Cyclodynon

Quick links to important sections

Cyclodynon

Selected form

Method of action: Dopaminomimetic

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Cyclodynon

Quick Facts

Property Description
Active ingredient Vitex Agnus Casti Fructuum Extract
Form Film-Coated Tablets (or Liquid drops)
Pharmacological class Herbal Medicinal Product / Gynecological
Common use Supporting menstrual cycle well-being
Origin Natural, derived from Chaste Tree fruit

Defining Cyclodynon: Identity, Class, and Active Substance

Cyclodynon is a recognized herbal medicinal product intended for women, derived from the Vitex agnus-castus L. plant, commonly known as the chaste tree. The active component is the standardized dry extract of Vitex Agnus Casti Fructuum, obtained from the fruit. The substance Agni casti fructus is grouped under the general category of Other Gynecologicals (ATC G02CX03). Its identity as a single-ingredient phytomedicine focuses its application specifically on addressing hormonal modulation related to the reproductive cycle. The product is manufactured by BIONORICA SE and is frequently recognized as a non-prescription (OTC) option in many markets.


Origin and Physical Form: What Cyclodynon is Made Of

The primary ingredient originates from the dried fruits of the Mediterranean Vitex agnus-castus plant, confirming its natural source. The product is distinguished by the use of a specifically standardized extract to ensure consistent levels of key substances like diterpenes and flavonoids. The active components are concentrated using an extraction solvent such as ethanol, a process critical for isolating the medicinal properties. The final dosage form is predominantly the Film-Coated Tablet, designed for oral ingestion, providing a precise and convenient measure of the standardized extract compared to loose herbal preparations.


General Purpose: How Cyclodynon Relates to the Menstrual Cycle

The general purpose of Cyclodynon is to support and normalize the natural rhythm and overall well-being of the menstrual cycle. Its action is centered on a dopaminergic effect that modulates the neuroendocrine system. Compounds in the extract, particularly diterpenes, effectively bind to dopamine D2 receptors, inhibiting the release of the hormone prolactin. This mechanism is clinically recognized for aiding in the management of cyclical physical discomforts linked to hormonal fluctuations, thereby supporting the stable periodic processes of the female reproductive system.

What side effects are possible with Cyclodynon?

Possible Side Effects and Safety Information

The safety profile for preparations containing Vitex Agnus Casti Fructuum Extract, such as Cyclodynon, is officially documented based on post-marketing surveillance and clinical data, categorized by frequency and the body's systems affected.

Documented Adverse Reactions

The most commonly reported side effects affect the digestive, nervous, and skin systems. The frequency classification for these events is derived from regulatory standards, such as those used by the European Medicines Agency (EMA).

System Organ Class (SOC) Adverse Reaction Frequency Classification
Immune System Disorders Mild allergic reactions (e.g., rash, urticaria, pruritus) Uncommon
Immune System Disorders Severe allergic reactions (e.g., facial swelling, difficulty breathing) Not known
Nervous System Disorders Headaches, Dizziness Not known
Gastrointestinal Disorders Nausea, Abdominal pain Not known
Skin and Subcutaneous Tissue Disorders Acne Not known

Note: 'Not known' means the frequency cannot be estimated from the available data.

Contraindications and Safety Restrictions

Official regulatory documentation identifies specific limitations for product use, primarily due to the hormonal effects of the active ingredient:

  • Estrogen-Sensitive Conditions: The product is contraindicated in patients with estrogen-sensitive cancers or a history of such cancers.
  • Pituitary Disorders: Use is contraindicated in individuals diagnosed with pituitary tumors.
  • Concomitant Medication: Caution is advised, and use may be restricted, when taken concurrently with dopamine agonists, dopamine antagonists, or other medications that affect the prolactin axis.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is strictly based on official government regulatory documents, such as those issued by the European Medicines Agency (EMA).

The official regulatory profile for Cyclodynon, which contains Vitex agnus-castus (Chaste tree extract), is characterized by a significant lack of human overdose data.

Documented Overdose Information

Overdose Component Official Regulatory Statement
Reported Cases None documented. Official labels state that no case of overdose has been reported in humans.
Symptoms No specific symptoms or clinical manifestations of overdose are officially listed.
Antidote No specific antidote is mentioned or recommended.
Population Notes No specific overdose considerations are documented for pediatric, elderly, or renally/hepatically impaired populations.

Required Emergency Action

Because no specific overdose syndrome is defined, the required management is based on general medical procedures. Official regulatory guidance mandates that in the event of an overdose or suspicion of an overdose, the treatment is symptomatic.

Patients are advised to contact a doctor, pharmacist, or other healthcare professional immediately. Seeking this professional advice is the primary action required by regulatory documents when overexposure is suspected.

