Jess® Plus (Yaz® Plus)
If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of using Jess® Plus should be carefully weighed in each individual case and discussed with the woman before she decides to start taking of this drug.
For disorders of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking COCs. These diseases are rare.
The risk of developing VTE is greatest in the first year of taking COCs. An increased risk is present after initial use of a COC or resumption of use of the same or a different COC (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients indicate that this increased risk is predominantly present during the first 3 months.
The overall risk of VTE in women taking low-dose COCs (<0.05 mg ethinyl estradiol) is two to three times higher than in non-pregnant patients not taking COCs, although this risk remains lower than the risk of VTE during pregnancy and childbirth.
VTE can be life-threatening or lead to death (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any COC.
It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis: unilateral swelling of the lower extremity or along a vein in the lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, local increase in temperature in the affected lower extremity, redness or discoloration of the skin on the lower extremity.
Symptoms of pulmonary embolism: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke include: sudden weakness or loss of sensation in the face or limbs, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without convulsions. Other signs of vascular occlusion: sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, left upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal.
In women with a combination of several risk factors or high severity of one of them (for example, complicated heart valve diseases, uncontrolled arterial hypertension, extensive surgical interventions with prolonged immobilization, etc.), the possibility of their mutual reinforcement should be considered. In such cases, the total value of the existing risk factors increases. In this case, taking Jess® Plus is contraindicated (see section “Contraindications”),
The risk of developing thrombosis (venous and/or arterial), thromboembolism or cerebrovascular disorders increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
— obesity (body mass index more than 30 kg/m2);
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Jess® Plus;
- prolonged immobilization, extensive surgery, any operation on the lower extremities or major trauma. In these situations, it is necessary to stop taking Jess® Plus (in the case of a planned operation at least four weeks before it) and not to resume taking it for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of venous thromboembolism, especially in the presence of other risk factors;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation.
The use of any combined hormonal contraceptives increases the risk of developing VTE.
The use of drugs containing levonorgestrel, norgestimate or norethisterone carries the lowest risk of developing VTE. The use of other drugs, such as Jess® Plus, can lead to a twofold increase in risk. The choice to use a COC with a higher risk of developing VTE can only be made after consultation with the patient to ensure that she fully understands the risk of VTE associated with the use of Jess® Plus, the effect of the drug on her existing risk factors and that The risk of developing VTE is greatest during the first year of using the drug. According to some data, an increased risk is observed when COC use is resumed after a break of 4 weeks or more.
About 9-12 out of 10,000 women taking COCs containing drospirenone may develop VTE within a year, compared with about 6 in 10,000 women for COCs containing levonorgestrel.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during use of the drug Jess® Plus (which may precede cerebrovascular disorders) is grounds for immediate discontinuation of the drug.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<0.05 mg ethinyl estradiol).
Tumors
The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs has not been proven. The possibility of the relationship of these data with screening for cervical diseases and with characteristics of sexual behavior (less frequent use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in current or recent COC users is small relative to the overall risk of breast cancer. Its connection with COC use has not been proven. The observed increased risk may be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using COCs, the biological effects of sex hormones, or a combination of both factors. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.
In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some patients led to life-threatening intra-abdominal bleeding, was observed. If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.
Other states
Clinical studies have shown no effect of drospirenone on the concentration of potassium in the blood plasma of patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial potassium concentration at the upper limit of normal, the risk of developing hyperkalemia cannot be excluded while taking medications that lead to potassium retention in the body.
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs. Although slight increases in blood pressure (BP) have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops while taking Jess® Plus, this drug should be discontinued and treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of worsening the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis during the use of COCs have also been described.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of Jess® Plus until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of the drug Jess® Plus.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus using low-dose oral contraceptives (<0.05 mg ethinyl estradiol). However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma while taking Jess® Plus should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Folates may mask vitamin B12 deficiency.
Laboratory tests
Taking Jess® Plus may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the concentration of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond normal values. Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.
Reduced efficiency
The contraceptive effectiveness of Jess® Plus may be reduced in the following cases: when pink pills are missed, gastrointestinal disorders while taking pink pills, or as a result of drug interactions.
