Tri-regol - instructions for use, indications, hormone composition, side effects, analogues and price. Tri-regol, film-coated tablets Tri-regol three-phase at what height

The drug Tri-Regol is a combined 3-phase contraceptive for oral administration. Instructions for use of Tri-regol contain data on the action of the drug: it suppresses ovulation, blocking the formation of LH and FSH in the pituitary gland, and stimulates the process of secretory transformation of the endometrium. The product helps to increase the viscosity of cervical mucus, creating obstacles to the penetration of sperm.

The drug is distinguished by its ability to reduce the secretion of gonadotropic hormones. And sequential intake of tablets with different contents of levonorgestrel and ethinyl estradiol provides the amount of these hormones close to the indicators of the menstrual cycle, which contributes to the process of secretory transformation of the endometrium.

The impact of Tri-Regol is associated with the action of the following mechanisms:

• levonorgestrel interferes with the release of releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus and negatively affects the formation of gonadotropic hormones by the pituitary gland - this causes inhibition of ovulation;
• the substance ethinyl estradiol makes cervical mucus more viscous, which creates obstacles for sperm to enter the uterus.

The abstract contains data that, in addition to the contraceptive effect, the product normalizes the menstrual cycle.

Composition of the drug and release form

The dosage form of the drug is film-coated tablets: round, glossy, biconvex, white at the break (21 tablets in one blister, 1 or 3 blisters in a box). The package contains 3 types of tablets.

Active ingredients of pink tablets (blister pack - 6 pcs.):

• Levonorgestrel in a volume of 50 micrograms;
• Ethinyl estradiol in a volume of 30 mcg.

Active ingredients of white tablets (5 pcs in blister):

• Levonorgestrel in a volume of 75 mcg;
• Ethinyl estradiol in a volume of 40 mcg.

Active ingredients of dark yellow tablets (blister pack - 10 pcs.):

• Levonorgestrel in a volume of 125 mcg;
• Ethinyl estradiol in a volume of 30 micrograms.

Excipients of the drug: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, talc, corn starch.

Shell composition: calcium carbonate, titanium dioxide (E171), copovidone, sucrose, macrogol 6000, talc, povidone, carmellose sodium, colloidal silicon dioxide. In addition, pink tablets contain dye E172 - red iron oxide, dark yellow tablets - yellow iron oxide (E172).

Tri-Regol must be stored at a temperature of +15°C – +25°C.

Instructions for use

First use of Tri-Regol. The drug is used one tablet/day from the first day of the cycle for three weeks. It is also possible to start taking it from days 2 to 7, and in the first cycle it is additionally recommended to use non-hormonal methods of contraception in the first week of the course.

Since the composition of the different colored tablets varies, it is recommended to take pink tablets for six days, then white tablets for five days, followed by 10 days of dark yellow tablets.

After completing the 3-week course, you should take a break for one week (at which time menstrual-like bleeding usually occurs - most often on the 2-3rd day).

On the first day after the end of the break, if protection is necessary, you should start the 3-week course again. When taken regularly, the contraceptive effect extends during the week-long break.

Switching from another contraceptive: the first tablet should be taken the next day after the last hormone-containing contraceptive tablet - and no later than 1 day after the break when using the previous combined hormonal drug.

Switching from a drug containing only progestogen: you can switch at any time during the menstrual cycle (from an injection - you can switch to Tri-Regol on the day the injection is prescribed, from an intrauterine contraceptive device and implant the next day after their removal). In such a case, it is additionally recommended to use a barrier method of contraception during the week of taking Tri-Regol.

After an abortion or childbirth in the 2nd trimester of pregnancy, use should begin after 3 to 4 weeks for a woman who is not breastfeeding. If oral contraception starts later, then you should additionally use one of the barrier methods of contraception for a week from the start of taking the pills.

Missing a dose: when a woman does not take a pill on time, it must be taken within 12 hours and as quickly as possible. This situation does not require the use of other methods of contraception.

If more than 12 hours have passed, you should immediately take the missed tablet, even if you need to take two tablets a day. Then continue taking the drug as usual. During the week, other methods of contraception are necessary.

Gastrointestinal diseases: the effectiveness of the drug is reduced in the presence of diarrhea or vomiting. This is due to incomplete absorption of the active components of the substances. In this case, the instructions contain instructions on the use of other methods of contraception until the symptoms disappear, as well as over the next week.

