Cyclodynon^® (Tablets, Drops) Instructions for Use

ATC Code

G02CX03 (Chaste tree fruits)

Active Substance

Vitex agnus-castus

Vitex agnus-castus (SP State Pharmacopoeia)

Clinical-Pharmacological Group

Herbal preparation used for menstrual cycle disorders, mastodynia, and premenstrual syndrome

Pharmacotherapeutic Group

Other agents used in gynecology

Pharmacological Action

The components of the drug have a normalizing effect on the concentration of prolactin and sex hormones.

The active component of the drug is dry extract of Vitex agnus-castus fruits. The dopaminergic effects of the drug, by reducing prolactin production, eliminate hyperprolactinemia.

Elevated prolactin concentration disrupts the secretion of gonadotropins, which can lead to disturbances in follicle maturation, ovulation, and corpus luteum formation, subsequently leading to an imbalance between estradiol and progesterone and potentially causing menstrual cycle disorders, as well as mastodynia.

Prolactin also has a direct stimulating effect on proliferative processes in the mammary glands, enhancing the formation of connective tissue and causing dilation of the milk ducts.

A decrease in prolactin concentration leads to the regression of pathological processes in the mammary glands and relieves pain. Rhythmic production and normalization of the ratio of gonadotropic hormones leads to normalization of the second phase of the menstrual cycle.

Preclinical safety data

In preclinical data obtained from standard single-dose and repeated-dose toxicity studies and genotoxicity studies, no specific risk to humans was identified.

Indications

For women over 18 years of age with

• Menstrual cycle disorders;
• Symptoms of premenstrual syndrome;
• Mastodynia.

ICD codes

Dosage Regimen

Tablets

The recommended dose is 1 tablet once a day (in the morning) or as directed by a doctor.

The drug is taken orally, without chewing, with a small amount of water (e.g., one glass).

The duration of the treatment course is at least 3 months (without interruption during menstruation).

Use of the drug for more than 3 months is possible after consultation with a doctor.

Children

Safety and efficacy in children aged 0 to 18 years have not been established to date.

No data available.

Patients with renal and hepatic impairment

There are no data to change the recommended daily dose of the drug for patients with renal and/or hepatic impairment.

Drops

The drug is taken orally, 40 drops once a day (in the morning) or as directed by a doctor.

The required dose is measured using the dropper bottle and taken with a small amount of water (e.g., one glass).

40 drops is equivalent to 1.9 ml and/or 1.87 g of the drug.

The duration of the treatment course is at least 3 months (without interruption during menstruation).

Use of the drug for more than 3 months is possible after consultation with a doctor.

Shake before use.

Children

Safety and efficacy in children aged 0 to 18 years have not been established to date.

No data available.

Patients with renal and hepatic impairment

There are no data to change the recommended daily dose of the drug for patients with renal and/or hepatic impairment.

Adverse Reactions

When assessing the frequency of adverse reactions, the following categories were used: very common (≥1/10), common (≥1/100 but <1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

Immune system disorders frequency not known – systemic allergic reactions to the components of the drug (skin rash, urticaria, angioedema, dyspnea, dysphagia).

Gastrointestinal disorders frequency not known – epigastric pain, nausea.

Nervous system disorders frequency not known – headache, dizziness.

Other frequency not known – acne, menstrual cycle disorders.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug.

Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to the active substance and/or to any of the excipients of the drug;
• Breast cancer;
• Pituitary tumors.

Use with caution in the presence of a history of estrogen-dependent malignant neoplasms and pituitary diseases.

Use in Pregnancy and Lactation

Pregnancy

The drug is not used during pregnancy.

Breastfeeding period

The drug should not be used during breastfeeding due to insufficient experience of use, as well as possible reduction of lactation based on animal studies.

Fertility

Special studies regarding the effect of the drug on fertility have not been conducted.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated for use under the age of 18 years (no data on efficacy and safety of the drug in this age group).

Special Precautions

Consult a doctor before starting to use the drug.

If symptoms of the disease persist after 3 months or if symptoms worsen during therapy with the drug, it is necessary to consult a doctor.

If complaints reappear after completion of treatment, it is necessary to consult a doctor.

If you feel tension and swelling of the mammary glands and/or weakness, depression, as well as in case of menstrual cycle disorders, you should consult a doctor for additional examination.

To monitor the effectiveness of the treatment, monthly consultation with a doctor is recommended.

The possibility of masking the clinical manifestations of a prolactin-secreting pituitary tumor while taking the drug should be considered.

During storage, slight opalescence (cloudiness) may occur, which does not affect the quality and efficacy of the drug.

Excipients

The drug contains 17-19% (by volume) ethanol, i.e., up to 290 mg per single dose, which is equivalent to less than 8 ml of beer or 3 ml of wine.

Due to the ethanol content, the drug should not be taken by patients with alcoholism, as well as after treatment for alcohol dependence.

The presence of ethanol in the drug should be taken into account by pregnant or breastfeeding women, children, and persons from high-risk groups, such as patients with liver diseases or epilepsy.

Cyclodynon^® contains sorbitol.

The drug should not be taken by patients with rare hereditary fructose intolerance.

This drug contains less than 1 mmol (23 mg) of sodium per single dose, which does not need to be considered in hypertension (or a salt-free diet).

Information for patients with diabetes – the drug does not contain a sufficient amount of carbohydrates to be calculated in bread units (BU).

Children and adolescents

The drug should not be prescribed to children from 0 to 18 years old, because safety and efficacy in this age group have not been established to date.

No data available.

Effect on ability to drive vehicles and operate machinery

When used in recommended doses, the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery, work of a dispatcher and operator).

Overdose

To date, no cases of overdose with the drug have been reported.

Symptoms: possible increase in the severity of dose-dependent adverse reactions.

Treatment: symptomatic therapy.

Drug Interactions

Mutual reduction of efficacy is possible with simultaneous use of dopamine receptor antagonists, as well as interaction with dopamine receptor agonists, estrogens, and antiestrogens.

When taking such drugs, the patient should consult a doctor before starting the use of Cyclodynon^®.

Interaction with other medicinal products is unknown to date.

Storage Conditions

The drug should be stored in the original packaging (bottle, cardboard box) to protect from light, in a place inaccessible to children.

No special temperature storage conditions are required for this medicinal product.

Shelf Life

Shelf life – 3 years. After opening the bottle – no more than 6 months.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.