Instructions for use KLIMONORM

Compound

The package contains two types of dragees: brown (12 pcs.) and yellow (9 pcs.).
1 yellow dragee contains 2 mg estradiol valerate . 1 brown tablet contains 150 mcg of levonorgestrel and 2 mg of estradiol valerate. Auxiliary components: carnauba wax, magnesium stearate, potato starch, lactose monohydrate, polyvidone, titanium dioxide, calcium carbonate, magnesium carbonate, purified water, macrogol, glucose, gelatin.

pharmachologic effect

An antimenopausal agent containing gestagen and estrogen . In a woman’s body, estrogen, presented in the drug in the form of estradiol valerate, is metabolized to natural 17 beta-estradiol. Thanks to the addition of levonorgestrel (gestagen) for 12 days of each cycle, it is possible to prevent the development of endometrial malignancy and hyperplasia . In patients suffering from irregular menstruation, while taking the medication, the menstrual cycle (relevant for women with a non-removed uterus).

Estradiol is able to compensate for the lack of estrogen in a woman’s body upon the onset of menopause and allows to relieve negative psycho-emotional manifestations and vegetative symptoms:

• dizziness;
• excitability;
• rushes of blood flow to the face;
• irritability;
• decreased libido;
• increased sweating;
• cardialgia;
• migraine headache;
• joint pain;
• sleep disorders;
• nervous excitability;
• muscle pain;
• vaginal dryness;
• pain during sexual intercourse.

With a lack of estrogen, bone loss occurs. Estradiol helps prevent bone destruction. The principle of action is based on a shift in bone remodeling (towards the formation of bone tissue) and suppression of osteoclast activity. It has been proven that long-term hormone replacement therapy can significantly reduce the risk of fractures in women entering menopause. Properly selected hormonal therapy slows down the aging process, the formation of facial wrinkles, increases the level of collagen in the skin, and has a beneficial effect on its density.

Additionally, the drug lowers cholesterol and stabilizes the ratio of lipid profile indicators. It has been observed that hormonal therapy in postmenopausal women reduces the risk of developing colon cancer .

Side effects of the drug Klimonorm

In clinical studies, side effects associated with taking the drug were reported, which in some cases were probably manifestations of menopause. Frequency: common (1/100, ≤1/10) From the nervous system: headache. From the cardiovascular system: hypertension. From the reproductive system and mammary glands: benign mastopathy. General disorders: hot flashes. Frequency: uncommon (1/1000, ≤1/100) From the nervous system: migraine, memory loss, depressed mood, dizziness. From the cardiovascular system: tachycardia, varicose veins. From the gastrointestinal system: nausea, flatulence, abdominal pain, constipation, dyspepsia. Skin: acne, itching. From the reproductive system and mammary glands: intermenstrual bleeding, a feeling of tension or pain in the mammary glands, mastitis, vaginitis, vaginal discharge, thickening of the endometrial layer, glandular cystic endometrial hyperplasia. From the respiratory system: infectious diseases of the respiratory tract. Eyes: blurred vision. Liver and gallbladder: cholangitis, cholecystitis, increased activity of liver enzymes, bilirubinemia. General disorders: hypersensitivity reactions, weakness. Other disorders: increased blood sugar, changes in blood lipids, edema, changes in body weight, anemia, pelvic pain, nodules in the thyroid gland. The following adverse reactions have also been reported in association with therapy with other estrogen/progestogen combinations:

• benign and malignant estrogen-dependent neoplasms, such as endometrial cancer;
• venous thromboembolism, that is, deep vein thrombosis or pulmonary embolism, is more common in women using HRT than in women not using HRT;
• myocardial infarction or stroke;
• gallbladder disease;
• disorders of the skin or subcutaneous tissue: chloasma, erythema nodosum, exudative erythema multiforme, vascular purpura;
• possible development of dementia;
• possible development of a liver tumor.