Delayed menstrual bleeding: in order to delay menstrual bleeding, you must start using the product from a new package with dark yellow tablets the next day after the end of the previous package. The duration of the delay is determined by the number of dark yellow Tri-Regol tablets taken from the new package. Regular use of the drug can be resumed after a standard one-week break.

Interaction with other tools

You must inform your doctor if you have recently taken or are currently taking other medications.

1. Ampicillin, chloramphenicol, rifampicin, neomycin, tetracyclines, penicillin B, sulfonamides, dihydroergotamine, phenylbutazone, tranquilizers. In this case, the contraceptive effect may be reduced.
2. Anticoagulants, derivatives of indanedione, coumarin. A new determination of the prothrombin time is needed, and the dose of the anticoagulant should be changed if necessary.
3. Insulin, oral antidiabetic agents. It may be necessary to change the dosage of these medications.
4. Tricyclic antidepressants, maprotiline and beta blockers. Their toxicity and bioavailability may increase.
5. Bromocriptine. Efficiency decreases.
6. Hepatotoxic drugs, especially dantrolene. There is an increased risk of hepatotoxicity, this is especially true for women over 35 years of age.

Contraindications

The drug has the following contraindications:

• liver tumors;
• severe liver pathologies;
• chronic colitis;
• cholelithiasis;
• a history of cerebrovascular, severe cardiovascular changes, thromboembolism, as well as a predisposition;
• congenital hyperbilirubinemia (Rotor, Gilbert and Dubin-Johnson syndromes);
• cholecystitis;
• malignant hormone-dependent neoplasms of the mammary glands, genitals (and suspicion of them);
• phlebitis of the deep veins of the lower extremities;
• prolonged immobilization;
• arterial hypertension with diastolic/systolic blood pressure from 100/160 millimeters Hg;
• familial forms of hyperlipidemia;
• operations on the lower extremities;
• hemolytic chronic anemia;
• extensive injuries;
• pancreatitis (as well as a history), which is accompanied by severe hyperlipidemia, hypertriglyceridemia;
• jaundice due to taking drugs with steroids;
• sickle cell anemia;
• severe diabetes mellitus;
• vaginal bleeding of unknown etiology;
• otosclerosis, accompanied by deterioration of the condition during a previous pregnancy;
• hydatidiform mole;
• herpes of pregnant women (history);
• migraine;
• severe skin itching, idiopathic jaundice in pregnant women;
• age from 40 years;
• smoking of the patient over 35 years of age;
• glucose-galactose malabsorption, as well as lactose intolerance and lactase deficiency;
• pregnancy;
• breast-feeding;
• sensitivity to individual components of the drug.

The drug should be taken with caution in the following conditions:

• compensated diabetes mellitus, which is not accompanied by vascular complications;
• epilepsy;
• varicose veins;
• porphyria;
• arterial hypertension with diastolic/systolic blood pressure up to 100/160 millimeters Hg;
• multiple sclerosis;
• mastopathy;
• chorea;
• bronchial asthma;
• tetany;
• adolescence (no regular ovulatory cycles);
• tuberculosis;
• uterine fibroids;
• depression.

Dosage

Under normal conditions, for contraception, a daily dose of one tablet/day is prescribed as part of a 3-week course, then a week break is taken. The next package of 21 film-coated tablets must be taken on the 8th day after the break.

Side effects

Possible side effects from the use of the drug are classified into categories depending on the likelihood of their occurrence:

• very rarely (up to 0.0001%);
• rarely (from 0.0001% to 0.001%);
• sometimes (from 0.001% to 0.01%);
• often (from 0.01% to 0.1%);
• very often (from 0.1%).

Reproductive system: possible – decreased libido, as well as intermenstrual bleeding and engorgement of the mammary glands; less often – vaginal candidiasis, increased vaginal discharge.

Digestive system: may experience nausea, vomiting; less often - liver adenoma, hepatitis, jaundice and gallbladder diseases (for example, cholecystitis, cholelithiasis), diarrhea.

Sense organs: can be observed in some cases, blurred vision, conjunctivitis and swelling of the eyelids, discomfort when wearing lenses can be observed (these are temporary phenomena, they disappear after stopping the drug even without any treatment); with prolonged use, very rarely - hearing loss.

Nervous system: may be observed - depressed mood and headache; with prolonged use, very rarely - an increase in the incidence of epileptic seizures.

Metabolism: possible – increase in body weight; less often – an increase in the concentration of glucose and triglycerides, a decrease in glucose tolerance.

