Logest - instructions for use, doses, side effects, contraindications

Composition:Each tablet contains:
Core:
Active substances: 0.075 mg of Gestodene and 0.020 mg of Ethinylestradiol.
Excipients: lactose monohydrate 37.155 mg, corn starch 15.500 mg, povidone 25 thousand 1.700 mg, magnesium stearate 0.550 mg.
Sheath: sucrose 19.660 mg, povidone 700 thousand 0.171 mg, macrogol-6000 2.180 mg, calcium carbonate 8.697 mg, talc 4,242 mg, wax mountain glycol 0.050 mg.

Description:The tablets are coated with a white color of round shape. View at the break: the core is white to almost white, the shell is white.

Pharmacotherapeutic group:Contraceptive agent combined (estrogen + progestogen)

ATX: & nbsp

G.03.A.A.10 Gestodene and ethinyl estradiol

Pharmacodynamics:The drug Logest® is a low-dose monophasic oral combined estrogen-gesaggen contraceptive.
The contraceptive effect of Logest® is achieved through complementary mechanisms,the most important of which are suppression of ovulation and increased viscosity of the secretion of the cervix.
The increased risk of venous thromboembolism (VTE) associated with the use of combined oral contraceptives (COCs) is due to the presence of estrogen. The scientific debate on the modulating effect of the progestin component of drugs from the KOC group on the risk of developing WTO continues. In carrying out epidemiological studies that compared the risk of developing VTE when using COCs containing ethinyl estradiol / gestodene, with the risk of using COCs. Containing inconsistent results. Some studies have demonstrated an increased risk of using drugs containing ethinyl estradiol / gestodene, while other studies have not shown differences in risk values.
In women taking COC, the cycle becomes more regular, the soreness and intensity of menstrual bleeding decreases, which reduces the risk of iron deficiency anemia.In addition, there is evidence that the use of COC reduces the risk of developing endometrial cancer and ovarian cancer.
When properly applied, the Perl index (an indicator that reflects the frequency of pregnancy in 100 women during the year of use of the contraceptive) is less than 1. When incorrectly used tablets, including when missing tablets, the Pearl index may increase.

Pharmacokinetics:- Gestoden
Absorption. After oral administration, Gestodene is quickly and completely absorbed, its maximum concentration in the blood plasma, equal to 3.5 ng / ml, is reached after about 1 hour. Bioavailability is approximately 99%.
Distribution. Gestodene binds to blood plasma albumin and to sex hormone binding globulin (SHBG). In a free form in blood plasma there is only about 1.3% of the total concentration of the substance; about 69% - are specifically related to SHGS. Induction with ethinylestradiol synthesis of SHBG affects the binding of Gestodene to plasma proteins. The average apparent volume of distribution of Gestodene is 0.7 l / kg.
Metabolism. Gestodene is almost completely metabolized. The clearance from the blood plasma is approximately 0.8 ml / min / kg.
Excretion. Concentration of Gestodene in blood plasma is reduced biphasic.The half-life in the terminal phase is about 12 hours. In unmodified form, Gestodene is not excreted, but only in the form of metabolites that are excreted by the kidneys and through the intestine in a ratio of approximately 6: 4 with a half-life of about 24 hours.
Equilibrium concentration. The pharmacokinetics of Gestodene are influenced by the concentration of SHBG in the blood plasma. With a daily intake of the drug, the concentration of the substance in the blood plasma increases approximately 4 times in the second half of the cycle.
- Ethinylestradiol
Absorption. After ingestion ethinyl estradiol quickly and completely absorbed. The maximum concentration in the blood plasma, equal to about 65 ng / ml, is achieved in 1.7 hours. During the intake and "primary passage" through the liver ethinyl estradiol is metabolized, as a result of which its bioavailability when ingested is an average of about 45% with a high interindividual variability - from 20 to 65%.
Distribution. Ethinylestradiol nonspecifically, it binds firmly to blood plasma albumin (about 98%) and induces an increase in the concentration in the blood plasma of SHBG. The apparent volume of distribution by this mud estradiol and is about 2.8 - 8.6 l / kg.
Metabolism. Ethinyl estradiol undergoes presystemic conjugation both in the mucosa of the small intestine and in the liver. The main pathway of metabolism is the aromatic hydroxylation. The clearance rate from blood plasma is 2.3-7 ml / min / kg.
Excretion. Reduction in the concentration of ethinyl estradiol in blood plasma is biphasic; the first phase is characterized by a half-life period of about 1 hour, the second-10-20 hours. Unchanged from the body is not excreted. Metabolites of ethinyl estradiol are excreted by the lobes and through the intestine in a ratio of 4: 6 with a half-life of about 24 hours.
Equilibrium concentration. The equilibrium concentration is reached after about one week.