Indications for use

• urogenital dystrophy (reverse form of development of female genital organs);
• menstrual irregularities due to menopause ;
• atrophic changes in the mucous membranes and skin (thinning, dryness);
• prevention of osteoporosis ;
• emotional instability due to menopausal syndrome;
• hormonal therapy after surgical removal of the ovaries;
• irritation of the urethra and bladder, urinary incontinence due to stress during postmenopause.

Contraindications

• hereditary pathology of lipid metabolism;
• neoplasms of liver tissue, severe liver disease;
• individual hypersensitivity;
• myocardial infarction;
• thromboembolism;
• pathological genital bleeding, endometriosis ;
• diagnosis or suspicion of the presence of hormone-dependent tumors of the mammary glands, ovaries, uterus;
• acute stage of cerebrovascular accident ;
• carrying a pregnancy ;
• diabetic angiopathy , severe diabetes ;
• breast-feeding;
• progressive otosclerosis, herpes infection , skin itching , idiopathic form of jaundice .

Contraindications to the use of the drug Klimonorm

Klimonorm should not be used for any of the following conditions. If any of these conditions occur during therapy, the drug should be discontinued immediately:

• diagnosed or suspected breast cancer, or a history of this disease;
• diagnosed or suspected estrogen-dependent tumors (for example, endometrial cancer);
• vaginal bleeding of unknown etiology;
• untreated endometrial hyperplasia;
• history of venous thromboembolism of unknown etiology or existing venous thromboembolism (deep vein thrombosis, pulmonary embolism);
• arterial thromboembolism in the acute stage or recent arterial thromboembolism (for example, angina pectoris, myocardial infarction);
• severe liver disease at a given time or in history, until laboratory indicators of the functional state of the liver are normalized;
• known hypersensitivity to the active substances or any of the auxiliary components of the drug;
• porphyria;
• hereditary fructose intolerance, galactose intolerance, lactose deficiency, glucose-galactase maladsorption or sucrose-isomaltase deficiency.

Instructions for Klimonorm (Method and dosage)

Instructions for using Klimonorm while maintaining the menstrual cycle: start treatment on the 5th day of the cycle (the first day is counted from the moment menstrual bleeding appears). In case of rare menstruation, amenorrhea , or during menopause, the drug can be started on any day, excluding pregnancy. The package is designed for 21 days. Treatment begins with taking yellow tablets: 1 pc. every day for 9 days. Then take 1 brown tablet daily for 12 days. After this, a 7-day break is taken, during which bleeding occurs, similar to menstruation. Then they begin treatment again, taking the pills according to the same regimen. Dragees are not designed to be chewed; they must be swallowed whole with water. It is recommended to take the drug every day at a specific time. , vaginal bleeding may occur .

Use of the drug Klimonorm

Klimonorm is taken 1 tablet per day (preferably in the evening) for 21 days. Reception begins with a pill marked with number 1 on the blister and then continues in the direction of the arrow. After taking 9 yellow tablets, take 12 brown tablets. After all the pills have been taken for 3 weeks, there is a seven-day break without taking the drug. During this period, you should expect the appearance of another menstrual-like bleeding. After a seven-day break, start taking pills from the next package, regardless of whether the bleeding has stopped or is still ongoing. If HRT drugs have not been used in the previous period: if the patient still experiences menstrual bleeding (premenopausal period), the first Klimonorm tablet is taken on the 5th day of the menstrual cycle. During the menopausal period or with long periods of time between spontaneous menstrual bleeding, the drug can be started at any time. Before starting therapy, pregnancy must be excluded. Use of the drug Klimonorm, if the patient has previously used another drug for HRT. When switching to Klimonorm after the previous use of a combined drug for continuous HRT, the patient can begin taking Klimonorm tablets after completing the cycle of previous therapy. If the patient switches to Klimonorm after a cyclic combination drug for HRT, taking Klimonorm tablets should begin after the end of the break without taking pills. The pills are taken without chewing. To avoid gastrointestinal disorders, it is recommended to take the tablets in the evening after meals. The duration of treatment is determined by the doctor individually. It is advisable to take the pills at the same time every day. If you miss taking another pill, it must be taken within the next 12 hours. If the delay in taking the pill is more than 12 hours, the missed pill should be left in the package. If you miss taking the tablets, the likelihood of sudden bleeding or spotting increases.

