If there is any of the conditions or risk factors listed below, the possibility of using Gestarella® should be discussed with a woman in advance. In the event of a worsening or appearance of any of the conditions or risk factors for the first time, a woman should be advised to consult her doctor to decide whether to continue or stop taking the drug.
Due to the fact that the contraceptive effect of Gestarella is mainly observed by the 14th day from the beginning of the intake, it is recommended to use nonhormonal (barrier) methods of contraception in the first 2 weeks of taking the drug.
Diseases of the cardiovascular system
The risk of venous thromboembolism (VTE)
The use of any COC increases the risk of VTE, but compared with women who do not take these drugs.
Before starting Gestarella, a woman should have a higher (almost 2-fold) risk of developing VTE compared to other COCs containing levonorgestrel, norgestimate or noregisterone. This risk is highest in the first year of taking the drug or when it resumes after a break for 4 weeks or more.
The results of the epidemiological study showed that among women who do not take COCs and are not pregnant, VTE occurs in approximately 2 out of 10,000 during the year. However, in some women, the risk may be significantly higher, depending on the underlying risk factors (see below). According to experts, during the year VTE occurs in 9-12 out of 10 000 women taking COC containing gestodene. In both cases, the number of VTEs per year is less than the number of expected VTE during pregnancy or in the puerperium.
Risk factors for thromboembolic complications
The risk of venous and arterial thromboembolic complications in women taking COCs can increase significantly if there are additional risk factors, especially if the risk factors are multiple (see Table 1 and No. 2).
The drug Gestarella® is contraindicated if a woman has multiple risk factors for VTE or ATE. If a woman has more than one risk factor, it is possible that the risk of developing thromboembolic complications will be greater than the simple sum of individual factors. If the ratio of benefit to risk turns out to be negative, do not prescribe Gestarella®.
Risk Factors of VTE
Table 1. Risk Factors of VTE | Risk Factor | A comment |
| Obesity (body mass index (BMI)> 30 kg / m2) | The risk increases significantly with an increase in BMI. This risk factor is especially important in women with additional risk factors. |
| Long-term immobilization, extensive surgical intervention, any surgical intervention on the lower extremities or pelvic region, neurosurgery or extensive trauma Note: temporary immobilization, including air travel> 4 hours, may also be a risk factor for VTE, especially in women with other risk factors. | In such situations, it is recommended to stop using patches / pills / rings (in the case of a scheduled operation, at least four weeks before the event) and not renewed within 2 weeks after complete remobilization. To avoid unwanted pregnancies, you should use another method of contraception. Consideration should be given to the need for antithrombotic therapy if Gestarella® was not discontinued in advance. |
| Weighed family history (VTE from siblings or parents, especially at a relatively young age, for example, up to 50 years) | If hereditary predisposition is presumed, the woman should be referred for consultation to a specialist before deciding on the use of any COC. |
| Other medical conditions associated with the development of VTE | Oncological disease, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia. |
| Age | Especially older than 35 years. |
There is no consensus on the possible role of varicose veins and thrombophlebitis of superficial veins in the development or progression of venous thrombosis.An increased risk of thromboembolism during the first 6 weeks of the postpartum period should be considered.
Symptoms of VTE (deep vein thrombosis (DVT) and thromboembolism of the pulmonary artery (PE))
If there are symptoms of VTE, a woman should immediately seek emergency medical attention and inform the doctor that she is taking the COC.
Symptoms of DVT may include:
- a one-sided swelling of the lower extremity and / or of the foot or along the vein on the lower limb;
-been in the lower extremities or soreness when touched, which can be felt only when standing or walking;
- increased temperature of the skin of the affected lower limb;
Reddening or pallor of the skin of the lower limb.
Symptoms of PE include:
- sudden unexplained dyspnea or rapid breathing;
- a sudden cough, which can be accompanied by hemoptysis;
- Acute pain in the chest;
- nausea, vomiting, dizziness;
- Frequent or irregular heartbeat.