Indications:Oral contraception.

Contraindications:The use of the drug Logest® is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time against the background of taking the drug, then the drug should be immediately canceled.
- Thrombosis (venous and arterial), thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders - currently or in the anamnesis.
- Conditions preceding thrombosis (including, transient ischemic attacks, angina pectoris) are presently or in the anamnesis.
- The presence of a high risk of venous or arterial thrombosis (see section "Special instructions").
- Migraine with focal neurologic symptoms at present or in anamnesis.
- Diabetes mellitus with vascular complications.
- Pancreatitis with severe hypertriglyceridemia at the present time or in the anamnesis.
- Liver failure and severe liver disease (until liver tests are normal).
- Liver tumors (benign or malignant) at present or in the anamnesis.
- Identified hormone-dependent malignant neoplasms (including genital organs or mammary glands) or suspected of them.
- Bleeding from the vagina of an unknown origin.
- Pregnancy or suspicion of it.
- The period of breastfeeding.
- Lactose intolerance, sucrose, deficiency of lactase, sucrose / isomaltase, glucose-galactose malabsorption.
- Hypersensitivity to any of the components of the drug Logest®.

Carefully:Potentialrisk and the expected benefit of using COCs in each case individually in the presence of the following diseases / conditions and risk factors:
- Risk factors for thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in someone of the next of kin; obesity; dyslipoproteinemia, arterial hypertension; migraine without focal neurological symptoms; heart valve diseases; heart rhythm disturbances, prolonged immobilization; serious surgical interventions; extensive injury.
- Other diseases in which there may be violations of peripheral circulation: diabetes mellitus without vascular complications; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease and ulcerative colitis; sickle-cell anemia; phlebitis of superficial veins.
- Hypertriglyceridemia.
- Liver disease, not related to contraindications (see section "Contraindications").
- Diseases that first occurred or worsened during pregnancy or on the background of previous administration of sex hormones (eg, jaundice and / or itching associated with cholestasis,gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham's chorea).
- In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.

Pregnancy and lactation:The drug Logest® is contraindicated for use during pregnancy and during breastfeeding.
If pregnancy is detected during the administration of the drug Logest®, the drug should be immediately discontinued. However, numerous epidemiological studies have not revealed an increase in the risk of developmental defects in children born to women who received sex hormones before pregnancy, or the presence of teratogenic effects, when sex hormones were taken carelessly in the early stages of pregnancy.
Reception of the drug Logest®, as well as other COCs. can reduce the amount of breast milk and change its composition, so the use of the drug is contraindicated until the termination of breastfeeding. A small amount of sex hormones and / or their metabolites can penetrate into breast milk and influence the health of the child.

