How to take jess for treatment. Instructions for use Jess: method and dosage

Acne in adolescence is the most common picture. And to explain their appearance is very simple - there is a complete hormonal transformation of the body. But at an age that is no longer considered adolescence, acne can also appear due to hormonal imbalances.

There is only one way to treat such acne - with the help of hormonal drugs. They should also include drug Jess, a female contraceptive that not only helps protect against unwanted pregnancy, but also cleanses the skin and makes it smooth and tender.

So is jess suitable for treating acne, and how should this contraceptive be taken?

The action of all birth control pills is based on suppressing ovulation, that is, preventing the egg from maturing and leaving the ovary.

Also, to prevent conception, they make the secret of the cervical canal (the vestibule of the uterus) very viscous. It is quite difficult for spermatozoa to get through it. This is the contraceptive effect of these drugs.

But there are contraceptives that not only reduce pregnancy to a minimum probability, but also lower the amount of male sex hormones - testosterone. Yes, they are also produced in the female body.

It is testosterone that affects the activity of the sebaceous glands, which causes acne.

Yarina, zhanin and some others also belong to this class.

Do jess pills treat acne

How effective are jess tablets in the treatment of acne? The drug is prescribed if a woman or girl - a teenager regularly has sex. After all, the main function of this tool is to prevent pregnancy.

If you had seen my face 5 years ago, you would have been horrified! Pimples were very different - large and small, they were everywhere. I was ashamed to go outside. I was treated with affordable folk methods - chamomile and celandine. They didn't help as much as I would like.

I had complexes, my mother tried to help me, but acne did not want to go away. I seem to have come to terms with my problem. And even learned to live with acne.

But one day a friend of my mother came to visit us. And when I saw the terrible state of my face, I was very surprised that we had not yet bought an amazing remedy. She gave us its name - and that's how I found out about Aknelocin. read

Stands in front of a modern woman. Many of the fair sex choose hormonal drugs that have many benefits. Among other oral contraceptives, Jess is also popular. Gynecologists recommend it to their patients.

Features and benefits of birth control pills Jess

Jess is a combined hormonal contraceptive. Due to the fact that the composition includes drospirenone, it has antiandrogenic and antimineralcorticoid effects.

In women who take Jess contraceptive pills, the menstrual cycle becomes regular, the pain during menstruation disappears or becomes less pronounced, and there is a decrease in the abundance of blood discharge.

Thanks to drospirenone, when taking the drug, body weight does not increase, and edema does not occur. In addition, the substance has a positive effect on the premenstrual cycle. Pain, irritability and other signs of PMS go away. Drospirenone also has an antiandrogenic effect, and therefore, when taking the drug, acne and pimples on the face and body disappear.

The main purpose of Jess is contraception. But it is also prescribed in the treatment of acne or severe PMS. It is not surprising that the majority of reviews of Jess contraceptive pills are positive. Taking the drug allows you to perfectly protect yourself from, maintain a slim figure and improve skin condition.

Birth control pills Jess: contraindications

Despite the fact that Jess plus contraceptive pills have a positive effect on the body, they also have contraindications for taking. You should not take the drug if you:

• thrombosis of any kind;
• diabetes mellitus with vascular complications;
• kidney failure;
• liver failure or liver tumor;
• pancreatitis;
• adrenal insufficiency.

You should also refuse to take the drug if you:

• pregnant;
• breastfeed your baby;
• have hypersensitivity to one of the components of the drug.

How to take birth control pills Jess: instructions for use

Jess contraceptive pills are available in blister packs of 28 pieces. The package contains 24 active tablets and 4 inactive. For the convenience of women, there is a self-adhesive calendar in the package, in which you can mark when the pill is drunk. According to the instructions for Jess' birth control pills, you need to drink them regularly, without taking a break between packs. It is advisable to take the tablets every day at the same time.

How to take a contraceptive Jess for the first time?

If you have not previously taken any hormonal contraceptives, then the first Jess tablet should be drunk on the first day of menstruation. You can also start taking it on another day of menstruation, in which case the first 7 days must be additionally protected by barrier contraceptives,.

How to switch from hormonal contraceptives to Jess contraceptive pills?

If you have previously taken other combinations, then you can start drinking Jess the next day. It is important not to take breaks between drugs. Additional contraception in this case is not required. But if you took mini-pills, then the first 7 days after switching to Jess, additionally protect yourself with condoms.

What to do if Jess contraceptive pills are missed?

If for some reason you missed taking the drug, then immediately drink it as soon as you remember. If you follow the instructions for taking contraceptive pills Jess, then the contraceptive must be taken regardless of the time of taking the next pill. Maybe even two at once, if it's time.

If you missed a pill, you should know what to do:

1. If 36 hours have not passed since the last dose, then it is enough to immediately take a pill, and then take the drug at the set time.
2. If more than 36 hours have passed, then you need not only to drink the missed pill, but also for 7 days after that, additionally protect yourself with barrier methods.

Keep in mind that the risk of getting pregnant in the case of a missed pill increases regardless of whether there was sexual intercourse before or after.

Contraceptive pills Jess: reviews of doctors and patients

On many sites on the Internet, you can easily find reviews of Jess contraceptives. Most women respond positively to the drug. While taking Jess contraceptive pills, disruptions in the menstrual cycle disappear, the skin becomes clearer. But most importantly, women note that the drug is highly effective and does not contribute to weight gain, like some hormonal contraceptives.

Indications for the appointment of the drug "Jess" are: contraception, treatment of severe premenstrual syndrome, acne therapy. "Jess" is taken 1 time per day, preferably at the same time, in accordance with the order indicated on the package. There should be no break between packs. Withdrawal bleeding begins 2-3 days after taking the inactive tablet and may not end before the next pack is used.

The drug is started on the 1st day of the cycle (on the 1st day of bleeding). It is allowed to start taking it on the 2nd-5th day of the cycle, in this case it is necessary to additionally use barrier contraception during the 1st week of using the drug. In case of switching from other oral combined contraceptive preparations, it is recommended to start taking "Jess" the next day after the last active tablet was drunk from the previous package, but in no case later than the next day after a 7-day break (for contraceptives containing 21 tab.) or after taking the last inactive tablet (for contraceptives containing 28 tab.).

When switching from preparations containing gestagens (the so-called "mini-pills"), "Jess" can be taken on any day (without a break), barrier contraception must be used for a week. The drug is started on the day of removal of the progestogen-releasing intrauterine contraceptive, while barrier contraception should be used during the 1st week of taking the tablets.

