Regulon method of administration and dosage. Regulon reviews of medical specialists. Regulon - official instructions for use

Among the variety of modern birth control pills Regulon is isolated on a hormonal basis. The components of the dragee disrupt the production of gonadotropins. The viscosity of mucus increases, the components prevent ovulation, spermatozoa lose their ability to penetrate into the uterus.

The drug has an effect on the endometrium, preventing the introduction of a fertilized egg into the uterine mucosa. Usage contraceptive drug not only protects against unwanted pregnancy, but also improve the metabolic processes in the body of a woman.

Taking a Regulon tablet, strictly following the instructions, a woman improves her condition not only reproductive organs but also metabolism in general. Improves lipid metabolism, increases the concentration of high-density lipoproteins in blood plasma, without affecting the state of low-density lipoproteins.

Contraceptive reduces blood loss during menstruation, normalizes the menstrual cycle, relieves acne and rashes.

Before starting to use a contraceptive, a woman undergoes an examination by a gynecologist and a general check-up of the body. Special attention are given to the analysis of the cervical smear, mammary glands, organs of the pelvic area. The audit is carried out every six months.

Composition and form of release

Film-coated pills are packaged in 21 pieces in a blister pack. A cardboard box contains 1-3 blisters. The main components of the dragee:

Ethinylestradiol - 30 mcg;
Desogestrel - 150 mcg.

The action of the drug

The contraceptive belongs to the category of oral combined monophasic contraceptives. Inhibits the synthesis of gonadotropins, suppresses the process of ovulation. When using Regulon, the viscosity cervical mucus increases, sperm lose the ability to fertilize the egg, and the endometrium, which has changed its structure, does not allow it to attach.

Purpose

Instructions for use states that the main purpose of the remedy is to prevent unwanted conception. medical practice, patient reviews claim that when taking Regulon, the instruction does not tell about all possible positive effects.

Regular intake of tablets affects the condition and functioning of the reproductive organs. If a woman has dysfunctional uterine bleeding, suffers from pain during the premenstrual period. Pain, which appears from time to time during menstruation in the lower abdomen, disappears completely if one main rule of admission is observed - exactly following the instructions without skipping the use of dragees.

Discomfort and a feeling of pain in the mammary glands pass.

Women suffering from endometriosis are familiar with these pills, they are often prescribed to improve the effectiveness in the treatment of the disease. Known pathology, uterine fibroids, on early stages treated with hormonal contraceptive Regulon. The tumor stops growing if its size does not exceed 20 mm. In the event of a retention ovarian cyst, the pills contribute to the resorption of formations.

Women who have reached the age mark of 40 usually already have resolved questions regarding the family and the number of children, and therefore most doctors advise using hormonal contraceptives. Regulon prevents abortion, Negative consequences. Pregnancy at this age range often ends in miscarriages, and pills help to avoid them and maintain good health.

Contraindications

The presence of individual intolerance to the components in the composition of the contraceptive;
Pregnancy of a woman;
The period of breastfeeding;
Severe liver disease;
The presence of functional hyperbilirubinemia, including a form of pigmentary hepatosis, inherited;
The presence of jaundice;
Familial form of hyperlipidemia;
Persistent Boost blood pressure, severe form of arterial hypertension;
Predisposition, severe symptoms of onset or the presence of thrombosis, thromboembolism;
If the patient suffers from herpes type 2;
The appearance of bleeding from the vagina, whose nature of origin is unknown;
Suspicion or presence of estrogen-dependent tumors;
Diabetes;
Migraine;
In violation of the hemocoagulation system;
Severe itching associated with pregnancy or the use of glucocorticosteroids.

Side effects

The drug is canceled in cases where at least one of the following occurs side effects:

The appearance of arterial hypertension;
If there is a thromboembolism of the veins or arteries, taking into account deep veins, strokes, myocardial infarctions, etc.;
The occurrence of thromboembolism of arteries and veins in the kidneys and liver;
Deterioration or loss of hearing caused by otospongiosis;
The appearance of porphyrin disease;
The occurrence of hemolytic-uremic syndrome;
If the course of a disease called reactive systemic lupus erythematosus worsens;

Less dangerous side effects:

Cervical fluid, mucus in the vagina, changed condition;
The emergence of abundant blood secretions, bleeding from the vagina, not related to the menstrual cycle;
The mammary glands have increased, cause discomfort, pain is felt;
Inflammatory processes began in the vagina;
A woman discovers the appearance of thrush;

There is a feeling of nausea, the woman experiences vomiting;
Jaundice, itching associated with cholestasis develops or worsens;
Crohn's disease;
Headaches appear;
Mood changes quickly, depression appears;
The cornea of the eyes becomes more sensitive;
Decreased tolerance for carbon;
A rash occurs;
Body weight gradually increases;
Fluid is poorly excreted from the body;
Allergic reactions are formed.

Admission rules

The drug is used from the first day of the onset of menstruation, swallowing one tablet daily at the same time. Use contraceptives for 21 days without gaps.

At the end of the use of the package, a week pass is made so that blood discharge similar to menstruation passes in a seven-day period. On the 8th day after the final tablet was taken, even with still spotting, a new blister pack is opened and the tablet is taken at the same time as before.

While a woman will need a contraceptive effect, pills are being taken. When the pills are taken according to the instructions given in the manual, Regulon has a protective effect against unwanted conception even during a week's rest.

