Bloody, brown or spotting discharge when taking birth control pills. The best medicine for the liver

TRI-REGOL ®

21+7 tablets

RGD: 52156/R/2
RGD: 50159/H/2

What is the drug Tri-Regol 21+7 and what is it used for?

A three-phase hormonal contraceptive drug containing female sex hormones in small doses.

Active ingredients

Pink tablets contain 0.03 mg ethinyl estradiol and 0.05 mg levonorgestrel,
white tablets contain 0.04 mg ethinyl estradiol and 0.075 mg levonorgestrel,
dark yellow tablets contain 0.03 mg ethinyl estradiol and 0.125 mg levonorgestrel,
brown tablets contain 76.05 mg of ferrous fumarate.

Excipients: lactose, sucrose, titanium dioxide, dye (E 172).

The drug exerts its effect by inhibiting ovulation and increasing the viscosity of cervical mucus, which prevents sperm from moving into the uterine cavity.
Use only as directed by a physician and with regular medical supervision.

In what cases is it not allowed to take Tri-Regol 21+7?

It is not allowed to take the drug during pregnancy, with severe liver disease, with lipid metabolism disorders, with severe hypertension, severe diabetes mellitus, vaginal bleeding of unknown origin, with jaundice or herpes during previous pregnancies, if you have or previously had:
severe heart disease,
gallbladder diseases,
thrombosis or predisposition to it,
liver tumors,
malignant tumors mammary glands or uterus.

Special care required when using the drug in patients with diabetes mellitus, hypertension, phlebitis, varicose veins, epilepsy, chorea and benign tumors uterus
You must inform your doctor about these and other diseases before starting to take the drug.

When breastfeeding, due to a decrease in milk secretion under the influence of a hormonal contraceptive drug, use is allowed only after consultation with a doctor.
When taking the drug, you must undergo a medical examination every 6 months.
After hepatitis, oral hormonal contraceptives should not be taken for 6 months.

Women taking oral contraceptives may be more likely to develop certain bleeding disorders. This risk increases with age (over 30 years), but mainly in smokers. In this regard, women over 30 years of age are advised to completely stop smoking when taking hormonal contraceptives.

You should stop taking the drug immediately and consult a doctor if:

suspicion of pregnancy,
new, worsening migraine-like or unusually severe headache,
deterioration of vision and loss of senses,
unusual severe pain in the legs
development of jaundice or itching distributed throughout the body,
increased blood pressure,
seizure attack.

Against the background of long-term use of sex hormones, the appearance of benign liver tumors was very rarely observed, and malignant liver tumors were extremely rarely observed.
If you experience sharp, persistent pain in the upper abdomen, you should consult a doctor.
Brown pills do not contain hormones and are designed for continuity. They contain iron, which must be taken into account when taking other iron-containing medications.

How should I use Tri-Regol 21+7 tablets?

From the first day of menstruation, one tablet, always at the same time of day, for 28 days.
When taking 7 brown tablets, menstrual-like bleeding appears.
After taking all the tablets in the pack, you should continue taking the next 28 tablets without interruption, even if the bleeding has not stopped yet.

Correct sequence of administration(first 6 pink, then 5 white, 10 apricot tablets and 7 brown tablets) is indicated on the package as a number and arrow.
If the tablet is not taken at the usual time, you should take an additional missed tablet within the next 12 hours.

36 hours after taking the last pill, the contraceptive effect cannot be considered reliable, so in this case another (non-hormonal) method should be additionally used, and the calendar method and temperature measurement method are unreliable. Taking Tri-Regol must be continued minus the missed tablets from the already started package.

In case of vomiting and diarrhea, taking the drug must be combined with another (non-hormonal) contraceptive method.

If intermenstrual bleeding occurs, you should continue taking it, as bleeding usually stops spontaneously. If bleeding does not stop or recurs, you should consult a doctor.

If bleeding does not occur while taking 7 brown tablets, the drug should be discontinued until pregnancy is ruled out.

If according to medical indications If an earlier start of contraception is justified, then taking the pills should start on the first day of the first menstruation, but in the first two weeks it must be combined with another (non-hormonal) method of preventing pregnancy.

You should only take other medications (for example, antibiotics, anticoagulants, antidepressants, antidiabetic drugs) after consulting your doctor.

What undesirable effects may Tri-Regol 21+7 tablets have, and what to do in such cases?

As a rule, hormonal oral contraceptives are well tolerated. Rarely, nausea, vomiting, headache, tension in the mammary glands, weight changes, depressed mood, discomfort when wearing contact lenses, intermenstrual bleeding, which does not require discontinuation of the drug and goes away on its own after 2-3 months of regular use. With longer use, very rarely observed dark spots, increased blood pressure, increased blood sugar, skin rashes, thromboembolic diseases, liver and gallbladder diseases, increased fatigue, diarrhea.

When using brown tablets, due to the iron content, complaints may sometimes occur from gastrointestinal tract: nausea, vomiting, diarrhea or constipation. Black stool may appear.