Skin, subcutaneous tissues: chloasma may be observed; less often – hair loss and skin rash; extremely rarely with prolonged use - generalized itching.

Other side effects: rarely - increased fatigue, thrombosis, venous thromboembolism, increased blood pressure; With long-term use, very rarely observed - deepening of the voice and cramps of the calf muscles.

The drug as a whole has positive characteristics. Good tolerance is noted, Tri-Regola. Rare side effects only in the first few months of taking the drug.

Analogs

The drug has the following analogues:

1. Triziston belongs to the group of combined estrogen-progestogen drugs. The medicinal components and action are identical to Tri-Regol; they differ in the dosage of the active components of the substances. Also, women who have increased stress on the vocal cords (speakers, professional lecturers) should not take the drug. The cost of the drug is from 460 to 520 rubles.
2. Triquilar– a therapeutic three-phase contraceptive agent. The principle of action and active ingredients are similar to Tri-Regol. The cost of the drug is 600 rubles.
3. Ovidon– monophasic combination drug. It differs in its indications for use - it is recommended for women of an estrogenic phenotype (with a feminine appearance), since the drug contains an increased concentration of levonorgestrel. This is the cheapest analogue of Tri-Regol, the cost of the drug is from 350 to 500 rubles.

Price

The average cost of a package depends on the number of tablets:

• 21 tablets – from 256 to 293 rubles;
• 63 tablets – from 690 to 744 rubles.

Overdose

If the therapeutic dose is significantly exceeded, nausea, vomiting, or even uterine bleeding may occur. In this case, intestinal lavage, gastric lavage, intestinal sorbents and symptomatic therapy are performed.

In this article you can read the instructions for use of the drug Three Regol. Feedback from site visitors - consumers of this contraceptive hormonal medication, as well as the opinions of specialist doctors on the use of Tri Regola in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Tri Regola in the presence of existing structural analogues. Use for contraception in women, including during pregnancy and breastfeeding. Composition of the drug.

Three Regol- combined (three-phase) oral contraceptive estrogen-progestogen drug. When taken, it inhibits the pituitary secretion of gonadotropic hormones. Sequential administration of tablets containing varying amounts of progestin (levonorgestrel) and estrogen (ethinyl estradiol) provides concentrations of these hormones in the blood close to their concentrations during the normal menstrual cycle and promotes secretory transformation of the endometrium.

The contraceptive effect is associated with several mechanisms. Under the influence of levonorgestrel, the release of releasing factors (luteinizing 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). Ethinyl estradiol maintains the high viscosity of cervical mucus (it makes it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, the menstrual cycle is normalized by replenishing the level of endogenous hormones with the hormonal components of Tri Regol tablets. In 7-day periods, when the next break in taking the drug follows, uterine bleeding occurs.

Compound

Ethinyl estradiol + Levonorgestrel + excipients.

Pharmacokinetics

Levonorgestrel

Levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel does not have a first-pass effect through the liver. Most of the levonorgestrel in the blood is bound to albumin and sex hormone-binding globulin.

Ethinyl estradiol

Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract. Ethinyl estradiol undergoes a first-pass effect through the liver. Metabolism occurs in the liver and intestines. When taken orally, ethinyl estradiol is released from the blood plasma within 12 hours. Ethinyl estradiol metabolites: water-soluble derivatives of sulfate or glucuronide conjugation enter the intestine with bile, where they undergo disintegration with the help of intestinal bacteria. 60% of levonorgestrel is excreted by the kidneys, 40% by the intestines, 40% of ethinyl estradiol is excreted by the kidneys and 60% by the intestines.

Indications

• oral contraception.

Release forms

Film-coated tablets 21 and 28 (21+7) pieces per package.

Instructions for use and dosage regimen

The drug should be taken orally at the same time of day, if possible in the evening. The tablets are swallowed whole, without chewing and washed down with a small amount of liquid.

For the purpose of contraception in the first cycle, Tri Regol is prescribed daily, 1 tablet per day for 21 days, starting from the 1st day of the menstrual cycle, then take a 7-day break, during which menstrual bleeding occurs. The next package containing 21 film-coated tablets should be taken on the 8th day after a 7-day break.

The drug is taken as long as there is a need for contraception.

When switching from another oral contraceptive to taking Tri Regol, a similar regimen is used.