Reception is carried out on the first day of the cycle, there is no need for additional protective drugs. When the reception begins on days 2-5, then during the first seven days of use, other barrier-type means are used additionally, for example, condoms. If more than 5 days have passed since the onset of menstruation, then the remedy begins to be used with next cycle.

Reception after the birth of a child

If a young mother does not feed her baby with breast milk, then after 3 weeks you can start using dragees, but it is strictly forbidden to start taking it without consultation and examination by a gynecologist. There is no need to use other types of contraceptives.

In a situation where a woman had sex after giving birth, the pills are taken from the next cycle. When you start using Regulon after more than 21 days, condoms are additionally used for the first week.

If there was an abortion

When the doctor, having examined the patient, does not find any contraindications, then the pills can be taken from the first day after the abortion. No additional birth control is needed. In case of curettage, Regulon is often prescribed.

The essence of using the drug after curettage, abortion, or if there was a frozen pregnancy, is to start the process of restoring ovarian function, their full work, to avoid the appearance of pathologies, inflammatory processes appearing, according to statistics, in every third girl after the 2nd abortion.

The lack of progesterone is replenished thanks to hormonal agents. Proliferative processes are excluded in the system of organs responsible for reproductive function. The list consists of thecal tissue hyperplasia, polycystic ovaries, mastopathy, endometriosis, endometrial hyperplasia, fibroids, adenomyosis and others.

How to switch to Regulon

The transition from one type of contraceptive pill to another is carried out according to the scheme of using the first pill of a new type on the next day of the completed course of the previous pills. The first day after 28 days of admission (three weeks of use and a week of rest) is the countdown for the course of taking Regulon. There is no need to use other contraceptives.

When a woman switches from a one-component mini-drink, the pill is swallowed on the first day of the cycle. In the absence of blood discharge during the use of the mini-pill, a new remedy is started on any day if the girl has not become pregnant. During the initial week, it is advisable to use secondary contraceptive drugs: condoms, spermicide caps, or abstain from sex, the calendar method does not work.

Changing the time of the onset of menstruation

When changing the days of menstruation, the tablets are taken without a break for a week, given period high probability of occurrence menstrual bleeding breakthrough type, soiling type, not reducing the protective effect.

Pass funds

A woman who forgot about the pill missed the dose, she uses the pill as soon as she remembers it, if no more than 12 hours have passed since the scheduled appointment. In the scheme of contraceptive use, nothing changes, they are used at the previously appointed hour.

If a tablet is missed, more than 12 hours have passed since the scheduled time of use, then the effectiveness of protection may noticeably decrease, doctors recommend using secondary types of contraception before starting a new cycle.

If a girl missed 1 tablet in the first week or two, then she takes 2 pills the next day, then the course is carried out according to the usual scheme, but with other contraceptives. A pill missed between the 2nd and 3rd week is continued with the missed pill and without a week break.

Overdose symptoms

The woman sinks into depression;
Experiences a feeling of nausea, vomiting;
Appears strong headache;
There is spasm in the calf muscles from time to time;
There are bloody discharges that are not related to menstruation.

The drug "Regulon" is a monophasic oral contraceptive. Its main action is to suppress the synthesis of gonadotropins and prevent ovulation. Due to the increase in the viscosity of the cervical mucus, there is a slowdown in the movement of spermatozoa through cervical canal, the state of the endometrium changes, and the implantation of a fertilized egg does not occur.

Pharmacological properties

Ethinylestradiol and desogestrel are the main components of the Regulon contraceptive. Instructions, reviews of experts report that these substances, when ingested, not only protect against the onset of unwanted pregnancy, but also have a beneficial effect on the health status of women in general. The drug has a good effect on lipid metabolism, increasing the content of HDL in the blood plasma, but without changing the concentration of LDL. It's not the only therapeutic effect, which is provided by the contraceptive "Regulon". The doctors' comments indicate that in patients using this remedy, the menstrual cycle normalizes, in the case of initial menorrhagia, blood loss during menstruation is significantly reduced. In addition, the drug has a beneficial effect on the skin, allows you to eliminate acne vulgaris.

Indications for use

The drug is used as oral contraception, as well as for premenstrual syndrome, functional disorders menstrual cycle.

Reception features

From the very first day of the menstruation cycle, you should start taking Regulon tablets. Reviews of experts contain information that the drug is most effective when it is taken at the same time. Tablets are intended for oral use, they need to be drunk every day, one piece for 3 weeks. After taking the last pill, you should take a break for 7 days, at which time menstruation should begin. After a week-long pause, they begin taking the next package of the Regulon contraceptive. Reviews of doctors warn that it is necessary to pay attention to the use of the drug and not to forget to drink pills at the same time every day. If a woman did not take the remedy on time, she must take it later, but no later than 12 hours after the pass, otherwise the effectiveness of the use of the contraceptive in the current cycle will be significantly reduced.

Side effects of the drug "Regulon". Reviews of doctors

Experts say that patients, as a rule, do not complain about the development of any negative effects while taking the drug. However, in some cases there are unpleasant symptoms such as vaginal discharge, genital pain, breast enlargement, etc. May present side effects not associated with the reproductive system, for example, nausea, vomiting, ulcerative colitis, dermatological reactions in the form of a skin rash, nodular or exudative erythema, chloasma. Some patients develop headaches, depression, mood lability. In case of wearing contact lenses may increase corneal sensitivity. Sometimes, on the part of metabolism, such disorders as fluid retention in the body and, as a result, weight gain, and a decrease in carbohydrate tolerance are recorded. In cases of occurrence of any of the listed reactions, you need to consult a doctor regarding the advisability of continuing to use the drug "Regulon". The doctors' comments also contain recommendations on when to stop using the contraceptive. So, experts advise to immediately stop taking the pills if there is a suspicion of pregnancy, vaginal bleeding is noticed, there are problems with hearing. Among the side effects requiring the abolition of the drug include arterial hypertension, venous and arterial thromboembolism(including stroke, myocardial infarction), porphyria, hemolytic uremic syndrome.

