Klimadynon

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Klimadynon (Klimadinon)
2.8 mg, coated tablets
Cimicifugae racemosae rhizomatis extractum siccum
Klimadynon and Klimadinon are the same brand names of the same medicine written in
Polish and Bulgarian.
Please read the leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Contact your doctor if the patient does not feel better after 6 to 8 weeks, or feels worse.

Contents of the leaflet:

1. What Klimadynon is and what it is used for
2. What you need to know 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 Klimadynon is and what it is used for

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

2. Important information before taking Klimadynon

When not to take Klimadynon:

• if the patient has hypersensitivity (allergy) to black cohosh rhizome ( Cimicifuga racemosa (L.) Nutt., rhizoma) or to 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 develops signs and symptoms suggestive of liver damage (fatigue, loss of appetite, yellowing of the skin or eyes, or severe abdominal pain with nausea and vomiting, or dark urine). The patient should stop taking Klimadynon and seek immediate medical advice.
• if vaginal bleeding occurs or if unclear or new symptoms appear.
• if the patient has previously been 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 situations apply, the patient should not take
Klimadynon without consulting a doctor.
Children and adolescents
Klimadynon is not indicated for use in children and adolescents for this therapeutic indication.
Klimadynon with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient plans to take.
Medicinal products may interact with each other when used concomitantly. However, no such interactions have been observed, and no studies have been conducted on interactions involving Klimadynon coated tablets.
Pregnancy, breastfeeding and fertility
Klimadynon is not recommended for use during pregnancy. While experiencing menopausal symptoms, a woman may still become pregnant and should therefore use an effective method of contraception.
It is unknown whether the active substance passes into human milk. Klimadynon should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and using machines
Studies on the influence of this medicine on the ability to drive motor vehicles and operate machinery have not been conducted.
Klimadynon contains lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
Klimadynon contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Klimadynon

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
The usual dose for adult women in the menopausal period is 1 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 taken with 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 used for longer than 6 months without medical advice.
Use in children and adolescents
Klimadynon is not indicated for use in children and adolescents for this therapeutic indication.
Special patient groups:
There is insufficient data regarding specific dosage recommendations in 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").
Accidental overdose of Klimadynon:
No cases of overdose have been reported. If a patient takes more medicine than recommended, inform the 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 Klimadynon:
Stopping treatment with Klimadynon usually does not cause harmful effects.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the following adverse reactions is unknown:

• Use of products containing the rhizome of Cimicifuga racemosa is associated with hepatotoxic effects (including hepatitis, jaundice, abnormal liver function test results).
• Allergic skin reactions (urticaria, pruritus, rash)
• Swelling of facial tissues and lower limbs
• Gastrointestinal symptoms (e.g. dyspeptic disorders, diarrhoea)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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.
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Klimadynon

Keep this medicine out of sight and reach of children.
Store below 30°C.
Keep blister packs 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Klimadynon contains
The active substance in Klimadynon is dry extract of rhizome of black cohosh (Cimicifugae racemosae rhizomatis extractum siccum).
One coated tablet contains 2.8 mg of dry extract from Cimicifuga racemosa (L.) Nutt., rhizoma (rhizome of black cohosh) (DER 5-10:1), extraction solvent: ethanol 58% (V/V).

Other ingredients are:
Monohydrate lactose, 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, ammonium methacrylate copolymer (type A), 30% dispersion (Eudragit RL 30D), sorbic acid, sodium hydroxide.

What Klimadynon looks like and contents of the pack
Brown-red, round, biconvex tablets with a smooth surface.
Packaging contains 60 coated tablets.
Packaging contains 90 coated tablets.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing authorisation holder in Bulgaria, 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Bulgaria, country of export: 20160333
Parallel import authorisation number: 318/24

This medicinal product is authorised for sale in the European Economic Area (EEA) Member States 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