About the appearance side effects it is necessary to inform the doctor.

How to store Tri-Regol 21+7?

Store at 1530°C.
Keep the drug out of the reach of children!
The drug can only be used within the expiration date indicated on the packaging.

If you have any other questions, please contact your doctor or pharmacist.

Contraceptives are used to prevent the onset of unwanted pregnancy or to normalize hormonal levels during the development of certain diseases, for example, ovarian cysts, endometriosis, etc. But often when taking them, heavy vaginal discharge occurs, which naturally alarms every woman. They can be either white mucous or bloody.Discharge when taking birth control pillsmay arise for various reasons. And it is very important to install them in a timely manner, since when taking incorrectly selected oral contraceptives (hereinafter ok), you may experience serious problems with health, which are unlikely to be resolved within a short time.

general information

To understand why there aredischarge while taking birth control pillsagents, it is necessary to consider their mechanism of action. Everything is ok mainly contain hormones that suppress female function. That is, they prevent the formation of eggs on the surface of the ovaries, thereby preventing its onset, but do not change menstrual cycle. On the contrary, when taking contraceptives in tablets, menstruation occurs “clockwise” and at the same time becomes less painful for the woman.

It is necessary to take contraceptive medications strictly according to the instructions at the same time. If they are taken at different periods of time, this will lead to serious hormonal disorders, against the background of which in the tissues of organs reproductive system pathological processes may begin. And they are often accompanied by vaginal discharge, which can be of a different nature.

Most often, women are worried about bloody andbrown discharge when taking ok, which occur outside of menstruation. And there are several reasons for this - the body’s addiction, non-compliance with the drug dosage regimen, or abrupt withdrawal of the drug. Why this happens and what to do about it, we will now discuss in more detail.

Profuse leucorrhoea

White vaginal discharge that occurs while taking birth control pills is completely natural. They do not indicate development pathological processes and do not require special treatment.

Increased leucorrhoea when taking oc is caused by changes in the vaginal microflora. Under the influence of hormones, the glands located on the surface of the uterus and its cervix begin to actively produce a protective secretion, which a woman can mark on her panties every day. It does not have a strong odor and does not cause discomfort.

According to doctors, physiological leucorrhoea in women can intensify during certain periods of the cycle. Namely, at the onset of ovulation and a few days before the onset of menstruation. And even when receiving contraception they also appear in large numbers. In the first case, their occurrence is caused by suppressive processes in the ovaries (the growth of the egg slows down and the process of its release from the follicle is prevented), in the second - by the preparation of the uterus for the upcoming menstruation.

All these processes are completely natural when taken and do not require treatment. But if the character of the leucorrhoea changed (they began to deplete bad smell, provoke the appearance of itching and burning), then you should immediately seek help from a doctor. The thing is that all these symptoms are signs of the development of thrush, which in this case can often appear due to changes in the vaginal microflora.

IN female body There are constant hormonal surges either towards estrogen or progesterone. This allows you to control your menstrual cycle. When active production of estrogen occurs, the endometrium of the uterus prepares for the upcoming ovulation, and when progesterone synthesis increases, it prepares for menstruation.

Birth control pills contain small doses of hormones and at the very beginning of their use they may not be enough to stop the active synthesis of estrogen, resulting in intermenstrual bleeding.

Most often, this happens only in the first 1-2 months of starting to take the drug, when adaptation of the body is observed. In this case, bleeding may occur in the middle of the cycle and its beginning. Normally, they are scanty in nature (the so-called daub begins) and are not accompanied by painful sensations in the lower abdomen. Their appearance does not mean that birth control pills are not suitable for you. You need to continue to drink them strictly according to the scheme and as soon as the adaptation period is over, the bleeding will stop after the next menstruation.

Important! Don't panic if you've just started taking ok and you have vaginal discharge. stood out a little blood. This is natural, since the body is experiencing severe hormonal stress!

It is necessary to consult a doctor ifspotting when taking birth control pillslasts for 3-4 months and is accompanied by:

  • Abdominal pain.
  • Discomfort in the lower abdomen during intimacy or during heavy physical activity.
  • Breast engorgement and soreness.

When is replacement needed?

If the adaptation period has already ended, and there is more and more bleeding when taking birth control pills, it is necessary to replace approx. Depending on exactly what periods of the cycle bleeding appears when taking birth control pills.

So, for example, if a woman takes pills and experiences spotting immediately after her period or in the middle of her cycle, this may indicate that her body is deficient in estrogen and needs medications containing a higher dosage of this hormone.

If a woman experiences bloody or brown discharge before menstruation, this already indicates an insufficient amount of gestagen in the body and in this case, it is necessary to take pills containing a high concentration of this particular hormone.

Bleeding in the middle of the cycle can signal the development of atrophic processes in the epithelial tissues and requires immediate treatment, since death can occur with large blood loss. Bleeding can also occur as a result of improper intake of ok, against the background of which a hormonal surge occurred.

