Instructions for use VENDIOL

Pharmacodynamics and pharmacokinetics

The drug Venodiol is an angioprotective and venotonic agent, the main effect of which is aimed at reducing venous stasis and distensibility of veins , increasing their tone , reducing fragility and permeability , and increasing their resistance. The drug also has a beneficial effect on vascular lymphatic drainage and microcirculation .

Ascorbic acid, which is part of the drug, increases vascular elasticity , normalizes hematopoiesis and capillary permeability , and activates the protective internal forces of the human body.

Systematic administration of the drug can reduce the severity of clinical symptoms of chronic venous insufficiency (CVI) of the lower extremities of a functional and organic nature.

Venodiol, instructions for use

Instructions for use of Venodiol provide two equivalent regimens for taking tablets:

• 1 tablet twice every 24 hours throughout the entire course of recommended therapy;
• 1 tablet twice every 24 hours for 14 days, with further transition to a one-time daily dose of 2 tablets.

It is recommended to take the tablets with meals.

The practical use of the drug demonstrates a directly proportional relationship between the duration of Venodiol administration and the initial severity of the disease state.

Therapy of the initial stages of CVI , expressed by the “ heavy legs ” syndrome, as a rule, requires a two-month course, with repeated courses at a frequency of 2-3 times a year.

More severe manifestations of CVI with swelling, pain and convulsive syndromes will require taking pills for 3-4 months.

Therapy for trophic venous ulcers can take about 6 months or even more.

In case of hemorrhoidal attack, it is recommended to take 6 tablets every 24 hours for 4 days, after which, over the next 3 days, they switch to taking 4 tablets per day.

VENODIOL No. 60 tablet

VENODIOL No. 60 tablet

Release form
Tablets for oral administration

Compound

1 tablet contains:

Active ingredients: diosmin 450 mg; hesperidin 50 mg; ascorbic acid 100 mg.

Package

30 pcs.

pharmachologic effect

Venodiol has angioprotective and venotonic effects. Reduces the distensibility of veins, increases their tone and reduces venous stagnation; reduces permeability and fragility of capillaries and increases their resistance; improves microcirculation and lymphatic drainage.

Ascorbic acid (vitamin C), which is part of the drug Venodiol, improves the elasticity of blood vessels, normalizes capillary permeability, promotes normal hematopoiesis, and increases the body's defenses.

With the systematic use of the drug Venodiol, the severity of clinical manifestations of chronic venous insufficiency of the lower extremities of an organic and functional nature decreases.

Indications

Venodiol, indications for use

Chronic venous insufficiency of the lower extremities of a functional and organic nature: a feeling of heaviness in the legs, pain, cramps, trophic disorders; acute hemorrhoidal attack.

Contraindications

The drug is contraindicated in case of hypersensitivity to any of the components of the drug.

Directions for use and doses

An important feature of the drug Venodiol, which greatly simplifies its use, is the standard daily dosage. There are two equivalent ways to take the drug:

• prescribing the drug 1 tablet (500 mg) 2 times a day with meals for the entire treatment period;
• Another dosing option involves taking Venodiol 1 tablet 2 times a day for the first two weeks, and then 2 tablets (1000 mg) 1 time a day with meals. Experience with the use of the drug indicates that the duration of use of Venodiol is directly proportional to the initial severity of the disease.

In the treatment of initial forms of chronic venous insufficiency, manifested by “heavy legs” syndrome, a 2-month course is usually sufficient, repeated as necessary, usually 2-3 times a year. In more severe cases, when pain, convulsive and edematous syndromes predominate, Venodiol is taken must be continued for 3-4 months. Treatment of venous trophic ulcers may require a longer course - 6 months or more. In case of an acute attack of hemorrhoids, 6 tablets per day are prescribed for the first 4 days, then 4 tablets per day for the next 3 days. When prescribing Venodiol, it is important to remember that this drug is not addictive.

