Lindynette 30
If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of gestodene + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting to take the drug. If any of these conditions, diseases or risk factors worsen, intensify or appear for the first time, a woman should consult her doctor to decide whether to stop taking the drug.
Risk of developing venous and arterial thromboembolism (VTE and ATE)
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 DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition. COCs containing levonorgestrel, norgestimate or norethisterone as a progestogen component are associated with the lowest risk of VTE. When using other COCs, such as the combination of gestodene + ethinyl estradiol, the risk of developing VTE is twice as high.
The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking such drugs. An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more). The increased risk of developing VTE is present primarily during the first 3 months.
VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/or PE, can occur with all COCs.
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 DVT:
unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.
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).
ATE can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke
: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, one- or two-sided loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.
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, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. ATE can be life-threatening and lead to death.
In women with a combination of several risk factors or high severity of one of the factors, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, taking the combination of gestodene + ethinyl estradiol is contraindicated.
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
-with age;
- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);
- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 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 COCs;
- for obesity (with a BMI more than 30 kg/m2);
- with dyslipoproteinemia;
- for arterial hypertension;
- for migraine;
- for diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, serious surgery, any operation on the lower extremities, in the pelvic area or extensive trauma.
In these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the woman has fully regained mobility.
Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.
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 (which may precede cerebrovascular events) during the use of COCs is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to the development of 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/disease may reduce the associated risk of thrombosis.
Tumors
The most significant risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing CC with long-term use of COCs. However, the connection with taking COCs has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior patterns (less use of barrier methods of contraception, greater number of sexual partners).
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. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors.
In rare cases, during the use of COCs, 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. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
Depressed mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be a serious disorder and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including soon after starting treatment.
In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs.
Although slight increases in blood pressure 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 during the use of COCs, the COC should be discontinued and treatment of arterial hypertension should be initiated. COC use 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 relationship with COC use has not been proven: cholestatic 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 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 COCs 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 COC use.
Although COCs may have an effect on insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose COCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.
Effect on liver function tests
In clinical studies involving patients receiving hepatitis C viral therapy (a combination of drugs containing ombitasvir, paritaprevir, ritonavir, dasabuvir, with or without ribavirin), increases in ALT activity more than 5 times the upper limit of normal were recorded more often in patients using ethynyl-containing COCs.
If a course of therapy with this combination of drugs is necessary, a patient using the contraceptive drug gestodene + ethinyl estradiol should be switched to alternative methods of contraception (non-hormonal or contraceptives containing only gestagen) before starting the course of treatment. You can resume taking the combination of gestodene + ethinyl estradiol no earlier than 2 weeks after the end of the course of therapy with antiviral drugs.
Laboratory tests
The use of drugs such as gestodene + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis). These changes usually remain within normal physiological values.
Reduced efficiency
The effectiveness of COCs may be reduced in the following cases: in case of missed pills, gastrointestinal disorders or as a result of drug interactions.
Effect on bleeding pattern
While taking COCs, irregular bleeding may occur (“spotting” and/or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only 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.
Some women may not develop bleeding during a break in taking pills. “ooContraindications” and “With caution.”
-Local compaction in the mammary gland.
-Concomitant use of other medications.
-If prolonged immobilization is expected (for example, a cast is applied to the lower extremity), hospitalization or surgery is planned (at least four weeks before the proposed operation).
-Unusually heavy bleeding from the vagina.
-Missed a pill in the first week of taking the drug 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.
This medicine contains lactose (in the form of lactose monohydrate) and sucrose. Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome, as well as rare congenital forms of fructose intolerance or sucrase-isomaltase deficiency should not take this drug.
Lindineth
Contraceptive pill form. One package contains 21 tablets. The active ingredients are ethinyl estradiol (estrogen) and progestogen (gestodene). It interferes with the ovulation process and increases the viscosity of cervical mucus, thereby making it difficult for sperm to penetrate the uterus.
In addition to preventing unwanted pregnancy, Lindinet regulates the menstrual cycle, reduces pain and helps reduce the intensity of bleeding. For oily skin and acne - has a beneficial effect on oil levels, improves skin condition and intensity of rashes. The drug also inhibits the development of iron deficiency anemia, reduces the risk of cysts and tumors of the genital organs and mammary glands, the risk of ectopic pregnancy, pelvic inflammatory diseases and endometrial cancer.
Reception scheme
Lindinet is taken one tablet per day, preferably at the same time. The duration of continuous use is 21 days. This is followed by a week-long break, during which menstrual-like bleeding occurs. Then the reception continues - from the next package. It turns out that the menstrual cycle lasts four weeks, three of which the woman takes Lindinet, and one she does not take. Each new package starts on the same day of the week.
