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MENOPRET FILM-COATED TABLETS

Active substance(s): CIMICIFUGA EXTRACT

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Patient Information Leaflet

®

Menopret
film-coated tablets

Black Cohosh root extract 6.5 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 Menopret is and what it is used for
2. Before you take Menopret
3. How to take Menopret
4. Possible side-effects
5. How to store Menopret
6. Further information

1. What Menopret is and what it is used for
This product is a traditional medicinal product containing black cohosh root extract. Each filmcoated tablet contains 6.5 mg of extract (as dry extract) from black cohosh rhizome and root
(Cimicifuga racemosa (L.) Nutt.) (4.5 - 8.5:1) (equivalent to 29.25-55.25 mg of black cohosh).
Extraction solvent: Ethanol 60 % V/V.
Menopret is a traditional medicinal product used for the relief of symptoms associated with the
menopause, such as hot flushes, night sweats, poor sleep, mood changes and irritability,
based on traditional use only.
As there is evidence that black cohosh may have hormone-like actions, it should only be used
by women of childbearing potential if contraception is used.

2. Before you take Menopret
Do not take this product if you:
O
• have or ever have had liver or kidney disease
(e.g. hepatitis, jaundice or cirrhosis)
• have or ever have had an oestrogen dependent tumour
• are of childbearing potential and do not use
contraception
• are attempting to become pregnant
• are pregnant or 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:
• are currently using any
medicine containing oestrogen
• have an intolerance to some
sugars (see section 6)
Tell your doctor while taking
this product if you:
• notice any re-appearance or
change in menstrual bleeding
• develop any new menstrual
symptom(s)

3. How to take Menopret
Directions
Women experiencing menopausal symptoms: Take 1 tablet daily.
Not suitable for children or adolescents under 18 years of age.
Swallow the tablets whole with some water or other liquid. Menopret should be taken
at the same time each day if possible (preferably in the evening).
Do not exceed the stated dose.
If your symptoms persist or worsen
You must speak to a doctor if your symptoms worsen or do not improve after 3 months.
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.
Rare side-effects (affecting fewer than 1 in 1,000 people):
• digestive upsets such as indigestion or
diarrhoea
• swelling of the face and/or extremities
• weight gain






• 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.

Very rare side-effects (affecting fewer than 1 in 10,000 people):
• breast tenderness

• menstruation-like bleedings

Other side-effects:
Black cohosh may rarely cause liver problems.
Signs and symptoms of a liver problem include:
• yellowing of the eyes and/or skin
• nausea
• vomiting
• dark urine
• abdominal pain
• unusual tiredness
• loss of appetite

Stop taking this product immediately
and seek medical advice if you become
unwell with any of these signs/
symptoms.

If you notice any other side-effect not mentioned above, tell your doctor or pharmacist.
In addition, you can help 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 from your local pharmacy or GP‘s surgery.

5. How to store Menopret


O Do not use these tablets after the expiry date. The expiry date is printed on the box and
blister pack.



Store the tablets in a cool dry place where the temperature does not go above 30°C.


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 6.5 mg of extract (as dry extract) from black cohosh
rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5 - 8.5:1) (equivalent to 29.25-55.25 mg of
black cohosh).
This product also contains the following
ingredients: Tablet core: Cellulose powdered,
silica colloidal anhydrous, lactose monohydrate,
magnesium stearate, maize starch, calcium
hydrogen phosphate dihydrate, sodium starch
glycolate (type A).

Film-coating: Lactose monohydrate,
hypromellose, macrogol 4000, titanium
dioxide E 171, iron (III)-oxide E 172 (red
iron oxide), iron oxide hydrate E 172
(yellow iron oxide).

This product contains 23 mg lactose monohydrate. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this product.
Each pack contains 30 or 90 film-coated tablets.
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 26411/0002
For a large print, Braille or audio version of this leaflet please call 0845 180 0609.

Certification Mark

WP 1818601 UK

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BIONORICA INTERN
Druckreif

Korrektur

Abteilung

Name

Datum

Unterschrift

30.03.10 17:25

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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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