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LEAFLET SPEC


PATIENT INFORMATION LEAFLET


HOLLAND ft BARRETT

FEMLIEVE AGNUS CASTUS TABLETS Agnus Castus fruit extract 4 mg


Important notes

U Please read this leaflet carefully before you start taking these tablets: It contains some important information about Holland & Barrett Femlieve Agnus Castus tablets.

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


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    Possible side-effeCts

5    How to store this product

6    Further information


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

This product is a traditional herbal medicinal product containing Agnus Castus fruit. It is a traditional herbal medicinal product used to help relieve symptoms of premenstrual syndrome such as irritability, mood swings, breast tenderness, bloating and menstrual cramps. This usage is based on traditional use only.


3 - How to take this product

For women experiencing premenstrual symptoms

Take 1 tablet daily. Try to take the tablet at the same time each day either in the morning or evening. Swallow the tablet whole with some water or other liquid. Do not chew the tablets. You can take the tablet with or without food. The maximum beneficial effect of this product may take up to 3 months to develop in some women.

Do not exceed the stated dose.

Do not give to children or adolescents under 18 years old.

If you take too much of this product

(overdose): If you take more than the recommended dose, speak to a doctor, pharmacist or qualified 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 large 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 qualified healthcare practitioner


Reporting of side effects. If you get any

side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.


5 - How to store this product

U Do not use your tablets after the expiry date U 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 U This medicinal product does not require any special storage conditions U Keep the tablets out of the reach and sight of children

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


2 - Before you take this product

Do not take this product if you are:

U Lactose-intolerant (react badly to lactose or milk)

U Pregnant or trying to become pregnant U Breastfeeding

U Allergic to any of the ingredients (see section 6)

U Suffering from a pituitary disorder U Under 18 years of age Tell your doctor before taking this product if you have:

U An intolerance to some sugars (see section 6)

U Had a pituitary disorder in the past

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


4 - Possible side-effects

Like all medicines, this product can have side-effects although not everyone gets them. The frequency is not known. Possible side effects are:

U Gastrointestinal disorders (nausea, abdominal pain)

U Allergic skin reactions (rash, urticaria)

U Headache U Dizziness

U Acne

U Menstrual disorders U Severe allergic reactions such as face swelling, shortness of breath and swallowing difficulties

If any of the above side-effects become serious or if any side-effects not listed above occur; a Doctor or a qualified Healthcare Practitioner should be consulted.

If you experience any allergic reactions, stop taking this product immediately and consult a Doctor


6 - Further information

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

This product also contains the following ingredients: Tablet core: Liquid glucose, 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 (E 171), iron (III)-oxide (E 172).

If 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 124mg of lactose and 36mg of liquid glucose.

Each pack contains 30 or 60 film-coated tablets.


Registration holder for this product

Schwabe Pharma (UK) Ltd,

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 IFX

Manufactured for:

NBTY Europe Limited by:

Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenburen, Germany

Traditional herbal registration number:

THR 23056/0002

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

NBTY Europe Limited Regulatory Services Department Samuel Ryder House Barling Way Nuneaton

Warwickshire, CVI0 7RH United Kingdom

Is this leaflet hard to see or read?

Contact us on:

Telephone: +44 (0) 2476 215 400

Fax: +44 (0) 2476 215 452

Email: customerservices@NBTYeurope.com

This leaflet was prepared on: 23/07/2014


CERTIFICATION MARK


THR"


HB35285/35286 AGNUS CASTUS LEAFLET

LEAFLET SIZE: 140mm x 180mm (flat)

45mm x 140mm (folded)

BLEED: N/A BULK: N/A ISSUE: 00A BARCODE: N/A

CHANGES FROM LAST PRINT: None

COLOURS:

K

P364

FONTS:

Gil Sans

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CAUTION: It is the vendors responsibility to print a scannable UPC code from either our artwork or your alternative UPC method

COLOUR MATCH:


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