Cyclodinon®

Instructions for Medical Use of the Medicinal Product CYCLODYNONÂ CYCLODYNONÂ

Excipients: povidone; sorbitol solution, non-crystallizing (70%) (E 420); polysorbate 20; sodium saccharin dihydrate; peppermint flavor; ethanol 19% (v/v); purified water.

40 drops correspond to 1.93 ml.

Pharmaceutical form. Oral drops.

A clear, yellow-brown liquid with the odor of common elderberries.

Slight clouding or formation of a minor precipitate may occur during storage.

Pharmacotherapeutic group. Medicinal products used in gynecology.

ATC code G02C X03.

Pharmacological properties.

Pharmacodynamics.

The medicinal product is a herbal remedy used for the treatment of menstrual cycle disorders, mastodynia, and premenstrual syndrome.

The components of the product exert a regulatory effect on sex hormone levels. The dopaminergic effects of the product lead to a reduction in prolactin production, thereby eliminating hyperprolactinemia. Elevated prolactin concentration disrupts gonadotropin secretion, which may result in disturbances in follicular maturation, ovulation, and the corpus luteum phase, ultimately leading to an imbalance between estradiol and progesterone. This hormonal imbalance causes menstrual disorders as well as mastodynia. Prolactin also exerts a direct stimulatory effect on proliferative processes in the mammary glands, enhancing connective tissue formation and ductal expansion. Reduction in prolactin levels leads to regression of pathological processes in the mammary glands and alleviates pain symptoms. Normalization of sex hormone levels contributes to the normalization of the second phase of the menstrual cycle.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

Menstrual cycle disorders.

Mastodynia (swelling and tenderness of the breasts), often accompanied by pain (mastalgia).

Premenstrual syndrome (psychological lability, headache or migraine, constipation).

Contraindications. Hypersensitivity to the fruits of Vitex agnus-castus or to any of the excipients, pregnancy.

Interaction with other medicinal products and other forms of interaction.

Interaction with dopamine agonists, dopamine antagonists, estrogens, and antiestrogens cannot be excluded due to possible dopaminergic and estrogenic effects of Vitex agnus-castus.

Special precautions for use.

Shake well before use! The bottle should be held vertically when administering the drops.

The fruits of common chasteberry may positively affect female fertility by regulating the menstrual cycle.

Patients who have or have had estrogen-dependent malignant tumors, as well as patients taking dopamine agonists, dopamine antagonists, estrogens, or antiestrogens, should consult a physician before using products containing common chasteberry (Vitex agnus-castus).

Patients with a history of pituitary disorders should consult a physician prior to using this product, as the fruits of common chasteberry affect the hypothalamic-pituitary system.

Use of common chasteberry fruits may mask symptoms of prolactin-secreting pituitary tumors.

If symptoms worsen during treatment, medical advice should be sought.

This medicinal product contains sorbitol. The product should not be taken by patients with rare hereditary fructose intolerance. In case of established intolerance to certain sugars, consult a physician before taking this medicinal product.

The medicinal product contains 19% (v/v) ethanol (alcohol), i.e. 290 mg/dose, equivalent to 7 ml of beer or 3 ml of wine per dose. Due to its ethanol content, the product should not be taken by individuals suffering from alcoholism. There is also a health risk for patients with epilepsy and liver disease.

Note for diabetic patients. Since the product does not contain a significant amount of carbohydrate servings (bread units), Cyclo-Dioneâ oral drops can be used by patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

Due to lack of data on reproductive toxicity, the product should not be used during pregnancy.

Due to insufficient data on the passage of the drug or its metabolites into breast milk, risk to the infant cannot be excluded. Research data indicate that common chasteberry (Vitex agnus-castus) may affect lactation. Therefore, the product should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery. If dizziness occurs during treatment with this product, patients should refrain from driving or operating machinery.

Method of Administration and Dosage.

Take 40 drops once daily, preferably with a sufficient amount of water.

For optimal therapeutic effect, treatment should continue uninterrupted for 3 months, including during menstruation. Treatment should be continued for several weeks after improvement of symptoms.

If symptoms do not resolve after 3 months of taking the medication, consult a physician.

Children. Due to insufficient data, the medication should not be used in children and adolescents (under 18 years of age).

Overdose. In case of overdose, symptomatic treatment is recommended.

Side Effects. Following the use of medicinal products containing fruit of black cohosh (Actaea racemosa), allergic reactions have been reported, including skin rash, urticaria, facial swelling, dyspnea, and difficulty swallowing, as well as gastrointestinal disorders (including nausea, abdominal pain), headache, dizziness, acne, and menstrual cycle disturbances.

If any adverse reactions occur, discontinue use of the medication and consult a physician.

Shelf Life. 4 years.

Do not use after the expiry date stated on the packaging.

After first opening of the bottle, the product is suitable for use for 6 months.

The shelf life is defined as valid until the last day of the month indicated.

Storage Conditions. Store protected from light in the original packaging at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging. 50 ml or 100 ml in a brown glass bottle with a closure system consisting of a dropper dispenser and a screw cap with a tamper-evident ring; 1 bottle per cardboard box.

Pharmaceutical Category. Over-the-counter (without prescription).

Manufacturer/Applicant. Bionorica SE/Bionorica SE.

Address of Manufacturer and/or Applicant and/or Applicant's Representative.

Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Contact details of the manufacturer's representative in Ukraine, LLC "Bionorica":

Phone: 044 521 86 00; Fax: 044 521 86 01, [email protected]