Universal reference book for medicines
Product name: YARINA ® PLUS (YARINA ® PLUS)

Active ingredient: drospirenone, ethinylestradiol, levomefolate calcium

Type: Monophasic oral contraceptive with antiandrogenic properties

Manufacturer: BAYER PHARMA (Germany)
Composition, form of production and packaging

Tablets, film-coated (active combined) orange, round, biconvex, on the same side with "Y +" embossing in a regular hexagon (21 pcs in a blister).

1 tab.

ethinyl estradiol (micronized, in the form of betadecase clathrate) 30 μg

drospirenone (micronized) 3 mg

calcium levometholate (micronized) 451 μg

Excipients: lactose monohydrate - 45.319 mg, microcrystalline cellulose - 24.8 mg, croscarmellose sodium - 3.2 mg, giprolose (5 cP) - 1.6 mg, magnesium stearate - 1.6 mg.

Composition of the coating: orange lacquer - 2 mg or (alternatively): hypromellose (5 cP) - 1.0112 mg, macrogol 6000 - 202.4 μg, talc - 202.4 μg, titanium dioxide - 527.1 μg, iron oxide oxide yellow - 44.6 μg, iron oxide red - 12.3 mcg.

The film-coated tablets (auxiliary vitamins) are light orange, round, biconvex, on the same side with "M +" embossed in the correct hexagon (7 pcs in the blister).

1 tab.

calcium levometholate (micronized) 451 μg

Excipients: lactose monohydrate - 48.349 mg, microcrystalline cellulose - 24.8 mg, croscarmellose sodium - 3.2 mg, giprolose (5 cP) - 1.6 mg, magnesium stearate - 1.6 mg.

The composition of the coating: lacquer light orange - 2 mg or (alternatively): hypromellose (5 cP) - 1.0112 mg, macrogol 6000 - 202.4 μg, talc - 202.4 μg, titanium dioxide - 572.3 μg, iron dye oxide yellow - 8.9 μg, dye iron oxide red - 2.8 mcg.

28 pcs.
(set: 21 active combination tablets and 7 auxiliary vitamin tablets) - packings of cellular contour (blisters) (1) complete with a block of self-adhesive labels for the appointment calendar - packs of cardboard.
28 pcs.
(set: 21 active combination tablets and 7 auxiliary vitamin tablets) - packings of cellular contour (blisters) (3) complete with a block of self-adhesive labels for registration of the appointment calendar - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Yarina® Plus is a low-dose monophasic combined estrogen-progestational medication that includes active tablets and supplementary tablets containing calcium levometholate.

The contraceptive effect of Yarin® Plus is mainly due to the suppression of ovulation and the increase in the viscosity of the secretion of the cervix.

In women taking combined oral contraceptives, the cycle becomes more regular, the soreness, intensity and duration of menstrual bleeding decrease, which reduces the risk of iron deficiency anemia.
There is also evidence of a reduced risk of endometrial and ovarian cancer.
Two post-registration studies were conducted to assess the risk of VTE using Yarin® (ethinyl estradiol / drospirenone at doses of 0.03 mg / 3 mg).
The first prospective observational study showed that the incidence of VTE in women using Yarin ® , with or without other VTE risk factors, was in the same range as for women using levonorgestrel-containing and other combined oral contraceptives. A second prospective, controlled study of databases comparing women using Yarin ®with women using other combined oral contraceptives also confirmed a similar incidence of VTE among all cohorts of women.
Drospirenone, contained in the drug Yarina® Plus, has antimineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can manifest itself in reducing body weight and reducing the likelihood of peripheral edema.
Drospirenone also has anti-androgenic activity and helps to reduce acne (acne), oiliness of the skin and hair (seborrhea). These features of drospirenone should be considered when choosing a contraceptive for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. By its characteristics, drospirenone is similar to the natural progesterone produced by the female body. When used correctly, Perl's index (the indicator reflecting the number of pregnancies in 100 women who use the contraceptive during the year) is less than 1. When missing tablets or improperly used, the Pearl index may increase.
The acid form of calcium levomefolata, in its structure is identical to natural L-5-methyltetrahydrofolate (L-5-methyl-THF), the main folate form contained in food.The average concentration of L-5-methyltetrahydrofolate in the blood plasma of people who do not consume food enriched with folic acid is about 15 nmol / l.Levomefolat, in contrast to folic acid, is a biologically active form of folate.
Due to this, it is digested better than folic acid. Levomefolat is indicated for meeting the increased need and providing the necessary folate content in the woman's body during pregnancy and during lactation. The introduction of calcium levomefolate in the oral contraceptive reduces the risk of neural tube defect in the fetus if the woman becomes pregnant immediately after the termination of contraception (or, in very rare cases, with oral contraception).
PHARMACOKINETICS