Use during pregnancy and breastfeeding

To date, no side effects have been reported when using the drug in pregnant women. Breastfeeding is not recommended during the entire period of treatment with Venodiol, since there is no data on the release of the active substances of the drug into breast milk. Experimental studies have not revealed teratogenic effects.

Side effects

No adverse reactions leading to discontinuation of the drug were recorded. Only some patients in the first days of taking Venodiol experience vegetative reactions (increased weakness, dizziness, feeling of heat and tingling in the skin of the lower extremities). The appearance of these symptoms is not a reason to discontinue the drug, since they usually disappear spontaneously after 2-3 weeks.

special instructions

In case of exacerbation of hemorrhoids, the use of Venodiol does not replace the specific treatment of diseases of the anorectal area. The drug is prescribed for a short course. If the treatment is ineffective, an additional examination should be carried out and therapy adjusted. When prescribing the drug to patients with venous circulation disorders, they should be informed about the need to avoid prolonged exposure to the sun, reduce body weight and wear special stockings that improve blood circulation. Patients suffering from erosive and ulcerative lesions of the gastrointestinal tract in the acute phase. Effect on the ability to drive vehicles and operate machinery Venodiol does not affect the ability to drive a car and perform work that requires a high speed of psychomotor reactions.

special instructions

The use of Venodiol during exacerbation of hemorrhoids does not replace the need for specific therapy for painful conditions of the anorectal area .

Tablets are used for a short course. If the therapy is ineffective, it is necessary to conduct a comprehensive additional examination of the patient and adjust further treatment.

In case of CVI , to improve the results of therapy, patients should be informed about the need to lose weight and the harmful effects of exposure to sunlight. You can also recommend the use of special compression stockings or socks that improve blood circulation .

Venodiol should be taken with caution by patients with erosive and ulcerative diseases of the gastrointestinal tract during an exacerbation.

Instructions for use VENDIOL

If any of the conditions/diseases or risk factors listed below are present, the potential risks and expected benefits of using Vendiol should now be carefully assessed in each individual case.

Circulatory system disorders

Risk of venous thromboembolism (VTE)

The use of COCs increases the risk of VTE. Drugs containing levonorgestrel, norgestimate, or norethisterone are associated with the lowest risk of VTE. Other drugs, such as Vendiol, have a 2-fold higher risk. The decision to use a drug that is not on the list with the lowest risk of VTE should be made only after a conversation with the woman. It is important to ensure that she understands the magnitude of the risk of VTE when taking Vendiol, how it is affected by her risk factors, and that the greatest risk of developing VTE is observed in the first year of use of the drug. In addition, there is evidence that the risk increases when COC use is resumed after a break of 4 weeks or more.

Approximately 2 in 10,000 non-pregnant women not taking COCs develop VTE per year. However, a woman's individual risk of developing VTE may be much higher, taking into account her risk factors.

Over the course of a year, 9-12 out of 10,000 women taking COCs containing gestodene will develop VTE (compared to approximately 6 women taking COCs containing levonorgestrel).

In both cases, the number of VTEs per year is less than the number expected during pregnancy or the postpartum period.

VTE can be fatal in 1-2% of cases

Number of cases of VTE among 10,000 women per year

img_vendiol.|jpg

Thrombosis of other arteries and veins, for example, hepatic, mesenteric, renal, and retinal vessels, has been observed extremely rarely when taking combined hormonal contraceptives.

Risk factors for developing VTE

The risk of developing venous thromboembolic complications when using COCs may be significantly increased in women with additional risk factors, in particular, with multiple risk factors (see table).

The drug Vendiol is contraindicated in women with multiple risk factors that place the patient at high risk of developing venous thrombosis.

If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than with a simple summation of individual factors:

• in this case, the overall risk of developing VTE should be taken into account. If the risk-benefit ratio is unfavorable, the use of COCs should be abandoned.

Table. Risk factors for developing VTE

There is no consensus on the possible role of varicose veins and superficial vein thrombophlebitis in the development or progression of venous thrombosis.