Frequency and severity of menstrual-like bleeding
While taking Jess® Plus during the first few months, irregular (acyclic) bleeding from the vagina may be observed (“spotting” spotting and/or “breakthrough” uterine bleeding). You should use hygiene products and continue taking your pills as usual. Any irregular bleeding should be assessed after an adaptation period of approximately 3 cycles of dosing.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
No regular menstrual bleeding
Some women may not develop bleeding while taking the supplementary light orange tablets; “ooContraindications” and “Use with caution”;
— Local compaction in the mammary gland;
- Concomitant use of other medications (see also section “Interaction with other medications and other types of interactions”);
- If prolonged immobility is expected (for example, a cast is applied to the lower limb), hospitalization or surgery is planned (at least 4 weeks before the proposed operation);
- Unusually heavy bleeding from the vagina;
- Missed a pill in the first week of taking the package and had sexual intercourse seven days or less before;
— Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).
You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.
Buy Jess Plus film-coated tablets No. 28 in pharmacies
Instructions for use Jess Plus
Buy Jess Plus TB 3mg+0.03mg+0.451mg
Dosage forms film-coated tablets 3mg+0.03mg+0.451mg Manufacturers Bayer Schering Pharma AG (Germany) Group Oral contraceptives and estrogen-gestagen agents International nonproprietary name Drospirenone+Ethinylestradiol+Calcium levomefolinate Synonyms Yarina Plus
DESCRIPTION
JES PLUS Composition and release form Jess Plus film-coated tablets 1 active combination tablet contains drospirenone (micronized) 3 mg, ethinyl estradiol betadex clathrate, micronized (in terms of ethinyl estradiol) 0.02 mg, calcium levomefolate (micronized) 0.451 mg; 1 supplementary vitamin tablet contains calcium levomefolate (micronized) 0.451 mg. per pack 28 pcs.
Pharmacological action Jess Plus is a low-dose monophasic oral combined estrogen-progestogen contraceptive drug, including active tablets and auxiliary vitamin tablets containing calcium levomefolate.
The contraceptive effect of Jess Plus is mainly achieved by suppressing ovulation and increasing the viscosity of cervical mucus.
In women taking combined oral contraceptives (COCs), the cycle becomes more regular, the pain, intensity and duration of menstrual bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduced risk of endometrial and ovarian cancer.
Drospirenone, contained in Jess Plus, has an antimineralocorticoid effect and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a decrease in the likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps reduce acne (blackheads), oily skin and hair. This effect of drospirenone is similar to the effect of natural progesterone produced in the female body. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. When used correctly, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.
The acid form of calcium levomefolate is structurally identical to naturally occurring L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration in the blood plasma of people who do not consume foods fortified with folic acid is about 15 nmol/l.
Levomefolate, unlike folic acid, is a biologically active form of folate. Thanks to this, it is absorbed better than folic acid. Levomefolate is indicated to meet the increased need and ensure the necessary folate content in a woman’s body during pregnancy and lactation. The addition of levomefolate calcium to an oral contraceptive reduces the risk of developing a neural tube defect if a woman becomes unexpectedly pregnant immediately after stopping contraception (or in very rare cases, when using oral contraception).
Jess Plus, indications for use are contraception, intended primarily for women with symptoms of hormone-dependent fluid retention in the body; contraception and treatment of moderate acne (acne vulgaris); contraception in women with folate deficiency; contraception and treatment of severe premenstrual syndrome (PMS). Contraindications
Jess Plus is contraindicated in the presence of any of the conditions/diseases listed below. If any of these conditions/diseases develop for the first time while taking the drug, the drug should be discontinued immediately: hypersensitivity or intolerance to any of the components of Jess Plus; thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders; conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history; the presence of multiple or severe risk factors for venous or arterial thrombosis; migraine with focal neurological symptoms currently or in history; diabetes mellitus with vascular complications; liver failure and severe liver diseases (until normalization of liver tests); severe and/or acute renal failure; liver tumors (benign or malignant) currently or in history; identified hormone-dependent malignant neoplasms (including genital organs or mammary glands) or suspicion of them; bleeding from the vagina of unknown origin; pregnancy or suspicion of it; breastfeeding period; the presence of rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption. Use during pregnancy and breastfeeding
Pregnancy The drug is contraindicated during pregnancy. If pregnancy is detected while taking Jess Plus, the drug should be discontinued immediately. Data on the results of taking Jess Plus during pregnancy are limited and do not allow us to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and newborn child. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who took COCs before pregnancy or teratogenic effects in cases of inadvertent use of COCs in early pregnancy. Specific epidemiological studies have not been conducted regarding the drug Jess Plus.