Reception should begin no earlier than the 1st day of the menstrual cycle. During lactation, the use of the drug is contraindicated.

If a woman has not taken Tri Regol within the prescribed period, she should take the missed pill within the next 12 hours. If 36 hours have passed after taking the pill, contraception cannot be considered reliable. However, in order to avoid intermenstrual bleeding, it is necessary to continue taking the drug from the already started package minus the missed tablet(s). At this time, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier).

Side effect

• nausea, vomiting;
• headache;
• engorgement of the mammary glands;
• weight gain;
• decreased libido;
• depressed mood;
• intermenstrual bleeding;
• swelling of the eyelids;
• conjunctivitis;
• visual impairment;
• discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy);
• decreased glucose tolerance;
• increased blood pressure;
• hepatitis;
• liver adenoma;
• gallbladder diseases (for example, cholelithiasis, cholecystitis);
• thrombosis and venous thromboembolism;
• skin rash;
• hair loss;
• increased vaginal discharge;
• vaginal candidiasis;
• increased fatigue;
• diarrhea;
• generalized itching;
• cramps of the calf muscles;
• hearing loss;
• increased frequency of epileptic seizures;
• deepening of the voice.

Contraindications

• severe liver disease;
• liver tumors;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• cholelithiasis;
• cholecystitis;
• chronic colitis;
• presence or indication in history of severe cardiovascular (including decompensated heart defects) and cerebrovascular changes, thromboembolism and predisposition to them;
• phlebitis of the deep veins of the lower extremities;
• hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them);
• familial forms of hyperlipidemia;
• arterial hypertension with systolic/diastolic blood pressure 160/100 mm Hg. and higher;
• surgical interventions, surgical operations on the lower extremities;
• long-term immobilization;
• extensive injuries;
• pancreatitis (including a history), accompanied by severe hypertriglyceridemia and hyperlipidemia;
• jaundice due to taking medications containing steroids;
• severe forms of diabetes mellitus;
• sickle cell anemia;
• chronic hemolytic anemia;
• vaginal bleeding of unknown etiology;
• migraine;
• hydatidiform mole;
• otosclerosis with worsening during previous pregnancy(s);
• idiopathic jaundice of pregnant women, severe skin itching of pregnant women, history of herpes during pregnancy;
• smoking over the age of 35, age over 40;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption (the dosage form of the drug contains lactose);
• pregnancy;
• lactation period;
• hypersensitivity to any component of the drug.

Use during pregnancy and breastfeeding

During pregnancy and lactation, taking Tri Regol is contraindicated.

special instructions

Before starting to use the drug, it is necessary to exclude pregnancy and conduct a general medical and gynecological examination (breast examination, cytological smear analysis).

While taking the drug, regular gynecological examinations are required every 6 months.

The use of oral contraception is allowed no earlier than 6 months after viral hepatitis and subject to normalization of liver functions.

If sharp pain appears in the upper abdomen, hepatomegaly or signs of intra-abdominal hemorrhage, a liver tumor may be suspected. In this case, the drug should be stopped.

If acyclic bleeding occurs, it is possible to continue taking the drug Tri Regol after the attending physician has ruled out organic pathology.

If abnormal liver function is detected during the use of the drug, the question of the advisability of continuing to take the drug Tri Regol should be decided.

In case of vomiting or diarrhea, the drug should be continued, and it is recommended to additionally use another, non-hormonal method of contraception.

At least 3 months before the planned pregnancy, the drug must be stopped.

Under the influence of oral contraceptives (due to the estrogen component), some laboratory parameters may change (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, blood coagulation and fibrinolytic factors, levels of lipoproteins and transport proteins).

The drug should be stopped immediately in the following cases:

• for the first time or worsening migraine-like or unusually severe headache, for acute deterioration of visual acuity, for suspected thrombosis or heart attack;
• with a sharp increase in blood pressure, the appearance of jaundice or hepatitis without jaundice, the occurrence of generalized itching or an increase in epileptic seizures;
• upon pregnancy;
• 6 weeks before the planned operation, with prolonged immobilization (for example, after injury).

Impact on the ability to drive vehicles and operate machinery

Taking the drug does not affect the ability to drive a car or operate other mechanisms.

Drug interactions

When taking the drug Tri Regol simultaneously with ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone, because these drugs may weaken the contraceptive effect. Therefore, it is recommended to additionally use another, non-hormonal contraceptive method.