Dosing and Administration:The calendar package of Logest® contains 21 tablets. Tablets should be taken orally one at a time, for 21 days at about the same time, with a small amount of water. Each tablet must be taken on the appropriate day of the week indicated on the package, following the arrows. Receiving tablets from the next package begins after a 7-day break, during which menstrual bleeding (bleeding "cancellation") usually occurs. As a rule, it begins on the 2-3 day after the last pill and may not end before taking the tablets from the new package. After a 7-day break, it is necessary to start taking the tablets from the new package even if the menstrual bleeding has not stopped. This means that it is necessary to start taking the tablets from the new package one day on the same day of the week, and that each month the bleeding of the "cancellation" will occur on the same day of the week.
Receiving tablets from the first package of Logest®
- when no hormonal contraceptive was used in the previous month
The drug Logest® should be started on the first day of the menstrual cycle (ie on the first day of menstrual bleeding). It is necessary to take a tablet, according to the day of the week indicated on the package. Then take the pill in order. It is acceptable to start taking the drug on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to use the barrier method of contraception (for example, a condom) during the first 7 days of taking the tablets from the first package.
- When switching from other COCs, vaginal rings or contraceptive patches
It is preferable to start Logest® the day after receiving the last tablet from the previous package, but in no case later than the day after the usual 7-day break (for preparations containing 21 tablets) or the day after the last tablet from the previous packaging (for preparations containing 28 tablets in a package). The drug Logest® should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is stuck.
- In the transition from contraceptives containing only gestagens ("mini-pili", injectable forms, implant), or from the intrauterine therapeutic system with the release of the progestogen (Mirena®)
Go from the "mini-drink" to the drug Logest® it is possible any day (without interruption), with an implant or vpaditritochnogo contraceptive with gestagen - the day of its removal, with the injection form - from the day. when the next injection is to be made. In all cases, during the first 7 days of taking the tablets, an additional barrier method of contraception (for example, a condom) should be used.
- After abortion (including spontaneous) in the first trimester of pregnancy
You can start taking the drug immediately. If this condition is met, additional contraceptive measures are not required.
- After childbirth (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy
It is recommended to start taking the drug on the 21-28th day after giving birth (if there is no breastfeeding), or immediately after the abortion (including spontaneous) in the second trimester of pregnancy. If the drug is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.If sexual contact occurred before the drug Logest® was administered, pregnancy should be excluded.
Acceptance of missed tablets
If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. It is necessary to take the missed tablet as soon as possible, the next tablet is taken at the usual time.
If the delay in taking the drug is more than 12 hours, contraceptive protection can be reduced. The more pills are missed, and the closer the pass to a 7-day break in taking pills, the higher the probability of pregnancy.
In this case it is necessary to remember:
- The drug should never be discontinued for more than 7 days.
- 7 days of continuous intake of tablets are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.
Accordingly, if the delay in taking the tablets was more than 12 hours (the interval from the time of taking the last tablet is more than 36 hours), depending on the week when the tablet was missed, the following recommendations can be given:
- The first week of taking the drug
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers it (even if it means taking two tablets at the same time).The next tablet should be taken at the usual time. Within the next 7 days, a barrier method of contraception (eg, a condom) should be used additionally. If sexual intercourse took place during the pedal before passing the pill, it is necessary to take into account the possibility of pregnancy.
- The second medication
It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers it (even if it means taking two tablets at the same time). The next tablet should be taken at the usual time.
Provided, the woman sat down taking the tablets correctly for 7 days preceding the first missed pill, there is no need to use additional methods of contraception. Otherwise, as well as when two or more tablets are missed, barrier methods of contraception (for example, a condom) should be used additionally for the next 7 days.
- The third week of taking the drug
The risk of reducing contraceptive reliability is inevitable due to the upcoming interruption in the intake of tablets. In this case, you must adhere to the following algorithms:
- if within 7 days preceding the first missed tablet, all tablets were taken correctly, there is no need to use additional methods of contraception. When accepting the missed tablets, follow steps 1 or 2.
- if the tablets were taken incorrectly during the 7 days preceding the first missed tablet, then the barrier method of contraception (for example, a condom) should be used additionally within the next 7 days, in which case the paragraph 1 should be used to receive missed tablets.
1. It is necessary to take the last missed tablet as soon as possible, as soon as the woman remembers it (even if it means taking two tablets at the same time). The following tablets are taken at the usual time, until the tablets from the current package run out. Receiving tablets from the next package should start immediately without the usual 7-day break. Bleeding "cancellation" is unlikely until the tablets from the second package run out, but there may be "smearing" discharge and / or "breakthrough" bleeding on the days of taking the drug.
2. You can also interrupt the taking of tablets from the current package, take a break for 7 or less days (including the days of missing tablets), and then start taking the tablets from the new package.
If a woman misses taking pills, and then during a break in admission she does not have a bleeding "withdrawal", it is necessary to exclude pregnancy.