Therapeutic Uses of Cyclodynon

Quick Facts: Uses of Cyclodynon

  • May assist in the management of premenstrual syndrome (PMS) symptoms.
  • Intended for the relief of menstrual cycle-associated complaints, such as cyclical breast tenderness (mastodynia).
  • May offer support for menstrual cycle irregularities.

Cyclodynon, a medicinal product containing an extract of Vitex agnus-castus (Chaste Tree) fruit, is indicated for women seeking support for the management of certain menstrual cycle disorders. It is primarily used to address symptoms associated with premenstrual syndrome (PMS), such as feelings of tension, discomfort, and general malaise. The product may contribute to the relief of key physical symptoms, including cyclical breast tenderness, also known as mastodynia.

Additionally, this product may be considered for the supportive treatment of menstrual cycle irregularities. Its use may be associated with an improvement in cycle-related complaints for some individuals, which may include aspects of menstrual pain and cycle regularity. As with all medications, patients should consult with a healthcare professional to discuss if this treatment option is appropriate for their specific condition and medical history. The duration of use is typically recommended for at least three months to allow for an observable therapeutic response.

Eligibility and Restrictions for Use

Who Can and Cannot Use Cyclodynon?

Official regulatory labeling specifies that Cyclodynon is indicated solely for female adults aged 18 years and older. Eligibility is strictly defined by contraindications and conditional-use restrictions documented by health authorities.

Absolute Non-Eligibility (Contraindications): The medicine is formally contraindicated for several groups. This includes patients with a known hypersensitivity (allergy) to the active substance or any excipient, women who are pregnant, and women who are lactating (breastfeeding). Use is also prohibited for individuals with a current pituitary disorder.

Conditional and Restricted Use: Use in children and adolescents under 18 years of age is not established due to insufficient regulatory data. A special warning is issued for patients who suffer or have suffered from an oestrogen-sensitive cancer or a past pituitary disorder; these individuals must seek medical consultation before use. Additionally, use is restricted for patients concurrently taking dopamine agonists, hormone therapy, or antioestrogens, due to documented pharmacological effects.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Cyclodynon, which contains Vitex Agnus Casti Fructuum Extract, focuses on potential pharmacodynamic interactions derived from its established effects on dopamine and estrogen receptors. Specific clinical data confirming drug-drug interactions are generally absent from regulatory monographs, leading to a focus on theoretical risk and required precautions.

Classification Interacting Product Categories (Documented Risk)
Dopaminergic Agents Dopamine Agonists (e.g., used for Parkinson's disease) and Dopamine Antagonists (e.g., antipsychotic drugs, some antiemetics).
Hormonal Medicines Estrogens, Anti-estrogens (e.g., tamoxifen), Hormone Replacement Therapy (HRT), and Oral Contraceptives.

The possibility of interaction with dopamine agonists and dopamine antagonists cannot be excluded due to the extract's D2 receptor binding properties, which could lead to additive or antagonistic effects. Similarly, interactions with hormonal preparations are advised against because the extract may interfere with the efficacy of these medicines, including a specific regulatory caution regarding the potential for reduced contraceptive effectiveness of oral contraceptives.

Excipient-Based Interaction: The liquid drop formulation contains ethanol as an extraction solvent. This content must be factored into the overall safety assessment, particularly when co-administered with other medications sensitive to alcohol or in specific patient populations.

Regulatory agencies consistently advise that individuals using any of the listed dopaminergic or hormonal medicinal products should consult a healthcare professional, as official labeling does not specify any mandatory timing separation requirements for administration.

Mechanism of Action

Dopaminergic Agonism and Neuroendocrine Regulation

The core mechanism involves specific diterpenes in the extract acting as agonists at the central Dopamine D2 Receptors ( D2 R), primarily located in the anterior pituitary gland. This action triggers a cascade that results in the inhibition of the hormone Prolactin (PRL) release. This systemic Prolactin suppression reduces PRL's inhibitory influence on the corpus luteum, thereby affecting the function of the luteal phase.


Secondary Modulation of Local Mediator Pathways

A complementary mechanism involves components of the extract acting as inhibitors of the enzyme 5-Lipoxygenase (5-LO). This enzymatic inhibition reduces the local synthesis of Leukotrienes, which are inflammatory mediators. This action modulates tissue responses by affecting smooth muscle contractility, which complements the primary hormonal pathway modulation.

Dosage and Administration Information

Cyclodynon is an orally administered herbal medicinal product whose use is defined by standardized instructions to ensure consistent intake. The standard dosage for adults involves taking one film-coated tablet once daily.


