Tri-Merci®

Release form and composition

Tri-Mercy is available in the form of film-coated tablets:

• yellow tablets: biconvex, round, yellow, on one side of the tablet there is an engraving VR above the number 4, on the other there is an engraving ORGANON with the image of a five-pointed star; the cross section shows a white core;
• red tablets: biconvex, round, red, on one side of the tablet there is an engraving VR above the number 2, on the other there is an engraving ORGANON with the image of a five-pointed star; the cross section shows a white core;
• white tablets: biconvex, round, white, on one side of the tablet there is an engraving TR above the number 5, on the other there is an engraving ORGANON with the image of a five-pointed star; the cross section shows a white core.

The tablets are packaged in blisters of 21 pieces (7 pieces - yellow, 7 pieces - red and 7 pieces - white), each blister is in a hermetically sealed sachet made of laminated aluminum foil, in a cardboard pack of 1, 3 or 6 sachets.

Composition for 1 yellow tablet:

• active ingredients: ethinyl estradiol – 35 mcg, desogestrel – 50 mcg;
• auxiliary components: lactose monohydrate, colloidal silicon dioxide, hypromellose, talc, alpha-tocopherol, potato starch, stearic acid, macrogol, povidone, titanium dioxide, yellow iron oxide dye.

Composition for 1 red tablet:

• active ingredients: ethinyl estradiol – 30 mcg, desogestrel – 100 mcg;
• auxiliary components: lactose monohydrate, colloidal silicon dioxide, hypromellose, talc, alpha-tocopherol, potato starch, stearic acid, macrogol, povidone, titanium dioxide, red iron oxide dye.

Composition for 1 white tablet:

• active ingredients: ethinyl estradiol – 30 mcg, desogestrel – 150 mcg;
• auxiliary components: lactose monohydrate, colloidal silicon dioxide, hypromellose, talc, alpha-tocopherol, potato starch, stearic acid, macrogol, povidone, titanium dioxide.

Tri-merci®

Manufacturer: NV ORGANON (Netherlands)

tab., cover film cover, three types: 21 pcs. in a blister, 1, 3 or 6 blisters in a pack, including: tab. yellow 35 mcg+50 mcg: 7 pcs. in a blister; tab. red 30 mcg+100 mcg: 7 pcs. in a blister; tab. white 30 mcg+150 mcg: 7 pcs. in blister Reg. No.: P N012322/01

Clinical and pharmacological group:

Triphasic oral contraceptive

Release form, composition and packaging

Film-coated tablets

, three types.

Yellow film-coated tablets

, round, biconvex, engraved with “VR” above the number “4” on one side of the tablet and “ORGANON” with a five-pointed star on the other side of the tablet; on the cross section - white (7 pieces in a blister).

Excipients:

α-tocopherol - 0.08 mg, lactose monohydrate - 55 mg, potato starch - 6.5 mg, povidone - 1.95 mg, colloidal silicon dioxide - 0.65 mg, stearic acid - 0.65 mg, iron oxide yellow dye - 0.04 mg, hypromellose - 0.75 mg, macrogol - 0.15 mg, talc (magnesium hydrosilicate) - 0.19 mg, titanium dioxide - 0.11 mg.

Red film-coated tablets

, round, biconvex, engraved with “VR” above the number “2” on one side of the tablet and “ORGANON” with a five-pointed star on the other side of the tablet; on the cross section - white (7 pieces in a blister).

Excipients:

α-tocopherol - 0.08 mg, lactose monohydrate - 55 mg, potato starch - 6.5 mg, povidone - 1.95 mg, colloidal silicon dioxide - 0.65 mg, stearic acid - 0.65 mg, red iron oxide dye - 0.08 mg, hypromellose - 0.75 mg, macrogol - 0.15 mg, talc (magnesium hydrosilicate) - 0.19 mg, titanium dioxide - 0.11 mg.

White film-coated tablets

, round, biconvex, engraved with “TR” above the number “5” on one side of the tablet and “ORGANON” with a five-pointed star on the other side of the tablet; on the cross section - white (7 pieces in a blister).

Excipients:

α-tocopherol - 0.08 mg, lactose monohydrate - 55 mg, potato starch - 6.5 mg, povidone - 1.95 mg, colloidal silicon dioxide - 0.65 mg, stearic acid - 0.65 mg, hypromellose - 0.75 mg, macrogol - 0.15 mg, talc (magnesium hydrosilicate) - 0.19 mg, titanium dioxide - 0.11 mg.

