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Patient Information Leaflet

Kira ®

PMS relief

film-coated tablets

Agnus Castus fruit dry extract 4 mg

THR

Certification Mark

Please read this leaflet carefully before you start taking these tablets. It contains some important information about Kira® PMS relief.

Keep this leaflet with the tablets. You may want to read it again or show it to your doctor, pharmacist or healthcare practitioner.

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What is in this leaflet

1.    What this product is and what it is used for

2.    Before you take this product

3.    How to take this product

4.    Side effects

5.    After taking this product

6.    Product description

1.    What this product is and what it is used for

Kira® PMS relief is a traditional herbal medicinal product containing Agnus Castus fruit. Each film-coated tablet of this product contains 4 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 % v/v.

Kira® PMS relief is a traditional herbal medicinal product used to help relieve the symptoms associated with premenstrual syndrome. This usage is based on traditional use only.

2.    Before you take this product

Do not take this product if you:

-    Are lactose-intolerant (react badly to lactose or milk)

-    Are pregnant, trying to become pregnant or are breast-feeding

-    Are allergic to any of the ingredients (see section 6)

-    Are suffering from a pituitary disorder

-    Are under 18 years of age

Tell your doctor before taking this product if you have:

-    An intolerance to some sugars (see section 6)

-    Had a pituitary disorder in the past

If you are taking dopamine-receptor antagonists or agonist-type drugs, there is a theoretical risk that this product may affect the way they work.

3.    How to take this product

For women experiencing premenstrual symptoms, take 1 tablet daily. Tablets should be taken at the same time of day if possible (morning or evening). Swallow the tablet whole with plenty of water or other liquid. Do not chew the tablets.

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You can take the tablets with or without food. The maximum beneficial effect of this product may take up to 3 months to occur in some women.

Do not exceed the stated dose.

Do not give Kira® PMS relief to children or adolescents under 18 years of age.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or healthcare practitioner and take this leaflet with you.

A small overdose (up to 8 tablets) may not cause any symptoms. In the event of a larger overdose (more than 8 tablets) advice should be sought from a doctor.

If you forget to take this product

Continue to take your usual dose at the usual time, it does not matter if you have missed a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner.

4. Side effects

Like all medicines, this product can have side effects. Any side effects associated with Kira^® PMS relief are usually mild and disappear in a few days. Side effects that have been reported are listed below.

-    Nausea or feeling sick

-    Indigestion

-    Digestive upsets such as wind, bloating or diarrhoea

-    Headache

If these persist for more than a few days, or become troublesome, stop taking this product.

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These common side effects are often only temporary.

- Allergic skin reactions such as nettle rash, itching of the skin

Stop taking this product immediately if you experience any allergic skin reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. After taking this product

Do not use your tablets after the expiry date. Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

This medicine does not require any special storage conditions.

Keep your tablets out of the reach and sight of children.

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Keep your tablets in the blister pack until it is time to take them.

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g 6. Product description

Each film-coated tablet contains 4 mg of extract (as dry extract) from Agnus Castus fruit (Vitex ag° nus castus L.) (7-13:1) (equivalent to 28-52 mg of §■ Agnus Castus). Extraction solvent: Ethanol 60 % v/v.

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This product also contains the following ingredients:

Tablet core:

Liquid glucose, lactose monohydrate, silica colloidal anhydrous, magnesium stearate, maize starch, cellulose microcrystalline, sodium starch glycol-late (type A)

Film-coating:

Lactose monohydrate, Hypromellose, macrogol 4000, titanium dioxide (E171), iron (III)-oxide (E172).

If you think you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 124 mg of lactose and 36 mg of liquid glucose.

Each pack contains 30 film-coated tablets.

Registration holder for this product

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

Manufacturer of this product

Klosterfrau Berlin GmbH Motzener Strasse 41 12277 Berlin Germany

Traditional herbal registration number: THR 29860/0003

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If you would like further information about this product, please contact:

Ceuta Healthcare Ltd.,

41 Richmond Hill,

BOURNEMOUTH BH26HS,

United Kingdom.

Telephone: 01202 780558

Fax: 01202 780559

Email.: info@ceutahealthcare.com

This leaflet was prepared in May 2015.

For a large print, Braille or audio version of this leaflet, call Ceuta Healthcare Ltd.

Cassella-med GmbH is a company of the

KLOSTERFRAU

HEALTHCARE GROUP

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