Klimadinon

LEAFLET INCLUDED IN THE PACKAGING

Leaflet included in the packaging: patient information

Klimadynon 2.8 mg

coated tablets
Cimicifugae racemosae rhizomatis extractum siccum

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 or pharmacist. 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:

• if the patient is allergic (hypersensitive) to black cohosh (Cimicifuga racemosa (L.) Nutt., rhizoma) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment, discuss with your doctor:

• if the patient has a history of liver function disorders. Liver function tests should be performed.
• if the patient experiences objective and subjective symptoms suggesting liver damage (fatigue, loss of appetite, yellowing of the skin and eyes, or severe abdominal pain with nausea and vomiting, or dark urine). The patient should stop taking Klimadynon and consult a doctor immediately.
• if vaginal bleeding occurs or unclear or new symptoms appear.
• if the patient has been previously treated or is currently being treated for breast cancer or other hormone-dependent tumors
• if the patient is taking estrogens.
• if symptoms worsen during treatment.

If any of the above applies 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 interaction studies have been conducted with Klimadynon coated tablets.

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, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine.

Driving and using machines

No studies have been conducted on the effect of this medicine on the ability to drive and use machines.

Klimadynon contains lactose.

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 it 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).
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 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 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 a doctor (see section 2 "Warnings and precautions" and section 4 "Possible side effects").

Taking a higher dose of Klimadynon than recommended:

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

Missing a 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, this medicine 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 (i.e., dyspeptic disorders, diarrhea)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to
the Department of Post-Marketing Surveillance of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw
Phone: +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. Side effects can also be reported to the marketing authorization holder.

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 outer packaging.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Klimadynon contains

The active substance of the medicine 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 (E172), red iron oxide (E172), Macrogol 6000, ammonio methacrylate copolymer (type A) sorbic acid, sodium hydroxide.

What Klimadynon looks like and contents of the pack

Brown-red tablets, round, biconvex with a smooth surface.
The pack contains 60 coated tablets.
The pack contains 90 coated tablets.
Not all pack sizes may be marketed.

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

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
e-mail: [email protected]
To obtain more detailed information, contact the representative of the marketing authorization holder:
Bionorica Polska Sp z o.o.
ul. Hrubieszowska 6 B

• 01 - 209 Warsaw Poland Phone / Fax +(48) 22 886 46 06 e-mail: [email protected]

Date of last revision of the leaflet:12/2020
Signature Not Verified
Document signed by Anna
Mackiewicz-Williams
Date: 2021.02.09 11:35:36 CET