21 pcs. - blisters (1) - sachets made of laminated aluminum foil (1) - cardboard packs. 21 pcs. - blisters (1) - sachets made of laminated aluminum foil (3) - cardboard packs. 21 pcs. - blisters (1) - sachets made of laminated aluminum foil (6) - cardboard packs.

Contraindications

Absolute:

• arterial thrombosis (including stroke and myocardial infarction) or precursors of thrombosis (including angina pectoris, transient ischemic attack), including a history;
• venous thrombosis (including pulmonary embolism and deep vein thrombosis), including a history;
• identified predisposition to arterial or venous thrombosis;
• multiple or severe risk factors for arterial or venous thrombosis;
• diabetic angiopathy;
• migraine with a history of focal neurological symptoms;
• severe liver disease (history or current);
• pancreatitis accompanied by severe hypertriglyceridemia (in history or currently);
• bleeding from the vagina of unknown origin;
• malignant or benign liver tumor (in history or currently);
• suspected or diagnosed hormone-dependent malignancies (for example, tumors of the mammary glands or genital organs);
• suspected or diagnosed pregnancy;
• lactation period;
• nicotine addiction in women aged 35 years and older (smoking more than 15 cigarettes per day);
• hypersensitivity to the main or auxiliary components of the drug.

Relative (Tri-Mercy is used with caution):

• arterial hypertension;
• sickle cell anemia;
• atrial fibrillation;
• heart valve diseases;
• varicose veins, superficial thrombophlebitis;
• hemolytic-uremic syndrome;
• diabetes mellitus without angiopathy;
• dyslipoproteinemia;
• hypertriglyceridemia (including family history);
• obesity (in women with a body mass index of more than 30 kg/m²);
• changes in biochemical parameters that indicate the likelihood of an acquired or hereditary predisposition to arterial or venous thrombosis;
• systemic lupus erythematosus;
• chronic and acute liver diseases, including congenital hyperbilirubinemia;
• chronic inflammatory bowel diseases;
• migraine;
• age over 35 years;
• smoking;
• major surgery, prolonged immobilization, severe trauma, surgery on the lower extremities (the drug should be stopped 4 weeks before surgery and not resumed for 2 weeks after complete remobilization);
• unfavorable family history (for example, arterial or venous thromboembolism in parents, siblings or brothers at a relatively early age);
• the postpartum period in women who do not breastfeed.

Directions for use and dosage

Tri-Mercy tablets are taken orally at approximately the same time, washed down with a small amount of water or other liquid if necessary.

The drug is taken one tablet per day for 21 days (7 days for each color of tablet). Reception begins with yellow tablets, then switches to red, and after that to white. Tablets from a new package should be taken 7 days after the end of the three-week course. During these 7 days, as a rule, menstrual-like bleeding is observed, which begins 2-3 days after taking the last tablet from the blister and may not end by the time the woman starts taking tablets from a new package.

If a hormonal contraceptive is used for the first time, pills should be taken on the first day of the menstrual cycle. If use is started on days 2–5 of the cycle, it is recommended to use an additional barrier method of contraception during the first 7 days of using the pills.

When switching to Tri-Mercy from another combined hormonal contraceptive (vaginal ring, transdermal patch or combined oral contraceptive), it is advisable to start taking tablets the day after the last active dose of the previous contraceptive, but no later than the day after the end of the standard interval in taking active doses or period of use of tablets that do not contain hormones. When using a transdermal patch or vaginal ring, the drug should be taken on the day of their removal, but no later than the day when the next application of the patch is to be made or a new ring is inserted. With consistent and correct use of the previous method of contraception, as well as with a reliable absence of pregnancy, a woman can switch to taking Tri-Mercy on any day of the cycle.

You can switch from mini-pill progestin contraceptives to Tri-Mercy at any day. When using a progestogen implant or a progestogen-releasing intrauterine system, switching to Tri-Mercy occurs on the day of implant removal. The transition from injections containing progestogen should be carried out on the day of the next injection. In all three cases, in the first 7 days of using Tri-Mercy, it is necessary to additionally use barrier methods of contraception.

After an abortion performed in the first trimester, taking pills can be started on the day of the abortion. Additional contraception is not required.