If blood appears from the vagina in the middle of the cycle while taking approx., then, undoubtedly, the most the best option here is a trip to the doctor. However, if you carefully study the instructions for contraceptive medications, they clearly state that the appearance of such discharge is completely normal and if it occurs, you simply need to double the daily dosage of the OC (that is, take two instead of one tablet). You need to do this until hormonal background does not normalize and the discharge will not stop.

Important! You can’t stop drinking on your own in the middle of your cycle! This can increase bleeding, lead to a deterioration in general condition and anemia. With severe bleeding there is a high risk of loss of consciousness and large quantity blood, which could leave you in a hospital bed.

Other reasons

The appearance of discharge when taking ok may be associated not only with the adaptation period or an incorrectly selected drug. Vaginal smearing while taking a contraceptive may also occur for other reasons. For example:

  1. Having a bad habit such as smoking. Nicotine negatively affects hormonal levels, reducing the production of estrogen in the body.
  2. Taking some medicines. Not all drugs can be used in combination with birth control pills. Therefore, if you are taking any medication, be sure to inform your doctor.
  3. Development of infectious or inflammatory diseases reproductive system. They can be recognized by symptoms such as pain in the lower abdomen, the discharge has acquired a strong unpleasant odor, and its consistency has changed.

Remember that if there are any deviations from the norm, you should immediately visit a gynecologist. Only he will be able to determine the exact cause of such discharge and prescribe treatment that will get rid of it in a short time.

Registration certificate: LSR-008559/10

Trade name of the drug: Trigestrel

International nonproprietary name or generic name:
Levonorgestrel + Ethinyl estradiol

Dosage form:

film-coated tablets

Composition per tablet:

Brown pills(levonorgestrel 0.05 mg and ethinyl estradiol 0.03 mg):
Active substances: levonorgestrel 0.05 mg, ethinyl estradiol 0.03 mg;
Excipients: granulated lactose 58.42 mg (lactose 81.5%, sucrose 9.58%, corn starch 8.92%, disodium edetate 0.023%, methyl parahydroxybenzoate 0.134%), potassium polacrilin 1.0 mg, magnesium stearate 0.5 mg;
Sugar coating: ethylcellulose 0.325 mg, purified talc 10.71 mg, acacia gum 1.77 mg, disodium edetate 0.00585 mg, sucrose 15.61 mg, microcrystalline cellulose 0.22 mg, titanium dioxide 0.019 mg, red iron oxide dye 0.081 mg, macrogol 6000 (polyethylene glycol 6000) 0.268 mg.

White pills(levonorgestrel 0.075 mg and ethinyl estradiol 0.04 mg):
Active substances: levonorgestrel 0.075 mg, ethinyl estradiol 0.04 mg;
Excipients: granulated lactose 58.384 mg (lactose 81.5%, sucrose 9.58%, corn starch 8.92%, disodium edetate 0.023%, methyl parahydroxybenzoate 0.134%), potassium polacriline 1.0 mg, magnesium stearate 0.5 mg;
Sugar coating: ethylcellulose 0.325 mg, purified talc 10.53 mg, acacia gum 1.77 mg, disodium edetate 0.00585 mg, sucrose 15.61 mg, microcrystalline cellulose 0.22 mg, titanium dioxide 0.28 mg, macrogol 6000 (polyethylene glycol 6000 ) 0.268 mg.

Yellow pills(levonorgestrel 0.125 mg and ethinyl estradiol 0.03 mg):
Active substances: levonorgestrel 0.125 mg, ethinyl estradiol 0.03 mg.
Excipients: granulated lactose 58.344 mg (lactose 81.5%, sucrose 9.58%, corn starch 8.92%, disodium edetate 0.023%, methyl parahydroxybenzoate 0.134%), potassium polacrilin 1.0 mg, magnesium stearate 0.5 mg;
Sugar coating: ethylcellulose 0.325 mg, purified talc 10.71 mg, acacia gum 1.77 mg, disodium edetate 0.00585 mg, sucrose 15.61 mg, microcrystalline cellulose 0.22 mg, titanium dioxide 0.019 mg, iron dye yellow oxide 0.081 mg, macrogol 6000 (polyethylene glycol 6000) 0.268 mg.

Description

  1. Levonorgestrel 0.05 mg and ethinyl estradiol 0.03 mg: Brown, round, biconvex tablets, sugar-coated.
  2. Levonorgestrel 0.075 mg and ethinyl estradiol 0.04 mg: White, round, biconvex tablets, sugar-coated.
  3. Levonorgestrel 0.125 mg and ethinyl estradiol 0.03 mg: Yellow round biconvex tablets, sugar-coated. Cross-sectional view (for all dosages) - the core is white or almost white.