Drospirenone

Suction

After intake drospirenone quickly and almost completely absorbed.
After a single intake of C max drospirenone in blood plasma, equal to 38 ng / ml, is achieved after 1-2 hours. Food intake does not affect the bioavailability, which ranges from 76% to 85%.
Distribution

Drospirenone binds to serum albumin and does not bind to sex hormone binding globulin (SHBG) or corticosteroid-binding globulin (CSG).
Only 3-5% of the total concentration of the substance in the serum is present as a free hormone, 95-97% binds non-specifically to albumin. The increase in SHBG induced by ethinyl estradiol does not affect the binding of drospirenone to plasma proteins. The average apparent V d is 3.7-4.2 l / kg.
The concentration of SHBG does not affect the pharmacokinetics of drospirenone.
With daily administration of the drug inside, the concentration of drospirenone in the blood plasma rises by 2-3 times, C ss is achieved after 8 days of taking the drug.
Metabolism

After ingestion, drospirenone is intensively metabolized.
Most metabolites in the plasma are represented by acid forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the CYP3A4 isoenzyme. The clearance rate of drospirenone from the blood plasma is 1.2-1.5 ml / min / kg.
Excretion

The concentration of drospirenone in the blood plasma is reduced biphasic.
T 1/2 of drospirenone in the second phase is about 31 hours. Unchanged, drospirenone is excreted in trace amounts. Its metabolites are excreted through the digestive tract and kidneys in a ratio of approximately 1.2: 1.4. T 1/2 of the metabolites is approximately 40 hours.
Pharmacokinetics in specific patient groups

Studies have shown that the concentration of drospirenone in the blood plasma of women with mild renal dysfunction (KK 50-80 ml / min) when reaching an equilibrium state and in women with a preserved kidney function (KC more than 80 ml / min) are comparable.
Nevertheless, in women with moderate renal dysfunction (CK 30-50 ml / min), the average concentration of drospirenone in the blood plasma was 37% higher than in patients with preserved kidney function.There was no change in the concentration of potassium in blood plasma with drospirenone.
In women with moderate hepatic impairment (class B on the Child-Pugh scale), the AUC is comparable with that in healthy women with similar C max values ​​in the absorption and distribution phase.
T 1/2 of drospirenone in patients with moderate impairment of liver function was 1.8 times higher than in healthy volunteers with preserved liver function.
In patients with moderate impairment of liver function, a decrease in clearance of drospirenone by approximately 50% compared with women with preserved liver function was noted, and there was no difference in the potassium concentration in the blood plasma in the study groups.
In the detection of diabetes mellitus and concomitant use of spironolactone (both conditions are regarded as factors predisposing to the development of hyperkalemia), an increase in the concentration of potassium in the blood plasma is not established. The tolerability of drospirenone in women with mild and moderate impairment of liver function is good (class B on the Child-Pugh scale).
Ethinylestradiol

Suction

After ingestion, ethinylestradiol is rapidly and completely absorbed.
C max is achieved within 1-2 hours and is 100 pg / ml. During the absorption and "first passage" through the liver, ethinyl estradiol is metabolized, resulting in an average bioavailability of about 45%, with a high interindividual variability ranging from 20% to 65%. Simultaneous food intake in some cases is accompanied by a decrease in bioavailability of ethinyl estradiol by 25%.
Distribution

Ethinyl estradiol, non-specifically, but firmly binds to blood plasma albumin (about 98%) and induces an increase in the concentration in the plasma of SHBG.
The estimated V d is 5 l / kg.
The equilibrium concentration (C ss ) is reached in the second half of the intake cycle, when the concentration of ethinylestradiol in the blood plasma is increased by 40-110% compared to the single dose.