After an abortion or childbirth in the second trimester, Tri-Mercy should be taken no earlier than 21 days after the abortion or 28 days after birth. If taking the drug starts later, in the first 7 days it is necessary to additionally use a barrier method of contraception. When resuming sexual activity, before starting to take combined oral contraceptives, you should exclude the possibility of pregnancy or wait until menstruation.

If you miss taking the next pill (of any color), if the delay is less than 12 hours, the woman should take the Tri-Mercy pill as soon as she remembers, subsequent pills are taken at the usual time. The reliability of contraception in this case does not decrease.

If more than 12 hours have passed since the time when you needed to take the drug tablet, the effectiveness of contraception may decrease. In this case, you must adhere to two basic rules:

• taking the contraceptive should not be interrupted for more than 7 days;
• The tablets should be taken 7 days in a row (to ensure the necessary contraceptive effect).

Recommendations for skipping tablets of a certain color if more than 12 hours have passed since the omission:

• yellow tablets (first week): take the missed tablet as soon as the woman remembers, even if it is time for the next dose and you need to take 2 tablets at the same time. After this, the tablets are taken at the usual time. For 7 days it is necessary to use an additional barrier method of contraception;
• red pills (second week): take the missed pill as soon as the woman remembers, even if it is time for the next dose and you need to take 2 pills at the same time. Then the pills are taken at the usual time as usual. If there were no other violations in the regimen of taking the drug, additional methods of contraception are not required. If you miss more than one tablet within 7 days after resuming taking Tri-Mercy, you must use additional methods of contraception;
• white pills (third week): the reliability of contraception may decrease due to subsequent interruptions. When using any of the two options described below, additional contraception is not needed if the drug is taken on time during the 7 days preceding the first missed pill. In case of violations of the regimen, the woman should adhere to the first of the described options and use an additional method of contraception for 7 days. Option 1: the woman takes the missed pill as soon as she remembers, even if she has to take 2 pills at the same time, then the pills are taken as usual (the reliability of contraception is not reduced); tablets from the next package should be taken immediately after the end of the current one, that is, there is no break; Most likely, there will be no menstrual-like bleeding until the end of taking the tablets from the second package, but heavy or spotting bleeding may be observed. Option 2: stop taking tablets from the current blister pack and take a break for 7 days (days you missed tablets are included in this break); then take the tablets from a new package; If there was a gap in taking the drug, and there is no withdrawal bleeding in the next break, the possibility of pregnancy should be taken into account.

In case of severe gastrointestinal disorders (diarrhea, vomiting), the drug may not be completely absorbed, so it is necessary to use additional methods of contraception. If vomiting occurs during the first 3-4 hours after taking Tri-Mercy, you should follow the recommendations regarding missed tablets. If you do not want to change your usual regimen, a woman should take an additional tablet from a different package.

To delay the onset of menstrual bleeding, you should continue taking the white tablets from the new package. The delay in bleeding ranges from 1 to 7 days, that is, until the end of taking white tablets from the second package. During this period, bleeding of varying intensity may appear. Tri-Mercy is resumed after the usual 7-day break from taking the drug.

You can also shorten the break by the desired number of days. The shorter this period, the higher the likelihood of no withdrawal bleeding and the appearance of spotting while taking tablets from the second blister (similar to delaying bleeding).

Tri-Merci

Release form, composition and packaging

Film-coated tablets, three types.

Yellow film-coated tablets, round, 5 mm in diameter, marked “VP4” on one side and “Organon” on the other (7 per blister).

1 tab.

• ethinyl estradiol 35 mcg
• desogestrel 50 mcg

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

Shell composition: hypromellose, macrogol, titanium dioxide, talc, yellow iron oxide dye.

Red film-coated tablets, round, 5 mm in diameter, marked “VR2” on one side and “Organon” on the other (7 per blister).

1 tab.

• ethinylestradiol 30 mcg
• desogestrel 100 mcg

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

Shell composition: hypromellose, macrogol, titanium dioxide, talc, red iron oxide dye.

White, round, film-coated tablets, 5 mm in diameter, marked “TR5” on one side and “Organon” on the other (7 per blister).

1 tab.

• ethinylestradiol 30 mcg
• desogestrel 150 mcg

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

Shell composition: hypromellose, macrogol, titanium dioxide, talc.

Clinical and pharmacological group: Three-phase oral contraceptive

pharmachologic effect

Contraceptive drug.

Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system.

Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the menstrual cycle.

A progestin drug (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland (preventing follicle maturation), etc. blocks ovulation.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm.

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

During treatment, there is a significant decrease in the amount of blood lost (with initial menorrhagia).

It has a beneficial effect on the skin, especially improving its condition in cases of acne vulgaris; when taken regularly, it also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Indications

• Contraception.

Dosage regimen

Orally, 1 tablet per day (starting no later than the 5th day of the cycle; 1st day of the cycle is 1st day of menstruation) daily, at the same time, without a break, for 21 days, then take a break for 7 days. In the first 14 days, additional contraceptive measures must be used. If more than 5 days have passed since the start of menstruation, then taking the pills begins with the next cycle.

After childbirth, the drug should be taken on the first day of the first independent menstruation.

After a miscarriage or induced abortion, the drug must be taken immediately.

The full contraceptive effect is maintained provided that the tablets are taken systematically (maximum delay is no more than 12 hours).

If more time has passed, then the next day at the usual time you should take 2 tablets of the drug, but you must use additional contraception for the next 14 days or until the next menstruation occurs.

Side effect

Headache, gastralgia, nausea, vomiting; soreness and engorgement of the mammary glands; weight gain, impaired glucose tolerance, fluid retention in the body, changes in libido, decreased mood, swelling of the eyelids, skin rash, erythema nodosum, conjunctivitis, discomfort when wearing contact lenses, impaired perception (visual impairment, hearing loss, flickering before the eyes ), thrombophlebitis, thromboembolism, generalized itching, cholestatic jaundice, cholelithiasis, increased blood pressure, intermenstrual bleeding, changes in vaginal secretion (possible development of vaginal candidiasis). With long-term use (extremely rarely) - chloasma, hepatocellular adenoma.

Contraindications

• hypersensitivity,
• pregnancy,
• liver failure,
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes),
• liver tumors (hemangioma, liver cancer),
• thromboembolism (including a history and an increased risk of its development),
• cerebrovascular accidents (ischemic stroke, hemorrhagic stroke),
• IHD,
• arterial hypertension (severe forms),
• atherosclerosis,
• decompensated heart defects,
• myocarditis,
• diabetes,
• retinopathy,
• angiopathy,
• sickle cell anemia,
• breast and endometrial cancer,
• endometrial hyperplasia,
• endometriosis,
• breast fibroadenoma,
• metrorrhagia (of unclear etiology),
• disorders of fat metabolism,
• jaundice or itching during a former pregnancy,
• otosclerosis worsening during pregnancy,
• porphyria, women over 35 who smoke.

special instructions

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

It is a reliable contraceptive drug: Pearl index (the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) - 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of treatment it is recommended to additionally use non-hormonal methods of contraception.

After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months).

In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception).

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke).

The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

During lactation, milk secretion may decrease; small amounts are excreted in breast milk.

Estrogen-containing drugs increase the risk of thrombosis in women who have undergone surgery or prolonged immobilization.

Women who have chloasma should avoid sun exposure.

Overdose

Symptoms: metrorrhagia.

Drug interactions

Rifampicin, isoniazid, ampicillin, neomycin, penicillins, tetracycline, chloramphenicol, griseofulvin, barbiturates, carbamazepine, activated charcoal and laxatives reduce the effectiveness and contribute to the occurrence of “breakthrough” bleeding.

Reduces the effectiveness of oral anticoagulants, anxiolytics (diazepam), tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate, corticosteroids.

Storage conditions and periods

Data not provided.

Side effects

The following side effects may occur when using Tri-Mercy tablets: ulcerative colitis, Crohn's disease; chloasma; thromboembolism or thrombosis; increased blood pressure; acyclic bleeding (observed more often in the first months of use); systemic lupus erythematosus, porphyria, hemolytic-uremic syndrome; cholelithiasis; exacerbation or occurrence of itching and/or jaundice associated with cholestasis; herpes during pregnancy; chorea; hearing loss due to otosclerosis; hormone-dependent tumors; hypersensitivity reactions; angioedema.