Interaction

Before treatment, all hormonal contraceptives are discontinued. To prevent unwanted pregnancy, it is recommended to use non-hormonal contraception . Clinical effectiveness and clearance of sex hormones are reduced while taking liver enzyme inducers ( antibiotics , anticonvulsants). A similar effect is observed when treating with Rifampicin , Carbamazepine , barbiturates, Griseofulvin . The maximum rate of enzyme induction is recorded after 2-3 weeks of therapy and can persist for 4 weeks after discontinuation of the medication. A drop in estradiol levels is observed when taking Tetracycline and Penicillin.

Due to competitive inhibition of conjugation during absorption, the bioavailability of estradiol increases during simultaneous therapy with drugs that are largely subject to conjugation (including Paracetamol ).

In patients with diabetes mellitus, glucose tolerance may change, which requires adjustment of the dose of insulin and hypoglycemic drugs. Drinking alcoholic beverages can increase the level of extradiol in a woman’s body.

Interactions of the drug Klimonorm

Concomitant use of drugs that stimulate enzymes that metabolize active substances, in particular enzymes of the cytochrome P450-dependent system, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine) and drugs for the treatment of certain infectious diseases (for example, rifampicin, rifabutin, nevirapine, efavirez) , enhances the metabolism of estrogens and paragestogens. Although ritonavir and nelfinavir are known to be strong inhibitors, they exhibit inducing properties when used concomitantly with steroid hormones. Herbal medicines containing Hypericum perforatum can induce the metabolism of estrogens and progestogens. Increased metabolism of estrogens and progestogens can lead to a decrease in the clinical effectiveness of therapy and a change in the nature of uterine bleeding. Levels of the active substances of Klimonorm in the blood plasma may increase due to the use of drugs that inhibit enzymes that metabolize the active substances (for example, ketoconazole). Estrogens may increase the effects and side effects of imipramine. Changes in intestinal flora due to the use of antibiotics, such as ampicillin or tetracyclines, can cause a decrease in the level of active substances and, as a result, the effectiveness of the drug Klimonorm. In this regard, an increase in the number of non-cyclic bleedings has been reported. When co-administered with cyclosporine, the levels of cyclosporine, creatinine and liver transaminases may increase due to a decrease in the hepatic clearance of cyclosporine. Due to estrogen's effects on glucose tolerance (reduction) and insulin response, the need for oral antidiabetic agents or insulin dosage may change. Estrogens may affect the results of some laboratory tests, such as thyroid function parameters or glucose tolerance.

special instructions

Under no circumstances should the medication be used as a contraceptive . Before treatment, it is necessary to examine the condition of the mammary glands, liver system, cholesterol levels, and blood pressure . For porphyria, multiple sclerosis , otosclerosis, varicose veins , arterial hypertension , sickle cell anemia, additional consultation with specialists is carried out before starting hormonal therapy. of migraine headaches increases , if auditory or visual perception is impaired, bile stasis, or thromboembolic disorders, treatment is stopped.

