Agnucaston^® (Tablets, Drops) Instructions for Use

ATC Code

G02CX (Other drugs used in gynecology)

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

Herbal remedy

Indications

• Menstrual cycle disorders (dysmenorrhea, oligomenorrhea, amenorrhea) associated with corpus luteum insufficiency.
• Premenstrual syndrome (PMS), characterized by a complex of physical and psychological symptoms occurring in the luteal phase of the menstrual cycle, including irritability, mood lability, anxiety, headache, mastodynia, and bloating.
• Mastodynia (breast pain and tenderness) not associated with organic pathology of the mammary glands, often cyclic and related to the menstrual cycle.

The therapeutic effect is due to the dopaminergic action of the active components, which leads to a decrease in prolactin secretion. Reduced prolactin levels help to normalize the impaired luteal phase, balance the ratio of estrogen and progesterone, and thereby alleviate the symptoms associated with hormonal imbalance.

Contraindications

• Hypersensitivity to Vitex agnus-castus or any of the auxiliary components of the drug.
• Pregnancy and breastfeeding. The safety of use during these periods has not been established; due to the dopaminergic effect and potential hormonal influence, use is contraindicated.
• Children and adolescents under 18 years of age due to the lack of sufficient data on efficacy and safety in this age group.
• Endogenous depression and other conditions where dopamine antagonists are used, as the pharmacological action of the drug may interfere with the therapy.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets, as they contain lactose monohydrate).
• Alcoholism (for oral drops, due to their ethanol content).

Before starting treatment, it is necessary to exclude organic pathologies (e.g., pituitary tumors, malignant diseases of the breast or reproductive system) that may cause similar symptoms. Self-diagnosis and self-medication are unacceptable.

Dosage Regimen

Unless otherwise prescribed by a doctor, the following dosage regimen is recommended. The drug should be taken once a day, in the morning, with a sufficient amount of water (tablets) or liquid (drops).

For coated tablets: The recommended dose is one tablet (20 mg) once daily. The tablet should be swallowed whole, without chewing.

For oral drops: The recommended dose is 40 drops once daily. The drops should be taken with a small amount of water or other liquid. To ensure accurate dosing, hold the dropper bottle vertically.

The duration of treatment depends on the severity of symptoms and individual response. A noticeable improvement is usually observed after several weeks of continuous use. For persistent conditions, treatment may be continued for several months, including over repeated menstrual cycles. If symptoms do not improve or worsen after 3 months of use, consult your doctor. Treatment should be carried out under medical supervision.

Adverse Reactions

Adverse reactions are generally rare and mild in nature. The following undesirable effects have been reported, primarily at the beginning of therapy.

Gastrointestinal disorders: Nausea, abdominal pain, dry mouth, and mild gastrointestinal discomfort may occur in some patients.

Skin and subcutaneous tissue disorders: Isolated cases of skin reactions such as pruritus, urticaria, and rash have been observed. In case of severe skin reactions, discontinue the drug.

Nervous system and psychiatric disorders: Headache, dizziness, fatigue, and confusion may occur. In rare cases, agitation and hallucinations have been reported.

Reproductive system and breast disorders: Given the hormonal mechanism of action, intermenstrual bleeding or spotting may rarely occur. If such symptoms persist, a medical consultation is required.

If any of the side effects become severe, or if you notice any other side effects not listed in this leaflet, please inform your doctor or pharmacist. Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Drug Interactions

Due to its dopaminergic activity, Agnucaston^® may interact with other medicines. Concomitant use with dopamine receptor antagonists (e.g., metoclopramide, domperidone, certain antipsychotics such as haloperidol or chlorpromazine) may lead to a mutual decrease in therapeutic efficacy. Caution is advised when co-administering these drugs.

Hormonal preparations: The drug may affect the balance of sex hormones. The interaction with hormonal contraceptives, hormone replacement therapy (HRT), or other sex hormones has not been specifically studied. Patients using hormonal contraceptives should be closely monitored, as the effectiveness of contraception may theoretically be affected; the use of an additional non-hormonal method of contraception is recommended.

Alcohol: Patients taking the oral drops formulation should be aware of its ethanol content (17.0-19.0% by volume) and avoid concomitant consumption of alcoholic beverages, as this may enhance central nervous system depression effects.

Always inform your doctor or pharmacist about all the medicines you are currently taking, including prescription, non-prescription medicines, and herbal products.

Overdose

Cases of overdose with Agnucaston^® have not been reported to date. Given the pharmacological profile, symptoms of overdose are expected to be an extension of its known adverse reactions, primarily gastrointestinal discomfort (nausea, vomiting, diarrhea) and, in severe cases, possible confusion or hallucinations.

There is no specific antidote. In case of suspected overdose, treatment should be symptomatic and supportive. Gastric lavage may be considered if a large amount has been ingested recently. It is recommended to administer activated charcoal to reduce further absorption. Patients should be monitored and vital functions maintained as necessary. It is essential to consult a doctor or contact a poison control center immediately for advice.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.