Side effects likely related to Tri-Mercy or other combined oral contraceptives:

• gastrointestinal tract: often – abdominal pain, nausea; infrequently – diarrhea, vomiting;
• nervous system: often – headache; infrequently – migraine;
• psyche: often – mood swings, depression; infrequently – decreased libido; rarely – increased libido;
• organ of vision: rarely – intolerance to contact lenses;
• skin and subcutaneous tissues: uncommon – urticaria, skin rash; rarely – erythema multiforme, erythema nodosum;
• metabolism and nutrition: infrequently – fluid retention;
• reproductive system and mammary glands: often – soreness of the mammary glands, chest pain; infrequently – enlargement of the mammary glands; rarely – discharge from the mammary glands, vaginal discharge;
• instrumental and laboratory data: often - increase in body weight; rarely - weight loss;
• immune system: rarely – hypersensitivity reactions.

special instructions

Before starting to take Tri-Mercy, as well as when resuming use of the drug, you should collect a detailed medical history, including family history, and also exclude pregnancy. Blood pressure must be measured. If clinically significant signs are detected, a physical examination should be performed, based on existing contraindications and precautions. A woman must strictly adhere to the medical instructions for using the drug. The list and frequency of further periodic examinations are selected individually for each patient (but at least once every six months).

Oral contraceptives do not protect against sexually transmitted diseases.

The effectiveness of the drug may be reduced in case of gastrointestinal disorders, in case of missing a pill, or when used simultaneously with other drugs.

Some women may not experience menstrual bleeding between pills. In this case, if combined oral contraceptives are taken as recommended, the likelihood of pregnancy is low. In case of violations of the dosage regimen and the absence of withdrawal bleeding or in the absence of two menstrual-like bleeding in a row, a possible pregnancy should be excluded before resuming taking Tri-Mercy.

One tablet of the drug contains less than 65 mg of lactose, which should be taken into account by women with lactase deficiency, lactose intolerance or glucose-galactose malabsorption.

Tri-Mercy does not affect the patient's ability to drive vehicles or other potentially dangerous mechanisms.

Tri-Merci®

If you have the conditions/diseases or risk factors listed below, you should discuss the benefit-risk ratio of using Tri-Mercy® with the woman. If any of these conditions or risk factors worsen or manifest for the first time, a woman should contact her doctor. The decision on the need to stop using Tri-Mercy® is made by the doctor.

Vascular diseases

Risk of venous thromboembolism (VTE)

-The use of any COC increases the risk of developing VTE. Drugs containing levonorgestrel, norgestimate, or norethisterone are associated with the lowest risk of VTE. When taking Tri-Mercy® and similar drugs, the risk of VTE almost doubles. The decision to use any drug, with the exception of drugs that have the lowest risk of developing VTE, should be made only after discussing with the woman the benefits and possible negative effects of the contraceptive. A woman should understand the risk of developing VTE. associated with taking the drug, the influence of her existing factors on this risk, and that the risk of developing VTE will be highest in the first year of use. There is also some evidence to show that the risk increases when taking COCs again after a break of more than 4 weeks.

-Among women who are not pregnant or do not use COCs, about 2 in 10,000 will experience VTE within 1 year. However, each woman may have a higher risk depending on her risk factors (see below).

-It is estimated that 1 in 10,000 women using desogestrel-containing COCs, 9-12 women will experience VTE within 1 year, compared with approximately 62 women using levonorgestrel-containing COCs.

-In both cases, the number of VTEs per year is the same as the expected number of VTEs during pregnancy or the postpartum period.

-VTE can be fatal in 1-2% of cases.

1 This incidence rate is based on all available epidemiological studies of the relative risks for various drugs compared with levonorgestrel-containing COCs.

2 The midpoint of the range of 5 to 7 per 10,000 woman-years demonstrates a relative risk for levonorgestrel-containing COC users compared with nonusers of hormonal contraception, for whom the risk is approximately 2.3 to 3.6.

- In women taking COCs, thrombosis extremely rarely occurs in other blood vessels, for example, the liver, mesentery, veins and arteries of the kidneys or retina.

Risk factors for VTE

The risk of venous thromboembolism for COC users may be significantly increased by the presence of additional risk factors, especially if there are several of them (see table). Tri-Mercy® is contraindicated if a woman has several risk factors that increase her risk of developing venous thromboembolism (see section “Contraindications”). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in which case her resulting risk of VTE should be considered. If the risk outweighs the benefits of using the drug, COCs should not be used (see section “Contraindications”).

