Instructions for Cyclodinon film-coated tablets No. 30
Composition
active ingredient: 1 tablet contains 4 mg of native dry Agni casti fruit extract (Fructis Agni casti) (7-11:1), (extractant ethanol 70% (v/v);
Excipients: povidone; colloidal anhydrous silica; potato starch; lactose monohydrate; microcrystalline cellulose; magnesium stearate; talc; titanium dioxide (E 171); yellow iron oxide (E 172); indigo carmine (E 132); macrogol 6000; ammonium methacrylate copolymer (type A).
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a greenish-blue color with a matte surface.
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 irregularities. Mastodynia (swelling and tenderness of the breasts), which is 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
Common yam fruits can positively affect female fertility by regulating the menstrual cycle.
Patients who have or have had estrogen-dependent malignant tumors, as well as patients who use dopamine agonists, dopamine antagonists, estrogens, and antiestrogens, should consult a doctor before using preparations containing chaste tree (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.
The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The drug should not be taken by patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Note for diabetics. Since a single dose of the drug contains less than 0.01 bread units, Cyclodinon tablets 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
Take the drug 1 tablet once a day.
The film-coated tablets should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water).
The treatment lasts for 3 months without interruption, including during menstruation. The treatment should be continued for several more weeks even after the condition improves.
If symptoms do not go away after taking the drug for 3 months, consult a doctor.
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 and dizziness, acne, and menstrual irregularities, have been reported after the use of medicines containing common privet.
If any reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
5 years.
Do not use after the expiry date stated on the packaging.
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
15 film-coated tablets in a blister, 2 or 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Bionorica CE.
Location of the manufacturer and its business address
Kerchensteinerstrasse, 11-15, 92318, Neumarkt, Germany.
