Yarina

Name:Yarina

Indications for use:
Contraception (prevention of unwanted pregnancy).

The appointment of a combined contraceptive with antimineralocorticoid and antiandrogenic properties (Yarina) can be especially useful for women with hormone-dependent fluid retention, as well as women with acne (acne) and seborrhea.

Pharmachologic effect:
Low-dose monophasic oral contraceptive with anti-ISS and anti-androgenic action. The contraceptive effect is due to a number of factors, the most important of which are the inhibition of ovulation and changes in the viscosity of cervical mucus. The endometrium remains unprepared for egg implantation. As a result of an increase in the viscosity of cervical mucus, the penetration of spermatozoa into the uterine cavity is difficult. Drospirenone has anti-ISS activity, which can prevent weight gain and other symptoms associated with fluid retention (prevents estrogen-induced Na + retention, provides very good tolerance and has a positive effect on premenstrual syndrome). In combination with ethinyl estradiol, it improves the lipid profile and increases the concentration of HDL. Has antiandrogenic activity, which leads to a decrease in the formation of acne and a decrease in the production of sebaceous glands, does not affect the increase in the formation of sex hormone-binding globulin caused by ethinylestradiol (inactivation of endogenous androgens). Drospirenone is devoid of any androgenic, estrogenic, GCS and anti-GCS activity. This, in combination with anti-ISS and anti-androgenic activity, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. Like all combined oral contraceptives, it has a positive non-contraceptive effect: menstrual bleeding becomes easier and shorter, which reduces the risk of anemia, pain is less pronounced or completely disappears. does not affect the increase in the formation of sex hormone-binding globulin caused by ethinylestradiol (inactivation of endogenous androgens). Drospirenone is devoid of any androgenic, estrogenic, GCS and anti-GCS activity. This, in combination with anti-ISS and anti-androgenic activity, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. Like all combined oral contraceptives, it has a positive non-contraceptive effect: menstrual bleeding becomes easier and shorter, which reduces the risk of anemia, pain is less pronounced or completely disappears. does not affect the increase in the formation of sex hormone-binding globulin caused by ethinylestradiol (inactivation of endogenous androgens). Drospirenone is devoid of any androgenic, estrogenic, GCS and anti-GCS activity. This, in combination with anti-ISS and anti-androgenic activity, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. Like all combined oral contraceptives, it has a positive non-contraceptive effect: menstrual bleeding becomes easier and shorter, which reduces the risk of anemia, pain is less pronounced or completely disappears. in combination with anti-ISS and anti-androgenic action, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. Like all combined oral contraceptives, it has a positive non-contraceptive effect: menstrual bleeding becomes easier and shorter, which reduces the risk of anemia, pain is less pronounced or disappears completely. in combination with anti-ISS and anti-androgenic action, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. Like all combined oral contraceptives, it has a positive non-contraceptive effect: menstrual bleeding becomes easier and shorter, which reduces the risk of anemia, pain is less pronounced or completely disappears.

