SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Menopret® Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One 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).

Extraction solvent: Ethanol 60 % V/V.

One film-coated tablet contains 23 mg lactose monohydrate.

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets.

The film-coated tablets are terracotta-coloured, round, convex curved and with a line (notch) on one side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal 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.

Women of childbearing potential should use effective contraception.

Duration of use: If symptoms worsen or do not improve after 3 months a doctor should be consulted.

4.2 Posology and method of administration

For oral use only.

Women experiencing menopausal symptoms:

Take one film-coated tablet daily.

The film-coated tablets should be swallowed whole with some water or other liquid. Menopret should be taken at the same time each day if possible (preferably in the evening).

Children and adolescents under 18

There is no use in children or adolescents under 18 years of age.

Hepatic and renal impairment.

The safety of black cohosh has not been established in patients with hepatic and/or renal impairment, therefore the product should not be used by patients with these conditions.

4.3 Contraindications

Patients with known hypersensitivity to black cohosh or one of the excipients. Women with an oestrogen-dependent tumour or a history of the same condition. Patients with current or previous liver disease.

The product should not be taken by pregnant and lactating women and women attempting to become pregnant (see also section 4.6).

4.4 Special warnings and precautions for use

Rare cases of hepatic reactions following the use of black cohosh have been reported. Patients who develop any signs or symptoms of liver dysfunction (e.g. jaundice, upper abdominal pain with nausea and vomiting, loss of appetite, dark urine, fatigue) should discontinue the product immediately and consult a doctor.

Patients with a family history of oestrogen-dependent tumours should seek medical advice before using this product.

Oestrogens should only be used concurrently with this product under medical supervision as the effects of these drugs may be potentiated by black cohosh.

In cases of resumed menstrual bleeding a doctor should be consulted. If a new menstrual disorder arises or if an existing menstrual disorder persists excessively, a doctor should be consulted.

This medicine contains lactose.

Patients with rare 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

The simultaneous use of oestrogens may enhance their effect.

4.6 Pregnancy and lactation

The safety of black cohosh during pregnancy and lactation has not been established. Therefore this product should not be used by pregnant and lactating women and women attempting to become pregnant.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

The following side-effects have rarely (less than 1 in 1,000, but more than 1 in 10,000) been reported:

•    gastrointestinal symptoms such as dyspeptic symptoms and diarrhoea

•    allergic skin reactions

•    peripheral and facial oedema

•    weight gain

In rare cases black cohosh may cause liver reactions, including hepatitis, jaundice and disturbances in liver function tests.

In very rare cases a feeling of tenderness in the breasts and menstruation-like bleedings have been reported.

4.9 Overdose

No cases of overdose have been reported with the product.

In cases of overdose the patient should contact a doctor, pharmacist or healthcare practitioner. A small overdose is unlikely to result in any symptoms. In case of a larger overdose, management should be symptomatic and supportive.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: G02CP03

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

There are no studies on pharmacokinetics and bioavailability because the active substances are not yet known in detail.

5.3 Preclinical safety data

The Cimicifuga dry extract (special extract BNO 1055) was negative in a test (Ames test) for mutagenicity.

Tests on reproductive toxicity and carcinogenicity have not been performed.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Herbal preparation

Lactose monohydrate Cellulose powdered Silica, colloidal anhydrous Tablet core:

Cellulose powder Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate Maize starch

Calcium hydrogen phosphate Sodium starch glycolate (type A)

Tablet coating:

Lactose monohydrate Hypromellose Macrogol 4000 Titanium dioxide (E 171)

Iron oxide red (E 172)

Iron oxide yellow (E 172)

Incompatibilities

None known.

Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Package with 30 or 90 film-coated tablets.

Tablets are sealed in PVC/PVDC aluminium blisters which are packaged into a cardboard carton.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

BIONORICA SE KerschensteinerstraBe 11-15 92318 Neumarkt Phone: ++49 9181 231-90 Fax: ++49 9181 231-265 E-Mail: info@bionorica.de

8    MARKETING AUTHORISATION NUMBER(S)

THR 26411/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/06/2010

10    DATE OF REVISION OF THE TEXT

09/06/2010