When taking the drug Tri Regol simultaneously with anticoagulants, coumarin derivatives or indanedione, it may be necessary to immediately determine the prothrombin index and change the dose of the anticoagulant.

When taking the drug Tri Regol simultaneously with tricyclic antidepressants, maprotiline, beta-blockers, bioavailability and, therefore, toxicity may increase.

When taking the drug Tri Regol and oral hypoglycemic drugs, insulin simultaneously, it may be necessary to change their doses.

When taking the drug Tri Regol and bromocriptine simultaneously, the effectiveness of the latter decreases.

Tri-Regol is an estrogen-progestin contraceptive for oral use.

Release form and composition of Tri-Regol

The drug is available in the form of film-coated tablets of three types: pink; white and yellow.

The main active ingredients of the tablets are levonorgestrel and ethinyl estradiol.

The following are used as excipients: magnesium stearate, colloidal silicon dioxide, lactose monohydrate, talc, corn starch.

Tablets differ in the number of main active ingredients.

Pharmacological action of Tri-Regol

Tri-Regol is a three-phase oral contraceptive drug based on estrogens and gestagens. Taking Tri-Regol helps suppress the pituitary secretion of gonadotropic hormones.

This drug contains varying amounts of estrogen and progestogen and maintains these hormones in the female body at a level close to the normal menstrual cycle.

The contraceptive effect of Tri-Regol is based on the action of several mechanisms. Under the influence of levonorgestrel, the process of releasing releasing factors of the hypothalamus is blocked and the secretion of gonadotropic hormones is inhibited. As a result, the maturation of the egg and its release are inhibited. Ethinyl estradiol maintains significant viscosity of the cervical mucus, which leads to difficulty in the movement of sperm to the uterine cavity.

Indications for use of Tri-Regol

According to the instructions, Tri-Regol is used for oral contraception.

Contraindications

According to the instructions, Tri-Regol is not prescribed for:

• cholecystitis;
• severe liver diseases;
• chronic colitis;
• liver tumors;
• cholelithiasis;
• congenital Rotor, Dubin-Johnson, Gilbert syndromes;
• phlebitis of the deep veins of the legs;
• severe cardiovascular, cerebrovascular changes, thromboembolism in history and at present, as well as with a predisposition to them;
• malignant neoplasms of the mammary glands and genital organs (hormone-dependent);
• prolonged immobilization;
• familial forms of hyperlipidemia;
• extensive injuries;
• arterial hypertension;
• chronic hemolytic anemia;
• the presence of surgical interventions and surgical operations on the legs;
• history and current pancreatitis;
• sickle cell anemia;
• jaundice caused by taking steroid-containing medications;
• severe forms of diabetes mellitus;
• hydatidiform mole;
• vaginal bleeding of unknown cause;
• migraine;
• glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
• otosclerosis with worsening during pregnancy;
• idiopathic jaundice of pregnant women, herpes of pregnant women, severe skin itching of pregnant women;
• hypersensitivity to the components included in the drug;
• pregnancy and lactation;
• smoking at the age of over 35 years;

and also at the age of over 40 years.

Tri-Regol is prescribed with caution for:

• compensated diabetes mellitus without vascular complications;
• varicose veins;
• arterial hypertension with blood pressure less than 160/100;
• epilepsy;
• multiple sclerosis;
• porphyria;
• minor chorea;
• tetany;
• bronchial asthma;
• depression;
• mastopathy;
• uterine fibroids;
• tuberculosis;

as well as in adolescence, when a regular ovulatory cycle has not yet been established.

Method of use of Tri-Regol and dosage

The drug is intended for oral administration.

Tri-Regol tablets are taken at the same time, mainly in the evening. They should be swallowed whole, followed by a few sips of water.

In the first cycle, the drug is taken every day, 1 tablet from the first day of the cycle for 21 days, then a break is taken (7 days) when menstrual bleeding occurs. After the break, the next package of the drug, designed for 21 days, begins.

Tri-Regol should be taken as long as there is a need for contraception.

If you miss another dose of the drug, you need to take the pill within the next 12 hours. But if more than 36 hours have passed since taking Tri-Regol, then contraception with this drug is not reliable. Therefore, it is necessary to use an additional non-hormonal method of contraception.

Side effects of Tri-Regol

According to reviews, Tri-Regol may cause side effects.

Reproductive system: decreased libido, engorgement of the mammary glands, intermenstrual bleeding.

Nervous system: depressed mood, headache.