Table: Risk factors for VTE

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the occurrence or progression of venous thromboembolism. The increased risk of thromboembolism during pregnancy and especially in the first 6 weeks of the postpartum period must be taken into account (for information on pregnancy and breastfeeding, see the section “Use during pregnancy and breastfeeding”).

Symptoms of VTE (deep vein thrombosis or pulmonary embolism).

If symptoms occur, a woman is advised to seek immediate medical attention and inform her doctor that she is using COCs.

The following symptoms may indicate deep vein thrombosis:

- unilateral swelling of the lower limb and/or foot or along a vein in the lower limb;

- pain or tenderness in the lower limb, which can only be felt when standing or walking;

- increased temperature of the affected lower limb, redness or paleness of the lower limb.

The following symptoms may indicate pulmonary embolism:

-sudden unexplained shortness of breath or rapid breathing;

-sudden cough, possibly with hemoptysis;

-acute pain in the chest;

- severe dizziness or feeling of lightheadedness;

-fast or irregular heartbeat.

Some of these symptoms (such as shortness of breath, cough) are nonspecific and may be misinterpreted as characteristic of less severe illnesses (eg, respiratory tract infections).

Other signs that may indicate vascular occlusion:

sudden pain, swelling and slightly bluish discoloration of the limb.

If the occlusion occurs in the vessels of the eyeball, symptoms can range from painless blurred vision to loss of vision. Sometimes vision loss can occur almost suddenly.

Risk of arterial thromboembolism (ATE)

Epidemiological studies have associated the use of COCs with an increased risk of arterial thromboembolism (myocardial infarction) or cerebrovascular accident (eg, stroke, transient ischemic attack). Cases of arterial thromboembolism can be fatal.

Risk factors for ATE

The risk of arterial thromboembolic complications or acute cerebrovascular accident (ACVA) is increased in women taking COCs and having risk factors (see table). Tri-Mercy® is contraindicated if a woman has several risk factors that increase the risk of developing arterial thromboembolism (see section “Contraindications”). If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case the resulting risk of ATE should be calculated. If the risk outweighs the benefit, COCs should not be used (see section "Contraindications").

Table: Risk factors for ATE

Symptoms of ATE

If symptoms occur, a woman is advised to seek immediate medical attention and inform her doctor that she is using COCs.

The following symptoms may indicate acute cerebrovascular accident:

sudden numbness or decreased strength of the muscles of the face, upper or lower limb, especially pronounced on one side;

-sudden difficulty walking, dizziness, loss of balance or coordination;

-sudden confusion, difficulty speaking or understanding;

-sudden unilateral or bilateral visual impairment;

- sudden severe or prolonged headache without a specific cause;

-loss of consciousness or fainting with or without convulsions.

Temporary symptoms indicate a transient ischemic attack.

The following symptoms may indicate myocardial infarction:

- pain, discomfort, pressure or a feeling of heaviness, squeezing or bursting pain in the chest, arm or below the sternum;

-discomfort radiating to the back, jaw, neck, arm, stomach;

- feeling of fullness in the stomach, indigestion or choking;

- sweating, nausea, vomiting or dizziness;

-severe weakness, restlessness or shortness of breath;

-fast or irregular heartbeat.

Tumors

— Epidemiological studies indicate that long-term use of COCs is a risk factor for the development of cervical carcinoma in women infected with human papillomavirus. An increased risk of developing cervical cancer may be due to the characteristics of a woman’s sexual behavior (more sexual intercourse and less frequent use of barrier methods of contraception).

-There is evidence that there is a small increase in the relative risk (1.24) of developing breast cancer in women using COCs. The increased risk gradually decreases over 10 years after discontinuation of COCs. Because breast cancer is quite rare in women under 40 years of age, the increase in the likelihood of developing breast cancer in women who are currently using COCs or have recently stopped using them is small relative to the initial likelihood of developing breast cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer may be explained either by the fact that women taking COCs are diagnosed with breast cancer at an earlier stage, by the biological effects of COCs, or by a combination of both. Breast cancer in women who had ever taken COCs was usually detected at an earlier stage than in women who had never taken COCs.

- Cases of benign liver tumors have been extremely rarely reported, and even more rarely, cases of malignant tumors have been reported in women using COCs. In isolated cases, such tumors led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain, hepatomegaly or signs of intra-abdominal bleeding occur in a woman taking COCs, the possibility of a liver tumor should be considered in the differential diagnosis.