Side effects, contraindications to the use of "Jess"

When taking Jess, the following side effects may be observed: irregular bleeding, abdominal pain, vomiting, nausea, diarrhea, headache, syndrome, decreased mood, nervousness, migraine, decreased or increased libido. There may be: pain and / or engorgement of the mammary glands, vaginal candidiasis, discharge from the mammary glands, vaginal discharge, acne, rash, urticaria, erythema. Sometimes body weight increases or decreases, hypersensitivity reactions appear. In rare cases, thrombosis and thromboembolism develop. In women with hereditary angioedema, taking the drug may aggravate its symptoms.

"Jess" is contraindicated in arterial and venous thrombosis, thromboembolism, cerebrovascular disorders, migraine, diabetes mellitus, cardiac arrhythmias, diseases of the cerebral vessels or coronary arteries, uncontrolled arterial hypertension. The drug should not be used for pancreatitis, liver failure, severe liver pathologies, hormone-dependent malignant tumors, vaginal bleeding of unknown origin, during pregnancy and lactation.

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

Olga asks:

Hello! I am taking Jess for the first time, can I start taking Jess from the 7th or 8th day of the menstrual cycle or wait for the next one. monthly?

Olga asks:

Thank you for your answer! Well, I started taking jess on the first day of July 18, my period lasted 2 days, I didn’t feel sick. everything goes away. On July 21, I began to have spotting brown discharge. The question is: is it normal that menstruation lasted 2 days (and it went up to 5 days) and what I described, and when can I not use other contraceptives? and is it still possible drink ketorol for stomach pain? in advance Thank you very much!!!

The use of any painkillers in conjunction with Jess is undesirable, as they can reduce the contraceptive activity of the drug. There is nothing to worry about in shortening the duration of menstrual bleeding - this is the normal effect of a hormone-containing drug on the cycle. Full contraceptive activity when using Jess begins with the use of the seventh active tablet, before this period, additional contraceptives must be used.

Olga asks:

Thanks for the consultation!:)

We are always happy to help you.

Arina asks:

Hello, I'm 24, I've been taking Jess for 3 months, the intake is accompanied by nausea and migraines ... very frequent mood swings, feeling constantly PMS ... I haven't taken any pills before .... so I'm a little shocked by this effect ... but this not so important. for all the time I took the pills, I never had a period ... 2 days it will help and that's it ... I'm starting to get scared ...

In this case, it is recommended to consult with a gynecologist to decide whether to cancel the drug or replace it with another contraceptive drug. Read more about this drug in the article: "Jess"

Milan asks:

hello, I'm 15 years old, the gynecologist prescribed me Jess for acne. Hormone levels are good. Will it help me?

It is recommended to consult a dermatologist and take a scraping from the affected skin surface and exclude the presence of demodicosis. In the event that the level of hormones is within the normal range, there is no need to take hormonal drugs at puberty. Only after receiving the results of the examination, the dermatologist will make an accurate diagnosis and, if necessary, prescribe adequate treatment and decide on the need to use a hormonal drug. Read more about demodicosis by clicking on the link: Demodicosis.

Anna asks:

I drink jess regularly, as expected. Is there a risk of getting pregnant while taking inactive pills before menstruation begins? Or can you safely have unprotected intercourse?

In the event that you regularly took Jess during the entire menstrual cycle, did not take medications or substances that could reduce the activity of Jess (antibiotics, sorbents, alcohol), the contraceptive activity of Jess during the break will not decrease. The probability of pregnancy during the period of use of inactive tablets, subject to the above conditions, does not exceed that during the period of use of active Jess tablets. You can read more about Jess in our section of the same name: Jess.

Olga asks:

There are 4 empty tablets in the package of Jess, intended for the days of menstruation. If you need to drink the first pill on the first day of menstruation, then it will turn out that empty pills will be drunk on ordinary days. Should menstruation be rebuilt on these days? Is it worth taking protection on the days of taking empty pills? Thanks in advance for your reply!

Anna asks:

Good afternoon, I'm going to switch from Yarina (tormented by side effects) to Jess. Please explain how to do it right? There are 21 tablets in Yarina's package, after the last tablet I take I take a break for 7 days, then I start the next package. Jess has 28 tablets, when should I start drinking them, the day after the last Yarina (then there will be no menstruation this month), or after 7 days? And, yet, when I completely switch to Jess, do I need to drink them without interruption (I finished one package, started the next one the next day)? Thanks in advance for your reply.

In this situation, in order for the transition to occur more smoothly, you need to do the following. After applying the last (21st) tablet of Yarina, you should immediately (without a seven-day break) start using Jess. Jess will need to be taken completely (21 active tablets and 4 inactive tablets), after which the application of the next pack begins. In the event that you decide to take a break after using Yarina, you will need to start using Jess no later than the second day of menstrual bleeding, in addition, during the first ten days of using Jess, you will need to use additional contraception (condom). You can read more about the rules for using the contraceptive drug Jess in our thematic section of the same name: Jess.

Anna comments:

Good morning. Please specify, if I start drinking Jess immediately after the last pill of Yarina, will there be no menstruation this month? And, the second question, you write: "Jess will need to be taken completely (21 active tablets and 4 inactive tablets), after which the next pack begins" - and there are 28 tablets in a pack of Jess. Thanks in advance for your reply

On the first point: Yes, in this menstrual cycle, there will be no menstruation, it will have to begin with the use of inactive Jess tablets.
On the second point: This means the use of all Jess tablets (both active (there are 24 of them) and inactive (there are 4 of them)). When using Jess, you will need to carefully monitor the regularity of the drug and try to take the contraceptive at the same time. Even a few hours late can lead to breakthrough bleeding (withdrawal bleeding).

Sasha asks:

Hello!!! Tell me please, can I start taking Jess from the second day of menstruation ???

Katya asks:

Good afternoon
Now, if my period only lasts 3-4 days, on the fourth day, is it possible to start drinking jess?

It is recommended to start taking Jess contraceptive pills from the first day of menstrual bleeding - in this case, additional barrier methods of contraception are not required. In the event that you start taking pills from the 2nd-5th day (this is also allowed by the instructions for use), you need to use additional barrier methods of contraception during the first 7 days of taking them to avoid unwanted pregnancy. You can get more information about the hormonal contraceptive Jess, indications and contraindications for its use, rules and features of admission in the thematic section of our website: Jess

Victoria asks:

Should I take "Jess" during my period?