Digestive system: nausea, vomiting.

Sense organs: swelling of the eyelids, blurred vision, conjunctivitis.

Metabolism: increase in body weight.

Skin: chloasma.

Overdose

According to reviews of Tri-Regol, an overdose of the drug is manifested by nausea and uterine bleeding.

If these symptoms occur in the first 2-3 hours, it is necessary to perform gastric lavage and apply symptomatic treatment measures.

Interaction with other drugs

When taking Tri-Regol simultaneously with:

• rifampicin, ampicillin, neomycin, chloramphenicol, polymyxin B, tetracyclines, sulfonamides, dihydroergotamines, tranquilizers, phenylbutazone - the contraceptive effect of the drug is weakened;
• indandione or coumarin derivatives, anticoagulants - there may be a need for an unscheduled determination of the prothrombin index and adjustment of the anticoagulant dose;
• maprotiline, tricyclic antidepressants, beta-blockers - the toxicity of these drugs may increase;
• oral hypoglycemic drugs and insulin - their doses may need to be adjusted;
• drugs with possible hepatotoxic effects - the risk of increased hepatotoxicity increases.

special instructions

If hepatomegaly, severe pain in the upper abdomen or signs of intra-abdominal hemorrhage occur, Tri Regol should be discontinued.

In the presence of acyclic bleeding, after excluding organic pathologies, you can continue to take the drug.

If a woman is planning a pregnancy, then Tri-Regol should be discontinued three months before the planned pregnancy.

If vomiting or diarrhea occurs, you should continue to take the drug, but you must use an additional non-hormonal method of contraception.

Cancellation of Tri-Regol occurs in the following cases:

• upon pregnancy;
• 6 weeks before the planned surgical intervention;
• with a sharp increase in blood pressure, increased frequency of epileptic seizures, the occurrence of hepatitis or jaundice, generalized itching;
• with unusually severe headache, acute deterioration of vision, suspected heart attack or thrombosis.

Storage conditions Tri Regola

Tri-Regol is stored in a place protected from children at a temperature of 15-30ºС.

Manufacturer: Gedeon Richter (Gedeon Richter) Hungary

ATC code: G03AB03

Farm group:

Release form: Solid dosage forms. Pills.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

TRADENAME:

Tri-Regol® 21+7

International nonproprietary name:

DOSAGE FORM:

Film-coated tablets

COMPOUND

Active ingredients:

Tablets I: contain 0.03 mg ethinyl estradiol and 0.05 mg levonorgestrel,
Tablets II: contain 0.04 mg ethinyl estradiol and 0.075 mg levonorgestrel,
Tablets III: Contains 0.03 mg ethinyl estradiol and 0.125 mg levonorgestrel.

Placebo tablets:
Ferrous fumarate: 76.05 mg
Excipients

Tablets I.
Core:
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium, red iron oxide (E172).

Tablets II.
Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg).
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium.

Tablets III.
Core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate (33.0 mg).
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium, yellow iron oxide (E172).

Placebo tablets
Core: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone, talc, potato starch, corn starch, lactose monohydrate (24.55 mg).
Shell: sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone, colloidal silicon dioxide, povidone, macrogol 6000, carmellose sodium.

DESCRIPTION

Tablets I

Pink, round, biconvex, film-coated tablets with a glossy surface. White on the break.

Tablets II

White, round, biconvex, film-coated tablets with a glossy surface. White on the break.

Tablets III

Dark yellow, round, biconvex, film-coated tablets with a glossy surface. White on the break.

IV tablets - placebo containing iron furmarate

Round, biconvex, glossy, reddish-brown, film-coated tablets. Light brown on the fracture.

PHARMACOTHERAPEUTIC GROUP:

combined contraceptive (estrogen + gestagen).

ATX code: G03AB03

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Combined, oral three-phase contraceptive estrogen-progestogen drug. Suppresses ovulation by blocking the secretion of follicle-stimulating and luteinizing hormones in the pituitary gland, promotes the secretory transformation of the endometrium, and increases the viscosity of cervical mucus.
Consecutive administration of tablets of the drug containing different amounts of gestagen (levonorgestrel) and estrogen (ethinyl estradiol) allows you to replenish and ensure the concentrations of these hormones in the blood are close to physiological with the subsequent normalization of menstrual irregularities.

