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

Compound

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

special instructions

The drug should not be taken for more than 3 months without consulting a doctor.

When used in recommended doses, the drug does not affect the speed of reaction when driving vehicles and machinery.

If pregnancy occurs, you should stop taking the drug and consult a doctor.

The drops for oral administration contain 35–40 vol.% ethanol.

When using the bottle, keep it in an upright position.

During storage of the drops, a slight sediment or slight turbidity may occur, which does not affect the effectiveness of the drug.

Drops for oral administration should be shaken before use.

Instructions for diabetic patients. Patients with diabetes can take Klimadinon® tablets, because a single dose of this drug contains less than 0.04 XE.

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.

[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.

Conditions for dispensing from pharmacies

The drug is available without a prescription.

Special Instructions

The drug should not be used for more than 3 months without consulting a doctor.

The drug should be shaken before use.

The drug contains 35-40% ethanol (volume).

When using the bottle, keep it in an upright position.

During storage of the drug, slight turbidity of the liquid or slight precipitation may occur, which does not affect the effectiveness of the drug.

Impact on the ability to drive vehicles and machinery

When used in recommended doses, the drug does not affect the ability to drive vehicles or operate machinery that requires increased attention.

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.