Metabolism

Ethinyl estradiol undergoes significant primary metabolism in the intestine and liver.
Ethinyl estradiol and its oxidative metabolites are primarily conjugated to glucuronides or sulfate. The metabolic clearance rate of ethinylestradiol is about 5 ml / min / kg.
Excretion

Reducing the concentration of ethinyl estradiol in blood plasma is biphasic;
the first phase is characterized by T 1/2 about 1 h, the second - 20 h. Ethinyl estradiol is excreted only in the form of metabolites by the kidneys and through the intestine in a ratio of 4: 6 with T 1/2 about 24 h.
Pharmacokinetics in specific patient groups

There is no evidence of the influence of ethnicity (the study was conducted on cohorts of women of the Caucasian and Japanese women) on the parameters of the pharmacokinetics of drospirenone and ethinylestradiol.

Calcium levometholate

Suction

After ingestion of calcium, levomefolate is rapidly absorbed and incorporated into the body folate pool.
After a single oral intake of calcium levomefolate at a dose of 451 μg in 0.5-1.5 hours, C max becomes 50 nmol / l above the initial concentration.
Distribution

The pharmacokinetics of folate has a two-phase character: a pool of folates with fast and slow metabolism is determined.
The pool with fast metabolism is probably the newly introduced folate, which is consistent with T 1/2 calcium of levomeolate, which is about 4-5 hours after its single oral ingestion at a dose of 451 μg. A pool with a slow metabolism reflects the conversion of polyglutamate folate, T 1/2 of which is about 100 days. Incoming folates and folates passing the intestinal-hepatic cycle ensure the maintenance of a constant concentration of L-5-methyl-THF in the body.
L-5-methyl-THF is the main form of folate existence in the body, in which they are delivered to the peripheral tissues to participate in cellular folate metabolism.

The equilibrium concentration (C ss ) of L-5-methyl-THF in blood plasma after ingestion of calcium levomefolate at a dose of 451 μg is achieved after 8-16 weeks and depends on its initial concentration.
In erythrocytes, C ss is reached at a later date because of the lifespan of red blood cells, which is about 120 days.
Metabolism

L-5-methyl-THF represents the main folate transportable form in blood plasma.
When 451 μg calcium of levomefolate and 400 μg of folic acid were compared, similar metabolic mechanisms were established for other significant folate. Coenzymes of folates are involved in 3 main conjugated cycle of metabolism in the cytoplasm of cells. These cycles are necessary for the synthesis of thymidine and purines, the precursors of DNA and RNA, and also for the synthesis of methionine from homocysteine ​​and the conversion of serine to glycine.
Excretion

L-5-methyl-THF is excreted by the kidneys in unchanged form and in the form of metabolites, and also through the intestine.

INDICATIONS

- Contraception, intended primarily for women with symptoms of hormone-dependent fluid retention in the body;

- Contraception and treatment of moderate form of acne (acne vulgaris);

- contraception in women with folate deficiency.

DOSING MODE

Tablets should be taken orally in the order given on the package, every day at the same time, without chewing, squeezed with a small amount of water.
Take 1 tablet / day continuously for 28 days. Receiving tablets from the next package should begin immediately after the completion of the receipt of the previous package.
Bleeding cancellation, as a rule, begins 2-3 days after the start of taking inactive tablets and may not be completed before taking the tablets from the next package.

The package of Yarin® Plus contains 1 or 3 blisters containing 21 active tablets and 7 auxiliary tablets (last row).
The packing also includes a reception calendar consisting of 7 self-adhesive strips with the names of the days of the week marked on them. It is necessary to choose a strip, where the first day of the week, in which the reception of tablets begins, is indicated first. For example, if the beginning of taking tablets falls on the environment, you should use a strip that starts with "Cp".
The strip should be pasted along the top of the package, so that the designation of the first day is above the tablet on which the arrow with the inscription "Start" is pointing.
Thus, it will be seen on which day of the week you should take each pill.
Initiation of Yarin® Plus