Administration Schedule and Method

The medication should be administered once per day, preferably at the same time every day, to support a consistent dosing schedule. The film-coated tablets are designed for oral intake and should be swallowed whole with sufficient liquid, such as a glass of water. It is an explicit instruction that the tablets must not be chewed. The timing of intake is flexible; the product can be taken regardless of meals.


Course Duration and Consistency

Proper use requires a prolonged course, as the regimen is intended for continuous administration over at least three months to complete the prescribed cycle. This duration must be maintained uninterrupted, meaning the daily dose is continued even during menstruation. If the complaints addressed by the product persist after the three-month administration period, a consultation with a healthcare professional is necessary.


Population Rules

The use of this product is restricted to adult women. Cyclodynon is not recommended for use in children and adolescents under 18 years of age due to insufficient data supporting its safety or effectiveness in this population.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cyclodynon


Evidence for Use in Premenstrual Syndrome (PMS)

Research for this herbal medicinal product has been conducted using Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews. These studies was studied for use in adult women and used in research exploring how symptoms change over time. Researchers utilized these methods to explore conditions characterized by fluctuating or episodic manifestations.

Studies examined outcomes related to physical discomfort and outcomes related to systemic or functional imbalance, including irritability, mood alteration, headache, and cyclical breast discomfort. The studies focusing on episodes where symptoms become more noticeable reported how symptoms evolved in the observed populations across the span of several menstrual cycles. Findings describe patterns observed in the studies, such as variations in the overall symptom burden over the observation period. This evidence contributes to understanding symptom patterns associated with the condition.

It is important to note that long-term outcomes beyond the observation periods of the original trials are not well characterized. Data for certain groups remain insufficient for use in adolescents under 18 years of age, meaning results apply only to the populations studied (adult women). Furthermore, older studies included in scientific reviews sometimes showed unclear reporting or incomplete documentation of their methods, which introduces limitations for overall evidence certainty.


Evidence for Use in Cyclical Breast Tenderness (Mastodynia) and Cycle Irregularities

This part summarizes research that has explored the use of the extract in conditions characterized by fluctuating or episodic manifestations, specifically cyclical breast tenderness (mastodynia) and outcomes related to menstrual cycle regularity. Studies examined adult women with these specific complaints, monitoring outcomes linked to inflammatory or irritative states and outcomes related to systemic imbalance.

Controlled trials and large-scale, non-interventional studies were used in research exploring short-term symptom changes. These studies monitored outcomes describing episodic or acute changes. Research examined the intensity and duration of breast pain and studies monitored certain hormonal biomarkers like serum prolactin levels. Some reports documented the way menstrual cycle regularity evolved and described findings related to hormone level measurements.

Heterogeneity is noted across the research, meaning evidence quality varies across studies due to differing extract preparations and the varying symptom burdens of the studied populations. While research provides insight into short-term changes, the long-term effects are not fully established related to hormonal balance and sustained cycle regularity.


Evidence Quality and Comparator Trials

The core evidence landscape relies on Randomized Controlled Trials (RCTs), where the extract was evaluated in specific groups of patients against a placebo (an inactive substance) or other interventions. These study designs help show what has been observed so far in controlled research settings.

These studies focused on tracking patient-reported outcomes describing perceived discomfort. The findings describe group patterns, offering context but not individual predictions. Comparative evidence is lacking, and findings were mixed across different studies depending on the specific symptom axis being examined.


Long-Term Evidence and Follow-Up Duration

Studies exploring short-term symptom changes generally used follow-up durations that were limited, typically observing responses over defined time intervals spanning three consecutive menstrual cycles. This means that there is limited information for long-term outcomes or how symptom patterns changed over extended periods after the initial trial observation. Research does not determine whether an individual will respond similarly over many years of potential use.


Research in Specific Patient Groups

The evidence mainly derives from studies on adult women with typical presentations of PMS or mastodynia. Data for certain groups remain insufficient, particularly for use in adolescents under 18 years of age. Furthermore, evidence is limited for women with certain comorbid health conditions or for specific age groups outside of the primary adult demographic. Results apply only to the populations studied.


What Remains Uncertain in the Research Landscape

Research provides insight into short-term changes, but several limitations prevent a complete picture. Sample sizes were modest in some reports, and the evidence quality varies across studies due to differing methodological standards. Research describes symptom patterns, but the findings do not determine what an individual's personal outcome will be. The evidence highlights what is known and what is still uncertain regarding the extract's use, particularly regarding long-term effects and application across diverse populations.

Frequently Asked Questions (FAQ)

Common questions about Cyclodynon (FAQ)


Q: Is Cyclodynon the same as Vitex agnus-castus?

Cyclodynon is a commercial brand name for a medicinal product that uses the extract from the plant Vitex agnus-castus L., commonly known as the chaste tree. Specifically, the active component is a standardized dry extract derived from the fruit. This standardization ensures a consistent level of the medicinal substances, differentiating the product from the whole plant or an unprocessed herb.