Hormonal contraceptive Jess should be taken from the first day of menstruation and further according to the scheme, regardless of the time of onset and end of intermenstrual bleeding. Read more about the rules and features of taking this drug in the section of our website: Jess

Irina asks:

Hello! I bought Jess 28 tablets and found out that there are 21 tablets. What is the difference? Which ones should you buy? As I understand it, if I have a cycle of 21 days, do I need 21 tablets? Then what should I do if I have already started taking from the package where there are 28 tablets. Please explain to an ancient man)))

Jess pack contains 28 tablets, 24 of them are active and 4 tablets are inactive. Tablets should be taken strictly in order for 28 days, after which, without interruption, immediately start taking the tablets from the next package. Jess with the number of tablets 21 is not available, so follow the rules of administration described above. Jess tablets should be started on the first day of menstrual bleeding and then 1 per day at the same time until the end of the package. You can find out more detailed information on this issue in the relevant section of our website by clicking on the following link: Jess

Irina asks:

Hello! Started taking Jess after 3 patches. Menstruation was supposed to start last Thursday, and today is already Sat. They are not here. What to do?

In this case, it is necessary to exclude the possibility of pregnancy, so I recommend that you do a blood test for hCG. You can get more detailed information on the question you are interested in in the thematic section of our website by clicking on the following link: Analysis for hCG

Alesia asks:

Good afternoon. I started taking Jess from the 5th day of the menstrual cycle. In this case, is it also necessary to take all 28 before proceeding to the next package?

Regardless of when Jess was started, the pills should be taken strictly according to the scheme: active, then inactive, and after that you should immediately start taking pills from the next package. Read more on this issue in the thematic series of articles on our website by clicking on the link: Jess

Tatyana asks:

Good afternoon. Please tell me. In early December, I started taking Klaira, my period started at 21 tablets and did not end until I started a new pack. Although my normal cycle: 4 days go. On the second pack, my period came for 17 tablets. ?Or should I switch to other pills? And how do I do that? Thanks in advance.

In the first months of taking hormonal contraceptives, this is possible, so do not worry, I recommend that you continue taking Klaira according to the scheme. You can get more detailed information on the question you are interested in in the relevant section of our website by clicking on the following link: Hormonal contraceptives

Olga asks:

Hello! I started taking Jess Plus tablets from the third day of my period. The instructions indicate: in this case, be protected by the barrier method during the first 7 days of taking the tablets. I took 7 pills at the same time. 2 hours after taking the seventh pill, there was unprotected intercourse. What is the chance of pregnancy?

In this situation, given the regular use of the hormonal contraceptive Jess according to the instructions, the risk of unwanted pregnancy is practically eliminated, so there is no cause for concern. You can get additional information on your question in the relevant section of our website by clicking on the following link: Hormonal contraceptives

Lara asks:

Hello, please tell me, I am now starting to drink the first pack of jess, today is Friday, so should I start with the first pill or the fifth? The instructions say take a pill that is marked with the corresponding day of the week, does this mean that I need to take the fifth in a row?

The first day of taking the hormonal contraceptive Jess is considered the first day of menstruation - this number, no matter what day of the week it falls on, will be considered the first day of admission for you. Then you take all the pills strictly according to the scheme - after finishing one package, immediately go to the next one and take all the pills in order, from the first, etc. You can get more detailed information on the question you are interested in in the relevant section of our website by clicking on the following link: Jess. You can also get additional information in the following section of our website: Hormonal contraceptives

Botagoz asks:

Hello! I am 22 years old! Tell me, please! then from June 15 to June 20, and I started taking a pill on July 1 every day at 9 pm, at the beginning there were headaches, weakness and mood swings and severe nausea, then my period started on July 14 and still does not end then I 3 ( July 10, 11, 12) I missed the pills for a day because I had food poisoning, then how can I take the pills correctly? Why doesn't my period stop? Looking forward to your reply, thanks in advance!

In this situation, you need to continue taking the Jess pills according to the following scheme: if the gap is more than 2 days, then you should not take the pills for 4 days in total, and then start taking the pills regularly from the new package, regardless of the onset or end of menstrual bleeding . You can get more detailed information on the issue that interests you in the thematic section of our website by clicking on the following link: Jess. You can also get additional information in the following section of our website: Hormonal contraceptives

Sasha asks:

Good afternoon.
I am 22 years old. I'm finishing up taking 1 pack of Jess Plus. During the whole cycle spotting bleeding. The instructions say that this is normal during the adaptation period and I don’t particularly panic. But it still feels bad.
On the advice of a gynecologist, I still used barrier contraceptives for the first month. From the second pack of tablets I plan to stop using them. The question is: if the bleeding persists, can this somehow affect the effectiveness of the pills?

Indeed, in the first months of taking hormonal contraceptives, including Jess, spotting is possible, but after the first seven days of taking them, they do not affect the contraceptive effect, that is, additional barrier methods of contraception are required only during the first 7 days of taking in the first month.

You can get more detailed information on the issue you are interested in in the thematic section of our website by clicking on the following link: Jess - a completely new contraceptive regimen and in a series of articles: Contraception and contraceptives. You can also get additional information in the following section of our website: Hormonal contraceptives

Monophasic oral contraceptive with antiandrogenic properties

Active ingredients

Ethinylestradiol (ethinylestradiol)
- drospirenone (drospirenone)

Release form, composition and packaging

(active) light pink, round, biconvex, engraved with the letters "DS" in a regular hexagon on one side; at the break - a core from white to almost white and a light pink shell (24 pieces in a blister or 30 pieces in a flex cartridge).

Excipients: lactose monohydrate - 48.18 mg, corn starch - 28 mg, magnesium stearate - 0.8 mg.

Shell composition: hypromellose - 1.5168 mg, talc - 0.3036 mg, titanium dioxide - 1.1748 mg, iron dye red oxide - 0.0048 mg.

Film-coated tablets (placebo) white, round, biconvex, engraved with the letters "DP" in a regular hexagon on one side; at the break - a core from white to almost white and a white shell (4 pieces in a blister).

Excipients: lactose monohydrate - 23.205 mg, microcrystalline cellulose - 54.21 mg, magnesium stearate - 0.585 mg.

Shell composition: hypromellose - 1.0112 mg, talc - 0.2024 mg, titanium dioxide - 0.7864 mg.