Contraindications

If there are multiple or heavy factors the risk of arterial / venous thrombosis, the use of contraceptives should be abandoned. Migraine accompanied by focal neurological symptoms, diabetes, serious pathologies liver, pancreatitis with severe hypertriglyceridemia, hepatitis, cholelithiasis, otosclerosis, cholestatic jaundice - in all these diseases, the use of the drug "Regulon" is contraindicated. Women over 35 years of age who smoke more than 15 cigarettes daily should also not use this method of contraception. It is forbidden to take the drug in case of hypersensitivity to the substances included in the tablets, during periods of pregnancy, lactation.

Doctors strongly recommend that you undergo a general medical examination before starting a contraceptive. Should be held laboratory research, detailed personal and family history taken, completed gynecological examination, and only after that it is possible to make a decision on the advisability of using Regulon. Based on the results of the examination, the doctor evaluates the benefits and possible negative effects taking a hormonal contraceptive and communicates this information to the patient. Perhaps the specialist will advise you to prefer some other method of protection. All the best!

This drug can be taken for a long time. In some cases reception allowed this drug for up to eight years or more. But if you are finally “ripe” for the birth of an heir, what should you do? You must stop taking the drug at least three months before you plan to become pregnant. According to medical statistics, pregnancy after taking oral contraceptives occurs, on average, after six months. But sometimes you have to work on conception for ten to twelve months. This is not out of the norm.
Future mothers are always very worried about the condition of their unborn child. In the first weeks of pregnancy, when you are not even aware of it yet, you may accidentally allow yourself to drink alcohol or take medicine.

It turns out that in the fair sex, who use regulon, the same processes take place in the body as in a woman who is in the first weeks of pregnancy. And if this drug is taken long time a woman who already had children, then exactly the same processes take place in her reproductive system as in women who gave birth and nursed twelve children of their own. That is, this drug actually does what, in the end, nature itself would do if women dared such feats. Birth a large number children, by the way, is the most effective method prevention oncological diseases mammary glands and reproductive organs.

Such data completely refute the talk that when taking Regulon and other hormonal contraceptives latest generation You need to take breaks for a few months. In fact, such breaks are completely unnecessary. Today, doctors believe that breaks in use this drug and others hormonal contraceptives can harm a woman's health.

How longer woman takes regulon without intervals, the stronger the therapeutic effect of the drug. These drugs should be started as soon as sex life, and use as long as there is a need for contraception. It turns out that among patients who use hormonal contraceptives, the percentage of women with infertility is several times less than among those who have never used such means. When using this drug for a long time, the body creates best conditions for egg maturation. To maintain the reproductive system in proper condition vitamin supplements (biologically active supplements) should be taken.

Pharmacies are full of various contraceptives. How not to get confused in this abundance, how to choose the right drug for yourself? It is better, of course, if the choice is made by your gynecologist. But extra knowledge never hurt anyone. In this article, you will learn about one of the birth control pills.
This drug is available in the form of tablets packed in a blister. Each blister contains twenty-one tablets. There are three blisters in a carton box. Thus, if you choose these pills, then one box will last you three months.

Side effects of regulon are extremely rare. Nausea, vomiting, migraines, breast tightness, weight gain or loss, changes in libido may be present, Bad mood, in rare cases inconvenience when using contact lenses. But these effects usually do not last long and disappear without a trace after 2-3 months of regular use. With longer use, they rarely appear dark spots on the skin.

Very rare growth blood pressure, local thrombosis and thromboembolism, gallbladder pathology, hepatitis, skin rashes, hair loss, inversion of vaginal secretions, vaginal mycosis, severe fatigue, diarrhea.

The risk of implementing the above adverse reactions increases with the use of hormonal drugs without a doctor's certificate. The likelihood of adverse reactions with the correct selection of funds tends to zero.

Stop using Regulon immediately:

If you experience a migraine-like, abnormally severe headache for the first time or growing, plummet vision, with symptoms of thrombosis or cerebral infarction;

With a sudden increase in blood pressure, with the progression of jaundice or hepatitis without symptoms of jaundice, with the appearance of generalized itching, with the appearance or increase in cases of epileptic seizures;

If you have an operation (6 weeks before the operation), with prolonged immobility (for example, with fractures).

It is necessary to start using Regulon on the first day of menstruation. They drink 1 tablet at a certain constant time of day for only 21 days, after which a 7-day pause is necessary, during which menstrual bleeding occurs. On the 8th day, the use of tablets from the next pack should be resumed (even if the bleeding has not yet stopped). To avoid confusion in use, the number and arrow are shown on the packaging.

The periods of use of the remedy are carried out for a long time, for the amount of time until the absence of pregnancy is required. If the drug is used constantly, the contraceptive effect lasts about 7 days, until the next dose.

When changing any oral contraceptive to Regulon, the same method of administration is used.

After childbirth, for non-nursing women, the remedy can be prescribed after 21 days, breastfeeding women are allowed to take the remedy, starting from the 6th month. After an abortion, the use of the drug should be started immediately or on the second day.

