine antagonists, oestrogens and antioestrogens should consult their doctor before using Vitex agnus-castus. (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.

In cases of prolactin secreting tumours of the pituitary gland, the intake of Vitex agnus-castus, fructus can mask symptoms of the tumor.

Vitex agnus-castus, fructus is 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

4.5 Interaction with other medicinal products and other forms of interaction

Because of the possible dopaminergic and oestrogenic effects of Vitex agnus-castus fructus interactions with dopamine agonists, dopamine antagonists, oestrogens and antioestrogens cannot be excluded.

4.6 Fertility, pregnancy and lactation

There is no indication for use during pregnancy.

Data from reproductive studies suggest that extracts of Vitex agnus-castus, fructus may affect lactation. The use during lactation is not recommended.

Due to the potential for Vitex agnus-castus 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.

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 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

4.9    Overdose

In the event of an overdose, patients are advised to contact a doctor, pharmacist or healthcare professional.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

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 Vitex agnus-castus, fructus influence lactation.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet coreMicrocrystalline cellulose Croscarmellose sodium Magnesium Stearate Silica colloidal hydrated

For the coating:

Tablet Coating-

Hypromellose

Glycerol

Excipients in the extract:

Maltodextrin

Silica colloidal anhydrous

6.2    Incompatibilities

Not applicable.

6.3 Shelf life

3 years

Special precautions for storage

Do not store above 25°C.

Store in the original packaging Keep the bottle tightly closed

6.5    Nature and contents of container

Container:

Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The Inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film

Pack sizes:

30’s and 60’s

6.6    Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire CV10 7RH United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0033

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 31/07/2012

10 DATE OF REVISION OF THE TEXT

07/11/2014