In the absence of taking any hormonal contraceptives in the previous month, taking the drug Yarina® Plus should be started on the 1st day of the menstrual cycle (ie, on the 1st day of menstrual bleeding).
The drug Yarina ® Plus starts to act immediately, so there is no need to use additional barrier methods of contraception.
It is allowed to start taking the drug on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use the barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from other combination contraceptives, the vaginal ring or transdermal patch, it is preferable to start taking Yarin® Plus on the day after taking the last active tablet from the previous package, but never in the next day after the usual 7-day break preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per package).
The preparation of Yarin ® Plus 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.
When switching from contraceptives containing only gestagens ("mini-pili", injections, implants), or from the intrauterine therapeutic system with the release of progestin, it is possible to switch from "mini-pili" to the drug Yarina® Plus any day (without interruption), with an implant or IUD with gestagen - the day it is removed, with an injection contraceptive - the day the next injection is to be made.
In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After abortion (including spontaneous) in the first trimester of pregnancy, you can start taking the drug immediately.
If this condition is met, the woman does not need additional contraception.
After giving birth (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy , it is recommended to start taking the drug no earlier than 21-28 days after giving birth (without breastfeeding) or abortion in the second trimester of pregnancy.
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 sexual intercourse occurred before taking Yarin ® Plus, it is necessary to exclude pregnancy or wait for the first menstruation.
Acceptance of missed tablets

Skipping inactive tablets can be ignored.
Nevertheless, they should be thrown away, so as not to accidentally prolong the period of taking inactive tablets. The following recommendations apply only to the omission of active tablets:
If the delay in taking any active tablet is less than 12 hours , the contraceptive protection of the drug Yarin® Plus is preserved.
It is necessary to take the missed tablet as soon as possible, and take the following tablets at the usual time.
If the delay in taking any active tablet is more than 12 hours , the contraceptive protection can be reduced.
The more consecutive pills are missed and the closer the pass to the beginning of the reception or the end of the reception, the greater the probability of pregnancy.
In this case, you can follow the following two basic rules:

1. The drug should never be interrupted for more than 7 days.

2. To achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous intake of active tablets are required.

Accordingly, if the delay in reception of active tablets was more than 12 hours (the interval from the receipt of the last pill more than 36 hours), we can recommend the following:
First week dosing
missed tablet should be taken as soon as possible, once a woman to remember about it (even if this means taking two tablets at the same time). The next tablet should be taken at the usual time. In addition, during the next 7 days is necessary to additionally use a barrier method of contraception (e.g., condom). If intercourse took place during the 7 days before skipping pills, you must take into account the chance of pregnancy.
The second week of dosing
It is necessary to take the missed pill as soon as possible, as soon as she remembers about it (even if this means taking two tablets at the same time). The next tablet should be taken at the usual time. Subject to the reception mode of tablets for 7 days preceding the first missed tablet, there is no need to use additional contraceptive measures. Otherwise, as well as skipping of two or more tablets, it is necessary to additionally use a barrier method of contraception for 7 days.
Third week dosing
risk of pregnancy is increased due to the approaching reception phase inactive tablets. It is necessary to strictly adhere to one of the following options:
- if during the 7 days preceding the first missed tablet, all the pills are taken correctly, use additional contraceptive method is not necessary. When receiving the missing tablets should be guided paragraphs 1 or 2;
- if, within 7 days prior to the first missed tablet, tablets were made properly, then during the next 7 days is necessary to additionally use a barrier method of contraception (e.g., condoms) and in this case should be guided paragraph 1 for receiving the missed pills.
1. It is necessary to take the missed pill as soon as possible, as soon as she remembers about it (even if this means taking two tablets at the same time). The next pill at the usual time taken until no orange (active) tablets in a package. Seven Light Orange (ancillary) tablets should be discarded and immediately start receiving the orange (active) tablets from a new package. Until no orange (active) tablet of the second package, withdrawal bleeding is unlikely, however, may experience spotting and / or breakthrough bleeding.
2. Interrupt reception orange (active) tablets from the current package, and then make a break for 7 days or less (including the days of skipping pills), then should start taking the drug from a new package.
If the woman misses orange (active) and tablets during the reception of a light orange (auxiliary) tablets withdrawal bleeding has not come, it is necessary to verify the absence of pregnancy.
References in the gastro-intestinal disorders
In severe gastrointestinal disorders of absorption may not be complete, however be additionally use a barrier method of contraception.
If vomiting or diarrhea develops within 3-4 h after administration of active tablets to be guided to the recommendations when skipping tablets. If a woman does not want to change their usual dosage regimen and the postponement of the beginning of menstruation to another day of the week, more active pill should be taken from a new package.
Delaying the start of bleeding menstrualnopodobnoe
In order to delay the onset of bleeding menstrualnopodobnoe skip reception 7 inactive (light orange) tablets from the current packaging and begin receiving active (orange) of tablets of the following formulation package Yaryna ® Plus. If a woman has taken all the active tablets in the second package, should be taken as 7 inactive (light orange) tablets and immediately start taking pills from a new package. Thus, the cycle may be extended as desired for any period up to 3 weeks, including until all of the active tablets in the second package will be accepted.
If you want to menstrualnopodobnoe started bleeding earlier, you should stop taking the active (orange) tablets of the second pack, throw it away and take a break from taking the drug for no more than 7 days, and then start taking pills from a new package. In this case menstrualnopodobnoe bleeding begins after about 2-3 days after the last active (orange) from the second tablet packaging. During dosing Yaryna ® Plus the second pack may occur spotting and / or breakthrough bleeding.
Changing the date of the beginning menstrualnopodobnoe bleeding
If a woman takes pills in accordance with the recommendations menstrualnopodobnye bleeding will advance about the same day every 4 weeks.
If a woman wants to change the day of the menstrualnopodobnoe bleeding should stop taking the inactive (light orange) tablets as to how many days you want to change the start menstrualnopodobnoe bleeding.
For example, if the cycle usually starts on a Friday and in future she wants it began on Tuesday (3 days earlier), tablet-taking from the next pack should be started 3 days earlier than usual, ie, do not take the last 3 inactive (light orange) tablets from the current package and start taking the pill from the next pack. The smaller inactive (light orange) pill a woman takes, the higher the probability that menstrualnopodobnoe bleeding does not occur.
During reception Yaryna preparation ®Plus from the following packages can be marked spotting and / or breakthrough bleeding.
Discontinuation of the drug Yasmin ® Plus
You can stop taking the drug Yasmin ® Plus at any time. If pregnancy is not planned, it is necessary to take care of other contraceptive methods. If you are planning a pregnancy, you should simply stop taking the drug.
Specific categories of patients
The efficacy and safety of the drug Yasmin ® Plus been studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in the post-pubertal age of 18 are similar to those in women after 18 years. Use of the drug contraindicated until a menstrual cycle.
The drug is not shown after menopause .
The drug is contraindicated for use in women with severe hepatic impairment .
The drug is contraindicated for use in women with severe renal impairment, and acute renal failure.
SIDE EFFECT

Data on the frequency of occurrence of adverse reactions have been reported in clinical trials of the drug Yaryna ® involving 2614 patients are given below. Adverse reactions described for the preparation Yaryna ® , can also be attributed to the drug Yaryna ® Plus (the difference lies only in the presence of calcium levomefolata which is stabilized natural folates salt contained in food).
Within each group, selected depending on the frequency of occurrence of adverse reactions are presented in order of decreasing severity. According to the frequency they are divided as follows: Part (? 1/100 and <1/10), uncommon and rarely (1/10 000 and <1/1000?) (1/1000 and <1/100?). For additional adverse reactions identified only during post marketing studies, and for which the evaluation was not possible to hold the frequency of occurrence, indicated as "frequency is unknown."
Immune system: the frequency is unknown - a hypersensitivity reaction.
On the part of metabolism and nutrition: rarely - changes in body weight, fluid retention.
Mental disorders:often - depressed mood; infrequently - changes in libido; the frequency is unknown - mood swings.
From the nervous system: often - headache, migraine.
From a sight organ: the frequency is unknown - contact lens intolerance.
On the part of the organ of hearing: rarely - Gipoakuzija.
Cardio-vascular system: Infrequent - increased blood pressure, decreased blood pressure; rarely - thromboembolism.
The respiratory system: rarely - asthma.
On the part of the digestive tract: often - nausea; rarely - vomiting; the frequency is unknown - abdominal pain, diarrhea.
Skin and subcutaneous tissue disorders:infrequently - acne, eczema, pruritus, alopecia; the frequency is unknown - rash, urticaria, erythema nodosum, erythema multiforme.
On the part of genitals and mammary gland: often - pain in the breast (including breast engorgement), breast tenderness, whites (including vaginal discharge), vulvovaginal candidiasis, lack menstrualnopodobnoe bleeding, painful menstrualnopodobnye bleeding, abundant menstrualnopodobnye bleeding scarce menstrualnopodobnye allocation lack menstrualnopodobnoe bleeding, bleeding acyclic (typically decrease with long-term use of the drug); infrequently - vaginitis; rarely - discharge from the breasts; frequency is unknown - breast enlargement.
Adverse events were classified using MedDRA dictionary. Synonyms or related to the status of adverse reactions are not listed, but they should also be taken into account.
Reported the following serious adverse reactions in women using combined oral contraceptives:
- Venous thromboembolic disorders;
- arterial thromboembolic disorders;
- cerebrovascular disorders;
- increase in blood pressure;
- hyperkalemia (in patients with impaired renal function and potassium concentration in blood serum, exceeding reference values before the drug);
- hypertriglyceridemia;
- changes in glucose tolerance or effect on peripheral insulin resistance;
- liver tumors (benign or malignant);
- a violation of the functional parameters of the liver;
- chloasma;
- in women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema;
- onset or worsening of conditions for which the connection with the use of combined oral contraceptives is not uncontested: jaundice and / or pruritus related to cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham's chorea; herpes gestationis; hearing loss associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer.
The frequency of diagnosis of breast cancer in women who use oral contraceptives, increased only slightly. Breast cancer is rare in women under the age of 40 years, exceeding the frequency slightly relative to the total risk of breast cancer. Causation of breast cancer with the use of combined oral contraceptives has not been established.
CONTRAINDICATIONS