If the interval between the use of the drug was more than 1.5 days, there is a possibility of conception.

If you do not take one tablet in the first or second week of the cycle, you need to use 2 tablets on the next day and then return to the main scheme.

If two tablets in a row are not taken at 1-2 weeks of the cycle, it is required to use 2 tablets in the next 2 days, after returning to the main scheme, practicing other methods of contraception until the end of the cycle.

Pharmacology

Oral monophasic contraceptive consisting of estrogen and progestogen. The product contains artificially created gestagenic and estrogenic components, which are more effective than natural sex hormones. The effect is achieved, first of all, by blocking the production of follicle-stimulating and luteinizing hormones, which stops ovulation. This is achieved due to the increased viscosity of the cervical mucus, which prevents the entry of spermatozoa into the uterus. Regulon is a new low-dose contraceptive that contains the progestogen lll generation. Regulon does not negatively affect carbohydrate and lipid metabolism, which minimizes the harmful effect, and ensures normal tolerance with appropriate use.

Pharmacokinetics

Ethinylestradiol and desogestrel quickly and practically without residue penetrate the body through the upper sections small intestine. Ethinyl estradiol corresponds to first pass metabolism and enterohepatic circulation. Desogestrel is metabolized with the production of 3-keto-desogestrel, the remaining metabolites have no pharmacological effect. Both components have a strong (more than 90%) connection with plasma proteins. Most content in the blood is observed after 1.0-1.5 hours. Successfully spread through organs and tissues, ethinylestradiol is deposited in adipose tissue. Approximately 10% of the intake falls into breast milk. The half-life is usually 24 hours for ethinylestradiol and an average of 31 hours for desogestrel. Ethinylestradiol is eliminated by 40% by the kidneys as metabolites, by 60% by the liver.

Regulon from the Hungarian pharmaceutical company GEDEON RICHTER is a monophasic tableted contraceptive. When the first contraceptives were synthesized in the fifties of the last century, hardly anyone could have imagined that their therapeutic effect on the female body would be valued almost more than contraceptive effect. perennial clinical researches showed that patients taking the combined tablet contraceptives, much less often encountered not only gynecological, but also general somatic problems. In the course of improving the quantitative and quality composition of these drugs was found efficient mode reception, called prolonged, when the drug is taken continuously, without the traditional weekly interval. At the same time, it is possible to achieve not only the prevention of unplanned pregnancy, but also reduce the risk of developing many diseases. One drug suitable for use in this regimen is Regulon, a combination of ethinyl estradiol and desogestrel (a progestogen III generation). Even relatively a small amount desogestrel in excess is enough to suppress ovulation (60 micrograms of a substance per day suppress ovulation by 100%). Back in the late 90s of the last century, it was noted that etonogestrel, the active metabolite of desogestrel, has an extremely high affinity for progesterone receptors, has high progestogenic activity and exhibits a powerful antigonadotropic effect.

One tablet of Regulon includes 150 micrograms of desogestrel, i.e. 2.5 times more of it than is necessary to completely suppress ovulation. Another component of the contraceptive action of the drug is its ability to inhibit the formation of gonadotropins. In addition, due to the change rheological properties mucus slows down the progression of sperm through the cervical canal, and a change in the thickness and structure of the endometrium does not allow a fertilized egg to be implanted on its mucosa. The second component of the drug - ethinylestradiol - is an artificial analogue of the female sex hormone estradiol produced in the body. Regulon improves lipid profile, which manifests itself in an increase in the concentration of lipoproteins high density(“good” cholesterol) with a constant content of low-density lipoprotein (“bad” cholesterol). Taking the drug can significantly reduce blood loss during menstruation (with existing menorrhagia), improve skin condition, prevent the occurrence of acne. Before using Regulon, you must go through an in-depth medical checkup(history taking, blood pressure measurement, laboratory tests, gynecological examination). Such medical monitoring should be carried out during the period of use of the drug every six months.

Pharmacology

Monophasic oral contraceptive. The main contraceptive action is to inhibit the synthesis of gonadotropins and suppress ovulation. In addition, by increasing the viscosity of cervical mucus, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg.

Ethinylestradiol is a synthetic analog of endogenous estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, weak androgenic and anabolic activity.

Regulon has a beneficial effect on lipid metabolism: it increases the concentration of HDL in the blood plasma, without affecting the content of LDL.

When taking the drug, the loss of menstrual blood is significantly reduced (with initial menorrhagia), the menstrual cycle is normalized, a beneficial effect on skin especially in the presence of acne vulgaris.

Pharmacokinetics

Desogestrel

Suction

Desogestrel is rapidly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized to 3-keto-desogestrel, which is the biologically active metabolite of desogestrel.

C max is reached after 1.5 h and is 2 ng / ml. Bioavailability - 62-81%.

Distribution

3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone-binding globulin (SHBG). V d is 1.5 l / kg. C ss is established by the second half of the menstrual cycle. The level of 3-keto-desogestrel increases 2-3 times.

Metabolism

In addition to 3-keto-desogestrel (which is formed in the liver and in the intestinal wall), other metabolites are formed: 3α-OH-desogestrel, 3β-OH-desogestrel, 3α-OH-5α-H-desogestrel (metabolites of the first phase). These metabolites do not have pharmacological activity and are partially, by conjugation (the second phase of metabolism), converted into polar metabolites - sulfates and glucuronates. Clearance from blood plasma is about 2 ml / min / kg of body weight.

breeding

T 1/2 3-keto-desogestrel is 30 hours. Metabolites are excreted in the urine and feces (in a ratio of 4:6).

