PATIENT LEAFLET: INFORMATION FOR THE USER

MENSIFEM

film-coated tablets
Dry extract of Cimicifuga rhizome
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you notice a worsening of symptoms or if you do not notice any improvement after 6–8 weeks (40–60 days).

Contents of this leaflet

What MENSIFEM is and what it is used for
What you need to know before taking MENSIFEM
How to take MENSIFEM
Possible side effects
How to store MENSIFEM
Contents of the pack and other information

1. WHAT MENSIFEM IS AND WHAT IT IS USED FOR

MENSIFEM is a herbal medicinal product intended for adult women, used to relieve menopausal symptoms such as hot flushes and excessive sweating.

2. What you need to know before taking MENSIFEM

Do not take MENSIFEM

if you are allergic (hypersensitive) to Cimicifuga racemosa or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking MENSIFEM:

if you have a history of liver disease. You should undergo liver function tests;
if you develop signs and symptoms indicating liver damage (fatigue, loss of appetite, yellowing of the skin or eyes, severe pain in the upper stomach with nausea and vomiting, or dark urine). Stop taking MENSIFEM and contact your doctor immediately;
if vaginal bleeding occurs or if you experience unclear or new symptoms;
if you have undergone or are undergoing treatments for breast cancer or other hormone-dependent tumours;
if you are taking estrogens. If any of the above apply to you, do not take MENSIFEM without consulting your doctor.

Children and adolescents
This medicine must not be used in children and adolescents.

Other medicines and MENSIFEM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines can interact when taken concomitantly. However, no interactions have been reported and no interaction studies have been conducted with MENSIFEM.

Pregnancy and breastfeeding
The use of MENSIFEM during pregnancy is not recommended. Even if you are experiencing menopausal symptoms, you may still be able to become pregnant; therefore, use an effective contraceptive method during treatment.
It is not known whether the active substance is excreted in human milk. MENSIFEM must not be used during breastfeeding.

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive vehicles or operate machinery.

MENSIFEM contains lactose.
If you have been diagnosed by your doctor as having an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take MENSIFEM

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
The usual dose for postmenopausal adult women is 1 film-coated tablet twice daily, in the morning and evening (maximum 2 film-coated tablets per day).
Method of administration
For oral use. Take the film-coated tablets with liquid. The tablet must not be chewed or sucked.
Duration of treatment
If symptoms persist during treatment with this medicine, consult a doctor or pharmacist.
MENSIFEM must not be used for longer than 6 months without consulting a doctor.
Use in children and adolescents
This medicine must not be used in children and adolescents.
Special populations:
There are no data available regarding dosage instructions in case of impaired renal function.
Patients with a history of liver disease should not take MENSIFEM without consulting their doctor (see section 2. "Warnings and precautions" and 4. "Possible side effects").
If you take more MENSIFEM than you should
Cases of overdose have not been reported. Inform your doctor if you have taken more of this medicine than recommended. The doctor will decide on the necessary measures.
If you forget to take MENSIFEM
Do not take a double dose to make up for the forgotten tablet. Take the next tablet at the usual time.
If you stop taking MENSIFEM
Stopping treatment with MENSIFEM generally does not cause negative consequences.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown:

The use of products containing Cimicifuga is associated with liver toxicity (including hepatitis, jaundice, abnormalities in liver function tests).
Skin reactions (urticaria, pruritus, rash).
Swelling of facial and lower limb tissues (known as edema).
Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhea).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MENSIFEM

Do not store this medicine above 30 °C.
Keep this medicine out of the sight and reach of children.
Keep the blister packs inside the outer carton.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What MENSIFEM Contains
The active substance is:
2.8 mg of dry extract from Cimicifuga racemosa (L.) Nutt., rhizome (Cimicifuga racemosa) (DER 5-10:1),
corresponding to 14–28 mg of dried rhizome.
Extraction solvent: ethanol 58% (V/V).
The other components are:
Calcium hydrogen phosphate dihydrate; methacrylic acid copolymer ammonium type A, 30% dispersion (Eudragit RL 30D); red iron oxide (E 172); yellow iron oxide (E 172); lactose monohydrate; Macrogol 6000; magnesium stearate (vegetable); potato starch; sodium hydroxide; sorbic acid; talc; titanium dioxide (E 171).

Description of the Appearance of MENSIFEM and Contents of the Pack
MENSIFEM is available in PVC/PVDC/aluminum blisters.
Pack containing 60 film-coated tablets
Pack containing 90 film-coated tablets
Not all pack sizes may be marketed.
The tablets are terracotta-colored, round, biconvex, with a smooth surface. A film-coated tablet has a diameter of 7.0 – 7.2 mm.

This medicinal product is authorized in the EEA (European Economic Area) Member States under the following names:
Austria Mensifem Filmtabletten
Belgium, Croatia, Denmark, Estonia, Germany, Luxembourg, Norway, Poland, Slovenia, Sweden, Klimadynon
Bulgaria Климадинон
France, Italy, Spain Mensifem
Estonia Klimadynon
Czech Republic, Slovakia Menofem
Latvia Klimadynon 2.8 mg apvalkotās tabletes
Lithuania Klimadynon 2.8 mg plėvele dengtos tabletės

Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Germany
Telephone: +49 / (0)9181 / 231-90
Fax: +49 / (0)9181 / 231-265
e-mail: [email protected]