Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Klimadynon (Klimadinon) 2.8 mg
film-coated tablets
Cimicifugae racemosae rhizomatis extractum siccum
Klimadynon and Климадинон are the same trade names of the same medicinal product written in
Polish and Bulgarian respectively.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor
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, pharmacist or nurse. See section 4.
Contact your doctor if the patient does not feel better after 6 to 8 weeks of treatment, or feels worse.

Contents of the leaflet:

What Klimadynon is and what it is used for
Important information before taking Klimadynon
How to take Klimadynon
Possible side effects
How to store Klimadynon
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 relieve
menopausal symptoms such as hot flushes and excessive sweating.

2. Important information before taking Klimadynon

When not to take Klimadynon:

if the patient is allergic (hypersensitive) 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 symptoms suggesting liver damage occur, either objective or subjective (e.g. fatigue, loss of appetite, yellowing of the skin or eyes, severe abdominal pain with nausea and vomiting, or dark urine). The patient should stop taking Klimadynon immediately and consult a doctor without delay.
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 tumours.
if the patient is taking estrogens.
if symptoms worsen during treatment.

If any of the above situations apply, Klimadynon should not be taken without first consulting a doctor.

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

Klimadynon and other medicines
Inform your doctor or pharmacist about any medicines currently taken or recently taken, as well as any medicines planned for future use.
Medicinal products may interact with each other when used concomitantly. However, no such interactions have been observed, and no studies on interactions involving Klimadynon coated tablets have been conducted.

Pregnancy, breastfeeding and fertility
Klimadynon is not recommended for use during pregnancy. Women experiencing menopausal symptoms may still be fertile 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive motor vehicles or operate machinery.

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
This 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 leaflet, or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
The usual dose for adult women during menopause is one coated tablet twice daily, in the morning and evening (maximum 2 coated tablets per day).
Method of administration:
For oral administration. The coated tablets should be taken with liquid. Do not chew or suck the tablets.
Duration of treatment:
If symptoms persist during treatment with this medicinal product, 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 are insufficient data regarding specific dosage recommendations for patients with renal and/or hepatic impairment.
Patients with a history of liver dysfunction should not take Klimadynon without consulting a doctor (see section 2 "Warnings and precautions" and section 4 "Possible side effects").
Taking more Klimadynon than recommended
No cases of overdose have been reported. Inform your doctor if you have taken more of this medicine than recommended. 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 doubts concerning 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 everybody will experience them.
The frequency of the following adverse reactions is unknown:

Hepatotoxic effects have been associated with products containing the rhizome of Cimicifuga racemosa (including hepatitis, jaundice, abnormal liver function tests).
Allergic skin reactions (urticaria, pruritus, rash)
Swelling of facial tissues and lower limbs
Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Klimadynon

Keep this medicine out of the sight and reach of children.
Store below 30°C. Keep the 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 stated month.
Medicines must 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. Package contents 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;
coating: talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), macrogol 6000, ammonio methacrylate copolymer (type A) dispersion 30% (Eudragit RL 30D), sorbic acid, sodium hydroxide.

What Klimadynon looks like and contents of the pack
Brownish-red, round, biconvex tablets with smooth surface.
Pack contains 60 or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

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

Marketing Authorisation number in Bulgaria, country of export: 20160333
Parallel Import Licence number: 104/25

This medicinal product is authorised in the European Economic Area countries under the following trade 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