Pharmacotherapeutic group:

combined contraceptive (estrogen + gestagen)

ATX Code: G03AB03

pharmachologic effect
Pharmacodynamics
Trigestrel is a low-dose, three-phase oral combined (estrogen + gestagen) contraceptive drug. The contraceptive effect is achieved through several complementary mechanisms. Under the influence of levonorgestrel, the release of releasing factors (luteinizing and follicle-stimulating hormones and follicle-stimulating hormones) of the hypothalamus is blocked, the secretion of gonadotropic hormones by the pituitary gland is inhibited, which leads to inhibition of the maturation and release of an egg ready for fertilization (ovulation). Changes in the endometrium occur that prevent the implantation of a fertilized egg.
Ethinyl estradiol increases the viscosity of cervical secretions, making them impermeable to sperm.
Along with the contraceptive effect, Trigestrel reduces the pain and intensity of menstrual-like bleeding and reduces the intensity of bleeding, which, in turn, reduces one of the risk factors for the development of iron deficiency anemia. In seven-day periods, when the next break in taking the drug follows, uterine bleeding occurs.
When used correctly, the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during a year of using a contraceptive) is less than 1. If pills are missed or used incorrectly, the Pearl index may increase.

Pharmacokinetics

Levonorgestrel

Absorption.
After oral administration, levonorgestrel is quickly and completely absorbed, its maximum concentration in the blood plasma, about 2 ng/ml, is reached after about 1 hour. After a single oral dose of 0.125 mg of levonorgestrel along with 0.03 mg of ethinyl estradiol (which corresponds to the highest content of levonorgestrel in a triphasic drug) , the highest serum concentration of 4.3 ng/ml was determined after approximately 1 hour.

Distribution.
Levonorgestrel binds to serum albumin and sex hormone binding globulin (SHBG). Only 1.4% is found in free form total concentration in blood serum, while 55% are specifically associated with SHBG and about 40% with albumin. As a result of the induction of binding protein synthesis by ethinyl estradiol, the fraction associated with SHBG increases, while the fraction associated with albumin decreases. The apparent volume of distribution of levonorgestrel is approximately 128 L after a single oral dose of Trigestrel tablet containing the highest dose of levonorgestrel.

Equilibrium concentration.
The pharmacokinetics of levonorgestrel is affected by the concentration of SHBG in the blood serum, which increases approximately 2-fold over a 21-day course of taking Trigestrel. As a result of daily administration of the drug, the concentration of levonorgestrel in the serum increases approximately 2 times, and the equilibrium concentration is achieved in the second half of the course. The volume of distribution at steady state and clearance are reduced to 52 l and 0.5 ml/min/kg, respectively.

Metabolism.
Levonorgestrel is completely metabolized by a metabolic pathway characteristic of sex hormones. After a single oral dose of the highest dose of levonorgestrel, the plasma clearance rate is approximately 1 ml/min/kg.

Excretion.
The concentration of levonorgestrel in the blood serum undergoes a two-phase decrease. The half-life in the terminal phase is about 22 hours. Levonorgestrel is not excreted unchanged, but only in the form of metabolites by the kidneys and through the intestines with a half-life of about 24 hours in a ratio of approximately 1:1.

Ethinyl estradiol

Absorption.
After oral administration, ethinyl estradiol is absorbed quickly and completely. The maximum serum concentration of approximately 115 pg/ml is achieved in approximately 1.3 hours. Ethinyl estradiol is metabolized due to the first-pass effect through the liver, resulting in its oral bioavailability averaging about 45%, with significant interindividual variations. differences range from 20-65%.

Equilibrium concentration.
Equilibrium concentration is achieved after 1 week,

Distribution.
Ethinyl estradiol is almost completely (98%) bound to albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is approximately 3-8 l/kg.

Metabolism.
Ethinyl estradiol undergoes presystemic conjugation, as in the mucosa small intestine, and in the liver. The main route of metabolism is aromatic hydroxylation. Clearance from blood plasma is 2.3-7 ml/min/kg.

Excretion.
Serum ethinyl estradiol concentrations decrease biphasically; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and liver in a ratio of 4:6, with a half-life of about 24 hours.

Indications for use
Contraception.

Contraindications
Trigestrel should not be used if you have any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be discontinued immediately:

  • Hypersensitivity to any of the components of Trigestrel.
  • Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, thromboembolism pulmonary artery, myocardial infarction), cerebrovascular disorders.
  • Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
  • Multiple or severe risk factors for venous or arterial thrombosis, including damage to the heart valves, cardiac arrhythmias, deep vein thrombophlebitis, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension (see "Special Instructions").
  • Prolonged immobilization, extended surgical intervention, surgical interventions on lower limbs, extensive injuries.
  • Migraine with focal neurological symptoms currently or in history.
  • Diabetes mellitus with vascular complications.
  • Pancreatitis with severe hypertriglyceridemia, currently or in history.
  • Liver failure and serious illnesses liver (until liver tests return to normal).
  • Liver tumors (benign or malignant) currently or in history.
  • Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
  • Bleeding from the genital tract of unknown origin.
  • Pregnancy or suspicion of it.
  • Breastfeeding period.
  • Lactase deficiency, sucrase/isomaltase deficiency, fructose intolerance, lactose intolerance, glucose-galactose malabsorption.

