SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Premherb PMS Relief Tablets

Higher Nature Agnus Castus PMS Relief Film-coated Tablets Healthspan Agnus Castus Premenstrual Relief Tablets Boots PMS Relief Agnus Castus Tablets Holland & Barrett Femlieve Agnus Castus Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains: 4.0 mg of extract (as dry extract) from Agnus castus fruit (Vitex agnus castus L.) (7-13:1) (equivalent to 28-52 mg of Agnus castus).

Extraction solvent: Ethanol 60% m/m.

Excipients: 1 film-coated tablet contains 124 mg of lactose monohydrate and 36 mg of liquid glucose.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated tablet.

Salmon pink, round, convex, scored tablet.

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, based on traditional use only.

4.2 Posology and method of administration

4.3 Contraindications

For oral use only.

For women experiencing premenstrual symptoms, take 1 tablet daily. Tablets should be taken at the same time of day if possible (morning or evening) and swallowed whole with plenty of liquid. Some individuals may need to take PremHerb for up to 3 months for maximum benefit to occur.

Women suffering from a current pituitary disorder should not take this product.

Not for children and adolescents under 18 years.

4.4 Special warnings and precautions for use

Agnus castus 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.

This product contains glucose:

1 film-coated tablet contains max. 36 mg

This product contains lactose:

1 film-coated tablet contains max. 124 mg lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

There are no published data available on drug interactions with extracts of Agnus castus.

Animal experiments have shown that that the drug has a dopaminergic effect and so, theoretically, there could be a reduction in the effectiveness of dopamine-receptor antagonists, and/or a potentiation of dopamine-receptor agonists.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established, therefore it should be avoided during pregnancy or while breastfeeding.

Additionally, because of the potential for the product to have hormone-like actions the product should also be avoided by women who are trying to become pregnant.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Mild and reversible, transient side-effects are associated with Agnus castus use. Postmarketing surveillance studies suggest that the approximate incidence of adverse effects is between 1.9 - 5 %. Most frequently these are:

•    Nausea

•    Stomach disturbances

•    Headache

•    Diarrhoea

•    Allergic skin reactions.

If there are signs of an allergic reaction the product should be withdrawn.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

In the event of an overdose, patients are advised to contact a doctor, pharmacist or healthcare professional. A small overdose (up to 8 tablets) may not cause any symptoms. In the event of a large overdose (more than 8 tablets), advice should be sought from a doctor.

Management of an overdose should include appropriate symptomatic and supportive treatment as warranted by the clinical situation.

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

The non-clinical toxicology data available are limited. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients Tablet core:

Liquid glucose (dry substance)

Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate Maize starch

Cellulose, microcrystalline Sodium starch glycolate (Type A)

Film coating:

Lactose monohydrate

Hypromellose

Macrogol 4000

Titanium dioxide E171

Iron(III)-oxide E172 (==red iron oxide)

6.2    Incompatibilities

Not applicable

6.3    Shelf life

The shelf life is 3 years

6.4    Special precautions for storage

This product does not require any special storage instructions

6.5    Nature and contents of container

Original packages containing 30 (Premherb PMS Relief tablets, Higher Nature Agnus Castus PMS Relief Film-coated Tablets, Boots PMS Relief Agnus Castus Tablets, Holland & Barrett Femlieve Agnus Castus Tablets) or 60 (Healthspan Agnus Castus Premenstrual Relief Tablets, Holland & Barrett Femlieve Agnus Castus Tablets) film-coated tablets.

The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet

6.6 Special precautions for disposal

No special requirements

7. REGISTRATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8 MARKETING AUTHORISATION NUMBER(S)

THR 23056/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16^th October 2007

10 DATE OF REVISION OF THE TEXT

14/05/2015