Prospect: information for the user

Mensifem

Coated tablets

Dried extract of Cimicifuga racemosa L. rhizome

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Followexactly the administration instructions of the medicine contained in this prospect or those indicated by your doctoror pharmacist.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you do not improve after6 to8 weeks or if you worsen.

1. What is Mensifem and for what it is used

2. What you need to know before starting to take Mensifem

3. How to take Mensifem

4. Possible adverse effects

5. Storage of Mensifem

6. Contents of the package and additional information

Mensifemis a medication based onplantsindicated in adult women for the relief of menopausal discomforts, such as hot flashes and intensesweating.

You should consult a doctor if it worsens or does not improve after6 to8 weeks (40 to60 days) of treatment.

Do not take Mensifem

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

Warnings and precautions

Consult your doctor before starting to take Mensifem:

• If you have a history of liver disease. In this case, 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 stomach with nausea and vomiting, or dark urine). Discontinue taking Mensifem and consult your doctor immediately.
• If you experience vaginal bleeding or detect new or nonspecific symptoms.
• If you have been or are being treated for breast cancer or other hormone-dependent tumors.
• If you are taking estrogens.
• If symptoms persist during use of this medication.

If one of the above cases applies to you, do not take Mensifem without a doctor's prescription.

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

Children and adolescents

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

Taking Mensifem with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Medications can interact with each other if taken simultaneously. However, no interactions have been reported or studied with Mensifem.

Pregnancy, breastfeeding, and fertility

You should not take Mensifem if you are pregnant. It is unknown whether the active ingredient is excreted in breast milk. Mensifem should not be taken during lactation. 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, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

Mensifem contains lactose

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

Mensifem contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

The usual dose for adult women in menopause is 1 coated tablet twice a day, that is, one in the morning and one at night (maximum 2 coated tablets per day).

Administration form:

Oral route. The coated tablets are taken whole, without chewing or sucking, with a small amount of liquid.

Treatment duration:

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

Mensifem should not be taken for more than six months consecutively 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

The data are insufficient to establish specific dose recommendations in patients with renal or hepatic dysfunction.

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

If you take more Mensifem than you should:

No cases of overdose have been described. Inform your doctor if you took a dose of this medication higher 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 Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forgot to take Mensifem:

Do not take a double dose to compensate for the missed doses. Take the next tablet at the usual time.

If you interrupt treatment with Mensifem:

It is generally harmless to interrupt treatment with Mensifem.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of the following adverse effects is unknown:

• Use of products containing cimicifuga rhizome is associated with liver toxicity (including hepatitis, jaundice (yellow discoloration of the skin and eyes), fatigue, loss of appetite, upper stomach pain with nausea and vomiting, dark urine, and alterations in liver function tests).
• Skin allergic reactions (urticaria, pruritus, skin rash).
• Inflammation of facial and lower limb tissues (known as edema).
• Gastrointestinal symptoms (e.g., dyspeptic disorders, diarrhea).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

Store the blister packs in the outer packaging to protect them from light.

Do not use this medication after the expiration date shown on the box. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Mensifem

The active principle is:

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

solvent for extraction: ethanol at 58% (v/v)

The other components are calcium dihydrogen phosphate dihydrate; copolymer of ammonium methacrylate, 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 (vegetal); potato starch; sodium hydroxide; sorbic acid; talc; titanium dioxide (E171).

Appearance of the product and contents of the package

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

Box with 60 film-coated tablets

Box with 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 with the following names:

AustriaMensifem Filmtabletten

Belgium, Germany, Luxembourg, Poland, Slovenia, Estonia

Croatia, Denmark, Norway,SwedenKlimadynon

Bulgaria??????????

Spain, France, ItalyMensifem

Slovakia, Czech RepublicMenofem

LithuaniaKlimadynon 2.8 mg coated tablets

LithuaniaKlimadynon 2.8 mg coated tablets

Holder of the marketing authorization and responsible for themanufacturing

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt

Germany

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

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

Email: [email protected]

Last review date of this leaflet:December 2020

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