Klimadinon®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KLIMADYNONÒ (KLIMADYNONÒ)

Composition:

Active substances: 100 g of drops contains 12 g of liquid extract of black cohosh rhizome (1:5) (Cimicifuga rhizome); (extraction solvent: ethanol 50% v/v);

Excipients: sodium saccharin dihydrate, peppermint oil, ethanol 38%, purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: clear or slightly cloudy light brown liquid, sweet to taste, with an odor resembling wood.

Slight clouding or precipitation may occur during storage.

Pharmacotherapeutic group.
Medicinal products used in gynecology. Black cohosh rhizome. ATC Code: G02CX04.

Pharmacological Properties

Pharmacodynamics. A herbal medicinal product for the treatment of premenopausal and menopausal disorders.

Black cohosh extract exerts a positive effect on the neurovegetative system and reduces the level of psycho-emotional disturbances during the menopausal period. The use of the drug contributes to the alleviation or complete disappearance of symptoms associated with premenopausal and menopausal disorders, including hot flashes and excessive sweating.

Pharmacokinetics. Data are lacking.

Clinical characteristics.

Indications. Neurovegetative disorders during the menopausal period (hot flushes, excessive sweating, sleep disturbances, increased irritability, mood swings, apathy).

Contraindications. Hypersensitivity to the active substance or to other components of the medicinal product. Estrogen-dependent tumors.

Due to the presence of peppermint oil, Klimadinoon® oral drops should not be administered to patients suffering from bronchial asthma or other respiratory diseases associated with pronounced airway hypersensitivity. Inhalation of the product's vapors may cause bronchoconstriction.

Interaction with other medicinal products and other forms of interactions.

When taken concomitantly with estrogens, Klimadinoon® may enhance their effect (see section "Special instructions" of the instructions).

Special precautions for use

Patients with a history of liver function disorders should use the medication with caution. If signs of liver damage occur (increased fatigue, loss of appetite, yellowing of the skin or eyes, severe upper abdominal pain with nausea and vomiting, or dark urine), treatment with Climadinoon® must be discontinued immediately and medical advice should be sought urgently.

In case of menstrual disturbances or resumption of menstruation, as well as in case of prolonged menstrual bleeding or other complaints occurring during treatment, patients should consult a physician to reassess the treatment regimen.

Women of reproductive age must use effective contraceptive methods.

Climadinoon® should not be used without medical consultation if the patient is already taking female sex hormones (estrogens).

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

Patients who have been treated or are currently undergoing treatment for breast cancer or other hormone-dependent tumors should not use Climadinoon® drops without prior consultation with a physician.

This medicinal product contains 38% (v/v) ethanol (alcohol), i.e. 280 mg/mL, equivalent to 7 mL of beer or 3 mL of wine per dose. The product should not be taken by patients suffering from alcoholism or by those who have completed treatment for alcoholism. The alcohol content of the product must be taken into account when administering to high-risk patients, such as those with liver disease, epilepsy, or brain disorders.

Note for diabetic patients. A single dose of the medication contains no bread units (BU).

Use during pregnancy or breastfeeding. The safety of Cimicifuga during pregnancy or breastfeeding has not been established; therefore, Climadinoon® should not be used during these periods.

Ability to influence reaction speed while driving or operating machinery. At recommended doses, the product does not affect the ability to drive or operate machinery; however, it should be noted that the medicinal product contains ethanol.

Method of Administration and Dosage

Unless otherwise prescribed by a physician, postmenopausal women should take 30 drops twice daily (morning and evening). The drops are usually taken undiluted or with sugar. Shake well before use.

During storage, slight cloudiness or sediment formation may occur, which does not affect the drug's efficacy.

The duration of treatment is determined individually by a physician. If symptoms do not improve during treatment, consult a doctor.

Do not use the drug for longer than 6 months without consulting a physician.

Children. This medicinal product should not be administered to children.

Overdose. Cases of overdose have not been reported.

If doses exceeding the recommended amounts are taken, inform a physician immediately so that appropriate measures may be taken. In the event of overdose, symptomatic therapy should be administered.

Side effects.

When using preparations containing black cohosh, cases of gastrointestinal disorders (including dyspeptic disorders, diarrhea, nausea, vomiting), allergic reactions (including skin rashes, itching, urticaria), facial swelling and peripheral edema have been observed. Hepatotoxic reactions (including hepatitis, jaundice, changes in liver function laboratory parameters) have been associated with the use of preparations containing black cohosh. Reports have also included sensations of breast tension and menstrual-like bleeding.

If any adverse reactions occur, the use of the medication should be discontinued and medical advice should be sought.

Shelf life. 3 years.

After the first opening of the bottle, the medicinal product is suitable for use for 6 months. Do not use the medication after the expiry date stated on the packaging. The shelf life refers to the use of the product up to the last day of the stated month.

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 in a bottle with a dropper dispenser, placed in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer/Applicant. 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]