Yarina (Yarina) method of administration and dose:
Inside, 1 tablet, in the order indicated on the pack, every day at about the same time with a small amount of water, continuously for 21 days. Reception of each next package begins after a 7-day break, during which menstrual-like bleeding is observed. It usually starts 2-3 days after taking the next pill and may not end before starting a new pack. In the absence of taking any hormonal contraceptives in the previous month, the product is taken on the first day of the menstrual cycle (the first day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package. When switching from taking other combined oral contraceptives, it is preferable to start taking the product the next day after taking the last day of the active tablet from the previous package, but no later than the next day after the usual 7-day break in taking (for products containing 21 tablets) or after taking the last day of an inactive tablet (for products containing 28 tablets per pack). When switching from contraceptives containing only gestagens (mini-pills, injection forms, implant): you can switch from mini-pills on any day (without a break), from an implant – every day it is removed, from an injection form – from the day when you must the next injection was given. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. After an abortion in the first trimester of pregnancy, you can start taking it immediately. Under this condition, there is no need for additional contraceptive protection. After childbirth or abortion in the second trimester of pregnancy, it is recommended to start taking the product on days 21-28. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. If there is sexual intercourse, pregnancy must be excluded before the start of taking the product, or it is necessary to wait for the first menstruation. Taking missed pills: if the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. It is necessary to take a pill as soon as possible, the next one is taken at the usual time. If the delay in taking the tablets was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), contraceptive protection may be reduced. If you miss 1-2 weeks of taking the product, you must take the next missed tablet as soon as possible (even if this means taking 2 tablets at the same time). The next tablet is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. If sexual intercourse took place within 1 week before missing the pill, the possibility of pregnancy should be considered. The more pills missed, and the closer the missed pill is to a 7-day break in taking the product, the higher the risk of pregnancy. In case of missing 3 weeks of taking the product, you must take the next missed tablet as soon as possible (even if it means taking 2 tablets at the same time). The next tablet is taken at the usual time. In addition, a barrier method of contraception must be used for the next 7 days. In addition, taking tablets from a new package should be started as soon as the current pack is finished, i.e. nonstop. Most likely there will be no “withdrawal” bleeding until the end of the second pack, but “spotting” spotting or “withdrawal” uterine bleeding may occur on the days of taking the product from the second pack. In the event of a missed tablet intake and the absence of “withdrawal” bleeding in the first free from taking the product interval, pregnancy must be excluded. In case of missing a product intake, the following two basic rules can be followed: the product intake should never be interrupted for more than 7 days; 7 days of continuous tablet intake are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. In case of vomiting within 3-4 hours after taking the tablet, absorption may not be complete. In this case, it is necessary to follow the rules for taking the product in case of skipping tablets. If the patient does not want to change the normal mode of taking the product, she is obliged to take, if necessary, an additional tablet (or several tablets) from another package. To delay the day of the onset of menstruation, it is necessary to continue taking the tablets from the new package immediately after taking all the tablets from the previous one, without interrupting the intake. Tablets from the new package can be taken as much as possible until the pack is over. Against the background of taking the product from the second package, “spotting” bloody discharge from the vagina or uterine “breakthrough” bleeding may be noted. It is necessary to resume taking the product from a new pack after the usual 7-day break. To transfer the day of the onset of menstruation to another day of the week, it is necessary to shorten the next break in taking the pills by as many days as it is necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of “withdrawal” bleeding and further “spotting” discharge and “breakthrough” bleeding during the second pack (as in the case of a delay in the onset of menstruation). Against the background of taking the product from the second package, “spotting” bloody discharge from the vagina or uterine “breakthrough” bleeding may be noted. It is necessary to resume taking the product from a new pack after the usual 7-day break. To transfer the day of the onset of menstruation to another day of the week, it is necessary to shorten the next break in taking the pills by as many days as it is necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of “withdrawal” bleeding and further “spotting” discharge and “breakthrough” bleeding during the second pack (as in the case of a delay in the onset of menstruation). Against the background of taking the product from the second package, “spotting” bloody discharge from the vagina or uterine “breakthrough” bleeding may be noted. It is necessary to resume taking the product from a new pack after the usual 7-day break. To transfer the day of the onset of menstruation to another day of the week, it is necessary to shorten the next break in taking the pills by as many days as it is necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of “withdrawal” bleeding and further “spotting” discharge and “breakthrough” bleeding during the second pack (as in the case of a delay in the onset of menstruation). It is necessary to resume taking the product from a new pack after the usual 7-day break. To transfer the day of the onset of menstruation to another day of the week, it is necessary to shorten the next break in taking the pills by as many days as it is necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of “withdrawal” bleeding and further “spotting” discharge and “breakthrough” bleeding during the second pack (as in the case of a delay in the onset of menstruation). It is necessary to resume taking the product from a new pack after the usual 7-day break. To transfer the day of the onset of menstruation to another day of the week, it is necessary to shorten the next break in taking the pills by as many days as it is necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of “withdrawal” bleeding and further “spotting” discharge and “breakthrough” bleeding during the second pack (as in the case of a delay in the onset of menstruation).

Yarina (Yarina) contraindications:
Yarina is not required to be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the product should be immediately discontinued.

The presence of thrombosis (venous and arterial) at present or in history (for example, deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
Presence or history of pre-thrombotic conditions (eg, transient ischemic attacks, angina pectoris).
Diabetes mellitus with vascular complications.
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be considered a contraindication.
Current or history of severe liver disease (until liver tests return to normal).
Severe renal failure or acute renal failure.
Current or history of liver tumors (benign or malignant).
Identified hormone-dependent malignant diseases of the genital organs or mammary glands or suspicion of them.
Vaginal bleeding of unknown origin.
Pregnancy or suspicion of it.
breastfeeding period.
Hypersensitivity to any of the components of Yarina.

