Instructions for Cyclodinone oral drops, 50 ml bottle
Composition
active ingredient: 100 g of drops contains 0.24 g (240 mg) of native dry Agni casti fruit extract (Fructis Agni casti) (7-11:1), (extractant ethanol 70% (v/v);
Excipients: povidone; sorbitol solution, non-crystallizing (70%) (E 420); polysorbate 20; sodium saccharin, dihydrate; peppermint flavoring; ethanol 19% (v/v); purified water.
40 drops equals 1.93 ml.
Dosage form
Oral drops.
A clear, yellow-brown liquid with the smell of common bramble fruit.
During storage, cloudiness or slight precipitation may occur.
Pharmacotherapeutic group
Means used in gynecology.
ATX code G02C X03.
Pharmacological properties
Pharmacodynamics
The drug is a herbal medicine for the treatment of menstrual disorders, mastodynia, and premenstrual syndrome.
The components of the drug have a normalizing effect on the level of sex hormones. The dopaminergic effects of the drug cause a decrease in the production of prolactin, i.e. eliminate hyperprolactinemia. An increased concentration of prolactin disrupts the secretion of gonadotropins, as a result of which disturbances may occur during follicle maturation, ovulation and in the corpus luteum stage, which subsequently leads to an imbalance between estradiol and progesterone. This imbalance between sex hormones causes menstrual 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 expanding the milk ducts. A decrease in prolactin levels leads to the reverse development of pathological processes in the mammary glands and relieves pain. Normalization of the level of sex hormones contributes to the normalization of the second phase of the menstrual cycle.
Pharmacokinetics
Data is missing.
Indication
Menstrual cycle disorders. Mastodynia (swelling and tenderness of the breasts), often accompanied by pain (mastalgia). Premenstrual syndrome (psychological lability, headache or migraine, constipation).
Contraindication
Hypersensitivity to common thorn fruit or to any of the excipients of the drug, pregnancy.
Interaction with other medicinal products and other types of interactions
Interactions with dopamine agonists, dopamine antagonists, estrogens, and antiestrogens cannot be ruled out due to the possible dopaminergic and estrogenic effects of common primrose.
Application features
Shake before use! The bottle should be held vertically when instilling the drug.
Common yam fruits can positively affect female fertility by regulating the menstrual cycle.
Patients who have or have had estrogen-dependent malignancies, as well as patients taking dopamine agonists, dopamine antagonists, estrogens, and antiestrogens, should consult a doctor before using preparations containing chasteberry (Vitex agnus-castus).
If you have a history of pituitary disorders, you should consult a doctor before using the drug, as the fruits of common privet affect the hypothalamic-pituitary system.
The use of common yam fruit can mask the symptoms of prolactin-secreting pituitary tumors.
If symptoms worsen while using the drug, you should consult a doctor.
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicinal product. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The medicinal product contains 19% (v/v) ethanol (alcohol), i.e. 290 mg/dose, which is equivalent to 7 ml of beer or 3 ml of wine per dose. Due to the ethanol content, the medicinal product should not be taken by persons suffering from alcoholism. There is also a health risk for patients with epilepsy and liver disease.
Note for diabetics. Since the drug does not contain a significant amount of bread units, Cyclodinone oral drops can be used by diabetics.
Ability to influence reaction speed when driving vehicles or other mechanisms
If dizziness occurs during treatment with the drug, you should refrain from driving or operating other mechanisms.
Use during pregnancy or breastfeeding
Due to the lack of data on reproductive toxicity, the drug should not be used during pregnancy.
Due to the lack of data on the excretion of the drug or its metabolites into breast milk, a risk to the infant cannot be excluded. Research data suggest that chaste tree (Vitex agnus-castus) may affect lactation. Therefore, the drug should not be used during breastfeeding.
Method of administration and doses
To achieve optimal results, treatment should be continued for 3 months without interruption, including during menstruation. Treatment should be continued for several more weeks after improvement.
If symptoms do not go away after taking the drug for 3 months, you should consult a doctor.
Children
Due to insufficient data, the drug should not be used in children and adolescents (under 18 years of age).
Overdose
In case of overdose, treatment is symptomatic.
Adverse reactions
Allergic reactions, including skin rashes, hives, facial swelling, shortness of breath and difficulty swallowing, as well as gastrointestinal disorders (including nausea, abdominal pain), headache, dizziness, acne, and menstrual irregularities, have been reported after the use of medicines containing common privet.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
4 years.
Do not use after the expiry date stated on the packaging.
After first opening the bottle, the drug is suitable for use for 6 months.
The expiration date determines the use of the drug until the last day of the month.
Storage conditions
Store in the original packaging to protect from light at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
50 ml in a brown glass bottle with a closure system consisting of a dosing dropper, a screw-on cap with a tamper-evident ring; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Bionorica SE.
Location of the manufacturer and its business address
Kerchensteinerstrasse, 11-15, 92318 Neumarkt, Germany.