28 pcs. (24 active tablets and 4 placebo tablets) - blisters (1) - folding books (1) complete with a self-adhesive appointment calendar - film.
28 pcs. (24 active tablets and 4 placebo tablets) - blisters (1) - folding books (3) complete with a self-adhesive appointment calendar - film.
30 pcs. (30 active tablets) - flex cartridges (1) - blisters (1) - cardboard packs.
30 pcs. (30 active tablets) - flex cartridges (1) - blisters (3) - cardboard packs.
30 pcs. (30 active tablets) - flex-cartridges (1) - blisters (1) - individual cardboard packs (1) complete with Clyk dispenser - cardboard packs.

pharmachologic effect

Jess is a combined hormonal contraceptive with antimineralocorticoid and antiandrogenic effects.

The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which include the suppression of ovulation and changes in the properties of the cervical secretion, as a result of which it becomes less permeable to spermatozoa.

When used correctly, the Pearl Index (the number of pregnancies per 100 women per year) is less than 1. If pills are missed or used incorrectly, the Pearl Index may increase.

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful periods are less common, bleeding intensity decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of combined oral contraceptives reduces the risk of developing endometrial cancer and ovarian cancer.

Drospirenone contained in Jess has an antimineralocorticoid effect. Prevents weight gain and the appearance of edema associated with estrogen-induced fluid retention, which ensures good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). The clinical efficacy of the drug Jess in alleviating the symptoms of severe PMS, such as severe psychoemotional disorders, breast engorgement, headache, muscle and joint pain, weight gain and other symptoms associated with the menstrual cycle, has been shown.

Drospirenone also has antiandrogenic activity and helps reduce acne, oily skin and hair. This action of drospirenone is similar to the action of the natural one produced by the body.

Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone.

In combination with ethinylestradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in HDL.

The drug Jess can be used both in the usual mode (reception mode "24 + 4": for 24 days taking active tablets, then for 4 days - taking inactive tablets), and in a "flexible" mode.

The adaptable extended ("flexible") regimen of Jess is based on the previously approved "24 + 4" regimen and consists in the fact that the active tablets of the drug can be taken daily continuously for up to 120 days. Thus, the continuous period of taking active tablets can be 24-120 days, and the duration of the break in taking the tablets should not exceed 4 days. A "flexible" mode of administration is possible only if there is a dispenser Click (Clyk) and flex-cartridges that allow you to comply with the regimen of taking the drug.

The results of a multicenter comparative open randomized study in parallel groups showed that the "flexible" regimen of taking Jess, aimed at achieving the maximum duration of intervals without bleeding up to 120 days, reduced the total number of days of menstruation per year from 66 ("24 + 4" ) up to 41 days ("flexible" regimen).

Pharmacokinetics

Drospirenone

Suction

When administered orally, drospirenone is rapidly and almost completely absorbed. After a single oral administration, Cmax of drospirenone in serum is reached after about 1-2 hours and is about 38 ng / ml. Bioavailability - 76-85%. Compared with the intake of the substance on an empty stomach, food intake does not affect the bioavailability of drospirenone.

Distribution

After oral administration, a two-phase decrease in the level of drospirenone in serum is observed, with T 1/2, respectively, 1.6 ± 0.7 h and 27 ± 7.5 h. Drospirenone binds to serum and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CSG). Only 3-5% of the total serum concentration of the substance is present as a free hormone. The increase in SHBG induced by ethinylestradiol does not affect protein binding of drospirenone. The average apparent V d is 3.7±1.2 l/kg.

The equilibrium concentration during cyclic administration (C ss max) of drospirenone in serum is reached between the 7th and 14th day of treatment and is approximately 70 ng / ml. There was an increase in the concentration of drospirenone in serum by about 2-3 times (due to cumulation), which was determined by the ratio of T 1/2 in the terminal phase and the dosing interval. A further increase in the serum concentration of drospirenone is noted between 1 and 6 cycles of administration, after which no increase in concentration is observed.

Metabolism

Following oral administration, drospirenone is extensively metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the cytochrome P450 isoenzyme CYP3A4.

breeding

The rate of metabolic clearance of drospirenone in serum is 1.5±0.2 ml/min/kg. Unchanged drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted through the intestines and by the kidneys in a ratio of approximately 1.2:1.4. T 1/2 is approximately 40 hours.

Pharmacokinetics in special clinical situations

Serum C ss of drospirenone in women with mild renal insufficiency (CC 50-80 ml / min) were comparable to those in women with normal renal function (CC > 80 ml / min). In women with moderate renal insufficiency (CC 30-50 ml / min), the serum level of drospirenone was on average 37% higher than in women with normal renal function. Treatment with drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on serum potassium concentration. Pharmacokinetics in severe renal failure has not been studied.

Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment has not been studied.

Ethinylestradiol

Suction

After oral administration, ethinylestradiol is rapidly and completely absorbed. C max after a single oral intake is achieved after 1-2 hours and is about 88-100 pg / ml. Absolute bioavailability as a result of first pass conjugation and first pass metabolism through the liver is approximately 60%. Concomitant food intake reduces the bioavailability of ethinylestradiol in approximately 25% of those examined, while no such changes were noted in other participants in the study.

Distribution

The concentration of ethinylestradiol in serum decreases biphasically, T 1/2 of the terminal phase is 24 hours. Ethinylestradiol is largely, but not specifically, bound to serum albumin (approximately 98.5%) and causes an increase in serum SHBG concentrations. The apparent V d is about 5 l/kg. The equilibrium concentration (C ss) is reached during the second half of the treatment cycle, and the serum level of ethinylestradiol increases by about 1.5-2.3 times.

Metabolism

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

breeding

Ethinylestradiol is practically not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T 1/2 metabolites - 24 hours.

Indications

- contraception;

- contraception and treatment of moderate acne (acne vulgaris);

- contraception and treatment of severe premenstrual syndrome.

Contraindications

The drug Jess is contraindicated in the presence of any of the conditions listed below; if any of these conditions / diseases develop for the first time while taking the drug, the drug should be immediately discontinued:

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders;

- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

- Identified acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus);

- the presence of a high risk of venous or arterial thrombosis;

- migraine with focal neurological symptoms at present or in history;

- diabetes mellitus with vascular complications;

- liver failure and severe liver disease (until liver tests return to normal);

- liver tumors (benign or malignant) at present or in history;

- severe renal failure, acute renal failure;

- adrenal insufficiency;

- identified hormone-dependent malignant diseases (including the genital organs or mammary glands) or suspicion of them;

- bleeding from the vagina of unknown origin;

- pregnancy or suspicion of it;

- the period of breastfeeding;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the composition of the drug includes lactose monohydrate);

- hypersensitivity to any of the components of the drug Jess.