Yarina (Yarina) side effects:
The following undesirable effects have been described in women taking Yarina, and their relationship with the product has not been confirmed or refuted: soreness of the mammary glands, discharge from the mammary glands; headache; migraine; change in libido; decreased mood; poor tolerance to contact lenses; nausea; vomit; changes in vaginal secretion; various skin disorders; fluid retention; change in body weight; hypersensitivity reaction.

Occasionally, chloasma may develop, especially in women with a history of chloasma during pregnancy.

Pregnancy:
The drug should not be taken during pregnancy and lactation!

Overdose:
No serious side effects have been reported in overdose. Symptoms that may occur in this case are nausea, vomiting, and slight vaginal bleeding. There is no specific antidote; symptomatic treatment should be carried out.

Use with other medicinal products:
Drug interactions resulting in increased clearance of sex hormones may lead to breakthrough bleeding or decreased contraceptive reliability. This has been found for hydantoin, barbiturates, primidone, carbamazepine, and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, and griseofulvin. The mechanism of this interaction is based on a change in the work of liver enzymes. Maximum enzymatic induction usually does not occur for 2-3 weeks, but may then persist for at least 4 weeks after discontinuation of drug therapy.

Contraceptive protection is reduced when taking antibiotics such as ampicillins and tetracyclines. The mechanism of this action has not been elucidated.

Women receiving any of the above classes of medicinal products in a short course in addition to Yarina should temporarily use a barrier method of contraception during concomitant use of products and for 7 days after their withdrawal. While taking rifampicin and for 28 days after its withdrawal, in addition to Yarina, a barrier method of contraception (for example, a condom) should be used. If a co-administration of a product is started at the end of taking a pack of Yarina, the next pack of Yarina must be started without the usual interruption in intake.

In women who have been receiving products that affect liver enzymes for a long time, it is necessary to consider the use of other methods of contraception.

Other interactions

There is a theoretical possibility of an increase in serum potassium levels in women receiving Yarina at the same time as other products that can increase serum potassium levels. These foods include ACE (angiotensin-converting enzyme) inhibitors, angiotensin-II receptor antagonists, certain anti-inflammatory foods (eg, indomethacin), potassium-sparing diuretics, and aldosterone antagonists. However, in a study evaluating the interaction of an ACE inhibitor with a combination of drospirenone / estradiol in women with moderate arterial hypertension, there was no significant difference between the serum potassium concentration in women treated with enalapril, compared with placebo.

Impact on laboratory tests

The use of sex steroids can affect the biochemical parameters of liver, thyroid, adrenal and kidney function, as well as the levels of plasma transport proteins, such as corticosteroid-binding globulin and lipid / lipoprotein fractions, indicators of carbohydrate metabolism, coagulation and fibrinolysis. Changes usually occur within laboratory norms. Due to its antimineralocorticoid activity, drospirenone increases the activity of renin and plasma aldosterone.

Release form:
Coated tablets for oral administration.
Cycle pack containing 21 tablets.

Storage conditions: Shelf
life – 3 years.
Do not use after the expiration date!
Keep out of the reach of children!
Released by prescription.

Yarina (Yarina) composition:
Each coated tablet contains.
Active ingredients: 3 mg drospirenone, 0.03 mg ethinyl estradiol.
Excipients: lactose monohydrate, corn starch, modified starch (pregelatinized starch), polyvidone 25000, magnesium stearate, hydroxypropyl methylcellulose, macrogol 6000, talc, titanium dioxide, iron oxide yellow.

Additionally:
If any of the conditions/risk factors listed below are currently present, then the potential risk and expected benefit of Yarina treatment in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the product. In case of worsening, worsening or first manifestation of any of these conditions or risk factors, the woman is obliged to consult her doctor, who can decide whether to discontinue the product.

Diseases of the cardiovascular system
A number of epidemiological studies have revealed a slight increase in the incidence of venous and arterial thrombosis and thromboembolism when taking combined oral contraceptives.

