KLIMADYNON

PACKAGE LEAFLET

Package leaflet: Information for the patient

Klimadynon 2.8 mg
coated tablets
Cimicifugae racemosae rhizomatis extractum siccum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient information 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 or pharmacist. See section 4.
• Contact your doctor if the patient does not feel better after 6 to 8 weeks, or if she feels worse.

Contents of the leaflet:

1. What Klimadynon is and what it is 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 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 using 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 with Klimadynon, discuss with your doctor:

• if the patient has a history of liver function disorders. Liver function tests should be performed.
• if symptoms occur suggesting possible liver damage, either objective or subjective (such as fatigue, loss of appetite, yellowing of the skin or eyes, severe abdominal pain with nausea and vomiting, or darkening of the urine). The patient should discontinue taking Klimadynon and seek immediate medical advice.
• if vaginal bleeding occurs or if unclear or new symptoms appear.
• if the patient has previously or is currently being treated for breast cancer or other hormone-dependent tumours.
• if the patient is taking estrogens.
• if symptoms worsen during treatment with the medicine.

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 all medicines currently being taken or recently taken, as well as any medicines the patient intends to take.
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. 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 become pregnant, she should consult her doctor before using this medicine.

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

Klimadynon contains lactose.
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, which means the medicine is considered "sodium-free".

3. How to use Klimadynon

This medicine should always be taken exactly as described in this patient information leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
The usual dose for adult women during menopause 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 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 is insufficient data regarding specific dosing 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").
If you take more Klimadynon than you should:
No cases of overdose have been reported. Inform your doctor if you have taken more of the medicine than recommended. The doctor will decide on any necessary actions.
If you forget to take Klimadynon:
Do not take a double dose to make up for the 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 effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The frequency of the following adverse effects is unknown:

• Use of products containing rhizome of Cimicifuga racemosa has been associated with liver toxicity (including hepatitis, jaundice, abnormal liver function tests).
• Allergic skin reactions (urticaria, itching, rash)
• Swelling of facial tissues and lower limbs
• Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine. Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Klimadynon

Keep this medicine out of sight and reach of children.
Store below 30°C.
Keep 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 specified month.
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 package and other information

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

The other ingredients are:
Monohydrate lactose, calcium hydrogen phosphate dihydrate, potato starch, magnesium stearate, talc, titanium dioxide (E 171), yellow iron oxide (E172), red iron oxide (E172), Macrogol 6000, ammonium methacrylate copolymer (type A), sorbic acid, sodium hydroxide.

What Klimadynon looks like and contents of the pack
Brownish-red, round, biconvex tablets with a smooth surface.
Packaging contains 60 coated tablets.
Packaging contains 90 coated tablets.
Not all pack sizes may be marketed.

This medicinal product is authorised for marketing in 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 plėvelė dengtos tablets

Marketing Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Tel.: +49 / (0)9181 / 231-90
Fax: +49 / (0)9181 / 231-265
e-mail: [email protected]

For further information, please contact the local representative of the Marketing Authorisation Holder:
Bionorica Polska Sp. z o.o.
ul. Hrubieszowska 6 B
01 - 209 Warsaw
Poland
Tel/Fax +(48) 22 886 46 06
e-mail: [email protected]

Signature Not Verified
Document signed by Anna
Mackiewicz-Williams

Date: 2021.02.09 11:35:36 CET