Use with caution
If any of the conditions/risk factors listed below currently exist, the potential risk should be weighed against the expected benefit of using combined oral contraceptives in each individual case:

  • Risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or disorder cerebral circulation at a young age from one of the closest relatives; obesity (body mass index more than 30 kg/m2); dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms;
  • Other diseases in which peripheral circulatory disorders may occur: diabetes without vascular lesions; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins;
  • Hypertriglyceridemia;
  • Liver diseases;
  • Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, pregnancy herpes, Sydenham's chorea).

Pregnancy and lactation
Trigestrel is not prescribed during pregnancy and breastfeeding. If pregnancy is detected while taking Trigestrel, the drug should be discontinued immediately. Extensive epidemiological studies have not found any increased risk of developmental defects in children, born by women who received sex hormones before pregnancy or teratogenic effects, when sex hormones were taken inadvertently in early dates pregnancy.
Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, as a rule, their use is not recommended during lactation.
Small amounts of sex hormones and/or their metabolites may be excreted in breast milk, but there is no evidence that they negative impact on the baby's health.

Directions for use and doses
The tablets should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water. Take 1 tablet per day continuously for 21 days. The next package begins after a 7-day break from taking pills, during which withdrawal bleeding usually occurs.
Bleeding usually begins 2-3 days after taking the last tablet and may not stop until you start taking a new pack.

How to start taking Trigestrel

  • If you have not taken any hormonal contraceptives in the previous month.
    Taking Trigestrel begins on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). It is possible to start taking it on days 2-5 of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.
  • When switching from other combined oral contraceptives, vaginal ring or contraceptive patch.
    It is preferable to start taking Trigestrel the 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 products containing 21 tablets) or after taking the last inactive tablet (for products containing 28 tablets per package). Trigestrel should be started on the day the vaginal ring or patch is removed, but no later than the day when a new ring or patch is to be inserted.
  • When switching from contraceptives containing only gestagens ("mini-pills", injectable forms, implant) or from a gestagen-releasing intrauterine contraceptive.
    A woman can switch from a mini-pill to Trigestrel on any day (without a break), from an implant or intrauterine contraceptive with a gestagen - on the day of its removal, from an injection form - from the day when the next injection is due. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.
  • After an abortion in the first trimester of pregnancy.
    A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.
  • After childbirth or abortion in the second trimester of pregnancy.
    It is recommended to start taking the drug on days 21-28 after childbirth or abortion in the second trimester of pregnancy. If use is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already been sexually active, pregnancy should be excluded before starting to take Trigestrel or she must wait until her first menstruation.

Taking missed pills
If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as she remembers; the next one is accepted at the usual time. If you are late in taking your pills more than 12 hours, contraceptive protection may be reduced. The more pills are missed and the closer the missed pill is to the 7-day break in taking pills, the greater the likelihood of pregnancy. In this case, you can be guided by the following two basic rules:

  • The drug should never be interrupted for more than 7 days.
  • 7 days of continuous tablet use are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation. Accordingly, the following advice can be given:
  • First week of taking the drug A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used for the next 7 days. If sexual intercourse took place within a week before missing a pill, the possibility of pregnancy must be taken into account.
  • Second week of taking the drug A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablet is taken at the usual time. Provided that the woman has taken the pills correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.
  • Third week of taking the drug The risk of decreased reliability is inevitable due to the upcoming break in taking the pills. A woman must strictly adhere to one of the following two options. Moreover, if during the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. A woman should take the last missed pill as soon as she remembers (even if this means taking two pills at the same time). The next tablets are taken at the usual time until the tablets in the current pack are gone. You should start taking the drug from the next package immediately. Withdrawal bleeding is unlikely until the second pack is finished, but bleeding of varying intensity (from spotting to breakthrough bleeding) may occur while taking the tablets.
A woman can also stop taking pills from the current pack. Then she should take a break for 7 days, including the day she missed the pills, and start taking a new pack.
If a woman misses taking pills and then does not have withdrawal bleeding during a break in taking the drug, pregnancy must be ruled out.

Recommendations in case of vomiting and diarrhea
If a woman has vomiting or diarrhea within 4 hours of taking the tablets, absorption may be incomplete and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping pills.

Changing the day of the onset of menstrual bleeding
In order to delay the onset of menstrual bleeding, a woman should continue taking the drug, using the last 10 tablets from another package of Trigestrel, without taking a break. In this way, the cycle can be extended by up to 10 days until the end of the second package. While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Regular use of Trigestrel is then resumed after the usual 7-day tablet-free interval. In order to move the day of the onset of menstrual bleeding to another day of the week, a woman should reduce the next break in taking pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and, in the future, will have spotting or breakthrough bleeding while taking the second package (just as in the case when she would like to delay the onset of menstrual-like bleeding).

Children and teenagers
Trigestrel is indicated for use only after menarche.