Ethinylestradiol

Suction

Ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. C max is achieved 1-2 hours after taking the drug and is 80 pg / ml. The bioavailability of the drug due to presystemic conjugation and the effect of "first pass" through the liver is about 60%.

Distribution

Ethinylestradiol is completely bound to plasma proteins, mainly to albumins. Vd is 5 l/kg. C ss is established by 3-4 days of administration, while the level of ethinylestradiol in serum is 30-40% higher than after a single dose of the drug.

Metabolism

Presystemic conjugation of ethinylestradiol is significant. Bypassing the intestinal wall (first phase of metabolism), it undergoes conjugation in the liver (second phase of metabolism). Ethinylestradiol and its conjugates of the first phase of metabolism (sulfates and glucuronides) are excreted into the bile and enter the enterohepatic circulation. Clearance from blood plasma is about 5 ml / min / kg of body weight.

breeding

T1 / 2 ethinylestradiol averages about 24 hours. About 40% is excreted in the urine and about 60% in the feces.

Release form

Tablets, film-coated white or almost white color, round, biconvex, marked "P8" on one side and "RG" on the other.

Excipients: α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.

Compound film shell: propylene glycol, macrogol 6000, hypromellose.

21 pcs. - blisters (1) - packs of cardboard.
21 pcs. - blisters (3) - packs of cardboard.

Dosage

The drug is prescribed inside.

Reception of tablets is begun from the 1st day of a menstrual cycle. Assign 1 tablet / day for 21 days, if possible at the same time of day. After taking the last pill from the package, a 7-day break is taken, during which menstrual-like bleeding occurs due to drug withdrawal. The next day after a 7-day break (4 weeks after taking the first tablet, on the same day of the week), the drug is resumed from the next package, also containing 21 tablets, even if the bleeding has not stopped. This scheme of taking pills is followed as long as there is a need for contraception. Subject to the rules of admission, the contraceptive effect persists for the duration of the 7-day break.

First dose of the drug

The first tablet should be taken from the first day of the menstrual cycle. In this case, you do not need to use additional methods contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, additional methods of contraception should be used in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, you should postpone the start of taking the drug until the next menstruation.

Taking the drug after childbirth

Women who are not breastfeeding can start taking pills no earlier than 21 days after giving birth, after consulting with their doctor. In this case, there is no need to use other methods of contraception. If after childbirth there was already sexual contact, then taking the pills should be postponed until the first menstruation. If a decision is made to take the drug later than 21 days after birth, then in the first 7 days it is necessary to use additional methods of contraception.

Taking the drug after an abortion

After an abortion, in the absence of contraindications, pills should be started from the first day after the operation, and in this case there is no need to use additional methods of contraception.

Switching from another oral contraceptive

When switching from another oral drug(21- or 28-day): the first tablet of Regulon is recommended to be taken the day after the completion of the course of the 28-day pack of the drug. After completing the 21-day course, you must take the usual 7-day break and then start taking Regulon. There is no need to use additional methods of contraception.

Switching to Regulon after using progestogen-only oral hormonal preparations ("mini-pill")

The first tablet of Regulon should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.

If menstruation does not occur when taking the "mini-pill", then after the exclusion of pregnancy, you can start taking Regulon on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days (use of a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). Application calendar method in these cases it is not recommended.

Postponement of the menstrual cycle

If there is a need to delay menstruation, it is necessary to continue taking tablets from new packaging, without a 7-day break, according to the usual scheme. With a delay in menstruation, breakthrough or spotting bleeding may occur, but this does not reduce contraceptive action drug. Regular intake of Regulon can be restored after the usual 7-day break.

Missed pills

If a woman forgot to take a pill in a timely manner, and no more than 12 hours have passed after the missed one, you need to take forgotten pill, and then continue receiving in regular time. If more than 12 hours have passed between taking the pills - this is considered a missed pill, the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you skip one tablet in the first or second week of the cycle, you need to take 2 tablets. the next day and then continue regular intake using additional methods of contraception until the end of the cycle.

If you miss a pill in the third week of the cycle, you must take the forgotten pill, continue to take it regularly and do not take a 7-day break. It is important to remember that due to minimum dose estrogen increases the risk of ovulation and/or bleeding when a pill is missed and therefore additional contraceptive methods are recommended.

Vomiting/diarrhea

If vomiting or diarrhea occurs after taking the drug, then the absorption of the drug may be defective. If the symptoms have stopped within 12 hours, then you need to take another tablet in addition. After that, you should continue taking the tablets in the usual way. If vomiting or diarrhea continues for more than 12 hours, then additional methods of contraception should be used during vomiting or diarrhea and for the next 7 days.

Overdose

Symptoms: nausea, vomiting, in girls - bloody issues from the vagina.

Treatment: in the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

Interaction

Drugs that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort, reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually reached no earlier than 2-3 weeks, but may last up to 4 weeks after discontinuation of the drug.

Ampicillin and tetracycline reduce the effectiveness of Regulon (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method contraception throughout the course of treatment and within 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.

Side effects

Side effects requiring discontinuation of the drug

From the side of cardio-vascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis lower extremities, thromboembolism pulmonary artery); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

Others: hemolytic uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects which are more common but less severe. The expediency of continuing the use of the drug is decided individually after consultation with a doctor, based on the benefit / risk ratio.