The increased risk of thromboembolism during pregnancy and especially in the first 6 weeks of the postpartum period should be taken into account.

Symptoms of VTE (deep vein thrombosis and pulmonary embolism)

Women should be informed that if symptoms occur, they should seek emergency medical attention and tell a healthcare professional about using COCs.

Symptoms of deep vein thrombosis (DVT) may include:

• unilateral swelling of the lower limb or just the foot, or swelling along the vein of the lower limb;
• pain or tenderness in the leg that is only felt when standing or walking;
• increased skin temperature of the affected lower limb;
• redness or discoloration of the skin of the lower limb.

Symptoms of pulmonary embolism (PE) may include:

• sudden onset of causeless shortness of breath or rapid breathing;
• sudden cough for no apparent reason, possibly hemoptysis;
• sharp chest pain;
• severe lightheadedness or dizziness;
• fast or irregular heartbeat.

Some of the symptoms reported (eg, shortness of breath, cough) are nonspecific and may be mistaken for more common or less severe illnesses (eg, respiratory tract infections).

Other signs of vascular obstruction may include sudden pain, swelling, and mild bluishness of the limb.

When vascular thrombosis of the eye develops, symptoms can range from blurred vision (without pain) to progressive vision loss. In some cases, vision loss can develop almost immediately.

Risk of developing arterial thromboembolism (ATE)

The results of epidemiological studies have linked the use of COCs with an increased risk of arterial thromboembolism (myocardial infarction) or cerebrovascular accident (for example, transient ischemic attack, stroke). Cases of arterial thromboembolism can be fatal.

Risk factors for developing ATE

The risk of developing arterial thromboembolic complications or cerebrovascular accidents when using COCs increases in women with risk factors (see table). The drug Vendiol is contraindicated in women with one serious risk factor or multiple risk factors for the development of ATE, which place the patient at a high risk of developing arterial thrombosis. If a woman has more than one risk factor, a situation may arise in which the risk increases to a greater extent than with a simple summation of individual factors:

• in such a case the overall risk must be taken into account. If the risk-benefit ratio is unfavorable, the use of COCs should be abandoned.

Table. Risk factors for developing ATE

Symptoms of ATE

Women should be informed that if symptoms occur, they should seek emergency medical attention and tell their doctor about using COCs.

Symptoms of a cerebrovascular accident may include:

• sudden weakness or numbness of the face, arm, or leg, especially on one side of the body;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden confusion, difficulty speaking or understanding;
• sudden loss of vision on one or both sides;
• sudden, severe or prolonged headache without known cause;
• loss of consciousness or feeling of lightheadedness with or without convulsions.

The temporary nature of symptoms suggests a transient ischemic attack (TIA).

Symptoms of myocardial infarction (MI) may include:

• pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm or chest;
• discomfort in the left half of the chest radiating to the back, lower jaw, throat, arm, stomach;
• feeling of fullness, indigestion, or suffocation;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• fast or irregular heartbeat.

Tumors

Some epidemiological studies have reported an increased risk of cervical cancer with long-term COC use (more than 5 years). However, controversy remains regarding the extent to which this observation is related to sexual behavior and other factors, such as human papillomavirus (HPV) infection.

There is a slightly increased relative risk (RR = 1.24) of developing breast cancer (BC) in women taking COCs. Over the course of 10 years after stopping COC use, the additional risk gradually disappears. Since breast cancer is rare in women under 40 years of age, the additional number of breast cancer cases in patients who are constantly taking or have recently started taking COCs is small in relation to the total risk of developing breast cancer. A cause-and-effect relationship between an increase in the risk of developing breast cancer and the use of COCs was not identified in the clinical studies conducted. The increased risk of breast cancer may be due to its earlier diagnosis in patients taking COCs, the biological effects of COCs, or a combination of both factors. Patients who have taken COCs experience earlier stages of breast cancer than women who have never taken COCs.