Special instructions for the use of the drug Klimonorm

It is recommended that HRT be started for the treatment of postmenopausal symptoms only when such symptoms seriously affect quality of life. In any case, it is necessary to conduct a thorough analysis of the benefit-risk ratio of the drug every year and continue HRT only when the benefit outweighs the risk. Endometrial hyperplasia The risk of endometrial hyperplasia and cancer increases with prolonged estrogen monotherapy. This risk increases with the duration of treatment. Based on the results of epidemiological studies, the estimated risk for women who do not use HRT is about 5 cases of endometrial cancer diagnosed at the age of 50–65 years per 1000 women. Depending on the duration of treatment and the dose of estrogen, there is a 2-12 times increase in the development of endometrial cancer in women with estrogen monotherapy compared to women not using HRT. Including a progestogen in the treatment regimen of women with a non-removed uterus for at least 12 days/cycle significantly reduces this risk. During the first months of treatment, breakthrough bleeding or spotting may occur. If these phenomena are noted during therapy or continue after cessation of treatment, an examination should be performed to determine the etiology of the bleeding, which includes an endometrial biopsy to exclude a malignant endometrial tumor. Breast cancer Results from randomized placebo-controlled trials and epidemiological studies indicate an increased risk of developing breast cancer in women taking estrogens, estrogen-progestogen combinations, or tibolone for HRT over several years. For all types of HRT, this increased risk becomes apparent over several years of therapy and increases with the duration of treatment, but returns to baseline levels several (mostly 5) years after discontinuation. In studies, the relative risk of developing breast cancer with conjugated equine estrogens or estradiol (E2) was higher with cyclic or continuous progestogen in the treatment regimen, regardless of the type of progestogen. It is unknown whether there are differences in risk between different routes of administration. In studies conducted, continuous combination therapy with conjugated estrogen and medroxyprogesterone acetate was associated with breast cancer that was more invasive and more likely to metastasize to regional lymph nodes compared with placebo. HRT, in particular combined estrogen-progestogen therapy, increases the density of images in mammographic examinations, which may lead to incorrect assessment of the results of radiological examinations for breast cancer. Venous thromboembolism (VTE) The use of HRT is associated with an increase in the relative risk of developing VTE, that is, deep vein thrombosis or pulmonary embolism. Generally recognized risk factors for the development of VTE include: personal and family history, severe obesity (BMI 30 kg/m2) and systemic lupus erythematosus. The possible role of varicose veins in the development of VTE remains controversial. Patients with a history of VTE have an increased risk of developing VTE. HRT may slightly increase this risk. Therefore, the prescription of HRT should be preceded by a thorough study of the patient’s personal and family history, and attention should be paid to the presence of a history of repeated involuntary abortions. The use of HRT in such patients is contraindicated until the risk factors for thromboembolism have been fully assessed and the need for anticoagulant therapy has been prescribed. Women receiving anticoagulant therapy need to carefully assess the expected benefits and potential risks of using HRT. The risk of VTE may temporarily increase with prolonged immobilization, after major surgery, especially abdominal or lower extremity surgery, or major trauma. Therefore, consideration should be given to stopping HRT 4–6 weeks before surgery, if possible. Treatment is not recommended to be resumed until complete recovery. If VTE develops after starting HRT therapy, treatment should be stopped immediately. IHD The results of randomized controlled trials indicate a negative effect on the cardiovascular system when using continuous combination therapy with conjugated estrogens and medroxyprogesterone acetate (MPA). Based on clinical studies, a possible increase in the risk of developing cardiovascular diseases was shown within 1 year of use, which persisted with further use of the drugs. Stroke Another negative consequence is the increased risk of ischemic stroke in healthy women when using continuous combination therapy with conjugated estrogens and MPA. Ovarian cancer According to the results of studies, long-term (at least 5-10 years) estrogen monotherapy in women with a removed uterus was associated with an increased risk of developing ovarian cancer. It has not been determined whether there is a difference in this risk with long-term combination therapy of conjugated estrogens and MPA compared with estrogen monotherapy. Liver tumors After the use of hormonal substances, the components of which are contained in the drug Klimonorm, in isolated cases the development of benign, and even less often, malignant liver tumors was noted. In some cases, tumor growth was complicated by intra-abdominal bleeding, which was life-threatening. If there is pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, the possibility of a liver tumor should be taken into account when carrying out differential diagnosis. Other conditions The use of estrogens may lead to fluid retention. Given this, patients with functional impairment of cardiac or renal activity should be closely monitored. It is necessary to closely monitor the condition of patients with end-stage renal failure, since in these cases an increase in the level of circulating active substances of Klimonorm can be expected. Women with a history of hypertriglyceridemia require special monitoring during estrogen monotherapy or HRT using an estrogen/progestogen combination, since frequent cases of significant increases in plasma TG levels have been reported with estrogen monotherapy. In some cases, this led to the development of pancreatitis. There are no data regarding improvements in cognitive function. Some study results indicate an increased risk of possible development of dementia in women using continuous combined HRT with conjugated estrogens and MPA over the age of 65 years. Impact on laboratory results Estrogens increase the level of thyroid hormone binding globulin, which leads to an increase in circulating total thyroid hormone, which is determined by the level of T4 or T3 (using an immunological test). The concentrations of free T4 and T3 remain unchanged. Levels of other serum proteins, such as corticoid-binding globulin and sex hormone-binding globulin, may increase, resulting in increased concentrations of circulating corticosteroids and sex steroids, respectively. The concentrations of free or biologically active hormones remain unchanged. Plasma levels of other proteins (renin/angiotensinogen substrate, alpha-1 antitrypsin, ceruloplasmin) may increase. Conditions Requiring Close Monitoring If any of the following conditions or illnesses are diagnosed, suspected, or experienced in a patient and/or aggravated during pregnancy or previous hormonal therapy, the patient should be closely monitored medically. The possibility of relapse or exacerbation of the following conditions should be taken into account when using the drug Klimonorm: leiomyoma (uterine fibroids) or endometriosis; risk of thromboembolic disorders or a history of such disorders; the risk of developing estrogen-dependent tumors, for example breast cancer in one of the first-degree relatives; AH (arterial hypertension); liver diseases (for example hepatoadenoma); diabetes with or without vascular complications; cholelithiasis; migraine or severe headache; systemic lupus erythematosus; history of endometrial hyperplasia; epilepsy; BA; otosclerosis. Medical examination/consultation Before starting or restarting HRT, a detailed family history should be obtained and a complete physical examination (including pelvic and breast examination) should be performed, taking into account contraindications and precautions for HRT use. It is recommended to repeat such examinations periodically: conduct a breast examination, including mammography, in accordance with existing standards of medical practice, taking into account the individual characteristics of each patient. Use during pregnancy and lactation Klimonorm should not be prescribed during pregnancy and lactation. If pregnancy occurs while taking Kliamonorm, treatment should be stopped immediately. Clinical data, based on a limited number of cases of use of the drug during pregnancy, do not indicate a negative effect of levonorgestrel on the fetus. Most epidemiological studies have not revealed teratogenic or fetotoxic effects of estrogen/progestogen combinations when taken accidentally during pregnancy. impact on the ability to drive vehicles or operate complex machinery .

