Klimadinon

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Klimadynon
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 Medicinal Product, as it Contains Important Information for You.

This medicinal product should always be taken exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or further information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not feel better after 6 to 8 weeks or if you feel 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 medicinal product indicated for use in adult women for the alleviation of menopausal symptoms such as hot flushes and sweating.

2. Important information before taking Klimadynon

When not to take Klimadynon:

Warnings and precautions

Before starting to take this medicinal product, discuss with your doctor:

If any of the above applies to you, do not take Klimadynon without consulting your doctor.

Children and adolescents

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

Klimadynon and other medicinal products

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

Pregnancy, breastfeeding, and fertility

Klimadynon is not recommended during pregnancy. During menopausal symptoms, you 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 you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicinal product.

Driving and using machines

No studies on the effects of this medicinal product on the ability to drive and use machines have been conducted.

Klimadynon contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Klimadynon contains sodium.

This medicinal product contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially 'sodium-free'.

3. How to take Klimadynon

This medicinal product should always be taken exactly as described in this leaflet for the patient or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The recommended dose is: usually one coated tablet twice daily, in the morning and evening (maximum 2 coated tablets per day). Method of administration: for oral use. The coated tablets should be swallowed with a liquid. Do not chew or suck the tablets. Duration of treatment: if symptoms persist during treatment, consult your doctor or pharmacist. Klimadynon should not be taken for more than 6 months without consulting your doctor.

Use in children and adolescents

Klimadynon is not intended for use in children and adolescents in this therapeutic indication. Special patient groups: there are insufficient data on 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 their doctor (see section 2 "Warnings and precautions" and section 4 "Possible side effects").

Overdose of Klimadynon

No cases of overdose have been reported. If you have taken more than the recommended dose of Klimadynon, tell your doctor. Your doctor will decide on the necessary actions.

Missed dose of Klimadynon

Do not take a double dose to make up for a forgotten 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 questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them. The frequency of the following side effects is not known:

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

Reporting of 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 for Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 medicinal product.

5. How to store Klimadynon

Keep this medicinal product out of the sight and reach of children. Store in a temperature below 30°C. Store the blisters in the original packaging. Do not use this medicinal product 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, 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 pack contains 60 coated tablets. The pack contains 90 coated tablets. For more detailed information, please contact the marketing authorization holder or the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20160333

Parallel import authorization number: 318/24

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 revision of the leaflet: 07.08.2024

[Information about the trademark]