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CYCLOPRET FILM-COATED TABLETS

Active substance(s): AGNUS CASTUS EXTRACT

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Patient Information Leaflet

Cyclopret

®

film-coated tablets
Agnus castus fruit extract 4 mg
Please read this leaflet carefully before you
start taking this product. It contains some
important information about this medicine.
Keep this leaflet with the tablets. You may
want to read it again or show it to your doctor,
pharmacist or healthcare practitioner.

In this leaflet
1. What Cyclopret is and what it is used for
2. Before you take Cyclopret
3. How to take Cyclopret
4. Possible side-effects
5. How to store Cyclopret
6. Further information

1. What Cyclopret is and what it is used for
This product is a traditional herbal medicinal product containing agnus castus fruit extract.
Each film-coated tablet contains 4 mg of extract (as dry extract) from Agnus castus fruit (Vitex
agnus castus L., fructus) (7-11:1). Extraction solvent: Ethanol 70 % V/V.
Cyclopret is a traditional herbal medicinal product used to help relieve premenstrual
symptoms such as irritability, mood swings, breast tenderness, bloating and menstrual
cramps, based on traditional use only.

2. Before you take Cyclopret

Do not take this product if you:
• are currently suffering from a pituitary disorder
• are pregnant or are trying to become pregnant
• are breastfeeding
• are under 18 years of age.
• are allergic to any of the ingredients
(see section 6 for list of ingredients. This product
contains lactose)

Tell your doctor before
taking this product if you:
• have previously had a
pituitary disorder
• have an intolerance to
some sugars
(see section 6).

Taking this product with other medicines
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.

3. How to take Cyclopret


Directions
Women experiencing premenstrual symptoms:
Take 1 tablet daily.
Not suitable for children or adolescents under 18 years of age.


Swallow the tablet whole with some water or other liquid. Tablets should be taken at
the same time each day if possible (either morning or evening). For some women the
maximum beneficial effect may take several months to develop.


Do not exceed the stated dose.
If your symptoms persist or worsen:
You must speak to a healthcare practitioner
If you take too much of this product (overdose)
Speak to a doctor, pharmacist or healthcare practitioner and take this leaflet with you.
If you forget to take a dose
Continue to take your next usual dose at the usual time. It does not matter if you miss a dose.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist
or healthcare practitioner.

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4. Possible side-effects
Like all medicines, this product can have side-effects. Possible side-effects are shown below.
Common side-effects (affecting fewer than 1 in 10 people)






nausea or feeling sick
indigestion
digestive upsets such as wind,
bloating or diarrhoea
headache

• allergic skin reactions such as nettle
rash or itching of the skin

If these persist for more than a few days,
or become troublesome, stop taking
the product.
These side effects are often only temporary.
Stop taking this product immediately if
you experience any allergic skin reaction.

Other possible side-effects:






allergic-type reactions with tissue
swelling, difficulty breathing and
difficulty swallowing
temporary restlessness,
confusion and hallucinations

Stop taking this product immediately if
you experience any of these side-effects.

If you notice any other side-effect not mentioned above, tell your doctor or pharmacist.
In addition, you can help to make sure that medicines remain as safe as possible
by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk;
alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm
Monday–Friday) or fill in a paper form available from your local pharmacy.

5. How to store Cyclopret
 Do not use these tablets after the expiry date. The expiry date is printed on the box
and blister pack.


This medicinal product does not require any special storage conditions.

Keep the tablets out of the reach and sight of children.
Keep the tablets in the blister pack until it is time to use them.

6. Further information
Each film-coated tablet contains 4 mg of extract (as dry extract) from Agnus castus fruit
(Vitex agnus castus L., fructus) (7-11:1). Extraction solvent: Ethanol 70 % V/V.
This product also contains the following ingredients:
Tablet core: Potato starch, lactose monohydrate, silicon dioxide, microcrystalline cellulose,
magnesium stearate, povidone.
Film-coating: : Talc, titanium dioxide (E 171), iron oxide yellow (E 172), indigo carmine (E 132),
macrogol 6000, ammonium methacrylate-copolymer (type A)
This product contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
Available in packs of 30 and 90 tablets.
Traditional herbal registration holder and manufacturer for this product
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt, Germany
This leaflet was prepared in April 2010.
Traditional herbal registration number: THR 26411/0001
For a large print, Braille or audio version of this leaflet, please call 0845 180 0609

Certification Mark

RF 1819401 UK

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BIONORICA INTERN
Druckreif

Korrektur

Abteilung

Name

Datum

Unterschrift

29.03.10 14:58

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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