From the reproductive system: acyclic bleeding / bloody discharge from the vagina, amenorrhea after discontinuation of the drug, change in condition vaginal mucus, the development of inflammatory processes of the vagina, candidiasis, tension, pain, enlargement of the mammary glands, galactorrhea.

From the side digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma.

From the side of the central nervous system: headache, migraine, mood lability, depression.

On the part of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).

On the part of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.

Other: allergic reactions.

Indications

Contraception.

Contraindications

the presence of severe and / or multiple risk factors for venous or arterial thrombosis (including arterial hypertension, severe or medium degree severity with BP ≥ 160/100 mm Hg);
the presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina);
migraine with focal neurological symptoms, incl. in history;
venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in history;
the presence of venous thromboembolism in history;
diabetes mellitus (with angiopathy);
pancreatitis (including history), accompanied by severe hypertriglyceridemia;
dyslipidemia;
severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in history (before the normalization of functional and laboratory indicators and within 3 months after their normalization);
jaundice when taking GCS;
cholelithiasis currently or in history;
Gilbert's syndrome, Dubin-Johnson syndrome, Rotor's syndrome;
liver tumors (including history);
severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone-dependent malignant neoplasms genital organs and mammary glands (including if they are suspected);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
hypersensitivity to the components of the drug.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg / m 2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, lower limb surgery, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, the presence of severe depression (including history), changes biochemical indicators(activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus, uncomplicated vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic diseases liver.

Application features

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

During lactation, it is necessary to resolve the issue of either discontinuing the drug or stopping breastfeeding.

Application for violations of liver function

Contraindicated in liver failure.

With caution, the drug should be prescribed for acute and chronic liver diseases.

Application for violations of kidney function

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for kidney failure(including in history).

special instructions

Before starting the use of the drug, it is necessary to conduct a general medical (detailed family and personal history, measurement of blood pressure, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis cervical smear). A similar examination during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 1 year) with correct application is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects their acceptance. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The state of health of women must be carefully monitored. If any of the following conditions / diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

diseases of the hemostasis system;
conditions/diseases predisposing to the development of cardiovascular, renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes mellitus, not complicated by vascular disorders;
severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used for correction);
sickle cell anemia, tk. in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism;
the appearance of abnormalities in laboratory tests for assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a link between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). Proved increased risk venous thromboembolic diseases, but it is much less than during pregnancy (60 cases per 100 thousand pregnancies).

Some researchers suggest that the likelihood of developing venous thromboembolic disease is greater with the use of drugs containing desogestrel and gestodene (drugs of the third generation) than with drugs containing levonorgestrel (drugs of the second generation).

The frequency of spontaneous occurrence of new cases of venous thromboembolic disease in healthy people non-pregnant women not taking oral contraceptives is about 5 cases per 100,000 women per year. When using second-generation drugs - 15 cases per 100 thousand women per year, and when using third-generation drugs - 25 cases per 100 thousand women per year.

When using oral contraceptives very rarely observed arterial or venous thromboembolism of the hepatic, mesenteric, renal vessels or retinal vessels.

The risk of developing arterial or venous thromboembolic diseases increases:

with age;
when smoking (heavy smoking and age over 35 are risk factors);
if there is a family history of thromboembolic diseases (for example, in parents, a brother or sister). If you suspect genetic predisposition, it is necessary to consult a specialist before using the drug;
with obesity (body mass index more than 30 kg / m 2);
with dyslipoproteinemia;
with arterial hypertension;
in diseases of the heart valves, complicated by hemodynamic disorders;
with atrial fibrillation;
with diabetes mellitus complicated by vascular lesions;
with prolonged immobilization, after a large surgical intervention, after surgery on the lower extremities, after a severe injury.

In these cases, a temporary cessation of the use of the drug is expected (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of developing venous thromboembolic diseases.

It should be borne in mind that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin III, the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When evaluating the benefit / risk ratio of taking the drug, it should be borne in mind that targeted treatment given state reduces the risk of thromboembolism. The symptoms of thromboembolism are:

sudden chest pain that radiates to the left arm;
sudden shortness of breath;
any unusually severe headache that continues for a long time or appearing for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of one half of the body, movement disorders, severe unilateral pain in calf muscle, sharp belly.

Tumor diseases

Some studies have reported an increase in the occurrence of cervical cancer in women who have been taking hormonal contraceptives for a long time, but the results of the studies are conflicting. play a significant role in the development of cervical cancer sexual behavior, human papillomavirus infection and other factors.

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but higher detection of breast cancer could be associated with more regular medical examination. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant tumor liver in women taking long-term hormonal contraceptives. This should be kept in mind in the differential diagnostic evaluation of abdominal pain, which may be associated with an increase in the size of the liver or intraperitoneal bleeding.

Chloasma can develop in women who have a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Regulon.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that can reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may be reduced if, after several months of their use, irregular, spotting or breakthrough bleeding, in such cases it is advisable to continue taking the tablets until they are finished in the next package. If, at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets and resume it only after pregnancy has been excluded.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After an acute viral hepatitis the drug should be taken after the normalization of liver function (not earlier than after 6 months).

For diarrhea or intestinal disorders, vomiting contraceptive effect may decrease. Without stopping the drug, it is necessary to use additional non-hormonal methods contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35) and on the number of cigarettes smoked.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and control mechanisms

The drug does not affect the ability to drive a car and work with mechanisms.

Before using the drug REGULON you should consult with your doctor. These instructions for use are for informational purposes only. For more complete information please refer to the manufacturer's instructions.