Q: How quickly should I expect to notice effects from Cyclodynon?

Official regulatory documents indicate that Cyclodynon is intended for continuous, prolonged use. They recommend maintaining administration for at least three months to complete the prescribed course of use or achieve the observed therapeutic effect. This suggests that the changes are not typically immediate and require consistent use over several menstrual cycles.


Q: Is Cyclodynon available over the counter in most countries?

In many countries where it is classified, this type of product is generally categorized for supply only in pharmacies. This may include availability as a non-prescription (over-the-counter) option in some markets. However, the classification may require confirmation depending on the country's specific regulations.


Q: What does official research say about the effectiveness of Cyclodynon?

Official research and studies have explored its use in adult women exploring symptom changes related to the menstrual cycle. This includes research examining conditions such as premenstrual symptoms (PMS) and cyclical breast tenderness (mastodynia). The findings describe patterns observed in groups of women over observation periods.


Q: Is Cyclodynon approved by the FDA or EMA for its uses?

The product is classified in European countries, and its use is detailed in the European Medicines Agency (EMA) Monograph and national regulatory documents (SmPC). Its regulatory status in the United States, which is governed by the FDA, is regulated differently.


Q: Is there a maximum time frame for how long Cyclodynon can be taken?

Official product information states that the minimum duration of use is three months. If symptoms persist after continuous use for this period, the product labeling states that consultation with a healthcare professional is necessary. The duration is thus guided by clinical necessity rather than a fixed maximum cutoff defined in the duration guidance.


Q: Is it common to feel tired or dizzy when first starting Cyclodynon?

Official product safety documents list dizziness as a reported adverse reaction. However, the frequency of this and many other effects is officially listed as 'Not known' frequency, meaning it cannot be estimated from the available data. Tiredness is not listed as a documented side effect in the regulatory reports.


Q: Does Cyclodynon contain any allergens, like gluten or lactose?

The film-coated tablets contain lactose monohydrate as an excipient (an inactive ingredient). Regulatory documents state that use is contraindicated for anyone with a known hypersensitivity to the active substance or any of the excipients, including lactose.


Q: Does Cyclodynon affect fertility or ability to conceive?

Due to the established hormone-like actions of the extract, regulatory documents specify that the product is to be avoided by women who are trying to get pregnant. The product is also formally contraindicated for use once pregnancy is established, as well as during lactation.


Q: Does Cyclodynon interact with antidepressant or anti-anxiety medications?

Official product information contains a warning regarding potential interactions with certain medicines. Because the extract has possible dopaminergic effects (meaning it affects dopamine pathways), interactions with dopamine antagonists cannot be excluded. This category can include certain medications used for mental health conditions, such as some antipsychotic drugs.


Q: Is the safety profile of Cyclodynon well-established in official documents?

The safety profile is documented based on both clinical trials and reports received after the product was marketed. While serious conditions that prohibit use (contraindications) are clearly defined, the official frequency of many common adverse reactions (such as nausea, headaches, and acne) is often listed as 'Not known', indicating limitations in the available frequency data.


Q: What does 'contraindication' mean in the context of Cyclodynon?

A contraindication is a specific health condition or situation where the official product label specifies that the medicine is prohibited from use. For Cyclodynon, examples include having an estrogen-sensitive cancer or a pituitary disorder, as using the product in these situations may present an unacceptable risk.


Q: Can Cyclodynon be taken by people with liver or kidney issues?

Regulatory documents state that use of this preparation is generally not established for individuals with serious kidney or liver impairment. This caution is issued due to a lack of clinical data specifically examining the product’s use in these patient groups.


Q: Are there any documented cases of overdose with Cyclodynon?

According to the official regulatory documents related to product safety, no case of overdose has been reported for the product.

How should Cyclodynon be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documents define specific conditions for storing Cyclodynon (Vitex Agnus Casti Fructuum extract) to ensure product stability and safety. The medicine must not be stored above 25^circC (twenty-five degrees Celsius). It is required that the film-coated tablets be kept in the original package and that the container remains tightly closed to provide necessary protection from light and moisture.

Stability and Safety Rules

Adhering to these storage rules maintains the approved shelf life of 5 years. The product must not be used after the expiry date printed on the carton. For safety, the medicine must be stored out of the sight and reach of children.

Disposal of Unused Product

There are no special requirements for disposal documented in the official regulatory information. Unused or expired Cyclodynon should be returned to a pharmacy or designated collection point to ensure safe pharmaceutical waste handling.

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

Available in countries:

Equivalent of Cyclodynon found in:

A-Z Index: