Klimadinon

Klimadinon is an original anti-climacteric herbal medicine based on black cohosh rhizome extract from the German pharmaceutical company. Climacteric syndrome and all the accompanying unpleasant phenomena of a physiological and psychological nature that arise during menopause inevitably await every woman aged 42-55 years. Menopausal hormonal “swings” are accompanied by increased irritability, fatigue, headache, sleep disturbance, sinusoidal changes in blood pressure, heart rhythm disturbances, hyperhidrosis and hot flashes. To mitigate the effects of menopause, there are currently a number of effective medicines, one of which is the herbal preparation climadinone. The advent of herbal remedies based on estrogen-like substances allowed women to expect the onset of menopause without shuddering. Herbal extracts can not only reduce menopausal symptoms, but also improve metabolic processes in bone tissue. Cosimifuga rhizome extract, the active component of climadinone, has all these abilities. The healing properties of cohosh have been used by humans since ancient times. This plant has a hormone-like effect, choosing the anterior lobe of the pituitary gland as its site of action: the direct participation of cohosh extract ensures a decrease in the secretion of luteinizing hormone. Klimadinon, like estrogen, affects the vaginal mucosa, softens the symptoms of menopause and has a positive effect on bone tissue. Phytoestrogens from black cohosh have a dopaminergic organoselective effect on the woman’s body. An assessment of the therapeutic effectiveness of climadinon in patients with menopausal syndrome showed that the drug has the most positive effect on the lipid profile, harmonizing the levels of “good” and “bad” cholesterol (HDL and LDL, respectively). Pharmacotherapy using climadinone helps normalize bone mineral density, thereby preventing the development of osteoporosis.

In studies, climadinone has demonstrated a positive effect on biochemical markers of bone metabolism and mineral density of all problem areas of the femur. During clinical trials of the drug, it was found that its combination with moexipril in patients with arterial hypertension in the postmenopausal period leads to a decrease in blood pressure in 75% of women. At the same time, in patients taking moexipril as monotherapy, this figure did not exceed 50%. During the study of climadinon, an assessment of the density of the mammary glands was also carried out. Based on 140 mammograms, no increase in breast density was noted, with the exception of one patient with initially high breast density. Klimadinon has a beneficial effect on the endometrium. His condition was assessed through a biopsy, which confirmed the stimulating effect of the drug on endometrial thickness. In addition to all of the above, it must be added that climadinone has sedative properties, which is also not superfluous during menopause.

Klimadinon is available in two dosage forms: tablets and drops for oral administration. The therapeutic effect of the drug appears gradually and becomes pronounced in the third week from the start of treatment. Tablet dosage regimen: 1 tablet 2 times a day, morning and evening. Drops dosing regimen: 30 drops 2 times a day in the morning and evening. You should try to take the drug at the same time. The duration of the medication course in all cases is determined by the doctor. Without consulting a specialist, climadinon can be taken for no more than 3 months. The onset of pregnancy is a reason to stop taking the drug and consult a doctor. Patients suffering from diabetes mellitus should be informed that a single dose of climadinone contains less than 0.04 carbohydrate units.

Instructions for medical use of the drug Klimadinon® (tablets)

Registration number: P N014246/01

Trade name: Klimadinon®

International non-proprietary or generic name: Cohosh racemose rhizome extract

Dosage form: Film-coated tablets Composition: 1 tablet of the drug contains: Active ingredient: Cohosh racemose rhizome dry extract* (5-10: 1) - 2.8 mg Excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, potato starch, magnesium stearate, talc, titanium dioxide (E 171), yellow iron oxide dye (E 172), red iron oxide dye (E 172), macrogol 6000, ammonium methacrylate copolymer (type A)**.

* - dry extract is obtained from the rhizomes of black cohosh - Cimicifuga racemosa (L.) Nutt. family Ranunculaceae by extraction with ethanol (ethyl alcohol) 58% by volume. ** - contains: Ammonium methacrylate copolymer (type A), sorbic acid, sodium hydroxide. Description Round, biconvex, film-coated tablets of pink color with a brown tint. Pharmacotherapeutic group Anti-climacteric agent of plant origin. ATX code: G02CX04

Pharmacological properties Pharmacodynamics The mechanism of action and the constituent components of the rhizomes of black cohosh, which help relieve menopausal symptoms, are unknown. Clinical and pharmacological studies show that the use of the extract of black cohosh rhizomes reduces the clinical manifestations of menopausal symptoms, such as hot flashes and increased sweating. Pharmacokinetics No data available. Indications for use The drug Klimadinon® is indicated to relieve symptoms of menopause, such as hot flashes and increased sweating. Contraindications Hypersensitivity to the active component and/or to any excipient in the composition of the drug. Pregnancy and breastfeeding period. Age up to 18 years. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose).

With caution: in patients with liver disease (only after examining liver function).

Use during pregnancy and breastfeeding The drug Klimadinon® is contraindicated for use during pregnancy and breastfeeding. Method of administration and dosage: Orally, 1 tablet daily, 2 times a day at the same time (morning and evening). The tablets should be swallowed without chewing, with a small amount of water. The drug Klimadinon® should not be used for more than 6 months without consulting a doctor.

Use of the drug in special clinical groups Children and adolescents under 18 years of age The use of the drug Klimadinon® in children and adolescents under 18 years of age is not indicated. In patients with impaired renal function, there is no sufficient clinical data to make specific recommendations on the dosage regimen of the drug in patients with renal failure. In patients with impaired liver function The use of the drug Klimadinon® in patients with impaired liver function is possible only after consultation with a doctor. Use the drug only according to the indication, method of administration and in the doses indicated in the instructions. If there is no effect from the therapy or the condition worsens, you should consult a doctor. Side effects During therapy with black cohosh drugs, cases of liver dysfunction (including hepatitis, jaundice, increased activity of liver transaminases) have been reported. Skin reactions (urticaria, itching, skin rash), facial swelling, peripheral edema, gastrointestinal disorders (eg, dyspepsia, diarrhea) have also been reported. It is impossible to estimate the incidence of adverse reactions based on the available data. If you experience any adverse reactions listed in the instructions, or if they worsen, or if you notice any other unwanted reactions not listed in the instructions, tell your doctor.

Overdose No cases of overdose have been registered. In case of overdose, symptomatic treatment. Interaction with other medicinal products Interaction with other medicinal products is currently not known. Special instructions The drug Klimadinon® should be used in patients with impaired liver function with extreme caution. Liver function testing should be performed before starting therapy. If symptoms of liver damage occur (yellowness of the skin and sclera, increased fatigue, loss of appetite, dark urine, nausea, vomiting, pain in the upper abdomen), you should immediately stop taking the drug and consult a doctor. Patients who are receiving or have received treatment for breast cancer or other hormone-dependent tumors should not take Klimadinon® without first consulting a doctor. If you experience bleeding from the genital tract or other symptoms, you should consult a doctor immediately. The drug Klimadinon® should not be taken simultaneously with estrogens without first consulting a doctor. For patients with diabetes: 1 tablet of the drug contains less than 0.04 “bread” units (XU).

Effect on the ability to drive vehicles and machinery. Studies of the effect of the drug Klimadinon® on the ability to drive vehicles and machinery have not been conducted. Release form: Film-coated tablets. 15 tablets in blisters made of aluminum foil and polyvinyl chloride/polyvinylidene chloride film. 4 or 6 blisters are placed together with instructions for use in a cardboard pack. Storage conditions In the original packaging (blister, cardboard box), at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 3 years. Do not use after the expiration date. Conditions of release Dispensed without a prescription.

