Klimadynon

Klimadynon Bionorica is available as film-coated tablets containing 2.8 mg of dry extract of Cimicifuga racemosa rhizome per tablet. 

Each pack contains 60 film-coated tablets, packaged in blister packs stored in a cardboard box to protect them from light and moisture.

Bionorica Klimadynon is indicated in adult women to relieve the symptoms of the menopause, particularly hot flushes and excessive sweating. These symptoms frequently occur in the context of a progressive decrease in oestrogen levels and may be accompanied by sleep disturbances, irritability, emotional instability and a reduced quality of life.

The treatment is intended exclusively for women in the menopause or going through the menopausal transition and is not indicated for other patient groups.

The recommended dose for adult women in the menopause is one coated tablet twice daily, in the morning and in the evening, without exceeding the maximum dose of 2 coated tablets per day.

Administration is oral; the tablets must be swallowed whole with a sufficient amount of liquid. They must not be chewed or sucked, to ensure the correct release of the plant extract.

There is insufficient data on dose adjustment in patients with renal or hepatic impairment; therefore, use in these groups should only be on the advice of a doctor.

Klimadynon Menopause is contraindicated in patients with known hypersensitivity to Cimicifuga racemosa or to any of the product’s excipients.

Furthermore, patients with a history of liver disease should not use this medicine without consulting a doctor, given the rare reports of impaired liver function associated with the use of black cohosh-based preparations.

A medical assessment is recommended before starting treatment, particularly in patients with liver disease, gynaecological disorders or a history of hormone-dependent neoplasms.

Use during pregnancy is not recommended. It is not known whether the active ingredient is excreted in breast milk; therefore, the product should not be used whilst breastfeeding.

No studies have been conducted on the effects on the ability to drive or operate machinery, but there is no data to suggest a significant negative impact in this regard.

In general, Klimadynon is well tolerated. However, rare adverse reactions may occur, such as mild gastrointestinal disturbances (nausea, abdominal discomfort), allergic skin reactions or, very rarely, changes in liver function.

If jaundice, pain in the right upper quadrant, marked asthenia or dark urine occur, treatment must be discontinued and immediate medical assessment is required.

No significant drug interactions have been reported. However, caution is advised when administered concomitantly with other hormonal therapies or drugs with potential hepatotoxicity.

No relevant interactions with food are known, and administration may be carried out regardless of mealtimes.

No documented cases of overdose with Klimadynon have been reported. In the event of accidental ingestion of a dose higher than the recommended dose, clinical monitoring and symptomatic treatment are recommended, if necessary.

The product must be stored at temperatures below 30 °C, in the original packaging, with the blister packs kept in the cardboard box to protect them from light and moisture.

Keep out of the reach and sight of children.

• WebMD, Black Cohosh
• NIH, Black Cohosh
• PubMed, Investigation of the efficacy and safety of the herb Black Cohosh (Cimicifuga racemosa) in the management of menopausal symptoms
• Springer Nature Link, Efficacy of the herb Cimicifuga racemosa L. in the treatment of early menopausal symptoms: a randomised clinical trial