Analogs

Level 4 ATX code matches:
Femoston

Structural analogues:

• Femoston;
• Cliogest;
• Climodien.

Medicines with similar pharmacological effects:

• Estrovel;
• Onagris;
• Menopace;
• Inoclim;
• Feminal.

What is better Femoston or Klimonorm?

When choosing a combined hormonal drug, the doctor always takes into account the patient’s age, the presence of contraindications, weight, and concomitant pathology. Therefore, it is better to rely on the opinion of your attending physician, who will take into account all the features and select exactly the medication that is most suitable for your body: Femoston or another combined hormonal medication.

Reviews of Klimonorm

Feedback from women about Klimonorm indicates the absence of pronounced negative reactions during treatment. Patients indicate that the drug really helps to cope with unwanted psycho-emotional reactions, reduces irritability and excitability. Forums on relevant topics contain reviews from doctors, who also confirm the high effectiveness of the drug in the treatment of negative symptoms of the postmenopausal period. In general, reviews of Klimonorm are positive.

Klimonorm price, where to buy

The price of Klimonorm depends on the region and varies in the range of 570-650 rubles. In Ukraine, the medicine can be bought for 130 UAH.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

Pharmacy Dialogue

• Klimonorm (other No. 21) Bayer
  RUR 1,571 order

show more

Pharmacy24

• Klimonorm No. 21 tablets Bayer Weimar GmbH & Co.
  KG, Nimechchyna 311 UAH. order

PaniPharmacy

• Klimonorm tablets Klimonorm film-coated tablets No. 21 Germany, Bayer Weimar

  331 UAH. order

show more