Климадинон

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Климадинон

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Климадинон

What is Климадинон? Definitive Overview

Property Description
Active Ingredient Dry extract of Cimicifuga racemosa rhizome
Form Film-coated tablet; Oral solution (drops)
Pharmacological Class Herbal medicinal product; Phytotherapeutic agent
Common Use Symptomatic support during the climacteric period
Origin Natural (Plant-derived: Black Cohosh)

Климадинон (Klimadynon) is officially classified as an herbal medicinal product intended for oral administration. It is a single-ingredient, non-hormonal agent derived exclusively from the plant source, the rhizome of Cimicifuga racemosa (Black Cohosh). This classification places it within the category of phytotherapeutic agents, which are utilized to provide support during the climacteric period. Marketed under the brand name Климадинон, it is often available as an Over-The-Counter (OTC) option in many regions, establishing its accessibility for adult women.


Composition and Differentiation

The sole active component is the dry extract of Cimicifuga racemosa rhizome (Cimicifugae racemosae rhizomatis extractum siccum). This extract is standardized to contain specific plant compounds, including characteristic triterpene derivatives, which are considered responsible for its effects. Standardized Cimicifuga extracts are clinically recognized for their ability to manage neurovegetative symptoms associated with menopause. The medication is formulated for patient convenience as a film-coated tablet or, alternatively, as an oral solution (drops). The choice between the solid tablet and the liquid preparation, which utilizes an aqueous-alcoholic base, is a key distinguishing factor of the product, offering flexibility in administration.


General Purpose and Function

The general purpose of Климадинон is to provide symptomatic support for neurovegetative ailments that often arise during the climacteric transition. The extract is understood to exert its influence by modulating the central neurovegetative system, rather than acting as a direct estrogen substitute. The non-hormonal action helps stabilize systemic imbalances, which aims to improve the overall quality of life by mitigating the frequency and intensity of common physical disturbances such as hot flashes and excessive sweating.

What side effects are possible with Климадинон?

Possible Side Effects and Safety Information

This information describes the possible side effects and safety considerations for Климадинон, based strictly on official government regulatory documents.

Adverse Reactions Classification

Adverse reactions are classified by frequency, though most reported events are considered Rare (occurring in fewer than 1 in 1,000 users) or of Not Known frequency (cannot be estimated from the available data).

System-Organ Class Frequency Reported Reactions (High-Level)
Gastrointestinal Disorders Rare Dyspeptic complaints, upset stomach, diarrhea
Skin and Immune Disorders Rare Allergic skin reactions, rash, itching
Hepatobiliary Disorders Not Known Cases of liver damage (Hepatotoxicity)

Serious Adverse Reactions

The most clinically significant safety concern documented in regulatory sources is the potential for liver injury (hepatotoxicity). Cases of severe liver damage, including hepatitis, jaundice, and liver failure, have been reported in association with the use of products containing Cimicifuga racemosa (the active substance). Regulatory agencies emphasize the need to discontinue use if symptoms suggestive of liver problems (such as fatigue, dark urine, or yellowing of the skin/eyes) occur.

Safety Restrictions and Limitations

Official safety profiles define specific restrictions for use:

  • Hormone-Dependent Tumors: Patients who have been treated for or are currently being treated for breast cancer or other hormone-dependent tumors should only use the medicine under medical supervision.
  • Treatment Duration: Due to a lack of long-term safety data, some regulatory bodies recommend limiting treatment to a maximum duration, typically 6 months.
  • Contraindications: The medicine is contraindicated in individuals with a known hypersensitivity to the active substance or excipients.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official regulatory information for products containing Cimicifuga racemosa (such as Klimadynon) indicates that no cases of acute overdose have been reported in regulatory documents.

Because no specific overdose syndrome is documented, the official labeling focuses on required actions if a higher-than-recommended dose is taken.


Immediate Actions and Management

Overdose Component Official Regulatory Statement
Documented Manifestations No specific signs or symptoms of acute overdose are documented.
Required Action Tell your doctor or pharmacist if you have taken a higher dose than recommended.
Management Your doctor will decide on the necessary measures for management and treatment.

Seeking Urgent Medical Attention

Official government-authorized documents require that patients who have taken an excessive amount must seek medical consultation. The decision regarding the urgency of the medical help, specific monitoring requirements, or supportive measures is entirely left to the attending physician, as no standardized treatment protocols or antidotes are mandated in the official overdose section.

Therapeutic Uses of Климадинон

What Климадинон Treats: Main Uses and Benefits

The primary therapeutic use of this agent is to provide symptomatic support for women experiencing the climacteric period, addressing symptoms related to systemic imbalance. The medication is traditionally applied in clinical settings that involve vasomotor complaints such as hot flushes and profuse sweating, and associated neuro-psychological complaints like nervousness and irritability.


