Tri-mercy tablet film pack contact cell/pack of cards x21

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 and 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 include sudden pain, swelling, and a 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 an 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, then the risk of pancreatitis may increase 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 require a break in taking COCs 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®.

Pharmacological properties

The contraceptive effect of Tri-Mercy, like all combined oral contraceptives (COCs), is based on various factors, the most important of which are inhibition of ovulation and changes in mucus secretion by the cervical epithelium. Along with contraceptive properties, COCs have a number of additional positive effects, which, after assessing possible negative effects (see Warnings, side effects), can be useful when choosing a method of contraception. Thus, the menstrual cycle becomes more orderly, menstruation is less painful, with less bleeding. The latter circumstance leads to a decrease in the incidence of iron deficiency anemia.

When using COCs with a high content of hormones (50 mcg ethinyl estradiol), a reduction in the risk of developing fibrocystic mastopathy, ovarian cysts, pelvic inflammatory diseases, ectopic pregnancy, ovarian and endometrial cancer was shown. The applicability of these data to low-hormone COCs requires further confirmation.

Pregnancy

The use of the drug during pregnancy is contraindicated. If pregnancy occurs while using the drug, you should stop taking it.

The drug may affect lactation, because combined oral contraceptives reduce the amount and change the composition of breast milk. Therefore, the drug is not recommended for use until the nursing mother completely stops breastfeeding. Small amounts of contraceptive steroids and/or their metabolic products may be excreted in breast milk.

Side effects

- Thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism, thromboembolism of the hepatic, mesenteric, renal arteries and veins, retinal arteries).

- Increased blood pressure.

- Crohn's disease and ulcerative colitis.

- Hormone-dependent tumors (liver tumors, breast cancer).

- Chloasma (especially if there is a history of chloasma during pregnancy).

- Acyclic bleeding is more common in the first months of use.

- New or worsening jaundice and/or pruritus associated with cholestasis, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, chorea minor, herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

- Hypersensitivity reactions.

Interaction with other drugs

Interactions between oral contraceptives and other drugs may lead to acyclic bleeding and/or decreased contraceptive effectiveness. The following interactions are described in the literature.

Hepatic metabolism: Interactions may occur with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones (eg, hydantoins, barbiturates, primidone, carbamazepine, rifampicin; and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort).

Maximum enzyme induction is usually not observed in the first 2-3 weeks of taking the drug, but may persist for at least 4 weeks after discontinuation of the drug.

Cases of decreased contraceptive effectiveness have been described with the simultaneous administration of certain antibiotics, such as ampicillin and tetracyclines. The mechanism of this effect is unclear.

Women who take any of the above medications should temporarily additionally use a barrier method of contraception or choose another method of contraception. When using microsomal enzyme inducers simultaneously, a barrier method of contraception should be used throughout the entire course of treatment and for 28 days after stopping treatment. With a long course of taking drugs that induce microsomal enzymes, you should consider choosing a different method of contraception. Women using antibiotics (with the exception of rifampicin and griseofulvin, which also induce microsomal enzymes) should use a barrier method of contraception throughout the course of treatment and for 7 days after the end of therapy. If the period during which a barrier method of contraception is used continues after the end of the tablets in the COC package, then the next package of the drug must be started without the usual dosing interval.

Oral contraceptives may affect the metabolism of other drugs.

Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Note: When treating with other medications, to determine possible interactions, you should read the instructions for medical use of these medications.

Contraindications

COCs (combined oral contraceptives) should not be used if any of the following conditions are present. If any of these conditions occur for the first time while using a COC, Tri-Mercy should be discontinued immediately. Venous thrombosis (including deep vein thrombosis, pulmonary embolism), incl. in the anamnesis. Arterial thrombosis (including myocardial infarction, stroke) or precursors of thrombosis (including transient ischemic attack, angina), incl. in the anamnesis. Known predisposition to venous or arterial thrombosis, including activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies. History of migraine with focal neurological symptoms. Diabetes mellitus with vascular damage. The presence of severe or multiple risk factors for venous or arterial thrombosis (including severe forms of arterial hypertension with blood pressure ≥160/100 mmHg; see paragraph “With caution”). Pancreatitis currently or in history accompanied by severe hypertriglyceridemia. Current or history of severe liver disease (before normalization of liver function parameters). Current or history of liver tumor (benign or malignant). Diagnosed or suspected hormone-dependent malignant tumors (for example, genitals and mammary glands). Vaginal bleeding unknown etiology. Diagnosed or suspected pregnancy. Breastfeeding period. Women over 35 years of age who smoke (more than 15 cigarettes per day). Hypersensitivity to the active substances or to any of Tri-Mercy's excipients.

Directions for use and dosage

How to take Tri-Mercy Tablets should be taken orally in the order indicated on the package, every day at approximately the same time of day, if necessary, with a small amount of liquid. Take 1 tablet per day for 21 days, starting with yellow tablets (7 days), then moving on to red tablets (7 days) and finally to white tablets (7 days). Taking tablets from a new package should begin 7 days after the end of the previous one; during these 7 days, menstrual-like bleeding usually occurs. It usually begins 2-3 days after taking the last pill and may not end by the time you start taking pills from a new package.