Pharmacokinetics

Levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel does not have a first-pass effect through the liver. The half-life is 8-30 hours (average 16 hours). Most of the levonorgestrel in the blood is bound to albumin and sex hormone-binding globulin.
Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in plasma is achieved in the range of 1-1.5 hours. The half-life is 26±6.8 hours. Ethinyl estradiol has a “first pass” effect through the liver (the so-called “first pass” effect). Metabolism occurs in the liver and intestines.
When taken orally, ethinyl estradiol is cleared from the blood plasma within 12 hours.
Ethinyl estradiol metabolites: water-soluble derivatives of sulfate or glucuronide conjugation enter the intestine with bile, where they undergo disintegration with the help of intestinal bacteria.

INDICATIONS FOR USE

Oral contraception.

CONTRAINDICATIONS

Hypersensitivity to any component of the drug.
Pregnancy, breastfeeding, severe liver diseases, liver tumors, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), cholelithiasis, cholecystitis, chronic colitis; the presence or indication in the anamnesis of severe cardiovascular (including decompensated heart defects) and cerebrovascular changes, thromboembolism and predisposition to them, phlebitis of the deep veins of the lower extremities, hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them), familial forms of hyperlipidemia, arterial hypertension with systolic/diastolic blood pressure 160/100 mm Hg. and above, surgical interventions, surgical operations on the lower extremities, prolonged immobilization, extensive trauma, pancreatitis (including a history), accompanied by severe hypertriglyceridemia and hyperlipidemia, jaundice due to taking medications containing steroids, severe forms of diabetes mellitus, sickle cell anemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine, hydatidiform mole, otosclerosis with worsening during previous pregnancy(ies); idiopathic jaundice of pregnant women, severe skin itching of pregnant women, history of herpes during pregnancy; smoking over the age of 35, age over 40; lactase deficiency, lactose intolerance, glucose-galactose malabsorption (the dosage form of the drug contains lactose).

CAREFULLY

Diabetes mellitus, diseases of the endocrine glands, diseases of the cardiovascular system, arterial hypertension with blood pressure up to 160/100 mm Hg, renal dysfunction, varicose veins, multiple sclerosis, porphyria, tetany, epilepsy, chorea minor, bronchial asthma.

PREGNANCY AND LACTATION

During pregnancy and lactation, taking Tri-Regol® 21+7 is contraindicated.

METHOD OF APPLICATION AND DOSES

Take orally, without chewing and with a small amount of liquid.
Starting from the first day of menstruation, take one film-coated tablet daily for 28 days, preferably at the same time of day. While taking the reddish-brown film-coated tablets, menstrual-like bleeding occurs. You should start taking tablets from the next package without observing a break between two packages, i.e. 4 weeks after starting the drug, on the same day of the week. It is important to follow the following order of taking the tablets: first, 6 pink ones, then 5 white ones, then 10 dark yellow ones, and finally 7 reddish-brown ones. In order to ensure the necessary sequence, numbers and an arrow are indicated on the packaging. If well tolerated, the drug is taken as long as there is a need for contraception.

Switching to Tri-Regol® 21+7 from another oral contraceptive carried out according to the same scheme.

After an abortion It is recommended to start taking the drug on the day of the abortion or the day after the operation.

After childbirth taking the drug can only be recommended for women who are not breastfeeding; reception should begin no earlier than the first day of menstruation.

During lactation, the use of the drug is contraindicated.

Missed pills: the missed pill should be taken within the next 12 hours. If 36 hours have passed since the last pill was taken, contraception is unreliable. In such cases, to prevent possible intermenstrual bleeding, taking the drug must be continued from the package already started, with the exception of the missed tablet(s).

In cases of missing pills on time, it is recommended to use another, additional, non-hormonal method of contraception (for example, barrier).
This rule does not apply to reddish-brown tablets, because they do not contain hormones.

SIDE EFFECT

Side effects observed with the use of the drug are classified into categories depending on the frequency of their occurrence: very often ≥1/10; often >1/100, ≤1/10, sometimes ≥1/1000, ≤1/100; rarely ≥1/10000, ≤1/1000; very rarely ≤1/10000 including isolated reports.
The drug is usually well tolerated.

Possible side effects that are transient in nature and do not require treatment: nausea, vomiting, headache, engorgement of the mammary glands, weight gain, decreased libido, depressed mood, intermenstrual bleeding, in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort during wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy). Rarely, increased concentrations of triglycerides, blood glucose, decreased glucose tolerance, increased blood pressure, hepatitis, liver adenoma, gallbladder diseases (for example, cholelithiasis, cholecystitis), thrombosis and venous thromboembolism, jaundice, skin rash, hair loss, increased discharge from the vagina, vaginal candidiasis, increased fatigue, diarrhea.

