KLIMADYNON 2.8MGTBL N90

ATC code: G02CX 

Active substances: Cimicifugae Rhizomae Extractum

Vendor, principal: Bionorica. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

KLIMADYNON 2.8MG N90

PACKAGE LEAFLET: INFORMATION FOR THE USER

Klimadynon 2,8 mg film-coated tablets

Cimicifuga rhizome dry extract

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse within 6 to 8 weeks (40 to 60 days).

What is in this leaflet:

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

Klimadynon is a herbal medicinal product indicated in female adults for the relief of menopausal complaints such as hot flushes and profuse sweating.

2.   What you need to know before you take Klimadynon Do not take Klimadynon

-   if you are allergic (hypersensitive) to Cimicifuga racemosa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor:
-   if you have a history of liver disorder. Liver function test should be performed.
-   if you develop signs and symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine). Please stop taking Klimadynon and immediately consult your doctor.
-   if vaginal bleeding occurs, or if you experience unclear or new symptoms.
-   if you have been treated or if you are undergoing treatment for breast cancer or other hormone-dependent tumours.
-   if you are taking oestrogens.
If any of the above applies to you, do not take Klimadynon without medical advice.

Children and adolescents

This medicine is not to be used in children and adolescents.

Other medicines and Klimadynon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Klimadynon is not recommended during pregnancy. It is still possible for you to become pregnant while experiencing menopausal symptoms so use effective contraception during treatment.
It is unknown whether the active substance is excreted in human milk. Klimadynon should not be used during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant, ask your doctor for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Klimadynon contain lactose.

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

3. How to take Klimadynon

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
The usual dose for female adults in the menopause is 1 film-coated tablet twice a day, morning and evening (maximum 2 film-coated tablets daily).
Method of administration:
For oral use. Take film-coated tablets with some liquid. Do not chew or suck.
Duration of treatment:
If the symptoms persist during the use of the medicinal product, a doctor or a pharmacist should be consulted.
Klimadynon should not be taken for more than 6 months without medical advice.

Use in children and adolescents

This medicine is not to be used in children and adolescents.
Special populations:
No data are available for a dosing instruction in case of impaired renal function.
Patients with a history of liver disorder should not take Klimadynon without medical advice (see section 2. ‘Warnings and precautions’ and 4. ‘Possible side effects’).

If you take more Klimadynon than you should:

No case of overdose has been reported. Please inform your doctor if you took more than the recommended dose of this medicine. Your doctor will decide on the necessary measures.

If you forget to take Klimadynon:

Do not take a double dose to make up for a forgotten tablet. Take your next tablet at the usual time.

If you stop taking Klimadynon:

Discontinuing Klimadynon is usually harmless.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

4.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency categories are used for the evaluation of side effects:

Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1000 people Very rare: may affect up to 1 in 10,000 people Not known: frequency cannot be estimated from the available data

The frequency of the following side effects is not known:
•   Liver toxicity (including hepatitis, jaundice, disturbances in the liver function tests) is associated with the use of Cimicifuga containing products.
•   Skin reactions (hives, itching, rash).
•   Swelling of the tissues of the face and the lower limbs (known as oedema).
•   Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Klimadynon

Do not store above 30 °C.
Keep this medicine out of the sight and reach of children.
Keep the blisters in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Klimadynon contains

The active substance is:
2.8 mg dry extract of Cimicifuga rhizome (5-10:1)
Extraction solvent ethanol 58% (V/V)
The other ingredients are:
Calcium hydrogen phosphate dehydrate, Ammonio methacrylate copolymer, Type A, Dispersion 30% (Eudragit RL 30D), Iron oxide red (E 172), Iron oxide yellow (E 172), Lactose monohydrate, Macrogol 6000, Magnesium stearate (vegetable), Potato starch, purified talc, Sodium hydroxide, Sorbic acid, Titanium dioxide (E 171).

What Klimadynon looks like and contents of the pack

Package with 60 film-coated tablets Package with 90 film-coated tablets
Not all pack sizes may be marketed.
The tablets are terracotta-coloured, round, biconvex with smooth surface.

Marketing Authorisation 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]
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Miecys-Pharm OÜ Vitamiini 4 Tartu 51014 Tel: +372 7380676

This medicinal product is authorised in the Member States of the EEA under the following names:

Mensifem Filmtabletten
Klimadynon
KaHMagHHOH
Mensifem
Klimadynon, 2,8 mg öhukese polümeerikattega tabletid
Menofem
Klimadynon 2,8 mg apvalkotās tabletes
Klimadynon 2,8 mg plevele dengtos tabletes

Austria
Belgium, Croatia, Denmark, Finland, Germany, Luxembourg, Norway, Poland, Slovenia, Sweden
Bulgaria
Czech Republic , France, Italy, Spain Estonia
Slovakia
Latvia
Lithuania

This leaflet was last revised in May 2018.