Instructions for use Klimadinon film-coated tablets No. 60
Composition
active ingredients: 1 tablet contains 20 mg of dry extract of Cimicifuga rhizome (5-10:1), which corresponds to 2.8 mg of native extract (extractant ethanol 58% (v/v);
excipients: lactose monohydrate; potato starch; magnesium stearate; calcium hydrogen phosphate dihydrate; talc, titanium dioxide (E 171); iron oxide yellow (E 172); iron oxide red (E 172); macrogol 6000; ammonium methacrylate copolymer.
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex, film-coated tablets, terracotta in color with a smooth surface.
Pharmacotherapeutic group
Means used in gynecology. Cimicifuge rhizome. ATX code G02CX04.
Pharmacological properties
Pharmacodynamics
Herbal medicine for the treatment of premenstrual and menopausal disorders.
Cimicifuga extract has a positive effect on the neurovegetative system and reduces the level of psychoemotional disorders during the climacteric period. The use of the drug contributes to the weakening or complete disappearance of symptoms of the disease in the pre-climax and climacteric periods, including hot flashes and profuse sweating.
Pharmacokinetics
Data is missing.
Indication
Neurovegetative disorders during menopause (hot flashes, increased sweating, sleep disturbances, increased irritability, mood swings, apathy).
Contraindication
Individual hypersensitivity to the active substance or to other components of the drug. Estrogen-dependent tumors.
Interaction with other medicinal products and other types of interactions
When taken simultaneously with estrogens, Klimadinon® may enhance their effect (see the section of the instructions "Special instructions for use").
Application features
Patients with a history of liver dysfunction should take the drug with caution. If signs of liver damage appear (increased fatigue, loss of appetite, yellowing of the skin and eyes or severe pain in the upper abdomen with nausea and vomiting or dark urine), you should stop using Klimadinon® and consult a doctor immediately.
If menstruation is disrupted or resumes, as well as in the case of prolonged menstruation or other complaints that arise during treatment, you should consult a doctor to review the treatment regimen.
Women of reproductive age need to use effective contraception.
Klimadinon® should not be used without consulting a doctor if the patient is already taking female sex hormones (estrogens).
If symptoms worsen while taking Klimadinon®, you should consult a doctor.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Note for diabetics: 1 tablet contains an average of 0.01 bread units (BTU).
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
The safety of cimicifuga during pregnancy or breastfeeding has not been established, therefore Klimadinon® should not be used during this period.
Method of administration and doses
Unless otherwise prescribed by a doctor, women during menopause should take 1 tablet 2 times a day (morning and evening).
The tablets should be swallowed whole with plenty of liquid. Do not take a double dose if you miss a dose.
The duration of treatment is determined by the doctor individually. If the symptoms do not disappear during treatment, you should consult a doctor.
The drug should not be used for more than 6 months without consulting a doctor.
Children
The drug should not be used to treat children.
Overdose
Cases of drug overdose are unknown.
If doses exceeding the recommended ones are taken, the doctor should be informed so that the necessary measures can be taken. In case of overdose, symptomatic therapy should be carried out.
Adverse reactions
Gastrointestinal disorders (including dyspepsia, diarrhea, nausea, vomiting), allergic reactions (including skin rash, itching, urticaria), facial edema, and peripheral edema have been reported with the use of black cohosh. Hepatotoxic reactions (including hepatitis, jaundice, and abnormal liver function tests) have been associated with the use of black cohosh. Breast tenderness and menstrual-like bleeding have been reported.
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.
The expiration date determines the use of the drug until the last day of the month.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Packaging
15 tablets in a blister; 4 blisters No. 60 (15x4) 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.