This phytotherapeutic option is commonly used across conditions involving episodic or fluctuating manifestations, and may be relevant for easing symptoms when they become more noticeable. It supports the easing of the symptom load of these manifestations, which contributes to easing the overall symptom load during symptomatic periods. It is relevant in therapeutic contexts where women in the perimenopausal and postmenopausal phases seek a non-hormonal option.

“This supportive therapy is used to assist with easing recurring vasomotor and neuro-psychological symptoms that may interfere with daily comfort.”

Quick Fact: Symptomatic Support for Vasomotor and Neuro-Psychological Complaints

Regulatory References

  1. European Medicines Agency monograph

Eligibility and Restrictions for Use

This section outlines the official eligibility and non-eligibility rules for Климадинон, an herbal medicinal product containing Cimicifuga racemosa (Black Cohosh) extract, as documented in authoritative government regulatory sources.

Contraindications and Absolute Exclusions

Population Status Eligibility Rule
Hypersensitivity Contraindicated for patients with a known allergy to the active substance or any other ingredient in the product.
Pregnancy Contraindicated / Not Recommended due to the absence of sufficient safety data.
Lactation (Breastfeeding) Not Recommended in the absence of sufficient data to establish safety.

Age and Comorbidity Restrictions

Population Group Eligibility Restriction
Children and Adolescents (Under 18 years) Use Not Intended or established for this age group for the specified indication.
Liver Disorders Must consult a doctor before use. Patients must stop taking the medicine immediately if they develop signs suggestive of liver injury (e.g., severe fatigue, yellowing of skin or eyes, severe upper stomach pain).
Hormone-Dependent Tumours Patients treated for or undergoing treatment for breast cancer or other hormone-dependent tumours should not use without medical advice.
Women of Childbearing Potential Should consider using effective contraception during the course of treatment.

Use is restricted for individuals with pre-existing conditions that require professional medical evaluation, such as liver disorders, due to the need for monitoring. The overall regulatory profile defines the allowed population as adult women who do not fall into the contraindicated categories and who adhere to the restrictions for conditional use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information regarding interactions with products containing Cimicifuga racemosa rhizome, the active ingredient in Климадинон, is structured around specific risk-mitigation precautions. Formal interaction studies are often stated as having not been performed.


Official Regulatory Constraints

Category Constraint or Precaution
Hormonal Agents Co-administration with oestrogens (estrogens) is a conditional restriction and should not occur unless specifically advised by a healthcare provider.
Hepatotoxic Agents Caution is required regarding concomitant use with other medicines known to be hepatotoxic (toxic to the liver). This precaution is due to a theoretical additive risk of liver adverse events.
Alcohol Use is constrained by the general precaution regarding other hepatotoxic agents, meaning alcohol should be avoided during treatment.

Population and Procedural Constraints

Official labeling identifies a population-specific constraint: patients with a history of liver disorder require increased caution, and some authorities advise against the use of the herb in this population without strict medical oversight. No mandatory timing separation rules (e.g., administering doses a certain number of hours apart) are specified in the official regulatory documents. These established regulatory constraints define the product’s official interaction profile, focusing on patient safety where formal interaction data may be limited.

Mechanism of Action

Central Neurotransmitter Pathway Modulation

This domain covers how the extract interacts with specific serotonin receptor subtypes (e.g., 5-HT1A) in the brain's thermoregulatory center (hypothalamus). This action modulates key neurotransmitter signaling, influencing the activity of vasomotor pathways.


Selective Neuroendocrine Regulation

This mechanism addresses the potential tissue-selective influence of the drug's components on estrogen receptors in certain non-reproductive tissues, such as the CNS and bone. By engaging mechanisms that regulate hormonal signaling specifically in these areas, it influences signaling within neuroendocrine regulatory centers through selective receptor engagement, limiting agonistic effects on peripheral reproductive tissues.


Anti-Inflammatory and Cytoprotective Actions

The components in the extract engage mechanisms that limit cellular damage and stress by inhibiting the production of certain inflammatory mediators and neutralizing reactive oxygen species (ROS). This action affects molecular cascades that involve the generation of inflammatory mediators and reactive oxygen species, resulting in altered mediator activity.

Dosage and Administration Information

Official Administration Guidelines for Климадинон (Cimicifuga racemosa Extract)

This section outlines the administration of the herbal preparation, focusing strictly on how the product is to be used. It does not contain information on therapeutic use, safety, or benefits.