It is allowed to take no more than two tablets in one day.
Recommendations for gastrointestinal disorders
In severe gastrointestinal disorders, absorption of the drug may be incomplete, so additional methods of contraception should be used.
If vomiting or diarrhea occurs within 3-4 hours after taking the tablets, depending on the week of taking the drug, you should be guided by the recommendations when skipping the tablets mentioned above. If a woman does not want to change her usual schedule of taking and transfer the onset of the bleeding "cancellation" to another day of the week, an additional pill should be taken from another package.
Discontinuation of Logest®
The drug Logest® can be stopped at any time. If a woman does not plan pregnancy, care should be taken for other methods of contraception. If pregnancy is planned, simply stop taking Logest® and wait for a natural menstrual bleeding.
Postponement of menstrual bleeding
In order to delay the onset of menstrual bleeding, it is necessary to continue taking the tablets from a new package of Logest® without a 7-day break. Tablets from a new package can be taken for as long as necessary, including until the tablets in the package are exhausted. Against the background of taking the drug from the second package, there may be "smearing" spotting from the vagina and / or "breakthrough" uterine bleeding. To resume the drug Logest® from the next package follows after a usual 7-day break.
Change in the day of menstrual bleeding
In order to postpone the start of menstrual bleeding the next day of the week, a woman should shorten (but not extend) the next 7-day break in taking pills for as many days as a woman wants. For example, if the cycle usually starts on Friday, and in the future the woman wants it to start on Tuesday (3 days earlier), taking the tablets from the next package should start 3 days earlier than usual.The shorter the break in taking the tablets, the higher the likelihood that menstrual bleeding will not occur, and during the reception of tablets from the second package, there will be "smearing" discharge and / or "breakthrough" bleeding.
Application in separate groups of patients
Children and adolescents
The drug Logest® is indicated only after the onset of menarche.
The elderly
Not applicable. The drug Logest® is not indicated after the onset of menopause.
With violations of liver function
The drug Logest® is contraindicated in women with severe liver disease until the liver function test results are normal. See also "Contraindications".
In case of violations of kidney function
The drug Logest® was not specifically studied in patients with impaired renal function. The available data do not suggest correction of the dosing regimen in such patients.

Side effects:

The most frequently described adverse events associated with the use of Logest® are nausea, abdominal pain, weight gain, headache, decreased mood, mood changes, pain in the mammary glands, breast engorgement. They are found in ≥ 1% of patients.
Serious adverse events are arterial and venous thromboembolism.
Against the background of taking COC in women, there were also other undesirable effects, the connection of which with taking drugs was not confirmed, but also not disproved.

System Class bodies (MedDRA)	Often (≥1/100)	Infrequently (≥ 1/1000 and <1/100)	Rarely (<1/1000)
Disturbances on the part of the organ of sight			intolerance to contact lenses (discomfort when wearing them)
Disorders from the gastrointestinal tract	nausea, abdominal pain	vomiting, diarrhea
Immune system disorders			hypersensitive
Are common disorders	weight gain		weight loss
Disorders from the metabolism and nutrition		fluid retention
Disturbances from the nervous system	headache	migraine
Violations psyche	decline mood, swings moods	decreased libido	rise libido
Violations of the genitals and mammary gland *	morbidity of the mammary glands, nerubanis mammary glands	mammary gland hypertrophy	discharge from the genital tract, discharge from the mammary glands
Disturbances from the skin and subcutaneous tissues		rash, urticaria	knotty erythema, multiform erythema
Vascular disorders			venous and arterial thromboemboliccomplications **

* In hodPost-marketing studies reported the following adverse events, the frequency of which could not be assessed: the absence of menstrual bleeding, acyclic bleeding, "spotting" bleeding, decreased menstrual bleeding, amenorrhea after the end of the drug.

** - Estimated frequency from epidemiological studies covering a group of women who received COCs.

Venous and arterial thromboembolic complications combine the following nosological forms: peripheral deep vein occlusion, thrombosis and thromboembolism / pulmonary vascular occlusion, thrombosis, embolism and myocardial infarction / cerebral infarction and stroke not classified as hemorrhagic.