Some of these symptoms (eg, "shortness of breath" or "cough") are non-specific and may be incorrectly regarded as manifestations of more frequent and less severe conditions (eg, respiratory tract infections).
Other signs of vessel occlusion may include: sudden pain, swelling and slight cyanosis of the limb.
With occlusion of the vessels of the eye, symptoms can vary from painless blurred vision that can progress to loss of vision. Sometimes the loss of vision can be acute.
The risk of arterial thromboembolism (ATE)
Epidemiological studies link the use of COCs with an increased risk of ATE (myocardial infarction) or cerebrovascular diseases (eg, transient ischemic attack (TIA), stroke). Arterial thromboembolic events can be fatal.
Risk Factors ATE
Table 2. Risk Factors ATE
| Risk Factor | A comment |
| Age | Especially older than 35 years. |
| Smoking | A woman should be advised not to smoke if she wants to take COC. Women over 35 who continue to smoke should be strongly advised to use another method of contraception. |
| Arterial hypertension | - |
| Obesity (BMI> 30 kg / m2 ) | The risk increases significantly with an increase in BMI. This risk factor is especially important in women with additional risk factors. |
| A burdened family history (arterial thromboembolism from siblings or parents, especially at a relatively young age, for example, up to 50 years) | If hereditary predisposition is presumed, the woman should be referred for consultation to a specialist before deciding on the use of any COC. |
| Migraine | An increase in the frequency or severity of migraine during the administration of COCs (which may be a condition prior to the development of cerebrovascular disease) may be the reason for the immediate discontinuation of the drug. |
| Other medical conditions associated with adverse and vascular events | Diabetes mellitus, hyperhomocysteinemia, ischemic heart disease and atrial fibrillation, dyslipoprogeinemia and systemic lupus erythematosus. |
Symptoms of Atherosclerosis
In the presence of symptoms of ATE, a woman should immediately seek emergency medical attention and inform the doctor that she is taking COC.
Symptoms of cerebrovascular diseases may include:
- sudden numbness or weakness of the muscles of the face, hands or feet, especially one side of the body;
- sudden difficulty in moving, dizziness, loss of balance or coordination;
- sudden confusion, problems with speech or understanding;
- sudden, severe or prolonged headache without a specific cause;
- sudden one- or two-sided loss of vision;
- loss of consciousness or fainting with seizures or without.
If these symptoms are observed for no more than a day, then this condition is regarded as an acute transient ischemic circulatory disorder - transient ischemic attack (TIA).
Symptoms of myocardial infarction (MI) may include:
- pain, discomfort, pressure, heaviness, a feeling of contraction or bursting in the chest or behind the breastbone, with irradiation in the back, neck, jaw, upper extremity, epigastric region;
- feeling of overflow of stomach, indigestion or suffocation;
sweating, nausea, vomiting and dizziness;
- extreme weakness, anxiety, or dyspnea;
- Frequent or irregular heartbeat. There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism with COCs.
However, the incidence of venous thromboembolism (VTE) developing with COC use is less than the frequency of VTE occurring during pregnancy (6 cases per 10 000 pregnant women per year).
Women taking COCs have extremely rare cases of thrombosis of other blood vessels, for example, liver, mesenteric, renal arteries and veins, the central vein of the retina and its branches. The connection with the reception of the COC was not proven.
Tumors
One of the significant risk factors for developing cervical cancer is persistent papillomavirus infection. There are reports of an increased risk of developing cervical cancer with prolonged use of COCs. However, the connection with the reception of the COC has not been proven. This increase may be due to the detection of cervical pathology during mandatory examination prior to the appointment of COCs or features of sexual behavior (the more rare use of barrier methods of contraception).
It was also found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used COCs, but the connection with their administration has not been proven. The observed increase in risk may be due not only to an earlier diagnosis of breast cancer in women using COC, but also to the biological effect of sex hormones or a combination of these two factors. Breast cancer in women who have or have taken COC in the past is usually found at clinically less advanced stages than women who never took these drugs.
