Klimadinon®

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

Composition:

Active substance: 1 tablet contains 20 mg of dry extract of black cohosh rhizome (Cimicifuga rhizome) (5–10:1), corresponding to 2.8 mg of native extract (extraction solvent ethanol 58% v/v);

Excipients: lactose monohydrate; potato starch; magnesium stearate; calcium hydrogen phosphate dihydrate; talc; titanium dioxide (E 171); yellow iron oxide (E 172); red iron oxide (E 172); macrogol 6000; ammonio-methacrylate copolymer.

Pharmaceutical form. Coated tablets.

Main physicochemical characteristics: round, biconvex, coated tablets of terracotta color with a smooth surface.

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.

Cimicifuga extract has 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 not available.

Clinical characteristics.

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

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

Interaction with other medicinal products and other types of interactions. When estrogens are taken concurrently, Klimadinon® may enhance their effect (see section "Special precautions for use" of the instruction).

Special precautions for use

Patients with a history of liver function disorders should take the medicinal product with caution. Liver function tests should be performed in such patients. If signs of liver damage occur (increased fatigue, loss of appetite, yellowing of the skin or eyes, severe pain in the upper abdomen with nausea and vomiting, or dark urine), use of Climadione® should be discontinued immediately and a physician should be consulted urgently.

In case of menstrual disturbances or irregularities, prolonged menstruation, or other complaints occurring during treatment, a physician should be consulted to reassess the treatment regimen.

Women of reproductive age should use effective contraceptive methods.

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

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

There is insufficient data on specific dosage recommendations for patients with impaired renal or hepatic function. The medicinal product contains lactose and therefore should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Note for diabetic patients. 1 tablet contains on average 0.01 bread units (BU).

Use during pregnancy or breastfeeding. The safety of cimicifuga during pregnancy has not been established; therefore, Climadione® should not be used during this period.

Due to lack of data on the passage of the drug or its metabolites into breast milk, risk to infants cannot be excluded. Therefore, the medicinal product should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery. No effect.

Dosage and method of administration.

Unless otherwise prescribed by a physician, postmenopausal women should take 1 tablet twice daily (in the morning and in the evening).

The tablets should be swallowed whole without chewing and taken with sufficient amount of liquid. A double dose should not be taken if a dose has been missed.

The duration of treatment is determined individually by a physician. If symptoms do not resolve during treatment, the patient should consult a doctor.

The drug should not be used for longer than 6 months without consulting a physician.

Children. This medicinal product is not intended for use in children.

Overdose. Cases of overdose are unknown.

If doses exceeding the recommended amounts are taken, a physician should be informed so that appropriate measures can be taken. In case of overdose, symptomatic therapy should be administered.

Side effects.

When using products 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, abnormal liver function tests) have been associated with the use of products containing black cohosh. Reports of breast tenderness and menstrual-like bleeding have also been received.

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

Shelf life. 4 years.

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

The shelf life refers to the product being suitable for use until the last day of the specified month.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging. 15 tablets in a blister; 4 blisters № 60 (15×4) in a cardboard box.

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

Manufacturer/Applicant. Bionorica SE / Bionorica SE.

Manufacturer’s address and place of business / Applicant’s and applicant’s representative’s address.

Kerchensteinerstrasse, 11-15, 92318, Neumarkt, Germany /

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]