Side effect
When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. While taking combined oral contraceptives, women experienced other undesirable effects, the connection of which with the drugs was not confirmed, but not refuted.

Organ systems Often (≥1/100) Uncommon (≥1/1000 and<1/100) Rarely (<1/1000)
Organ of vision - - intolerance to contact lenses (unpleasant sensations when wearing them)
Gastrointestinal tract nausea, abdominal pain vomiting, diarrhea -
The immune system - - allergic reactions
General symptoms weight gain - weight loss
Metabolism - fluid retention -
Nervous system headache migraine -
Psychiatric disorders decreased mood, emotional lability decreased libido increased libido
Reproductive system and mammary glands breast pain, breast engorgement mammary hypertrophy vaginal discharge, breast discharge
Skin and subcutaneous tissues - rash, hives erythema nodosum, erythema multiforme

As with other combined oral contraceptives, in rare cases, the development of thrombosis and thromboembolism (see also “Special Instructions”) and chloasma is possible.
Taking exogenous estrogens may cause or worsen symptoms of angioedema in women with hereditary angioedema.

Overdose
No serious adverse events have been reported following overdose. Symptoms that may occur in case of overdose: nausea, vomiting, spotting or metrorrhagia. There is no specific antidote; symptomatic treatment should be carried out.

Interaction with other drugs
Effect on hepatic metabolism: the use of drugs that induce liver microsomal enzymes can lead to increased clearance of sex hormones. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; There are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort (Hypericum perforatum).
HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof also have the potential to affect hepatic metabolism.
Effect on enterohepatic recirculation: According to individual studies, some antibiotics (for example, penicillins and tetracyclines) may reduce the enterohepatic recirculation of estrogens, thereby reducing the concentration of ethinyl estradiol.
While taking medications that affect liver microsomal enzymes, and for 28 days after their discontinuation, you should additionally use a barrier method of contraception.
While taking antibiotics (such as penicillins and tetracyclines) and for 7 days after their discontinuation, you should additionally use a barrier method of contraception. If the period of use of a barrier method of contraception ends later than the tablets in the package, you need to move on to the next package of Trigestrel without the usual break in taking the tablets.
Oral combination contraceptives may affect the metabolism of other drugs, resulting in increased (eg cyclosporine) or decreased (eg lamotrigine) plasma and tissue concentrations.
When taking combined estrogen-progestin contraceptives, adjustment of the dosage regimen of hypoglycemic drugs and indirect anticoagulants may be required. Interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or decreased contraceptive reliability.

special instructions
If any of the conditions/risk factors listed below currently exist, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking the drug. . If any of these conditions or risk factors worsen, intensify, or appear for the first time, a woman should consult her doctor, who may decide whether to discontinue the drug.

  • Diseases of the cardiovascular system
    There is epidemiological evidence of an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) when taking combined oral contraceptives. These diseases are rare. The risk of developing venous thromboembolism (VTE) is greatest in the first year of taking such drugs. Estimated incidence of VTE among women taking low-dose oral contraceptives (<0,05 мг этинилэстрадиола), составляет 4 на 10 000 женщин в год в сравнении с 0.5-3 на 10 000 женщин в год у женщин, не принимающих пероральные контрацептивные средства. Однако, частота ВТЭ у беременных женщин выше, чем у женщин, принимающих оральные контрацептивы, и составляет 6 на 10 000 женщин в год. Риск развития тромбоза (венозного и/или артериального) и тромбоэмболии повышается:
    • with age;
    • in smokers (with increasing number of cigarettes or increasing age, the risk further increases, especially in women over 35 years of age); in the presence of:
    • positive family history (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, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
    • if you have obesity (body mass index more than 30 kg/m2);
    • with dyslipoproteinemia;
    • with arterial hypertension;
    • for migraines;
    • for diseases of the heart valves;
    • with atrial fibrillation;
    • with prolonged immobilization, extensive surgery, any leg surgery or major trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least 4 weeks before it) and not to resume use for 2 weeks after the end of immobilization.
    The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.
    The increased risk of thromboembolism in the postpartum period should be taken into account.
    Peripheral circulatory disorders may 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 use of combined oral contraceptives (which may precede cerebrovascular events) may be grounds for immediate discontinuation of these drugs.
    When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant diseases can reduce the associated risk. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (
  • Tumors
    The most significant risk factor for developing cervical cancer is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives. The connection with the use of combined oral contraceptives has not been proven. Controversy remains regarding the extent to which these phenomena are associated with screening for cervical pathology or with sexual behavior (lower use of barrier methods of contraception).
    A meta-analysis of 54 epidemiological studies found 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 of stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer detection in women currently or recently taking combined oral contraceptives is small relative to the overall risk of breast cancer. Its connection with the use of combined oral contraceptives has not been proven. The observed increased risk may also be a consequence of earlier diagnosis of breast cancer in women using combined oral contraceptives.
    In rare cases, during 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 case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
  • Other states
    In women with hypertriglyceridemia (including a family history), there may be an increased risk of developing pancreatitis while taking combined oral contraceptives.
    Although slight increases in blood pressure have been described in many women taking combined oral contraceptives, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment of hypertension should be initiated. Taking combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.
    The following conditions 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; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described during the use of combined oral contraceptives.
    In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
    Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function tests return 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 have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in patients with diabetes mellitus using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема комбинированных пероральных контрацептивов.
    Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives. 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 normal values. Reduced efficiency
    The effectiveness of combined oral contraceptives may be reduced in the following cases: missed pills, vomiting and diarrhea, or as a result of drug interactions. Effect on the menstrual cycle
    While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three cycles.
    If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy. Some women may not develop withdrawal bleeding while off the pill. If combined oral contraceptives are taken as directed, the woman is unlikely to be pregnant. However, if combined oral contraceptives have not been taken regularly before or if there are no consecutive withdrawal bleeds, pregnancy should be ruled out before continuing to take the drug. Medical examinations
    Before starting or resuming the use of the drug Trigestrel, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical examination (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination (including examination of the mammary glands and cytological examination of the cervical mucosa), exclude pregnancy.
    The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months.
    The woman should be warned that hormonal contraceptives (including Trigestrel) do not protect against HIV infection and other sexually transmitted diseases! Impact on the ability to drive a car and equipment
    Not found. Release form.
    Film-coated tablets.
    6 brown tablets (levonorgestrel 0.05 mg and ethinyl estradiol 0.03 mg),
    5 white tablets (levonorgestrel 0.075 mg and ethinyl estradiol 0.04 mg),
    10 yellow tablets (levonorgestrel 0.125 mg and ethinyl estradiol 0.03 mg) in one PVC/PVDC/aluminum foil blister (21 tablets in total).
    1 or 3 blisters of 21 tablets each are placed in a cardboard box with instructions for use Storage conditions
    In a dry place, protected from light, at a temperature not exceeding 25 ° C.
    Keep out of the reach of children. Best before date
    3 years.
    Do not use after expiration date. Conditions for dispensing from pharmacies
    On prescription.