Clinical and pharmacological group

23.032 (Monophasic oral contraceptive)

Release form, composition and packaging

Tablets, film-coated, white or almost white, round, biconvex, marked "P8" on one side and "RG" on the other.

Excipients: α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.

The composition of the film shell: propylene glycol, macrogol 6000, hypromellose.

21 pcs. - blisters (1) - packs of cardboard.21 pcs. - blisters (3) - packs of cardboard.

pharmachologic effect

Ethinylestradiol is a synthetic analog of endogenous estradiol.

Desogestrel has a pronounced gestagenic and antiestrogenic effect, similar to endogenous progesterone, weak androgenic and anabolic activity.

Regulon has a beneficial effect on lipid metabolism: it increases the concentration of HDL in the blood plasma, without affecting the content of LDL.

When taking the drug, the loss of menstrual blood is significantly reduced (with initial menorrhagia), the menstrual cycle is normalized, and a beneficial effect on the skin is noted, especially in the presence of acne vulgaris.

Pharmacokinetics

Desogestrel

Suction

Desogestrel is rapidly and almost completely absorbed from the gastrointestinal tract and is immediately metabolized to 3-keto-desogestrel, which is the biologically active metabolite of desogestrel.

Cmax is reached after 1.5 hours and is 2 ng / ml. Bioavailability - 62-81%.

Distribution

3-keto-desogestrel binds to plasma proteins, mainly albumin and sex hormone-binding globulin (SHBG). Vd is 1.5 l/kg. Css is established by the second half of the menstrual cycle. The level of 3-keto-desogestrel increases 2-3 times.

Metabolism

breeding

T1 / 2 3-keto-desogestrel is 30 hours. Metabolites are excreted in the urine and feces (in a ratio of 4:6).

Ethinylestradiol

Suction

Ethinylestradiol is rapidly and completely absorbed from the gastrointestinal tract. Cmax is achieved 1-2 hours after taking the drug and is 80 pg / ml. The bioavailability of the drug due to presystemic conjugation and the effect of "first pass" through the liver is about 60%.

Distribution

Ethinylestradiol is completely bound to plasma proteins, mainly to albumins. Vd is 5 l/kg. Css is established by 3-4 days of administration, while the level of ethinylestradiol in serum is 30-40% higher than after a single dose of the drug.

Metabolism

breeding

T1 / 2 ethinylestradiol averages about 24 hours. About 40% is excreted in the urine and about 60% in the feces.

REGULON: DOSAGE

The drug is prescribed inside.

First dose of the drug

The first tablet should be taken from the first day of the menstrual cycle. In this case, you do not need to use additional methods of contraception. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle of using the drug, additional methods of contraception should be used in the first 7 days of taking the pills.

If more than 5 days have passed since the start of menstruation, you should postpone the start of taking the drug until the next menstruation.

Taking the drug after childbirth

Taking the drug after an abortion

After an abortion, in the absence of contraindications, pills should be started from the first day after the operation, and in this case there is no need to use additional methods of contraception.

Switching from another oral contraceptive

When switching from another oral preparation (21- or 28-day): the first tablet of Regulon is recommended to be taken the day after the completion of the course of the 28-day package of the drug. After completing the 21-day course, you must take the usual 7-day break and then start taking Regulon. There is no need to use additional methods of contraception.

Switching to Regulon after using oral progestogen-only pills ("mini-pill")

The first tablet of Regulon should be taken on the 1st day of the cycle. There is no need to use additional methods of contraception.

If menstruation does not occur when taking the “mini-pill”, then after the exclusion of pregnancy, you can start taking Regulon on any day of the cycle, but in this case, additional methods of contraception must be used in the first 7 days (use of a cervical cap with spermicidal gel, a condom, or abstinence from sexual intercourse). The use of the calendar method in these cases is not recommended.

Postponement of the menstrual cycle

If there is a need to delay menstruation, it is necessary to continue taking the tablets from the new package, without a 7-day break, according to the usual scheme. With a delay in menstruation, breakthrough or spotting bleeding may occur, but this does not reduce the contraceptive effect of the drug. Regular intake of Regulon can be restored after the usual 7-day break.

Missed pills

If a woman forgot to take a pill in a timely manner, and no more than 12 hours have passed after the missed one, you need to take the forgotten pill, and then continue taking it at the usual time. If more than 12 hours have passed between taking the pills - this is considered a missed pill, the reliability of contraception in this cycle is not guaranteed and the use of additional methods of contraception is recommended.

If you miss a pill in the third week of the cycle, you must take the forgotten pill, continue to take it regularly and do not take a 7-day break. It is important to remember that due to the minimum dose of estrogen, the risk of ovulation and / or bleeding increases when a pill is missed, and therefore the use of additional methods of contraception is recommended.

Vomiting/diarrhea

Overdose

Symptoms: nausea, vomiting, in girls - bloody discharge from the vagina.

Treatment: in the first 2-3 hours after taking the drug in a high dose, gastric lavage is recommended. There is no specific antidote, treatment is symptomatic.

drug interaction

Drugs that induce hepatic enzymes such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, St. John's wort drugs reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually reached no earlier than 2-3 weeks, but may last up to 4 weeks after discontinuation of the drug.

Ampicillin and tetracycline reduce the effectiveness of Regulon (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Oral contraceptives may decrease carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.

Pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

During the period of breastfeeding, it is necessary to resolve the issue of either discontinuing the drug or stopping it.