Venous thromboembolism (VTE), manifesting as deep vein thrombosis and / or pulmonary thromboembolism, can develop during the use of all combined oral contraceptives. The approximate incidence of VTE in women taking oral contraceptives with a low dose of estrogens (less than 50 micrograms of ethinyl estradiol) is up to 4 per 10,000 women per year compared with 0.5-3 per 10,000 women per year in women not using OCs. However, the frequency of VTE developing while taking combined oral contraceptives is less than the frequency associated with pregnancy (6 per 10,000 pregnant women per year).
In women taking combined oral contraceptives, extremely rare cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal arteries and veins, the central retinal vein and its branches, have been described. The relationship with the use of combined oral contraceptives has not been proven.

A woman should stop taking the product and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include: unilateral leg pain and/or swelling; sudden severe chest pain, with or without radiating to the left arm; sudden shortness of breath; a sudden attack of coughing; any unusual, severe, prolonged headache; increased frequency and severity of migraine, sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; dizziness; loss of consciousness with / or without a seizure; weakness or very significant loss of sensation that suddenly appeared on one side or in one part of the body; motor disturbances; “sharp” abdomen.

The risk of 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 further increases, especially in women over 35 years old);
if you have: a

family history (i.e. venous or arterial thromboembolism ever or in close relatives or parents at a relatively young age);
obesity (body mass index over 30 kg/m2);
dyslipoproteinemia;
arterial hypertension;
heart valve disease;
atrial fibrillation;
prolonged immobilization, major surgery, any operation on the legs, or major trauma.
In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking it for two weeks after the end of immobilization.
An increased risk of thromboembolism in the postpartum period should be taken into account. Circulatory disturbances 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 during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these products.

Biochemical parameters that may be indicative of a hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).

When considering the risk/benefit ratio, the physician should take into account that adequate treatment of these diseases may reduce the associated risk of thrombosis, and that the risk of thrombosis associated with pregnancy is higher than with combined oral contraceptives.

Tumors
An increased risk of developing cervical cancer with long-term use of combined oral contraceptives has been reported in some epidemiological studies. Its connection with the use of combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings relate to sexual behavior and other factors such as human papillomavirus (HPV).

A meta-analysis of 54 epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who were using combined oral contraceptives at the time of the study. Its connection with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives. Breast cancers in women who ever used combined oral contraceptives were clinically less pronounced than in women who never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of liver tumors was observed. 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
Potassium excretion may be reduced in patients with renal insufficiency. In a clinical study, drospirenone had no effect on serum potassium concentration in patients with mild or moderate deterioration in renal function. The theoretical risk of hyperkalemia can only be considered for patients whose pre-treatment serum potassium was in the upper limit of normal and who additionally use potassium-sparing foods.

In women with hypertriglyceridemia, or a family history of it, an increased risk of pancreatitis cannot be excluded while taking combined oral contraceptives.

Although a small increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases were not often noted. The relationship between taking combined oral contraceptives and clinically significant arterial hypertension has not been established. The antimineralocorticoid effect of drospirenone may counteract the ethinylestradiol-induced increase in blood pressure, which is observed in normotensive women taking other types of combined oral contraceptives. However, if persistent, clinically significant hypertension develops while taking combined oral contraceptives, it is prudent for the physician to discontinue these products and treat hypertension.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. Cases of Crohn’s disease and ulcerative colitis have also been described with the use of combined oral contraceptives, but the relationship with the intake of products has not been proven.

Acute or chronic liver dysfunction may require discontinuation of the use of combined oral contraceptives until liver function tests return to normal. Recurrent cholestatic jaundice that 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 combined oral oral contraceptives. However, women with diabetes should be closely monitored while taking combined oral contraceptives.

Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, the assessment of any irregular bleeding is only significant after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy. These may include diagnostic curettage.

In some women, withdrawal bleeding may not develop during the pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or if there are no consecutive withdrawal bleedings, pregnancy must be excluded before continuing to take combined oral contraceptives.

Medical examinations

Before starting the use of Yarina, a woman is recommended to undergo a thorough general medical and gynecological examination (including examination of the mammary glands and a cytological examination of cervical mucus), to exclude pregnancy. In addition, it is necessary to exclude violations of the blood coagulation system. A woman should be warned that products like Yarina do not protect against HIV infection (AIDS) and other sexually transmitted diseases!

In the case of long-term use of the product, it is necessary to carry out control examinations after 6 months.

Attention!
Before using the medication“Yarina (Yarina)” you need to consult a doctor.
The instructions are provided solely for familiarization with “Yarina (Yarina) ».