    Manufacturer:


    Fami Care Limited, India
    1608/1609 G.I.D.S.
    Saringam, Valsad district, Gujarat,
    India, 396155 Consumer complaints should be sent to:
    Dr Reddy's Laboratories Ltd
    115035 Moscow Ovchinnikovskaya embankment, 20, building 1

    • Release form:

    Film-coated tablets in blisters 21 or 63 tablets of three types (brown 6/18, white 5/15, yellow 10/30), 1 blister in a cardboard pack.

    Compound:

    Three types of tablets:

    One brown tablet contains

    Active substances: ethinyl estradiol 30 mcg, levonorgestrel 50 mcg.

    One white tablet contains

    Active substances: ethinyl estradiol 40 mcg, levonorgestrel 75 mcg.

    One yellow tablet contains

    Active substances: ethinyl estradiol 30 mcg, levonorgestrel 125 mcg.

    Description:

    Film-coated tablets of brown, white, yellow colors, round, biconvex.

    Pharmacotherapeutic group:

    • Hormones and their antagonists

    Pharmacological properties:

    Pharmacodynamics

    Contraceptive combined estrogen-progestogen drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a gestagenic component (progestin), it contains a derivative of 19-nortestosterone - levonorgestrel, which is more active than the corpus luteum hormone progesterone (and a synthetic analogue of the latter - pregnin), acts at the receptor level without preliminary metabolic transformations. The estrogenic component is ethinyl estradiol. Under the influence of levonorgestrel, the release of releasing factors (LH and FSH) of the hypothalamus is blocked, the secretion of gonadotropic hormones by the pituitary gland is inhibited, which leads to inhibition of the maturation and release of an egg ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol. Maintains high viscosity of cervical mucus (makes it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, when taken regularly, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, incl. tumor nature.

    Pharmacokinetics

    When taken orally, the active substances are quickly and completely absorbed from the gastrointestinal tract. TC max of levonorgestrel - 2 hours, ethinyl estradiol - 1.5 hours. Both components are excreted in breast milk. Active substances are metabolized in the liver. T1/2 - 2–7 hours. Excretion: levonorgestrel - 60% by the kidneys, 40% - through the intestines; ethinyl estradiol - 40% by the kidneys, 60% through the intestines.

    Indications for use:

    Contraception;

    Functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).