The following are undesirable events with a very low frequency or delayed development of symptoms that are presumably associated with the administration of COCs (see also "Contraindications", "Special instructions"):

Tumors

Women who use COC have a very low incidence of breast cancer detection. Because breast cancer is rare in women under the age of 40, an increase in the incidence of cancer in women using COC is insignificant in relation to the overall risk of breast cancer. A causal relationship with the use of COCs has not been identified.
Liver tumors (benign and malignant).

Other states

Women with hypertriglyceridemia (increased risk of pancreatitis with COCs).
Increase in blood pressure.
Onstasis or worsening of conditions in which communication with the use of COC is not uncontested: jaundice and / or itching associated with the holleStasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis.
In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.
Dysfunction of the liver.
Impairment of glucose tolerance or influence on peripheral insulin resistance.
Crohn's disease, ulcerative colitis.
Chloasma.

Vzaandmaboutdethart.vie

Due to the interaction of other drugs (inducers of enzymes) with oral contraceptives, "breakthrough" bleeding and / or a reduction in the contraceptive effect may occur (see "Interaction with Other Drugs").

Overdose:No serious violations were reported in case of an overdose. Symptoms that can be noted in an overdose: nausea, vomiting, "smearing" spotting. There is no specific antidote, symptomatic treatment should be performed.

Interaction:The effect of other drugs on Logest®
It is possible to interact with drugs that induce microsomal enzymes, as a result of which the clearance of sex hormones can increase, which in turn can lead to "breakthrough" uterine bleeding and / or a reduction in the contraceptive effect.
Women who are treated with induction drugs microsomal enzymes in addition to the drug Logest® is recommended to temporarily use the barrier method of contraception or choose a different non-hormonal method of contraception.The barrier method of contraception should be used during the entire period of taking concomitant medications and for another 28 days after their withdrawal.
If the use of the inductor preparation of microsomal liver enzymes continues after taking the last tablet of the drug Logest® from the current package, it is necessary to start taking the tablets from the new package without the usual break in taking the tablets. Continuous reception of the drug Logest® should also be continued for 28 days after the withdrawal of the induction drug microsomal enzymes.
- Substances that increase the clearance of the drug Logest® (weakening the efficiency by inducing enzymes):
phenytoin, barbiturates, primidon, carbamazepine, rifampicin and, possibly, also oxcarbazepine, topiramate, felbamate, griseofulvin, as well as preparations containing St. John's wort perforated.
- Substances with different effects on the clearance of the drug Logest®
When combined with the drug Logest®, many HIV protease or hepatitis C virus inhibitors and non-nucleicidic reverse transcriptase inhibitors can both increase and decrease the concentration of estrogens or progestins in the blood plasma.In some cases, such an effect may be clinically significant.
- Substances that reduce the clearance of the drug Logest® (enzyme inhibitors)
Strong and moderate inhibitors of CYP3A4, such as azole antimycotics (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of estrogen or progestin, or both.
It was shown that etorikoksib in doses of 60 and 120 mg / day when taken together with COC containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively.
Effect of COCs on other drugs
COCs can affect the metabolism of other drugs, leading to an increase (for example, ciclosporin) or decrease (for example, lamotrigine) of their concentration in blood plasma and tissues.
In vitro ethinyl estradiol is a reversible inhibitor of CYP2C19. CYP1A1 and CYP1A2, as well as the irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical trials, the appointment of a hormonal contraceptive containing ethinyl estradiol, did not lead to any increase or led only to a slight increase in the concentrations of CYP3A4 substrates in the blood plasma (for example,midazolam), whereas plasma concentrations of CYP1A2 substrates may increase slightly (for example, theophylline) or moderately (for example, melatonin and tizanidine).

