MENSIFEM FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mensifem

film-coated tablets

Dry extract of Cimicifuga racemosa L. rhizome

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if you do not improve after 6 to 8 weeks or if you worsen.

Contents of the package leaflet

1. What is Mensifem and what is it used for
2. What you need to know before taking Mensifem
3. How to take Mensifem
4. Possible side effects
5. Storage of Mensifem
6. Package contents and additional information

1. What is Mensifem and what is it used for

Mensifem is a herbal medicine indicated in adult women for the relief of menopausal symptoms, such as hot flashes and intense sweating.

You should consult a doctor if you worsen or do not improve after 6 to 8 weeks (40 to 60 days) of treatment.

2. What you need to know before taking Mensifem

Do not take Mensifem

• if you are allergic (hypersensitive) to Cimicifuga racemosaor to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Mensifem:

• If you have a history of liver disease. In such cases, a liver function test should be performed before starting treatment.
• If you detect signs or develop symptoms of liver damage (fatigue, loss of appetite, yellowing of the skin and eyes, or severe pain in the upper abdomen with nausea and vomiting or dark urine). Stop taking Mensifem and consult your doctor immediately.
• If you experience vaginal bleeding or detect new or non-specific symptoms.
• If you have been or are being treated for breast cancer or other hormone-dependent tumors.
• If you are taking estrogens.
• If symptoms worsen during the use of this medicine.

If any of the above cases apply to you, do not take Mensifem without a medical prescription.

If symptoms persist or worsen during treatment, consult your doctor or pharmacist.

Children and adolescents

There is no interest in using Mensifem in the pediatric population for the proposed therapeutic indication.

Taking Mensifem with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. Medicines can interact with each other if taken at the same time. However, no interactions have been reported, and no interaction studies have been conducted with Mensifem.

Pregnancy, breastfeeding, and fertility

Do not take Mensifem if you are pregnant. It is unknown if the active ingredient is excreted in breast milk. Mensifem should not be taken during the breastfeeding period. If there is a possibility of becoming pregnant, even during menopause, effective contraceptive methods should be used during treatment.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Mensifem contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Mensifem contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet, which is essentially "sodium-free".

3. How to take Mensifem

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

The usual dose for adult women in menopause is 1 film-coated tablet twice a day, i.e., one in the morning and one in the evening (maximum 2 film-coated tablets per day).

Method of administration:

Oral. The film-coated tablets are taken whole, without chewing or sucking, with some liquid.

Duration of treatment:

If symptoms persist during the use of the medicine, consult a doctor or pharmacist.

Mensifem should not be taken for more than six months in a row without medical indication.

Use in children and adolescents

There is no interest in using Mensifem in the pediatric population for the proposed therapeutic indication.

Special populations

There are insufficient data to establish specific dosage recommendations in patients with renal or hepatic impairment.

Patients with a history of liver disease should not take Mensifem without medical indication (see section 2 "Warnings and precautions" and section 4 "Possible side effects").

If you take more Mensifem than you should:

No cases of overdose have been reported. Inform your doctor if you took a higher dose of this medicine than recommended. Your doctor will decide what measures to take.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medicine and the amount used.

If you forget to take Mensifem:

Do not take a double dose to make up for forgotten doses. Take the next tablet at the usual time.

If you stop taking Mensifem:

As a general rule, it is harmless to stop taking Mensifem.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The frequency of the following side effects is unknown:

• The use of products containing Cimicifuga racemosa rhizome is associated with liver toxicity (including hepatitis, jaundice, fatigue, loss of appetite, pain in the upper abdomen with nausea and vomiting, dark urine, and changes in liver function tests).
• Cutaneous allergic reactions (urticaria, pruritus, skin rash).
• Inflammation of the facial tissues and lower limbs (known as edema).
• Gastrointestinal symptoms (e.g., dyspeptic disorders, diarrhea).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mensifem

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Keep the blisters in the outer packaging to protect them from light.

Do not use this medicine after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Mensifem

The active ingredient is:

2.8 mg of dry extract of Cimicifuga racemosa(L.) Nutt., rhizome (black cohosh) (5-10:1) *1

extraction solvent: ethanol 58% (v/v)

The other ingredients are calcium hydrogen phosphate dihydrate; ammonium methacrylate copolymer, type A, dispersion 3% (Eudragit RL 30D); red iron oxide (E 172); yellow iron oxide (E 172); lactose monohydrate; polyethylene glycol (macrogol 6000); magnesium stearate (vegetable); potato starch; sodium hydroxide; sorbic acid; talc; titanium dioxide (E 171).

Appearance of the product and package contents

Mensifem film-coated tablets are available in PVC/PVDC/aluminum blisters.

Box of 60 film-coated tablets

Box of 90 film-coated tablets

Only some package sizes may be marketed.

The tablets are terracotta-colored, round, and biconvex with a smooth surface. The film-coated tablet has a diameter of between 7.0 and 7.2 mm.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Mensifem Filmtabletten

Belgium, Germany, Luxembourg, Poland, Slovenia, Estonia

Croatia, Denmark, Norway, Sweden Klimadynon

Bulgaria ??????????

Spain, France, Italy Mensifem

Slovakia, Czech Republic Menofem

Latvia Klimadynon 2.8 mg apvalkotas tablets

Lithuania Klimadynon 2.8 mg plévele dengtos tablets

Marketing authorization holder and manufacturer

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt

Germany

Phone: +49 / (0)9181 / 231-90

Fax: +49 / (0)9181 / 231-265

Email: info@bionorica.de

Date of the last revision of this package leaflet:December 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/