The first tablet is taken on the first day of the menstrual cycle. After an abortion, if it occurred in the first trimester of pregnancy, taking the drug can be started immediately after surgery. Additional barrier methods of contraception are not required. If it was not possible to start taking the drug immediately after the abortion, then you can do this after 21-28 days (in the first seven days you need to use barrier methods of contraception), or wait until the first menstrual cycle.
The same should be done after childbirth - start taking it after 21-28 days, using additional contraceptives during the first week. If you wait until your first menstruation, then follow the rule “the first day of the cycle - the first pill.” Please note: if you have had sexual intercourse after childbirth or abortion and menstruation has not yet begun, pregnancy must be ruled out.
If you forget to take your pill...
In such cases, you need to proceed according to the following schemes.
If the delay in taking is less than 12 hours, then you need to take the pill as soon as possible and continue to follow the usual regimen. No other contraceptive measures are required.
If the delay is more than 12 hours, the contraceptive effect is reduced. You should act in the same way, but additionally use barrier methods of protection for a week.
Separately, it is worth noting the situation when you forgot to take a tablet, and there are less than 7 tablets left in the package. In this case, you need to take the pill as soon as possible, then stick to your usual schedule, and start taking the drug from the next package without interruption. Menstrual-like bleeding does not occur in this cycle; it should occur only after completing all the tablets from the second package. However, spotting or breakthrough bleeding may occur while taking it. If bleeding does not occur in the second cycle, then a pregnancy test must be taken.
Vomiting and/or diarrhea that occurs within three to four hours after taking the drug may affect the effectiveness of the drug. If such symptoms bother you within an interval of up to 12 hours, you need to additionally take another tablet and then proceed according to your usual schedule. If symptoms continue for more than 12 hours, then the contraceptive effect is reduced and it is necessary to additionally use barrier methods of contraception over the next week.
Contraindications to taking Lindinet are:
- liver diseases, dysfunctions and tumors;
- thrombosis and thromboembolism - currently diagnosed or occurring previously;
- myocardial infarction, heart failure;
- cerebrovascular disorders;
- transient ischemic attacks, angina pectoris;
- sickle cell anemia;
- breast or endometrial tumors;
- diabetes mellitus complicated by microangiopathies;
- uterine bleeding of unknown etiology;
- idiopathic jaundice and itching during pregnancy;
- history of genital herpes.
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Lindinet should not be taken during pregnancy and lactation.
Please pay special attention to the fact that taking other medications may reduce the effectiveness of Lindinet. Therefore, for any therapeutic appointments, inform your doctor that you are taking a contraceptive. It is recommended to use additional barrier methods of protection while you are taking the following drugs: ampicillin, tetracycline, rifampicin, barbiturates, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine, ritonavir. After completing the course of treatment, additional contraceptive measures should be used for the next week, or act in accordance with the doctor’s recommendations.
You should also know that a decrease in the contraceptive effect of Lindinet is caused by taking St. John's wort in any form (decoctions, infusions, etc.). The reason for this is the special effect that St. John's wort has on liver enzymes. This effect lasts during the course of taking St. John's wort, as well as for two weeks after its completion.
Side effects when taking Lindinet may be as follows:
- nausea, vomiting;
- emotional instability, irritability, depression, fatigue;
- headaches, dizziness;
- leg cramps;
- increased blood pressure;
- vaginal discharge of unknown origin;
- change in body weight, change in libido;
- pain in the lower abdomen;
- chloasma;
- swelling;
- discomfort when wearing contact lenses;
- allergic reactions.
The drug should be taken with extreme caution in the following cases:
- family history of breast cancer;
- kidney diseases;
- chorea of pregnancy;
- diabetes;
- epilepsy;
- gallbladder diseases, especially cholelithiasis;
- liver failure;
- cholestatic jaundice;
- high blood pressure;
- prolonged immobility (for example, in case of serious injury);
- surgical intervention;
- migraine.
Lindinet is not recommended for women over 35 years of age who smoke, as it may increase the risk of developing cardiovascular complications.
The drug should be stopped if:
- while taking it, there is an increase in the frequency and intensity of headaches and migraines;
- epileptic seizures occur;
- signs of depression increase;
- surgical intervention is pending (appointment is stopped 4 weeks before the planned operation and can be resumed 1 week after the patient is mobilized).
Please note: intermenstrual bleeding may occur in the first three months of taking Lindinet. If they occur after regular cycles have formed, pregnancy and malignant neoplasms should be excluded.
If menstrual-like bleeding does not occur during the period without taking pills (the week between two packs) and the dosage regimen was violated in the previous cycle, it is necessary to take a pregnancy test.