Special instructions:If any of the conditions, diseases or risk factors identified below are present, careful consideration should be given to the potential risk and expected benefits of using COC, including Logest®, in each individual case and to discuss it with a woman before , as she decides to start taking the drug. In the event of aggravation, intensification, or first manifestation of any of these conditions, diseases or risk factors, a woman should consult her physician to decide whether to stop taking the drug.
- Diseases of the cardiovascular system
Epidemiological studies indicate a relationship between the use of COCs and increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The risk of developing VTE is maximal in the first year of taking such drugs. An increased risk is present after the initial use of COC or the resumption of the use of the same or another COC (after a break between doses of 4 weeks or more). Data from a large prospective study with 3 groups of patients show that this increased risk is present mainly during the first 3 months.
The overall risk of VTE in patients taking low-dose COCs (containing less than 0.05 mg ethinyl estradiol a) two to three times higher than that of non-pregnant patients who do not take COC, however, this risk remains lower compared to the risk of B'GE in pregnancy and childbirth.
VTE can be life threatening or lead to a legal outcome (in 1-2% of cases).
VTE, manifested as deep vein thrombosis and / or pulmonary embolism, can occur with any COCs.
Very rarely, when using COC, thrombosis occurs in other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of deep vein thrombosis (DVT): unilateral swelling of the lower limb or along the veins of the lower limb,pain or discomfort in the lower extremity only in an upright position or when walking, a local increase in temperature, redness or discoloration of the skin in the affected lower limb.
Symptoms of thromboembolism of the pulmonary artery (PE): shortness of breath or rapid breathing; sudden cough, including hemoptysis; acute pain in the chest, which can increase with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, dyspnea, cough) are nonspecific and may be misinterpreted as signs of other more or less severe complications (eg, respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensitivity of the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one- or two-sided loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden strong orprolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, puffiness and weak blueing of the extremities, "sharp" abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, a feeling of squeezing or buckling in the chest or behind the breastbone, with irradiation in the back, jaw, upper limb, epigastric region; cold sweats, nausea, vomiting or dizziness, severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat. Arterial thromboembolism can be life threatening or fatal.
Women with a combination of several risk factors or high severity of one of them should consider the possibility of their mutual reinforcement. In such cases, the degree of risk increase may be higher than with a simple summation of factors. In this case, the use of the drug Logest® is contraindicated (see the section "Contraindications").
The risk of developing thrombosis (venous and / or arterial) and thromboembolism or cerebrovascular disorders is increased:
- with age;
- for smokers (with an increase in the number of cigarettes or an increase in the age of the risk increases, especially in women older than 35 years);
- in the presence of a family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In case of a hereditary or acquired predisposition, a woman should be examined by the appropriate specialist to decide on the possibility of taking COC;
- with obesity (body mass index more than 30 kg / m2);
- with dyslipoproteinemia;
- with arterial hypertension;
- with migraine;
- with diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, serious surgical intervention, any operation on the lower limbs or extensive trauma. In these situations, it is advisable to stop using COCs (in the case of a planned operation, but at least four weeks before) and not to resume admission within two weeks after the end of immobilization. Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially if there are other risk factors.
The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
You should consider the increased risk of thromboembolism in the postpartum period.
Violations of peripheral circulation can 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 disorders) during the use of COCs may be grounds for the immediate cessation of these medications.
Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocystsinemia, antithrombin III deficiency, protein C deficiency, protein deficiency S, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be borne in mind that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it.It should also be taken into account that the risk of thrombosis and thromboembolism in pregnancy is higher than with the use of inoculated COCs (containing less than 0.05 mg of ethinylestradiol).
- Tumors
The most significant risk factor for developing cervical cancer is persistent pain- lomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. However, the connection with the reception of the COC has not been proven. There are still contradictions as to the extent to which these data are associated with screening for cervical pathology or with peculiarities of sexual behavior (a more rare use of barrier methods of contraception).
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). Increased risk gradually disappears within 10 years after discontinuation of 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 who have recently taken COC is insignificant in relation to the overall risk of this disease.His connection with the use of COC has not been proven. The observed increase in risk may also be the result of an earlier diagnosis of breast cancer in women using COCs (they have earlier clinical forms of breast cancer diagnosed than women who did not take COCs), the biological effects of COCs, or a combination of both.