Very rarely, with longer use: chloasma.
Ferrous fumarate, which is part of the reddish-brown sugar-coated tablets, can cause irritation of the gastrointestinal mucosa, nausea, vomiting, diarrhea, constipation and turn stool black.

OVERDOSE

In case of accidental ingestion of large doses of the drug, an overdose is possible, incl. in children. Overdose symptoms: nausea, uterine bleeding. If signs of overdose appear in the first 2-3 hours, gastric lavage and symptomatic treatment are recommended. There is no antidote.

INTERACTION WITH OTHER MEDICINES

The use of Tri-Regol® 21+7 tablets requires caution when the following drugs are taken simultaneously with a contraceptive:
- ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone, because the latter may weaken the contraceptive effect; at the same time, it is recommended to use an additional, non-hormonal method of contraception;
- anticoagulants, derivatives of coumarin or indanedione (there may be a need for an extraordinary determination of the prothrombin index and changes in the dose of the anticoagulant);
- tricyclic antidepressants, maprotiline, beta-blockers (their bioavailability and toxicity may increase);
- oral hypoglycemic drugs, insulin (it may be necessary to change their dose);
- bromocriptine (reduced effectiveness of bromocriptine);
- drugs with potential hepatotoxic effects, for example, dantrolene.
The risk of hepatotoxicity increases with age, especially in women over 35 years of age.

SPECIAL INSTRUCTIONS

Before prescribing the drug, it is necessary to exclude pregnancy, conduct a general medical examination (including measuring blood pressure, laboratory tests of liver function and blood sugar levels) and a gynecological examination (condition of the mammary glands, cytological analysis of a vaginal smear).
While taking the drug, such general medical and gynecological examinations should be carried out regularly, every 6 months.
The use of oral contraception is allowed no earlier than 6 months after viral hepatitis, provided that liver functions are completely normalized.
If sharp pain appears in the upper abdomen, hepatomegaly and signs of intra-abdominal hemorrhage, a suspicion of a liver tumor may arise. In this case, taking the drug should be stopped.
If abnormal liver function is detected during the use of the drug, the question of the advisability of continuing to take the drug Tri-Regol® 21+7 should be decided. If acyclic bleeding occurs, it is possible to continue taking Tri-Regol® 21+7 tablets after the attending physician has ruled out organic pathology. In case of vomiting or diarrhea, the drug should be continued while using an additional, non-hormonal method of contraception.
At least 3 months before the planned pregnancy, you must stop taking the drug.
Under the influence of oral contraceptives (due to the estrogen component), the functional parameters of the liver, kidneys, adrenal glands, thyroid gland, blood coagulation and fibrinolytic factors, levels of lipoproteins and transport proteins may change.
The drug should be stopped:
in the event of the first occurrence or intensification of existing migraine-like pain, or the occurrence of unusually severe headaches;
with acute deterioration of visual acuity;
if thrombosis or heart attack is suspected;
with a sharp increase in blood pressure;
with the appearance of jaundice or hepatitis without jaundice, generalized itching;
with increased frequency of epileptic seizures;
before a planned operation (6 weeks before surgery), with prolonged immobilization;
upon pregnancy.

The effect of the drug on the ability to drive a car and other mechanisms
Studies have not been conducted to study the effect of the drug on the ability to drive a car and other mechanisms associated with an increased risk of injury.

RELEASE FORM

Film-coated tablets.
Tablets I pink - 6 pcs.
Tablets II white - 5 pcs.
Tablets III dark yellow - 10 pcs.
IV red-brown tablets - 7 pcs.
28 tablets (I, II, III, IV) in an Al/PVC blister. 1 or 3 blisters in a cardboard box with instructions for use.

STORAGE CONDITIONS

List B.
At a temperature of 15-30 °C, out of the reach of children.

BEST BEFORE DATE

5 years.
Do not use after expiration date.

CONDITIONS OF VACATION FROM PHARMACIES

On prescription.

Manufacturer

JSC "Gedeon Richter"
1103 Budapest, st. Demrei 19-21, Hungary

Consumer complaints should be sent to:

Moscow Representative Office of JSC Gedeon Richter
119049 Moscow, 4th Dobryninsky lane, building 8.