Preparation Yaryna ® Plus contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time in patients receiving the drug should be lifted immediately:
- thrombosis (arterial and venous) and thromboembolism present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident);
- state prior thrombosis (including transient ischemic attack, angina) currently or history;
- identifying acquired or inherited predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein deficit S, protein C deficiency, hyperhomocysteinemia, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
- the presence of high-risk venous or arterial thrombosis;
- Migraine with focal neurological symptoms in the present or in history;
- pancreatitis with severe hypertriglyceridemia at present or in history;
- diabetes mellitus with vascular complications;
- hepatic failure, and severe liver diseases (liver samples before normalization);
- severe and / or acute renal failure;
- liver tumors (benign or malignant) now or in the anamnesis;
- identified hormone malignancies (including genital or mammary glands) or suspicion of them;
- vaginal bleeding of unknown origin;
- pregnancy or suspected it;
- the period of breastfeeding;

- a rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the lactose content);
- hypersensitivity or intolerance to any of the components of the drug Yaryna ® Plus.
With caution

It is necessary to evaluate the potential risks and expected benefits of the drug Yasmin ® Plus in each individual case in the presence of the following diseases / conditions and risk factors:
- thrombosis risk factors for thromboembolism: smoking, obesity, dislipoproteinemia controlled hypertension, migraine without focal neurological symptoms, uncomplicated valvular disease, a genetic predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age someone from the next of kin);
- other diseases in which the may occur peripheral circulation disorders: diabetes without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
- hereditary angioedema;

- hypertriglyceridemia;
- liver disease not related to the contraindications;
- diseases caused or aggravated by the first time during pregnancy, or on the background of the previous use of sex hormones (eg, jaundice and / or pruritus related to cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes gestationis, Sydenham's chorea);
- post-partum period (not earlier than 21-28 days after birth in the absence of breastfeeding).
PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy.
If a pregnancy is detected during reception Yaryna preparation ® Plus, the drug should be immediately canceled. Data on the results of the drug Yasmin ® Plus during pregnancy are limited and do not allow any conclusions about the negative effects of the drug on pregnancy, health of the fetus and newborn child. At the same time, extensive epidemiological studies have revealed no increased risk of defects in children born to women taking combined oral contraceptives prior to pregnancy or teratogenic effects in cases of using combined oral contraceptives inadvertently in early pregnancy. Specific epidemiological studies on drug Yasmin ® Plus have been conducted.
The drug is contraindicated during lactation. The drug may reduce the amount of breast milk and change its composition, so use of the drug contraindicated until weaning. A small amount of sex hormones and / or metabolites thereof can vyvo
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