Other states

-If a woman or her family members are diagnosed with hypertriglyceridemia, there may be an increased risk of pancreatitis when taking COCs.

-If a woman using a COC develops persistent clinically significant hypertension, the physician should discontinue the COC and treat the hypertension. In some cases, after normalization of blood pressure against the background of antihypertensive therapy, you can resume taking COCs.

- Jaundice and/or pruritus caused by cholestasis have been reported: gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema edema develops or worsens both during pregnancy and when taking COCs, but the evidence for this in relation to COC use is inconclusive.

-Acute or chronic liver dysfunction may necessitate a break in COC use until liver function tests return to normal. Recurrence of cholestatic jaundice and/or pruritus that occurred during pregnancy or previous use of sex hormones requires discontinuation of COCs.

-Despite the fact that COCs can affect peripheral insulin resistance and glucose tolerance, dose adjustment and dosage regimen of hypoglycemic drugs in patients with diabetes mellitus using low-dose COCs is usually not required. However, such women should be carefully monitored by a doctor while taking COCs.

-There is evidence that there is a connection between taking COCs and Crohn's disease and ulcerative colitis.

-Sometimes when taking COCs, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet radiation from other sources when taking COCs.

Medical examinations/consultations

Before starting or resuming the use of Tri-Mercy® in a woman, it is necessary to obtain a detailed medical history (including family history) and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, guided by contraindications and precautions.

The woman should be provided with information regarding venous and arterial thromboembolism, including data indicating an increased risk when taking Tri-Mercy® compared to other COCs. The woman should be familiar with the symptoms of VTE and ATE, informed about known risk factors and what to do if thrombosis is suspected. The woman should be instructed to carefully read these instructions for use and adhere to the recommendations contained therein. The frequency and list of further periodic examinations should be based on generally accepted practice and selected individually for each woman (but at least once every 6 months).

The woman should be advised that hormonal contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.

Reduced efficiency

The effectiveness of COCs may be reduced if pills are missed (see section “What to do if a woman forgets to take a pill”) or if gastrointestinal disorders occur (see section “Recommendations in case of gastrointestinal disorders (vomiting, diarrhea)” ) or when used together with other drugs (see section “Interaction with other drugs”). Herbal medicines containing St. John's wort ( Hypericum perforatum

), should not be used in conjunction with Tri-Mercy®. as this may lead to a decrease in plasma concentrations and a decrease in the effectiveness of the Tri-Mercy® drug (see section “Interaction with other drugs”). Acyclic bleeding during use of the drug Tri-Mercy® Irregular bleeding (spotting or heavy) can occur when using any COC, more often in the first 3 months of adaptation.

If irregular bleeding occurs after previous regular cycles, non-hormonal causes should be considered and adequate diagnostic measures should be taken to exclude neoplasms or pregnancy. These examinations may include, but are not limited to, diagnostic curettage.

Some women may not have menstrual-like bleeding between pills. If COCs are taken as recommended above, there is little chance of pregnancy. If the dosage regimen was violated, then in the absence of the first “withdrawal” bleeding in a row, it is necessary to exclude pregnancy before resuming the use of COCs.

Laboratory indicators

The use of COCs may affect the results of a number of laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of carrier proteins, for example, corticosteroid binding globulin and lipid/lipoprotein fractions, some parameters of carbohydrate metabolism, as well as parameters of coagulation and fibrinolysis. Typically, these changes remain within normal laboratory values.

Lactose

Each Tri-Mercy® tablet contains less than 65 mg of lactose. Women with rare hereditary disorders such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should not take Tri-Mercy®.

Drug interactions

When used simultaneously with drugs that induce microsomal liver enzymes (barbiturates, rifampicin, hydantoins, primidone, oxcarbazepine, felbamate, griseofulvin, carbamazepine, ritonavir, topiramate, St. John's wort preparations), the effectiveness of oral contraceptives may decrease, therefore, during the period of taking any of the above-mentioned drugs , as well as within 28 days after the end of therapy, women should additionally use barrier methods of contraception or completely switch to another method of contraception.

When using antibiotics (except for griseofulvin and rifampicin), a barrier method of contraception should be used throughout the course of therapy, as well as for 7 days after the end of treatment.

Tri-Mercy and other oral contraceptives may change the metabolism of some drugs, increasing or decreasing their plasma concentrations (to determine possible interactions, you should read the instructions for the specific drug).