Use with caution

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case:

- risk factors for the development of thrombosis and thromboembolism (smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives; obesity; dyslipoproteinemia; arterial hypertension; migraine; heart valve disease; rhythm disturbance; prolonged immobilization; serious surgical interventions; extensive trauma);

- other diseases in which peripheral circulatory disorders may occur (diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins);

- hereditary angioedema;

- hypertriglyceridemia;

- liver disease;

- diseases that first appeared or worsened during pregnancy or against the background of a previous intake of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham's chorea);

- postpartum period.

Dosage

Reception mode "24+4"

Tablets should be taken in the order indicated on the package, every day at about the same time, with a small amount of water. Tablets are taken without interruption in admission. It should be taken 1 tablet / day consecutively for 28 days. Each subsequent pack should be started the next day after taking the last tablet from the previous pack. Withdrawal bleeding usually begins 2-3 days after the start of the inactive (white) tablets and may not yet be complete before the next pack. Pills from a new pack should always be started on the same day of the week, and withdrawal bleeding will occur on about the same days each month.

"Flexible" reception mode

The "flexible" mode of taking Jess can only be used if there is a Clyk dispenser and flex cartridges. The drug should be taken 1 tablet daily at the same time with a small amount of liquid. Tablets should be taken continuously for at least 24 days. Between 25 and 120 days of using the drug Jess, at the discretion of the patient, a 4-day break in taking the tablets can be made. The break in taking the tablets should not exceed 4 days. A 4-day break in taking the tablets must be taken no later than 120 days of continuous taking the tablets. After each 4-day break in taking the tablets, a new cycle begins with a minimum duration of 24 days and a maximum duration of 120 days. As a rule, withdrawal bleeding develops during the 4-day break in taking the pills, but may not end until the next pill is due. If spotting/bleeding from the vagina occurs for 3 consecutive days between days 25 and 120, it is recommended to take a 4-day break from taking the pills. This will reduce the total number of bleeding days.

Instructions for handling the packaging of the drug Jess for the "24 + 4" intake regimen

A blister is glued into the packaging of the Jess preparation, which contains 24 active hormone-containing light pink tablets and 4 inactive white, hormone-free tablets (last row). The package also includes an appointment calendar consisting of 7 self-adhesive strips with the names of the days of the week marked on them. You should select the strip where the first day of the week is indicated on which you plan to start taking the pills. For example, if a woman starts her pills on Wednesday, use the strip that starts with "Wed".

The strip should be glued along the top of the package so that the designation of the first day is above the tablet to which the arrow with the inscription "Start" is directed. Thus, it will be seen on which day of the week each tablet should be taken.

Instructions for use dispenser Click (Clyk)

Before starting and during operation, you should carefully read the detailed operating instructions for the dispenser.

General description of the dispenser Click (Clyk):

Side keys - pressing area to get a tablet;

Flex cartridge eject button - pressing this button ejects the flex cartridge;

Dispensing area of ​​the tablet - the part of the dispenser in which the dispensed tablets appear;

Pill time indicator - shows the time of taking the pill;

Display - displays the main screen and menu items;

OK Button - Pressing the button confirms an action, such as starting a 4-day pill break and changing the reminder tone.

Most Important Functions

Activating a new dispenser: the flex cartridge (containing 30 tablets) should be removed from the packaging and immediately inserted into the dispenser. Insert the narrow end of the flex-cartridge into the dispenser so that the dispenser window (as well as the tablets in the flex-cartridge) is clearly visible. The flex cartridge must be fully inserted.

The dispenser will automatically record the time the first tablet was dispensed, setting this time as "Time to take". Thus, a woman needs:

Make sure she unpacks and inserts the flex cartridge on the day she plans to start taking the pills;

To be sure that the time of dispensing the first tablet will be convenient for daily tablet intake.

Every 24 hours, a signal will appear on the dispenser display about the time to take the next tablet.

Pill extraction

With one hand, simultaneously press both side keys to remove the tablet, which is received with the other hand.

Replacing the Flex Cartridge

In normal use, the flex cartridge can only be removed if it is empty, otherwise follow the instructions in the detailed instructions for use of the Clyk dispenser. An empty flex cartridge is ejected by pressing the flex cartridge eject button. The dispenser saves all information about the current cycle, and a new filled flex cartridge should be inserted according to the instructions above.

Before starting and during use, you should carefully read the detailed instructions for using the Clyk dispenser, enclosed in the package with the drug.

Starting the drug

In the absence of taking any hormonal contraceptives in the previous month

Jess is started on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding), in which case additional contraceptive measures are not required. 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. The tablets should then be taken in the order indicated for the "24+4" or "flexible" regimen.

When switching from other combined oral contraceptives, vaginal ring or contraceptive patch

It is preferable to start taking Jess the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Taking the drug Jess should begin on the day the vaginal ring or patch is removed, but no later than the day when a new ring is to be inserted or a new patch is pasted.

When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant), or from a progestogen-releasing intrauterine contraceptive

A woman can switch from taking a "mini-drink" to a Jess drug on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injectable contraceptive - on the day when the next injection should 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 an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, the woman does not need additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy

The drug can be started on the 21-28th day after a spontaneous or medical abortion or after childbirth, in the absence of breastfeeding. 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. However, if sexual intercourse has already taken place, pregnancy should be excluded before taking Jess, or it is necessary to wait for the first menstruation.

Stopping Jess

You can stop taking the drug at any time. If a woman is not planning a pregnancy or pregnancy is contraindicated because she is taking medications that are potentially harmful to the fetus, other methods of contraception should be discussed with her doctor. If a woman is planning a pregnancy, it is recommended to stop taking the drug and wait for natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the gestational age and time of birth.

Taking missed pills

The omission of inactive tablets against the background of the "24 + 4" regimen can be ignored. However, they should be discarded so as not to accidentally prolong the period of taking inactive tablets. The following recommendations apply only to missing active (light pink) tablets.

If the delay in taking the drug was less than 24 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next one at the usual time.

If the delay in taking the tablets was more than 24 hours, contraceptive protection may be reduced. The more pills missed and the closer the skipped pills are to the inactive white pill phase on the 24+4 regimen or to the pill-free period on the flexible regimen, the higher the chance of pregnancy.

In this case, you can be guided by the following two basic rules:

- taking the drug should never be interrupted for more than 7 days (note that the recommended interval for taking inactive tablets is 4 days for the "24 + 4" regimen, and for the "flexible" regimen, the interval without taking tablets is not must exceed 4 days);

- to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

The Clyk dispenser allows you to control the intake of pills and warns the woman about the need to use an additional method of contraception. The exclamation mark warning symbol appears on the display when tablets are missed or if tablets are taken irregularly for more than 7 days in a row. The "exclamation mark" disappears after 7 days of continuous dispensing of tablets by the dispenser. If you miss taking more than one tablet, it is recommended to consult a doctor.

