Jess
Use during pregnancy and breastfeeding
Jess® is not prescribed during pregnancy and breastfeeding.
If pregnancy is detected while taking Jess®, the drug should be discontinued immediately. However, extensive epidemiological studies have not shown any increased risk of developmental defects in children born to women who received sex steroids (including combined oral contraceptives) before pregnancy, or teratogenic effects when sex steroids were taken inadvertently in early pregnancy.
Existing data on the results of taking the drug Jess® during pregnancy are limited, which does not allow us to draw any conclusions about the effect of the drug on the course of pregnancy, the health of the newborn and the fetus. There are currently no significant epidemiological data on the drug Jess®.
Taking combined oral contraceptives may reduce the amount of breast milk and change its composition, so their use is not recommended until you stop breastfeeding. Small amounts of sex steroids and/or their metabolites may be excreted in breast milk.
Use for liver dysfunction
The drug is contraindicated in:
- liver failure and severe liver disease (until liver tests return to normal);
- liver tumors (benign or malignant) currently or in history.
Use for renal impairment
The drug is contraindicated in severe renal failure, acute renal failure.
special instructions
If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or appear for the first time, a woman should consult her doctor, who may decide whether to discontinue the drug.
Diseases of the cardiovascular system
The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease) 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 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.
The overall risk of VTE in patients taking low-dose combined oral contraceptives (<50 mcg ethinyl estradiol) is 2-3 times higher than in non-pregnant patients not taking combined oral contraceptives, however, this risk remains lower than the risk VTE during pregnancy and childbirth. 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) include: unilateral swelling of the lower extremity or along a vein in the leg, pain or discomfort in the leg only when standing or walking, localized warmth in the affected leg, redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism (PE) include: 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 symptoms 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, arm or leg, 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 include: pain, discomfort, pressure, heaviness, a feeling of squeezing or fullness in the chest, arm, or behind the breastbone; 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 increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years of age);
- for obesity (BMI more than 30 kg/m2);
- if there is a family history (for example, venous or arterial thromboembolism ever occurred 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 combined oral contraceptives;
- with prolonged immobilization, major surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least four weeks before it) and not resume use for two weeks after the end of immobilization;
- with dyslipoproteinemia;
- with arterial hypertension;
- for migraines;
- for diseases of the heart valves;
- with 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 migraine during use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.
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 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 (<50 mcg 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 combined oral contraceptives. The connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior (lower use of barrier methods of contraception).
A meta-analysis of 54 epidemiological studies found that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking combined oral contraceptives (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 currently or recently taking combined oral contraceptives is small relative to the overall risk of breast cancer. The observed increased risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effects of oral contraceptives, or a combination of both factors. Women who have used combined oral contraceptives have clinically less severe breast cancer than women who have never used them.
In rare cases, during the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases 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.
Tumors can be life-threatening or fatal.
Other states
Clinical studies have shown no effect of drospirenone on serum potassium concentrations in patients with mild to moderate renal failure. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial potassium concentration at ULN who are simultaneously taking medications that lead to potassium retention in the body. However, in women at increased risk of developing hyperkalemia, it is recommended that plasma potassium concentrations be determined during the first cycle of taking Jess®.
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking combined oral contraceptives.
Although slight increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives 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 combined oral contraceptives, but their relationship with taking combined oral contraceptives 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 during the use of combined oral contraceptives.
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 combined oral contraceptives 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 combined oral contraceptives.
Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<50 mcg ethinyl estradiol). However, women with diabetes should be closely monitored while taking combined oral contraceptives.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.
Laboratory tests
Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond normal values.
Drospirenone increases plasma renin and aldosterone activity, which is associated with its antimineralocorticoid effect.
Medical examinations
Before starting or resuming the use of the drug Jess®, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical examination (including measuring blood pressure, heart rate, determining BMI) and gynecological examination (including examination of the mammary glands and cytological examination of cervical mucus), and exclude pregnancy. The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once a year.
The woman should be warned that combined oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of combined oral contraceptives may be reduced if active tablets (light pink) are missed, vomiting and diarrhea occur, or due to drug interactions.
Poor control of the menstrual cycle
While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three 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 from taking the active tablets (light pink). If combined oral contraceptives are taken as directed, the woman is unlikely to be pregnant. However, if combined oral contraceptives have not been taken regularly before or if there are no consecutive withdrawal bleeds, pregnancy should be ruled out before continuing to take the drug.
Impact on the ability to drive vehicles and operate machinery
Not found.
Oral contraceptives: harm or benefit? Gynecologist answers questions
Obstetrician-gynecologist of the network of clinics “Personal Doctor” Tatyana Valerievna Imidoeva answers questions
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Tatyana Valerievna, tell our readers about modern hormonal contraceptives, what are they and how do they work?