Taking high-dose COCs (50 mcg ethinyl estradiol) reduces the risk of developing endometrial and ovarian cancer. The applicability of this observation to low-dose COCs requires confirmation.

Liver neoplasms

In rare cases, benign and, somewhat less frequently, malignant liver tumors were detected in women taking COC drugs. In some cases, such tumors led to life-threatening intra-abdominal bleeding.

Headache

The emergence or exacerbation of migraine, the occurrence of unusual, recurring, prolonged or severe headaches requires immediate cessation of treatment and determination of the cause.

Other states

In women with hypertriglyceridemia or a family history of hypertriglyceridemia, the possible increased risk of pancreatitis should be taken into account when taking COCs.

While taking COCs, a slight increase in blood pressure was observed, but a clinically significant increase is rare. Immediate cessation of COC use is justified only in rare cases:

• If, while taking COCs in women with arterial hypertension, blood pressure values ​​are constantly elevated or, with a significant increase, do not decrease in response to antihypertensive therapy, COCs should be discontinued. If necessary, COC use can be resumed if normal blood pressure levels have been achieved with antihypertensive therapy.

The following conditions develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven:

• jaundice and/or itching associated with cholestasis;
• gallstones;
• porphyria;
• systemic lupus erythematosus;
• hemolytic-uremic syndrome;
• chorea;
• herpes during pregnancy;
• hearing loss due to otosclerosis.

In women with hereditary angioedema, exogenous estrogens may provoke or worsen symptoms of angioedema.

In acute and chronic liver failure, it may be necessary to stop taking COCs until liver function tests normalize. Recurrence of cholestatic jaundice and/or cholestasis-related pruritus that occurred earlier during pregnancy or during previous use of sex steroid hormones requires discontinuation of COC use.

Although COCs may affect peripheral insulin resistance and glucose tolerance, there is usually no need for dosage adjustment in diabetic patients using low-dose COCs (<0.05 mg ethinyl estradiol). However, women with diabetes should be carefully monitored while taking COCs.

Progression of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported while taking COCs.

There are known cases of the development of chloasma (especially with a history of chloasma in pregnancy). Patients prone to chloasma should avoid exposure to sunlight or ultraviolet radiation while taking COCs.

One tablet of Vendiol contains 40.118 mg of lactose monohydrate in active tablets and 37.26 mg of anhydrous lactose in placebo tablets. Patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Vendiol.

Medical examination/consultation

Before starting or re-prescribing Vendiol, a thorough medical history (including family history) should be taken and pregnancy should be excluded. Blood pressure should be measured and a physical examination should be performed, guided by information on contraindications, special instructions and precautions. It is important to draw a woman’s attention to the risk of venous and arterial thrombosis, including its risk with the use of Vendiol compared to other COCs, to the symptoms of VTE and ATE, as well as established risk factors and necessary actions if the development of thrombosis is suspected.

It is necessary that the woman carefully read the instructions for medical use of the drug and follow the recommendations contained therein.

The frequency and type of examinations should be based on practical recommendations individually for each individual woman.

The woman should be warned that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced if pills are missed, gastrointestinal problems occur, or other medications are used concomitantly.

Reduced cycle control

While taking COCs, irregular vaginal bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, assessing any irregular bleeding is only meaningful after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, non-hormonal causes should be excluded, with appropriate diagnostic measures carried out to exclude malignancy or pregnancy. These may include diagnostic curettage.

Some women may not develop withdrawal bleeding while taking placebo tablets. If COCs are taken according to the instructions described in the Dosage Regimen section, it is unlikely that the woman will become pregnant. However, if COCs were not taken as directed prior to the first absence of withdrawal bleeding, or if there are no two withdrawal bleedings in a row, then pregnancy should be ruled out before continuing to take the COC.

Impact on the ability to drive vehicles and machinery

The drug Vendiol does not affect or has an insignificant effect on the ability to drive vehicles and machines.

Venodiol price, where to buy

In Russian pharmacies, the average price of Venodiol is 450 rubles.

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

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