Lactation The drug is contraindicated during breastfeeding. Taking COCs can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. Small amounts of sex hormones and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of the child.
Method of administration and dosage : Orally, in the order indicated on the package, every day at approximately the same time, without chewing, with a small amount of water.
Take 1 tablet. per day, continuously, for 28 days. Taking tablets from the next package begins immediately after completing the previous one.
Start taking Jess Plus
Taking Jess Plus begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding).
Recommendations in case of vomiting and diarrhea
If vomiting or diarrhea occurs within 4 hours of taking the tablets, absorption may not be complete and additional measures should be taken to protect against unwanted pregnancy.
Use in certain groups of patients
Children. The effectiveness and safety of Jess Plus as a contraceptive have been studied in women of reproductive age. It is assumed that the effectiveness and safety of the drug in post-pubertal age up to 18 years are similar to those in women after 18 years. The use of the drug before menarche is not indicated.
Elderly patients. The drug Jess Plus is not used after menopause.
Liver dysfunction. The drug is contraindicated for use in women with severe liver dysfunction.
Renal dysfunction. The drug is contraindicated for use in women with severe renal impairment and acute renal failure.
Side effects
The most common adverse reactions reported in connection with the use of Jess are as follows:
- nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin (more than 3% of women using the drug for the indications “Contraception” and “Contraception and treatment of moderate acne /acne vulgaris/”);
- nausea, pain in the mammary glands, irregular uterine bleeding (in more than 10% of women using the drug for the indication “Contraception and treatment of severe premenstrual syndrome”).
Serious adverse reactions include arterial and venous thromboembolism. Below is the frequency of adverse reactions reported during clinical trials of Jess and Jess Plus for the indication “Contraception”, as well as for the indication “Contraception and treatment of moderate acne (acne vulgaris)” (n=3565) and “Contraception and treatment severe form of premenstrual syndrome" (n=289) for the drug Jess. Within each group, allocated depending on the frequency of occurrence, adverse reactions are presented in order of decreasing severity. The incidence of adverse events was classified as follows: frequent (≥1/100 and
From the side of the central nervous system: often - migraine.
Mental disorders: often - mood swings, depression/depressed mood; infrequently - decrease or loss of libido.
From the cardiovascular system: rarely - venous or arterial thromboembolism (approximate frequency based on the results of epidemiological studies covering a group of combined oral contraceptives. The frequency bordered on very rare. The term includes the following nosological units: peripheral deep vein occlusion, thrombosis and embolism/ pulmonary vascular occlusion, thrombosis, embolism and infarction, myocardial infarction, cerebral infarction and hemorrhagic stroke).
From the digestive system: often - nausea.
On the skin: frequency unknown - erythema multiforme.
From the reproductive system and mammary glands: often - pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin.
Adverse events were classified using the MedDRA (Medical Dictionary of Regulatory Activities) dictionary. Different MedDRA terms reflecting the same symptom were grouped together and presented as a single adverse reaction to avoid diluting or diluting the true effect.
special instructions
If any of the conditions, diseases and risk factors listed below currently exist, the potential risks and expected benefits of using Jess® Plus should be carefully weighed in each individual case and discussed with the woman before she decides to start taking drug of this drug.
Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.
The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. An increased risk is present after initial use of combined oral contraceptives or resumption of use of the same or different combined oral contraceptives (after a dosing interval of 4 weeks or more). Data from a large prospective study involving 3 groups of patients suggest that this increased risk is predominantly present during the first 3 months.
Overall risk of venous thromboembolism VTE in patients taking low-dose combined oral contraceptives (
VTE can be life-threatening or fatal (in 1-2% of cases).
VTE, manifested as deep vein thrombosis or pulmonary embolism, can occur with the use of any combined oral contraceptives.
It is extremely rare that when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.
Symptoms of deep vein thrombosis (DVT): unilateral swelling of the lower extremity or along a vein of the lower extremity, pain or discomfort in the lower extremity only in an upright position or when walking, local increase in temperature in the affected lower extremity, redness or discoloration of the skin on the lower extremity.
Symptoms of pulmonary embolism (PE): difficulty or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more or less severe events (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke: sudden weakness or loss of sensation in the face, upper or lower extremities, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden unilateral or bilateral vision loss; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure.
Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, acute abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm or chest; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.
Arterial thromboembolism can be life-threatening or fatal.