In the case of the "24 + 4" reception mode, as well as in the "flexible" mode, if the information from the Clyk dispenser is not available or there are doubts about its reliability, the following recommendations must be followed:

If missed during the 1st to 7th day of taking the tablets

The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.

If you miss from the 8th to the 14th day of taking the tablets with the "24 + 4" intake regimen or if you miss during the 8th to the 24th day of taking the tablets with the "flexible" intake regimen

The woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. She continues to take the next pills at the usual time.

Provided that the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, and if you miss two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days, and with a "flexible" regimen, barrier methods of contraception should be used until such time as the continuous period of taking pills is not reaches 7 days.

If you miss from the 15th to the 24th day of taking the tablets with the "24 + 4" intake regimen or if you miss during the 25th to the 120th day of taking the tablets with the "flexible" regimen

The risk of reduced reliability is inevitable due to the approaching phase of inactive white pills in the case of a "24+4" dosing regimen or a pill-free period with a "flexible" dosing regimen. One of the following two options must be strictly adhered to. Moreover, if during the 7 days preceding the first missed tablet, all the tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) for 7 days.

1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). For the "24+4" regimen: the next tablets are taken at the usual time until the active light pink tablets in the package run out, 4 inactive white tablets should be discarded and the tablets from the next package should be started immediately. Withdrawal bleeding is unlikely until the active light pink tablets in the second pack have run out, but spotting and/or breakthrough bleeding may occur while taking the tablets. In the case of a "flexible" regimen, at least 7 tablets (one tablet daily) should be taken without interruption.

2. For the "24+4" regimen: the woman can also stop taking active light pink tablets from the current package. Then you should take a break of no more than 4 days, including the days of skipping tablets, and then start taking the drug from a new package. If a woman missed taking the active light pink pills and no withdrawal bleeding occurred while taking the inactive white pills, pregnancy should be ruled out. For a "flexible" dosing regimen: a woman can also take a 4-day pill break, including a day of missing a pill, to induce withdrawal bleeding, and then start a new cycle of taking the drug. If a woman misses a pill and does not experience withdrawal bleeding during the next pill-off period, the possibility of pregnancy should be considered.

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken.

If within 3-4 hours after taking the active light pink tablet there was vomiting or diarrhea, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the start of her period to another day of the week, an additional active light pink tablet should be taken.

How to change the timing of withdrawal bleeding or how to delay the onset of withdrawal bleeding while on a 24+4 regimen

To delay the onset of withdrawal bleeding, the woman should continue taking the pills from the next pack of Jess, skipping the inactive pills from the current pack. Thus, the cycle can be extended, if desired, for any period until the active light pink tablets from the second package run out, i.e. about 3 weeks later than usual. If you plan to start the next cycle earlier, at any time, stop taking the active light pink tablets from the second package, discard the remaining active light pink tablets and start taking the white inactive tablets (within a maximum of 4 days), and then start taking the tablets from new packaging. In this case, about 2-3 days after taking the last light pink tablet from the previous package, withdrawal bleeding should begin. While taking the drug from the second package, a woman may experience spotting and / or breakthrough uterine bleeding. Regular intake of Jess is then resumed after the end of the period of taking inactive white tablets.

To bear the onset of withdrawal bleeding on the other day of the week, the woman will reduce the next period of taking inactive white tablets by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will have spotting and/or breakthrough bleeding while taking the pills from the second pack.

Additional information for special categories of patients

Children and teenagers

After menopause Jess is not indicated.

severe liver disease until liver function tests return to normal.

Jess is contraindicated in women with or with acute renal failure.

Side effects

The following most common adverse reactions were reported in women using Jess in the "24 + 4" regimen for "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)": nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin. These adverse reactions occurred in more than 3% of women. In patients using Jess for the indication "Contraception and treatment of severe premenstrual syndrome", the following most common adverse reactions were reported (in more than 10% of women): nausea, pain in the mammary glands, irregular uterine bleeding.

Serious adverse reactions are arterial and venous thromboembolism, and for the "flexible" regimen of the drug, breast cancer and focal nodular hyperplasia of the liver are additionally noted.

The following is the frequency of adverse reactions reported in the course of clinical trials of Jess for the "24 + 4" regimen according to the indications "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)" (n=3565), according to the indication " Contraception and treatment of severe premenstrual syndrome" (n=289), as well as a "flexible" regimen for taking Jess (n=2738). Within each group, allocated depending on the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided as follows: often (≥1 / 100 and<1/10), нечасто (≥1/1000 и <1/100) и редко (≥1/10 000 и <1/1000). Для дополнительных нежелательных реакций, выявленных только в процессе постмаркетинговых наблюдений, и для которых оценку частоты возникновения провести не представлялось возможным, указано "частота неизвестна".

The frequency of adverse reactions in clinical studies of the drug Jess (mode "24 + 4" and "flexible" regimen *)

From the blood and lymphatic system: rarely - anemia, thrombocytopenia.

From the immune system: rarely - allergic reactions; frequency unknown - hypersensitivity.

From the side of metabolism and nutrition: rarely - increased appetite, anorexia, hyperkalemia, hyponatremia.

From the side of the psyche: often - emotional lability, depression, decreased libido; infrequently - nervousness, drowsiness; rarely - anorgasmia, insomnia.

From the nervous system: often - headache; infrequently - dizziness, paresthesia; rarely - vertigo, tremor.

From the side of the organ of vision: rarely - conjunctivitis, dryness of the mucous membrane of the eyes.

From the side of the cardiovascular system: often - migraine; infrequently - varicose veins, increased blood pressure; rarely tachycardia, phlebitis, epistaxis, syncope, venous thromboembolism, arterial thromboembolism.

From the gastrointestinal tract: often - nausea; infrequently - abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhea; rarely - bloating, a feeling of heaviness in the abdomen, hiatal hernia, oral candidiasis, constipation, dry mouth.

From the side of the liver and biliary tract: rarely - biliary dyskinesia, cholecystitis.

From the skin and subcutaneous tissues: infrequently - acne, itching, rash; rarely - chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis, skin nodules; frequency unknown - erythema multiforme.

From the musculoskeletal system: infrequently - back pain, pain in the extremities, muscle cramps.

