SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Kira® PMS relief film-coated tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

4mg 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: One film-coated tablet contains 124 mg 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 curved and with a score mark on one side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to help relieve the symptoms associated with premenstrual syndrome, based on traditional use only.

4.2    Posology and method of administration

For oral use only.

For women experiencing premenstrual symptoms, take 1 tablet daily.

Tablets should be taken at the same time of the day if possible (morning or evening) and swallowed whole with plenty of liquid. Do not chew the tablets.

Some individuals may need to take Kira® PMS relief for up to 3 months for maximum benefit to occur.

Not for children and adolescents under 18 years.

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

4.3 Contraindications

Hypersensitivity to agnus castus fruit or any other ingredient of the product.

This product is not recommended for use in 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 a doctor before using this product.

This product contains glucose: One film-coated tablet contains max. 36 mg of glucose.

This product contains lactose: One film-coated tablet contains max. 124 mg of lactose.

Patient with 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 the drug has got a dopaminergic effect. Theoretically there could be a reduction in the effectiveness of dopamine-receptor antagonists and / or a potentiation of dopamine-receptor agonists.

4.6    Pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. Therefore it should be avoided during pregnancy or lactation.

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.

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 the use of agnus castus. 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 any signs of an allergic reaction occur the product should be withdrawn.

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:

Website: www.mhra.gov.uk/yellowcard

4.9    Overdose

In the event of an overdose, patients are advised to contact a doctor, pharmacist or qualified healthcare professional. A small overdose (up to 8 tablets) is unlikely to cause any symptoms. In the event of a larger overdose (more than 8 tablets), advice should be sought from a doctor. Management of a larger overdose should be symptomatic and supportive in nature.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

No pharmacodynamic studies with Kira® PMS relief have been conducted. The pharmacodynamic properties are unknown.

5.2    Pharmacokinetic properties

No data available.

5.3    Preclinical safety data

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

6.1    List of excipients

Tablet core:

Liquid glucose (dry substance)

Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate Maize starch

Cellulose, microcrystalline Sodium starch glycollate (type A)

Film-coating:

Hypromellose Lactose monohydrate Macrogol 4000 Titanium dioxide E 171 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 conditions.

6.5    Nature and contents of    container

Original packages containing 30 film-coated tablets.

Kira® PMS relief film-coated tablets are packed in white-opaque polypropylene blisters and inserted into a carton.

6.6    Special precautions for    disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50670 Cologne Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 29860/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07^th October 2009

10    DATE OF REVISION OF THE TEXT

06/07/2015