Klimadinon

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Klimadynon (Климадинон) 2.8 mg

coated tablets
Cimicifugae racemosae rhizomatis extractum siccum
Klimadynon and Климадинон are the same trade names for the same drug written in Polish and Bulgarian.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• Consult a pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• Consult a doctor if the patient does not feel better after 6 to 8 weeks or feels worse.

Table of Contents of the Leaflet:

• 1. What is Klimadynon and what is it used for
• 2. Important information before taking Klimadynon
• 3. How to take Klimadynon
• 4. Possible side effects
• 5. How to store Klimadynon
• 6. Contents of the pack and other information

1. What is Klimadynon and what is it used for

Klimadynon is a herbal medicine indicated for use in adult women to alleviate menopausal symptoms such as hot flashes and excessive sweating.

2. Important information before taking Klimadynon

When not to take Klimadynon:

Warnings and precautions

Before starting treatment, discuss with your doctor:

If any of the above cases apply to the patient, do not take Klimadynon without consulting a doctor.

Children and adolescents

Klimadynon is not intended for use in children and adolescents for the specified therapeutic indication.

Klimadynon and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Medicines can interact with each other if taken at the same time. However, no such interactions have been observed, and no studies on interactions with Klimadynon tablets have been conducted.

Pregnancy, breastfeeding, and fertility

Klimadynon is not recommended during pregnancy. During menopausal symptoms, the patient can still become pregnant and should use effective contraception. It is not known whether the active substance passes into breast milk. Klimadynon should not be taken during breastfeeding. If the patient is pregnant, breastfeeding, or thinks she may be pregnant, she should consult a 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.

Klimadynon contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, she should consult a doctor before taking the medicine.

Klimadynon contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Klimadynon

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. The recommended dose is: Usually, the dose for adult patients during menopause is 1 coated tablet twice a day, in the morning and evening (maximum 2 coated tablets per day). Administration: Oral. The coated tablets should be swallowed with a liquid. Do not chew or suck the tablets. Duration of treatment: If symptoms persist during treatment with the medicinal product, consult a doctor or pharmacist. Klimadynon should not be taken without consulting a doctor for more than 6 months.

Use in children and adolescents

Klimadynon is not intended for use in children and adolescents for the specified therapeutic indication. Special patient groups: There are insufficient data regarding specific dosage recommendations for patients with renal and/or hepatic impairment. Patients with a history of liver function disorders should not take Klimadynon without consulting a doctor (see section 2 "Warnings and precautions" and section 4 "Possible side effects").

Overdose of Klimadynon

No cases of overdose have been reported. If the patient has taken a larger dose of the medicine than recommended, she should tell her doctor. The doctor will decide on the necessary actions.

Missed dose of Klimadynon

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

Stopping treatment with Klimadynon

Stopping treatment with Klimadynon usually does not cause harmful effects. If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

• The use of products containing black cohosh is associated with toxic effects on the liver (including hepatitis, jaundice, abnormal liver function test results).
• Allergic skin reactions (hives, itching, rash)
• Swelling of facial and lower limb tissues
• Gastrointestinal symptoms (e.g., dyspeptic disorders, diarrhea)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Klimadynon

Keep the medicine out of sight and reach of children. Store in a temperature below 30°C. Store blisters in the original packaging. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Klimadynon contains

The active substance is dry extract of black cohosh (Cimicifugae racemosae rhizomatis extractum siccum). One coated tablet contains 2.8 mg of dry extract of Cimicifuga racemosa (L.) Nutt., rhizoma (black cohosh) (DER 5-10:1) extraction solvent: ethanol 58% (V/V). The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, potato starch, magnesium stearate; coating: talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), macrogol 6000, ammonio methacrylate copolymer (type A), 30% dispersion (Eudragit RL 30D), sorbic acid, sodium hydroxide.

What Klimadynon looks like and contents of the pack

The tablets are brown-red, round, biconvex with a smooth surface. The packaging contains 60 or 90 coated tablets. For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

BIONORICA SE, Kerschensteinerstrasse 11-15, 92318 Neumarkt, Germany

Manufacturer:

BIONORICA SE, Kerschensteinerstrasse 11-15, 92318 Neumarkt, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Bulgaria export permit number: 20160333

Parallel import permit number: 104/25

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

Austria, Mensifem Filmtabletten, Belgium, Croatia, Denmark, Estonia, Germany, Luxembourg, Poland, Slovenia, Sweden, Klimadynon, Bulgaria, Климадинон, France, Spain, Italy, Mensifem, Czech Republic, Slovakia, Menofem, Latvia, Klimadynon 2.8 mg apvalkotās tablets, Lithuania, Klimadynon 2.8 mg plėvele dengtos tablets

Date of approval of the leaflet: 24.03.2025

[Information about the trademark]