REGULON: SIDE EFFECTS

Side effects requiring discontinuation of the drug

From the side of the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

Others: hemolytic uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects that are more common but less severe. The expediency of continuing the use of the drug is decided individually after consultation with a doctor, based on the benefit / risk ratio.

On the part of the reproductive system: acyclic bleeding / bloody discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, enlargement of the mammary glands, galactorrhea.

From the digestive system: nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.

Dermatological reactions: erythema nodosum, erythema exudative, rash, chloasma.

From the side of the central nervous system: headache, migraine, mood lability, depression.

On the part of the organ of vision: increased sensitivity of the cornea (when wearing contact lenses).

On the part of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates.

Other: allergic reactions.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15 ° to 30 ° C. Shelf life - 3 years.

Indications

contraception.

Contraindications

the presence of severe and / or multiple risk factors for venous or arterial thrombosis (incl.
severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);
the presence or indication of a history of precursors of thrombosis (incl.
transient ischemic attack,
angina);
migraine with focal neurological symptoms,
including
in history;
venous or arterial thrombosis / thromboembolism (incl.
myocardial infarction,
stroke,
deep vein thrombosis,
pulmonary embolism) at present or in history;
the presence of venous thromboembolism in history;
diabetes mellitus (with angiopathy);
pancreatitis (incl.
in history)
accompanied by severe hypertriglyceridemia;
dyslipidemia;
severe liver disease
cholestatic jaundice (incl.
during pregnancy)
hepatitis,
including
in history (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
jaundice when taking GCS;
cholelithiasis at present or in history;
Gilbert's Syndrome
Dubin-Johnson Syndrome,
Rotor syndrome;
liver tumors (including
in history);
severe itching,
otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
hormone-dependent malignant neoplasms of the genital organs and mammary glands (incl.
if they are suspected);
vaginal bleeding of unknown etiology;
smoking over the age of 35 (more than 15 cigarettes per day);
pregnancy or suspicion of it;
lactation period;
hypersensitivity to the components of the drug.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, family history, obesity (body mass index over 30 kg / m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart defects, atrial fibrillation, prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, severe depression (including history), changes in biochemical parameters (resistance activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, including lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (incl. family history), acute and chronic liver disease.

special instructions

Before starting the use of the drug, it is necessary to conduct a general medical (detailed family and personal history, measurement of blood pressure, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). A similar examination during the period of taking the drug is carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 1 year), when used correctly, is about 0.05.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

diseases of the hemostasis system;
conditions/diseases
predisposing to the development of cardiovascular
renal failure;
epilepsy;
migraine;
the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
diabetes,
not complicated by vascular disorders;
severe depression (if depression is associated with impaired tryptophan metabolism,
then for the purpose of correction, vitamin B6 can be used);
sickle cell anemia,
in some cases (for example,
infection,
hypoxia) estrogen-containing drugs in this pathology can provoke thromboembolism;
the appearance of abnormalities in laboratory tests for assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a link between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic disease has been proven, but it is significantly less than during pregnancy (60 cases per 100,000 pregnancies).

The frequency of spontaneous occurrence of new cases of venous thromboembolic disease in healthy non-pregnant women not taking oral contraceptives is about 5 cases per 100,000 women per year. When using second-generation drugs - 15 cases per 100 thousand women per year, and when using third-generation drugs - 25 cases per 100 thousand women per year.

When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of developing arterial or venous thromboembolic diseases increases:

with age;
when smoking (heavy smoking and age over 35 are risk factors);
with a family history of thromboembolic disease (eg,
at parents,
brother or sister).
If a genetic predisposition is suspected,
it is necessary to consult a specialist before using the drug;
with obesity (body mass index over 30 kg/m2);
with dyslipoproteinemia;
with arterial hypertension;
in diseases of the heart valves,
complicated by hemodynamic disorders;
with atrial fibrillation;
with diabetes,
complicated by vascular lesions;
with prolonged immobilization,
after major surgery
after surgery on the lower extremities,
after a severe injury.

In these cases, a temporary cessation of the use of the drug is expected (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

When assessing the benefit / risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. The symptoms of thromboembolism are:

sudden chest pain
which radiates to the left hand;
sudden shortness of breath;
any unusually severe headache
continuing for a long time or appearing for the first time,
especially when combined with sudden complete or partial loss of vision or diplopia,
aphasia
dizziness
collapse
focal epilepsy,
weakness or severe numbness of half of the body,
movement disorders,
severe unilateral pain in the calf muscle,
sharp belly.

Tumor diseases

Some studies have reported an increase in the occurrence of cervical cancer in women who have been taking hormonal contraceptives for a long time, but the results of the studies are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection of breast cancer could be associated with more regular medical examinations. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women who take hormonal contraceptives for a long time. This should be kept in mind in the differential diagnostic evaluation of abdominal pain, which may be associated with an increase in the size of the liver or intraperitoneal bleeding.

Chloasma can develop in women who have a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with the sun's rays or ultraviolet radiation while taking Regulon.

Efficiency

The effectiveness of the drug may decrease in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that can reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they are finished in the next package. If, at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets and resume it only after pregnancy has been excluded.

Changes in laboratory parameters

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (not earlier than after 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking the drug, it is necessary to use additional non-hormonal methods of contraception.

A woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Influence on the ability to drive vehicles and control mechanisms

The drug does not affect the ability to drive a car and work with mechanisms.

Use for impaired renal function

With caution and only after a thorough assessment of the benefits and risks of use, the drug should be prescribed for renal failure (including history).

Use in violation of liver function

Contraindicated in liver failure.