In rare cases, with the use of COCs, liver tumors have been observed. This should be taken into account when making a differential diagnosis in the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding.
Other states
In women with hypertriglyceridemia (or in the presence of this condition in a family history), there may be an increased risk of developing pancreatitis while taking Gestarella.
Although a slight increase in blood pressure was described in many women taking COC, a clinically significant increase in blood pressure was rarely noted.Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of Gestarella, it is necessary to cancel the drug and begin treatment of hypertension. Gestarella® can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
Conditions such as jaundice and / or pruritus associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes during pregnancy, hearing loss associated with otosclerosis may develop or worsen both during pregnancy and during the administration of COC, but the causal relationship with their use has not been proven.
In women with hereditary forms of angioedema, COCs can cause or worsen the symptoms of angioedema. Also, cases of the development of Crohn's disease and ulcerative colitis have been described against the background of the use of COCs.
Acute illnesses or exacerbation of chronic liver diseases may require the discontinuation of Gestarella until the liver function returns to normal.Recurrent cholestatic jaundice, which is celebrated for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of the drug Gestarella®.
Although COCs may influence insulin resistance and glucose tolerance, there is no need to change dosage regimen hypoglycemic agents in patients with diabetes mellitus, host COCs with ethinylestradiol content in the tablet is less than 0.05 mg. In spite of this, women with diabetes should be carefully observed while taking Gestarella®.
Against the background of taking Gestarella, there may be a worsening of the course of endogenous depression and epilepsy. Women with a tendency to chloasma while taking Gestarella® should avoid prolonged exposure to sunlight and exposure to ultraviolet radiation.
The drug Gestarella® contains lactose monohydrate and sucrose. Patients with rare congenital forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption, as well as rare forms of congenital fructose intolerance or sucrase-isomaltase insufficiency should not take this drug.
Decreased effectiveness of contraception
The effectiveness of COCs may be reduced, for example, by skipping the administration of tablets, in case of gastrointestinal disorders (vomiting or diarrhea) or with the simultaneous use of other medications. In this case, without stopping the drug, additional nonhormonal (barrier) methods of contraception should be used at the same time.
Laboratory Tests
Taking Gestarella® can affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal, traffic protein concentrations, carbohydrate metabolism parameters, blood coagulation system parameters. Changes usually do not go beyond the limits of normal values.
Effects on the menstrual cycle
When Gestarella is used, irregular bleeding may occur ("spotting" bleeding or "breakthrough" bleeding), especially during the first month of use. For this reason it is expedient to find out the cause of irregular bleeding only after adaptation of the organism, i.e. after approximately three cycles of application.If irregular bleeding continues or occurs after previous regular cycles, appropriate diagnostic procedures should be performed to exclude a malignant tumor or pregnancy.
In some women, bleeding "cancellation" does not occur during a break in taking tablets. If the drug was taken in accordance with the instructions, the occurrence of pregnancy is unlikely. However, if the tablets were taken irregularly, or bleeding "withdrawal" did not occur two consecutive times, then before continuing the use of the drug should be excluded pregnancy.
When using the drug Gestarella, it should be borne in mind that against the background of taking hormonal contraceptives, the frequency and duration of menstrual bleeding, the rectal temperature and the properties of cervical mucus may change.
Medical examinations
Before starting or before recommencing Gestarella, a woman should undergo a thorough general medical and gynecological examination, including a detailed medical history (including a family history), blood pressure measurement, heart rate,determination of the body mass index, ultrasound examination of the abdominal and pelvic organs, examination of the mammary glands, cytological examination of the cervical epithelium. It is necessary to exclude pregnancy and violations by the blood coagulation system. It is very important to draw the woman's attention to information about venous and arterial thrombosis, symptoms of VTE and ATE, known risk factors, and what to do in case of suspicion of thrombosis. A woman should also be instructed to carefully read the leaflet and follow the recommendations given there.
A woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other diseases. sexually transmitted infections. The frequency and nature of such surveys should be based on existing standards of medical practice, taking into account the individual characteristics of each patient, but at least once every 6 months.