From the genitals and mammary gland: often - pain in the mammary glands, metrorrhagia **, absence of menstrual bleeding; infrequently - vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic formations in the breast, spotting / bleeding from the genital tract **, discharge from the genital tract, "hot flashes" with a feeling of heat, vaginitis, painful menstrual-like bleeding , scanty menstrual bleeding, heavy menstrual bleeding, dryness of the vaginal mucosa, abnormal Pap test results; rarely - dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast hyperplasia, neoplasm in the mammary gland, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.

Laboratory and instrumental data: infrequently - an increase in body weight; rarely - weight loss.

Others: infrequently - asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema); rarely - malaise.

* in cases where adverse reactions occurred with different frequencies against the background of the use of the "24 + 4" regimen and the "flexible" regimen, the highest frequency is indicated.

** The frequency of irregular bleeding decreases as the duration of taking Jess increases.

Additional Information

Listed below are adverse reactions with a very rare frequency of occurrence or with delayed symptoms, which are believed to be associated with the use of drugs from the group of combined oral contraceptives.

Tumors

The frequency of diagnosing breast cancer in women taking combined oral contraceptives is slightly increased. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women taking combined oral contraceptives is insignificant in relation to the overall risk of this disease;

Tumors of the liver (benign and malignant).

Other states

Erythema nodosum, erythema multiforme (only for the "flexible" mode of taking the drug);

Women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);

Increased blood pressure;

Conditions that develop or worsen while taking combined oral contraceptives, but their relationship has not been proven (jaundice and / or itching associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes during pregnancy; reduction hearing associated with otosclerosis);

In women with hereditary angioedema, estrogen use may cause or exacerbate symptoms;

Impaired liver function;

Change in tolerance to or effect on insulin resistance;

Crohn's disease, ulcerative colitis;

Chloasma;

Hypersensitivity (including symptoms such as rash, urticaria).

Interaction

Interactions of combined oral contraceptives with other medicinal products (enzyme inducers) may lead to breakthrough bleeding and/or decreased contraceptive efficacy.

Overdose

Serious violations in case of overdose have not been reported. Based on cumulative experience with combined oral contraceptives symptoms that may occur with an overdose of active tablets: nausea, vomiting, spotting or metrorrhagia.

Treatment: there is no specific antidote, symptomatic treatment should be carried out.

drug interaction

The influence of other drugs on the drug Jess

Interaction with drugs that induce microsomal enzymes is possible, as a result of which the clearance of sex hormones may increase, which, in turn, may lead to breakthrough uterine bleeding and / or a decrease in the contraceptive effect.

Women who receive treatment with such drugs in addition to Jess are recommended to use a barrier method of contraception or choose another non-hormonal method of contraception. The barrier method of contraception should be used during the entire period of taking concomitant drugs, as well as within 28 days after their withdrawal. If the period of use of the barrier method of contraception ends later than the active tablets in the Jess package, you should start taking the Jess tablets from a new package without interrupting the active tablets.

Drugs that increase the clearance of the drug Jess (weaken the effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.

Means with different effects on the clearance of the drug Jess: when used together with Jess, many HIV or hepatitis C protease inhibitors and non-nucleoside reverse transcriptase inhibitors can either increase or decrease plasma concentrations of estrogens or progestins. In some cases, this effect may be clinically significant.

Drugs that reduce the clearance of combined oral contraceptives (enzyme inhibitors): strong and moderate inhibitors of CYP3A4, such as azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolide antibiotics (eg, clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen or progestin, or both .

It was shown that etoricoxib at doses of 60 and 120 mg / day, when taken together with combined oral contraceptives containing 0.035 mg of ethinylestradiol, increases the concentration of ethinylestradiol in blood plasma by 1.4 and 1.6 times, respectively.

The effect of Jess on other drugs

Combined oral contraceptives may interfere with the metabolism of other drugs, leading to an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in plasma and tissue concentrations.

In vitro, drospirenone is able to weakly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19 and CYP3A4.

Based on in vivo interaction studies in female volunteers treated with omeprazole, simvastatin or midazolam as marker substrates, it can be concluded that a clinically significant effect of drospirenone 3 mg on cytochrome P450 enzyme-mediated drug metabolism is unlikely.

In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1, and CYP1A2, and an irreversible inhibitor of CYP3A4/5, CYP2C8, and CYP2J2. In clinical studies, the administration of a hormonal contraceptive containing ethinylestradiol did not lead to any increase or only a slight increase in plasma concentrations of CYP3A4 substrates (eg, midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (eg, theophylline ) or moderately (eg melatonin and tizanidine).

Other forms of interaction

In patients with intact renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in the blood plasma. However, the combined use of Jess with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma must be monitored during the first cycle of taking the drug.

special instructions

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, worsen, or first appear, the woman should consult her physician, who may decide whether to discontinue the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease). These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after the initial use of oral contraceptives or the resumption of use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more). Data from a prospective study in 3 groups of patients show that this increased risk is present predominantly during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (<50 мкг этинилэстрадиола), в 2-3 раза выше, чем у небеременных пациенток, которые не принимают комбинированные пероральные контрацептивы, тем не менее, этот риск остается более низким по сравнению с риском ВТЭ при беременности и родах. ВТЭ может угрожать жизни или привести к летальному исходу (в 1-2% случаев).

VTE manifesting as deep vein thrombosis or pulmonary embolism can occur with any combination oral contraceptive.

Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or vessels of the retina. There is no consensus regarding the relationship between the occurrence of these events and the use of combined oral contraceptives.

Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower extremity or along a vein in the lower extremity, pain or discomfort in the leg only when standing or walking, localized temperature increase in the affected lower extremity, redness or discoloration of the skin on the lower extremity .

Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden cough, incl. with hemoptysis; sharp pain in the chest, which may worsen with a deep breath; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as symptoms of other more or less severe events (eg, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensation in the face, arm or leg, especially on one side of the body, sudden confusion, problems speaking and understanding; sudden unilateral or bilateral loss of vision; sudden disturbance of gait, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache with no apparent cause; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blue discoloration of the extremities, the "acute abdomen" symptom complex.

Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of tightness or fullness in the chest, arm, or chest; discomfort with irradiation to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

Arterial thromboembolism can be life threatening or fatal.

In women with a combination of several risk factors or a high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, taking Jess is contraindicated.

The risk of developing 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 increases, especially in women over 35 years old);

- with obesity (BMI more than 30 kg / m 2);

- if there is a family history of indications (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;

- with 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 4 weeks before it) and not resume taking within 2 weeks after the end of immobilization. Temporary immobilization (eg, air travel longer than 4 hours) may also be a risk factor for venous thromboembolism, especially if other risk factors are present;

- with dyslipoproteinemia;

- with arterial hypertension;

- with migraine;

- in diseases of the heart valves;

- with atrial fibrillation.