Marketing authorization holder Bionorica SE, Kerschensteinerstrasse 11-15, 92318 Neumarkt, Germany

Manufacturer Bionorica SE, Kerschensteinerstrasse 11-15, 92318, Neumarkt, Germany

Production of finished dosage form Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, 59320 Ennigerlo, Germany

Filling/Packaging Bionorica SE, Kerschensteinerstrasse 11-15, 92318, Neumarkt, Germany

Release control Bionorica SE, Kerschensteinerstrasse 11-15, 92318, Neumarkt, Germany

Organization accepting consumer complaints Limited Liability Company "Bionorika" 119619 Moscow, 6th st. New Gardens, 2, bldg. 1. tel./fax, email address

Pharmacological properties of the drug Klimadinon

Preparations created on the basis of a special cohosh extract BNO 1055 contain highly specific and organoselective phytoestrogens. The active components of BNO 1055 have organoselective, estrogen-like and dopaminergic properties. The drugs have a complex estrogen-like effect on the body, which allows them to be used for replacement therapy for estrogen deficiency both during pre- and menopause, and after oophorectomy. The active component of the drugs, having an affinity for estrogen receptors in the hypothalamus, leads to a decrease in the release of LH RF and a subsequent decrease in LH secretion from the anterior pituitary gland. A decrease in the secretion of gonadotropins leads to the elimination of psycho-emotional and vegetative-vascular disorders that occur during the premenopausal and menopausal periods and are caused by a sharp decrease in estrogen production with a simultaneous increase in the secretion of LH and FSH. A positive effect of the special extract BNO 1055 on the parameters of bone metabolism has been established, confirmed by the effect on biochemical markers of bone tissue repair - insulin-like growth factor and bone-specific alkaline phosphatase. According to clinical trials, the effect of BNO 1055 on the MRS menopause rating scale is comparable to the effect of conjugated estrogens. Like estrogens, Klimadinon/Klimadinon Uno causes the proliferation of superficial cells of the vaginal epithelium, but does not cause a decrease in FSH levels below normal, which preserves the natural function of the ovaries and supports the production of its own estrogens. Unlike estrogens, it does not cause endometrial proliferation and does not have a stimulating effect on the proliferation of estrogen-sensitive breast carcinoma cells. The therapeutic effect appears 2 weeks after the start of administration.

Klimadinon drops for oral administration fl 50ml

Active substance

black cohosh (Cimicifuga)

ATX code

G02CX (Other preparations for gynecological use)

Release form, packaging and composition of the drug

◊ Drops for oral administration

in the form of a transparent liquid of light brown color, with the smell of wood; During storage, slight turbidity or slight precipitation may occur.

100 g
liquid extract of black cohosh rhizomes (Cimicifuga rhizome)	12 g
which is equivalent to 2.4 g of dried medicinal plant material

[PRING] saccharin sodium 2H2O, peppermint oil, ethanol 96% (v/v), purified water. Ethanol content: 35.0 – 40.0% (volume).

50 ml - dark glass bottles (1) with a dosing drip device - cardboard boxes. 100 ml - dark glass bottles (1) with a dosing drip device - cardboard boxes.

Clinical and pharmacological group

Herbal medicine used for menopausal syndrome

Pharmacotherapeutic group

Herbal anti-climacteric agent

Indications for use

vegetative-vascular disorders in menopause, pre- and post-menopause, increased sweating, sleep disturbances, increased nervous excitability, mood changes, apathy and others).

Dosage

The drug is taken orally 30 drops 2 times a day at the same time of day (morning and evening).

The duration of treatment is determined by the doctor.

Contraindications

estrogen-dependent tumors;
alcoholism;
hypersensitivity to the components of the drug.

Carefully

the drug should be prescribed for liver diseases, epilepsy, diseases and brain injuries (use is possible only after consultation with a doctor).

Overdose

Cases of overdose and intoxication are currently unknown.

Side effects

Maybe:

allergic reactions, weight gain;
in rare cases -
pain in the epigastric region, a feeling of tension in the mammary glands and menstrual-like bleeding.

Overdose

Interaction with other drugs is currently unknown.

Storage conditions

The drug should be stored in a dry place, protected from light, out of the reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years. Do not use after the expiration date.