Hormonal contraceptive pills can easily be called a unique discovery of the 20th century, which made a breakthrough in modern contraception. More than 50% of women in Europe and America prefer this method of preventing unwanted pregnancy. Unfortunately, oral contraceptives are not so popular in Russia. The main reason is myths and fears that prevent you from contacting a gynecologist, getting competent advice and a prescription for one of the most reliable contraceptives. Most of all, patients are frightened by the word “hormonal”, which paints the image of a “hairy fatty” who will no longer be able to have children or will certainly get cancer. These fears are from the past - from the 60-80s of the 20th century, when there were 2-3 drugs and the doses of hormones in them were more than 2-5 times higher than modern ones. Today, more than 20 oral contraceptives (OCs) with ideally selected microdoses of synthetic hormones are produced. Many of the modern OCs are not just means of preventing pregnancy, but also therapeutic drugs.
The principle of operation of all oral contraceptives is that under their influence, ovulation is blocked, i.e. the egg does not mature and does not leave the ovary, so the sperm have nothing to fertilize, and pregnancy does not occur.
Can taking hormonal contraceptives lead to infertility?
No, if the doctor prescribed contraceptives and prescribed the correct regimen for taking these drugs. The possibility of conception is restored 1 to 3 months after stopping taking the pills.
How long can you continue taking birth control pills without harming your body?
If there are no contraindications to taking birth control pills, then a woman can use this method of preventing unwanted pregnancy for as long as she needs it. Previously, it was believed that breaks were needed in taking oral contraceptives so that the ovaries did not “forget” their function. To date, there is no reliable statistical data that long-term use of OCs somehow negatively affects a woman’s reproductive system. On the contrary, there is evidence that breaks in taking birth control pills are a stress factor for the endocrine system, as they force the body to first spend a period adapting to taking OCs, and then again adjust to stopping the drug.
Is it necessary to change birth control pills periodically?
If the drug was correctly selected by the gynecologist and justified its effect, then there is simply no point in switching to another. It is advisable to replace the drug only if negative symptoms associated with taking OCs occur and they continue for more than three months from the start of taking the tablets. It must be remembered that contacting a gynecologist in this case is mandatory, since these symptoms may not indicate individual intolerance to a hormonal contraceptive, but the presence of some gynecological disease.
What is the likelihood of gaining excess weight while taking COCs?
A healthy woman who eats rationally and leads an active lifestyle can safely take birth control pills without fear of ruining her figure. The main thing is that before you start using hormonal contraception for the first time in your life, you must definitely contact a gynecologist for consultation and undergo all the necessary tests (detailed family and personal history, measurement of blood pressure, laboratory tests that necessarily include examination of blood clotting and hormonal levels), gynecological examination (including ultrasound examination of the pelvic organs, oncocytology) and consultation with a mammologist.
Until what age can you take birth control pills?
Age itself cannot serve as a contraindication for hormonal contraception. However, after the onset of menopause, when contraception is no longer required, using these drugs is inappropriate and sometimes even harmful to women’s health. In the period preceding menopause, it is also recommended, in consultation with a gynecologist, to replace conventional contraceptives with special hormonal agents used to compensate for the deficiency of hormones, the production of which significantly decreases with age (the so-called hormone replacement therapy (HRT)).
The correct selection of hormones in the period preceding menopause allows a woman to feel healthy, confident, and forget about hot flashes and sudden mood swings characteristic of the perimenopausal period.
Is the effect of oral contraceptives dangerous for the fetus if pregnancy occurs while taking them?
If the patient started taking oral contraceptives during pregnancy and this lasted no more than the first month of pregnancy, then they are completely safe for the unborn child. However, since in the sixth week of pregnancy the fetus begins to develop genital organs that are sensitive to the effects of hormones, hormonal medications can lead to certain disorders. In such cases, you should consult a doctor immediately.
Do oral contraceptives provide any protection against sexually transmitted diseases (STDs)?
No, birth control pills of any kind do not protect against sexually transmitted diseases and AIDS. In this sense, this method of contraception is suitable only for women who have a regular sexual partner, or for those who additionally use a condom. Only then can the actual safety of sexual intercourse be guaranteed.
How compatible are hormonal contraceptives with other medications?
The compatibility of drugs in each case may be different; it is best determined by a doctor. With this in mind, you must warn the specialist who prescribes you this or that drug that you are taking birth control pills, and accordingly, vice versa, the gynecologist should be informed about the medications you are using.
If there is a single or short-term need to take a drug that obviously reduces the contraceptive properties of the pills, during this period it is recommended to use an additional method of protection against unwanted pregnancy.
In what situations are additional contraceptive methods necessary?
The need for additional contraceptives may arise, as we have already said, in the case of taking a number of medications that reduce contraceptive properties. In addition, the use of condoms is recommended for vomiting or diarrhea that is caused by food poisoning. Hormonal substances are poorly absorbed into a weakened body, so the likelihood of pregnancy increases markedly.
In addition, it is recommended to use additional methods of contraception if you forget to take several pills. Be sure to also use a condom when having sexual intercourse with a new partner to ensure protection against sexually transmitted diseases.
In what cases is it necessary to contact a gynecologist when taking hormonal contraceptives?
In general, a woman needs to visit a gynecologist once every six months, and this applies to both those taking birth control pills and those who do not use them. However, if any unusual phenomena occur (for example, the appearance of spotting bloody discharge from the vagina), and even more so if pain occurs in the lower abdomen, it is necessary to visit a gynecologist unscheduled.
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