Administration Scope Detail
Route of Administration Oral (by mouth) in solid dosage forms (e.g., tablets).
Age-Group Rules Intended for use in adult women. There is no relevant indication for use in men, children, or adolescents.
Frequency and Timing The daily dose is typically administered once or twice a day, depending on the specific product formulation. Solid preparations (tablets) should be swallowed and not sucked.
Preparation Requirements No explicit preparation (e.g., dilution or shaking) is documented for solid oral dosage forms.
Missed-Dose Instructions Take the missed dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take a double dose to make up for a missed one.
Duration of Use The preparation should not be taken for more than 6 months without professional medical advice. Consultation is required if symptoms persist or worsen during use.

Official Dosing Schedule

The dosage is based on the quantity of herbal substance extract, which varies by preparation type (solvent, drug-to-extract ratio, and pharmaceutical form). The daily dose for an extract corresponds to approximately 40 mg of the herbal substance (Cimicifuga racemosa rhizome).

Example Daily Dose (Extract) Corresponds to Herbal Substance
5.6 mg of Extract 'A' (divided into 2 daily doses) 40 mg (approx.)
6.5 mg of Extract 'B' (1 single daily dose) 40 mg (approx.)

Note on Consistency: Users must follow the dosing instructions provided in the official product leaflet for the specific formulation they are using, as daily milligram doses of the extract itself can differ while remaining equivalent to the target quantity of the crude drug.

Recent Clinical Evidence

Overview of Clinical Evidence

Климадинон (Cimicifuga racemosa extract, also known as Black Cohosh) is authorized for relieving menopausal symptoms. Clinical research has long focused on whether specific extracts from this plant can modulate symptoms associated with menopause, such as hot flashes and profuse sweating.

Evidence from clinical trials investigating the effects of Black Cohosh extract remains varied. Some systematic reviews and randomized controlled trials (RCTs) indicate that certain standardized preparations are associated with a reduction in the severity of neurovegetative symptoms, while other reviews have concluded that there is not enough compelling evidence to establish clear superiority over placebo.

Key Research Findings

Symptom Group Study Findings (General) Notes
Vasomotor Symptoms (Hot flashes, sweating) Studies documented improvements in the frequency and intensity of symptoms in participants taking the extract compared to baseline measurements. This area shows the most documented shift in patient-reported severity across multiple trials.
Neurovegetative Symptoms (Sleep disturbance, nervousness) Some research suggested concurrent improvements in sleep quality and related psychological complaints. Improvements may be secondary to better management of hot flashes, which interfere with sleep.

Safety and Regulatory Status

The isopropanolic extract found in some authorized medicinal products is the most extensively studied Black Cohosh preparation. Regulatory agencies, including the European Medicines Agency (EMA), have issued monographs concluding a positive benefit–risk ratio for certain Cimicifuga racemosa preparations in alleviating climacteric symptoms.

Reported adverse events in clinical studies are generally mild and may include gastrointestinal discomfort or nausea. Decisions regarding the use of this, or any, treatment should be made following consultation with a healthcare provider who can evaluate individual medical history and needs.

Frequently Asked Questions (FAQ)

Common questions about Климадинон (FAQ)


Q: What is Климадинон used for?

Климадинон is traditionally used for relieving menopause symptoms such as hot flashes and excessive sweating. It contains an extract from the black cohosh root. The specific traditional uses may vary based on local regulatory approvals.


Q: How long does it take for Климадинон to start working?

The onset of action for products containing black cohosh extract, like Климадинон, is generally not immediate. Significant improvement may be observed after several weeks of consistent use. You should consult the patient information leaflet or discuss expected timelines with a healthcare provider.


Q: Can I take Климадинон if I am pregnant or breastfeeding?

Based on available regulatory information, Климадинон is not recommended for use during pregnancy or breastfeeding. It is essential to consult a healthcare professional before using any medicine or herbal product if you are pregnant, planning to become pregnant, or breastfeeding.


Q: Does Климадинон interact with other medicines?

As with many herbal products, there is a potential for interactions. It is important to inform your doctor or pharmacist about all other medications and supplements you are currently taking to avoid any potential risks or reduce effectiveness. This includes prescription, over-the-counter, and other herbal remedies.

How should Климадинон be stored and disposed of?

Storage and Handling Requirements

To ensure product stability and safety, Климадинон (Klimadynon) must be stored according to specific regulatory requirements. It is essential to keep the product out of the reach of children at all times.

Key storage conditions include:

  • Temperature: Store at a temperature not higher than 25°C (77°F).
  • Protection: The product must be protected from light.
  • Packaging: Keep the medication in the original packaging until use.

Disposal

No specific hazardous-waste or environmental disposal instructions are documented in the labeling. Patients should follow standard procedures by consulting a healthcare provider or pharmacist regarding proper disposal methods for any unused or expired medication. Do not dispose of this medication via household trash or wastewater unless specifically instructed to do so by local waste management regulations or a qualified professional.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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