The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);
in the presence of:
— obesity (body mass index more than 30 kg/m2);
- family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking the drug Jess Plus;
- prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these situations, it is advisable to stop using the drug Jess Plus (in the case of a planned operation, at least four weeks before it) and not to resume taking it for two weeks after the end of immobilization;
- dislipoproteinemia;
- arterial hypertension;
- migraine;
— diseases of the heart valves;
- atrial fibrillation.
The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account.
Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraines during use of Jess Plus (which may precede cerebrovascular events) may be grounds for immediate discontinuation of this drug.
Biochemical indicators indicating a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (
Tumors
The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of COCs. However, the connection with taking COCs has not been proven. The possibility of the relationship of these data with screening for cervical diseases and with characteristics of sexual behavior (less frequent use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in women who are currently or recently taking COCs is small relative to the overall risk of breast cancer. Its connection with the use of COCs has not been proven. The observed increased risk may be a consequence of careful monitoring and earlier diagnosis of breast cancer in women using COCs. Women who have ever used COCs are diagnosed with earlier stages of breast cancer than women who have never used them.
In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which in some patients led to life-threatening intra-abdominal bleeding.
If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be taken into account when making a differential diagnosis.
Tumors can be life-threatening or fatal.
Other states
Clinical studies have shown no effect of drospirenone on plasma potassium concentrations in patients with mild to moderate renal failure. However, in patients with impaired renal function and an initial potassium concentration at the upper limit of normal, the risk of developing hyperkalemia cannot be excluded while taking medications that lead to potassium retention in the body.
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs.
Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking Jess® Plus, this drug should be discontinued and treatment of arterial hypertension should be started. The drug can be continued if normal blood pressure values are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their association with COC use has not been proven: jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus: hemolytic-uremic syndrome; Sydenham's chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of Jess Plus until liver function tests return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the drug Jess Plus.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using Jess Plus. However, women with diabetes should be closely monitored while taking this drug.
Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma while taking Jess® Plus should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Folates may mask vitamin B12 deficiency.
Preclinical safety data
Preclinical data from routine repeated-dose toxicity, genotoxicity, carcinogenicity and reproductive toxicity studies do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.
Preclinical data from routine studies of levomefolate calcium for repeated-dose toxicity, genotoxicity and reproductive toxicity do not indicate a particular risk to humans.
Laboratory tests
Taking Jess Plus may affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal function, the concentration of transport proteins in plasma, indicators of carbohydrate metabolism, parameters of blood coagulation and fibrinolysis. Changes usually do not go beyond normal values. Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.
There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving Jess Plus simultaneously with other drugs that can increase the content of potassium in the blood plasma. These drugs include angiotensin II receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference in plasma potassium concentrations compared with placebo.
Reduced efficiency
The effectiveness of Jess Plus may be reduced in the following cases: if you miss pills, with vomiting and diarrhea, or as a result of drug interactions.
Frequency and severity of menstrual-like bleeding
While taking Jess Plus, irregular (acyclic) spotting and bleeding from the vagina (spotting or “breakthrough” uterine bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed after an adaptation period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop withdrawal bleeding during a break in taking the pills; the drug cannot be continued until pregnancy has been ruled out.
Medical examinations
Before starting or resuming use of the drug, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough physical examination (including measuring blood pressure, heart rate, determining body mass index, examining the mammary glands), gynecological examination, cytological examination of the cervix (Papanicolaou test), exclude pregnancy. When resuming taking Jess Plus, the volume of additional studies and the frequency of control examinations are determined individually, but at least once every 6 months.
The woman should be warned that Jess Plus does not protect against HIV infection and other sexually transmitted diseases.
Impact on the ability to drive vehicles and operate machinery
There have been no reported cases of adverse effects of the drug Jess Plus on the speed of psychomotor reactions; No studies have been conducted to study the effect of the drug on the speed of psychomotor reactions.
Overdose No cases of overdose of Jess Plus have been reported. Symptoms: nausea, vomiting, spotting vaginal discharge or metrorrhagia (more often in young women). Treatment: there is no specific antidote; symptomatic treatment should be carried out. Calcium levomefolate and its metabolites are identical to folates that are part of natural products, the daily consumption of which does not harm the body. Taking calcium levomefolate at a dose of 17 mg per day (the dose is 37 times higher than that contained in 1 tablet of Jess Plus) for 12 weeks was well tolerated.
Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