    Refers to diseases:

    • Dysmenorrhea
    • Contraception
    • PMS

    Contraindications:

    The drug should not be used if any of the conditions listed below are present:

    Hypersensitivity to the components of the drug;

    Venous thrombosis, incl. history, including deep vein thrombosis, pulmonary embolism;

    Arterial thrombosis, incl. history, including acute cerebrovascular accident, myocardial infarction, retinal artery thrombosis or precursors of thrombosis (including angina pectoris or transient ischemic attack);

    The presence of serious or multiple risk factors for arterial thrombosis (severe arterial hypertension - blood pressure more than 160/100 mm Hg; diabetes mellitus with vascular damage; hereditary dyslipoproteinemia);

    Hereditary predisposition to venous or arterial thrombosis, such as activated protein C resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);

    Migraine with aura;

    Confirmed or suspected breast cancer;

    Endometrial cancer and confirmed or suspected estrogen-dependent tumors;

    Liver adenoma and carcinoma;

    Genital bleeding;

    Postmenopausal period;

    Age up to 18 years;

    Postpartum period (4 weeks);

    Lactation period;

    Do not use on the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

    Carefully:

    Venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age;

    Prolonged immobilization;

    Obesity (body mass index more than 30 kg/m2, calculated as the ratio of body weight in kilograms to the square of height in meters);

    Thrombophlebitis of superficial veins and varicose veins;

    Dyslipoproteinemia;

    Arterial hypertension;

    Lesions of the valvular apparatus of the heart;

    Atrial fibrillation;

    Diabetes;

    Systemic lupus erythematosus;

    Hemolytic-uremic syndrome;

    Crohn's disease;

    Ulcerative colitis;

    Liver dysfunction;

    Hypertriglyceridemia, incl. in the family history;

    Acute liver dysfunction during a previous pregnancy or previous use of sex hormones;

    Menstrual irregularities;

    Renal dysfunction.

    Directions for use and dosage:

    Orally, 1 tablet 1 time per day, starting from the 1st day of the menstrual cycle for 21 days, followed by a 7-day interval.

    One calendar package contains dragees of different colors. The pills are taken without chewing and washed down with a small amount of liquid. The time of administration does not matter, however, subsequent doses should be taken at the same selected hour, preferably after breakfast or dinner (to ensure a constant concentration of hormones in the plasma, the interval between doses should not exceed 36 hours, it should be maintained at 22–26 h). If the drug was started in the second half of the week, the first menstrual cycle may be shorter than 4 weeks.

    After completing the drug, there is a 7-day break, after which typical menstrual bleeding should begin. Regardless of the occurrence and duration of bleeding, the next 21-day course of taking the drug should be started immediately after the end of the 7-day break (i.e. on day 8). Typically, the first menstrual cycle after stopping the drug is extended by 1 week.

    In case of a missed dose, you must take the drug within the next 12 hours. If the dosage interval is more than 36 hours, reliable contraceptive effect is not guaranteed (despite this, treatment should be continued in order to prevent the onset of premature menstruation associated with stopping the drug). During this period, it is recommended to use other non-hormonal methods of contraception (except for the Knaus-Ogino calendar method, as well as the temperature measurement method).

    Side effect:

    Nausea, vomiting, headache, engorgement of the mammary glands, increased body weight, decreased libido and mood, deepening of the voice, the appearance of intermenstrual bleeding, in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort when wearing contact lenses (these phenomena are temporary character and disappear after discontinuation without prescribing any therapy).

    With long-term use: chloasma, hearing loss, generalized itching, jaundice, calf muscle cramps, increased frequency of epileptic seizures.

    Rarely: hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, skin rashes, changes in the nature of vaginal secretion, vaginal candidiasis, increased fatigue, diarrhea.

    Overdose:

    There are no cases of drug overdose during clinical use.

    Use during pregnancy and breastfeeding:

    Excreted in small quantities into breast milk. Usually, taking oral contraceptives is indicated only during a long period of lactation, because During a short period of breastfeeding, the menstrual cycle, as a rule, is not restored. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Interaction with other drugs:

    Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can enhance the metabolism of the steroid hormones included in the drug.

    A decrease in contraceptive effectiveness can also be observed when administered simultaneously with certain antimicrobial drugs (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in the microflora in the intestine.

    When taking gestagen-estrogenic drugs, it may be necessary to adjust the dosage regimen of hypoglycemic drugs and indirect anticoagulants

    Special instructions and precautions:

    After stopping the drug, fertility is restored fairly quickly, within 1–3 menstrual cycles.

    Prescription after childbirth or abortion (miscarriage) is recommended no earlier than the first normal menstrual cycle has passed.

    Before starting contraception and every 6 months, a general medical and gynecological examination is recommended (including examination of the mammary glands, liver function, monitoring of blood pressure and cholesterol concentrations in the blood, urine analysis).

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

    With diarrhea and vomiting, the contraceptive effect is reduced (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).

    Treatment should be stopped immediately if pregnancy occurs, migraine-like headaches develop (if they did not exist previously), early signs of phlebitis or phlebothrombosis appear (unusual pain or swelling of the veins in the legs), jaundice, visual impairment, cerebrovascular disorders, stabbing pain of unknown etiology. when breathing or coughing, pain and tightness in the chest, with increased blood pressure, as well as 3 months before a planned pregnancy and approximately 6 weeks before a planned surgical intervention, with prolonged immobilization.

    Moderate bleeding during the course does not require discontinuation of use.

    Storage conditions:

    The drug should be stored out of the reach of children at a temperature not exceeding 25°C.