The use of any combined hormonal contraceptive increases the risk of VTE. The use of drugs containing levonorgestrel, norgestimate or norethisterone is associated with the lowest risk of VTE. The use of other drugs, such as Jess, can lead to a two-fold increase in risk. The decision to use another drug, except for the one with the lowest risk of developing VTE, should be taken only after a discussion with the woman to make sure that she understands that the use of Jess is accompanied by the likelihood of developing VTE, understands how her risk factors affect the likelihood of developing VTE and also understands that every first year of use of the drug, the risk of developing VTE for her is greatest. There is evidence that the risk of VTE increases with the resumption of combined hormonal contraceptives after a 4-week or more break in taking.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

An increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders 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) is the basis for the immediate discontinuation of these drugs.

Biochemical indicators that indicate a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).

When evaluating the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<50 мкг этинилэстрадиола).

Tumors

The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of some increased risk of developing cervical cancer with long-term use of combined oral contraceptives, but the relationship with taking combined oral contraceptives has not been proven. Controversy remains as to the extent to which these findings are related to screening for cervical pathology or sexual behavior (lower 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 combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of breast cancer diagnoses in women currently taking combined oral contraceptives or who have recently taken it is insignificant in relation to the overall risk of this disease. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effect of oral contraceptives, or a combination of both factors. In women who used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. 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.

Tumors can be life threatening or fatal.

Other states

Clinical studies have shown no effect of drospirenone on the concentration of potassium in the blood serum in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial concentration of potassium on the ULN, while taking drugs that lead to potassium retention in the body. In women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of potassium in the plasma during the first cycle of taking Jess.

In women with hypertriglyceridemia (or a family history of this condition), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of arterial hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea of ​​Sydenham; herpes of pregnant women; hearing loss associated with otosclerosis. There are also described cases of worsening of the course of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis against the background of the use of combined oral contraceptives.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Acute or chronic liver dysfunction may require the withdrawal of combined oral contraceptives until liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<50 мкг этинилэстрадиола). Тем не менее, женщин с сахарным диабетом следует тщательно наблюдать во время приема комбинированных пероральных контрацептивов.

Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Laboratory tests

Taking combined oral contraceptives may affect the results of some laboratory tests, including liver, kidney, thyroid, adrenal function, plasma transport protein concentrations, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the boundaries of normal values.

Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect.

Medical examinations

Before starting or resuming the use of the drug Jess, it is necessary to familiarize yourself with the history of life, the family history of the woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of BMI) and gynecological examination (including examination of the mammary glands and cytological examination of cervical mucus), exclude pregnancy. The volume of additional studies and the frequency of follow-up examinations is determined individually. Usually control examinations should be carried out at least 1 time in 6 months.

A woman should be warned that combined oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced in the following cases: if active light pink tablets are missed (when using the 24 + 4 regimen or light pink tablets if using the flexible regimen), vomiting and diarrhea, or as a result of drug interactions .

Insufficient control of the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting spotting or breakthrough bleeding) may occur, especially during the first months of use for both regimens. With the "flexible" regimen, irregular bleeding may develop during the fixed period of administration from 1 to 24 days). Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles (or 3 months for a "flexible" regimen).

If irregular bleeding recurs or develops after previous regular cycles, a thorough diagnostic examination should be performed to rule out malignancy or pregnancy.

Some women may not experience "withdrawal" bleeding while taking active light pink tablets ("24+4" regimen). If the drug was taken as directed, it is unlikely that the woman is pregnant. However, if the drug has been taken irregularly before, or if there are no consecutive withdrawal bleedings, pregnancy should be excluded until the drug is continued.

Against the background of a "flexible" regimen of taking the drug, withdrawal bleeding is not regular. Therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy. In such cases, there are difficulties with the timely diagnosis of pregnancy. This fact is of particular importance for women taking concomitant drugs with a teratogenic effect. And although the onset of pregnancy against the background of regular use of Jess is unlikely, at the slightest suspicion of pregnancy, a pregnancy test should be performed.

Preclinical safety data

Preclinical data obtained in the course of standard studies for the detection of toxicity with repeated doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors.

Influence on the ability to drive vehicles and control mechanisms

Not found.

Pregnancy and lactation

The use of the drug Jess is contraindicated during pregnancy and during breastfeeding.

The possibility of pregnancy should not be excluded in any patient of reproductive potential with symptoms characteristic of pregnancy, especially in those who did not comply with the drug regimen.

Of the symptoms characteristic of pregnancy, there may be not only the absence of withdrawal bleeding during the 4-day pill-free period ("flexible" regimen) or while taking white inactive pills ("24 + 4 regimen"), but also the appearance of morning weakness, vomiting or swelling of the mammary glands, although not all women develop these symptoms and, in addition, they can be caused by other reasons.

Withdrawal bleeding with the "flexible" regimen does not occur as usual every 4 weeks, but occurs at intervals of up to 120 days, depending on when the patient chooses a 4-day tablet break. Therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy. In such cases, there are difficulties with the timely diagnosis of pregnancy. Although the onset of pregnancy with strict adherence to the regimen of taking Jess is unlikely, if pregnancy is suspected, you should immediately stop taking Jess, consult a doctor and perform a pregnancy test.

If the patient is planning a pregnancy, she can stop taking Jess at any time. If the patient is simultaneously taking drugs that are potentially dangerous to the fetus (teratogenic) and therefore needs to prevent pregnancy, the decision to stop taking Jess can only be made after consulting a doctor.

If pregnancy is detected while taking Jess, the drug should be discontinued immediately. However, extensive epidemiological studies have not found any increased risk of malformations in children born to women who received sex hormones (including combined oral contraceptives) before pregnancy, or teratogenic effects when sex hormones were inadvertently taken in early pregnancy.

Existing data on the results of the use of Jess during pregnancy are limited, which does not allow drawing any conclusions about the effect of the drug on the course of pregnancy, the health of the newborn and fetus. There are currently no significant epidemiological data on Jess.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is not recommended until breastfeeding is stopped. A small amount of sex hormones and / or their metabolites can pass into breast milk and affect the body of the newborn.

Application in childhood

Children and teenagers the drug Jess is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.

For impaired renal function

Jess is contraindicated in women with severe renal failure or with Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life - 5 years (blister with 28 tablets), 3 years (flex-cartridge with 30 tablets).