In rare cases, the development of benign, and extremely rare, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage, was observed with the use of COCs. In the event of severe pain in the abdomen, liver enlargement, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
- Other conditions
In women with hypertriglyceridemia (or the presence of this condition in a family history) during the administration of COCs, an increased risk of developing pancreatitis may occur.
Despite the fact that a slight increase in blood pressure was described in many women taking COC, a clinically significant increase was noted rarely. Nevertheless,if a persistent clinically significant increase in blood pressure develops during the administration of COCs, these drugs should be discontinued and the treatment of hypertension should begin. Reception of COCs 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 when taking COC, but their association with COC use has not been proven: cholestatic jaundice and / or itching. associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis are also described against the background of COC use.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require cancellation of the COC until the liver function returns to normal. Recurrence of cholestatic jaundice, which developed for the first time during previous pregnancy or previous reception of sex hormones, requires discontinuation of COCs.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is usually no need to correct the dose of hypoglycemic drugs in diabetic patients who use low-dose COCs (containing less than 0.05 mg of these and silt estradiol). Nevertheless, women with diabetes should be carefully monitored while taking COC.
Sometimes chloasma can develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma while taking COC should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.
Each tablet of the drug Logest® contains 35 mg of lactose.
Laboratory Tests
The use of drugs such as Logest® can affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in the plasma (for example, globulin, corticosteroids, lipid / lipoprotein fractions, parameters of carbohydrate metabolism , coagulation and fibrinolysis). These changes, as a rule, remain within the limits of normal physiological values.
Decreased efficiency
The effectiveness of COCs can be reduced in the following cases: with the omission of tablets, gastrointestinal disorders or as a result of drug interactions.
Effect on the nature of bleeding
With the use of COC, irregular bleeding (spotting spotting and / or breakthrough bleeding) can 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, a thorough examination should be conducted to exclude malignant neoplasms or pregnancy.
Some women during the break in taking pills may not develop a bleeding "cancellation". If the drug Logest® was taken according to instructions, it is unlikely that a woman is pregnant. However, if before this drug Logest® was taken irregularly, or if there are no consecutive two bleeding "cancellations", the continuation of the drug should be excluded from pregnancy.
Medical examinations
Before starting or resuming the use of Logest®, you need to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, determination of the body mass index) and gynecological examination (including breast examination and cytology of the cervical epithelium), and exclude pregnancy. The volume of additional studies and the frequency of follow-up visits are determined individually. Usually, follow-up examinations should be performed less than once every 6 months.
It must be remembered that the drug Logest® does not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Conditions requiring medical advice
- Any changes in health, especially the occurrence of conditions listed in the sections "Contraindications" and "Use with caution";
- Local compaction in the mammary gland;
- Simultaneous reception of other medications (see also "Interaction with other drugs");
- If prolonged immobilization is expected (for example, gypsum is applied to the lower limb), hospitalization or surgery is planned (but at least,four weeks before the proposed operation);
- Uncommonly severe bleeding from the vagina;
- The tablet was skipped in the first pedal of taking the drug and there was sexual contact seven or less days before;
- The absence of another menstrual bleeding twice or in suspicion of pregnancy (do not start taking pills from the next package before consulting a doctor).
You should stop taking the pills and immediately consult a doctor if there are possible signs of thrombosis, myocardial infarction or stroke: an unusual cough; unusually severe pain behind the sternum, giving 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; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensitivity in any part of the body; severe pain in the abdomen; severe pain in the lower limb, or a sudden edema of any of the lower limbs.

Effect on the ability to drive transp. cf. and fur:Not found.

Form release / dosage:The tablets covered with a cover, 75 mkg + 20 mkg.

Packaging:For 21 tablets in a blister made of polyvinylchloride film and aluminum foil. 1 or 3 blisters are placed together with instructions for use in a cardboard box.

Storage conditions:Store at a temperature of no higher than 25 ° C in a dark place.
Keep out of the reach of children.

Shelf life:3 years.
Do not use after expiry date!

Terms of leave from pharmacies:On prescription

Registration number:П N013534 / 01

Date of registration:22.07.2009 / 14.01.2013

The owner of the registration certificate:Bayer Pharma AGBayer Pharma AG Germany

Manufacturer: & nbsp

DELPHARM LILLE, SAS France

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp2016-01-18

Illustrated instructions

Instructions

Logest® (Logest®)