Index of drugs

Oral contraceptive. When deciding to prescribe a woman, you should take into account the risk factors currently occurring in a given woman, particularly the risk factors for venous thromboembolism (VTE), as well as how the risk of VTE associated with this medicine is presented against the risk of with the use of other combined hormonal contraceptives.

1 tabl contains 250 μg of norgestimate and 35 μg of ethinyl estradiol. The preparation contains lactose.

A complex oral contraceptive. Norgestimate and ethinylestradiol work thanks to the mechanism of suppression of gonadotrophins as a result of estrogen and progestagen. The primary mechanism of action is inhibition of ovulation, but the effect of contraception on the cervical mucus, the motility of the fallopian tubes and endometrial mucosa may also contribute to the effectiveness of the contraceptive. Norgestimate and ethinyl estradiol are rapidly absorbed after oral administration. After single or multiple (three cycles) administration of norgestimate / ethinyl estradiol C_max metabolites of norgestimate (norelgestromin and norgestrel) are present in serum about 1.5 hours after administration; C_max ethinyl estradiol - after approx. 1.2 h. Norelgestromin and norgestrel (> 97%) bind to plasma proteins to a large extent (> 97%). Norelgestromin is associated with albumin, but not with SHBG, while norgestrel is mainly associated with SHBG, and to a much lesser extent with albumin. Ethinyl estradiol is highly bound to plasma albumin. Norgestimate is rapidly metabolised during the first pass (through the intestine and / or liver) to norelgestromin and norgestrel, which are pharmacologically active progestagens. Ethinyl estradiol is metabolised to various hydroxylated metabolites and their conjugated compounds, i.e. glucuronides or sulfates. Both norelgestromin, norgestrel, and ethinyl estradiol are then metabolized and their metabolites excreted via the kidneys and faeces. T values_0,5 in the elimination phase, the steady-state equals 10-15 h for ethinyl estradiol, 24.9 h for norelgestromin and 45 h for norgestrel.

Hypersensitivity to the active substances or to any of the excipients. Presence or risk of venous thromboembolism (VTE): venous thromboembolism - active VTE (during treatment with anticoagulants) or traveled (eg, deep vein thrombosis or pulmonary embolism); confirmed inherited or acquired predisposition to VTE, eg resistance to APC (including the presence of factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency; traveling a large surgical procedure combined with long-term immobilization; high risk of VTE due to the coexistence of several risk factors. Presence or risk of arterial thromboembolism: arterial thromboembolism - active arterial thromboembolism, history of arterial thromboembolism (eg myocardial infarction) or diseases heralding the occurrence of arterial thromboembolism (eg angina pectoris ); cerebrovascular disease - current stroke, previous stroke or disease heralding a stroke (e.g., transient ischemic stroke - TIA); confirmed hereditary or acquired predisposition to arterial thromboembolism, e.g. hyperhomocysteinemia and the presence of anti-phospholipid antibodies (anti-cardiolipin antibodies, lupus anticoagulant); positive history of migraine with focal neurological symptoms; high risk of arterial thromboembolism due to the coexistence of several risk factors or the presence of one serious risk factor, such as: vascular diabetes mellitus, severe hypertension, severe dyslipoproteinaemia. Breast-feeding mothers in less than 6 weeks after giving birth. Endometrial cancer or other, recognized estrogen-dependent cancer. Bleeding from the reproductive organs of unexplained etiology. Smoking 15 or more cigarettes a day for patients over 35 years of age.Acute or chronic liver disease such as hepatitis (viral or non-viral) or severe liver cirrhosis, or a history of these conditions for at least 3 months after return of abnormal values ​​of liver function tests to normal; liver adenomas or liver tumors. Diagnosed or suspected breast cancer. Pancreatitis, also in an interview, if it is associated with severe hypertriglyceridaemia. The preparation is contraindicated in girls who did not reach pubertal age - they did not start menstruation.

The use of any combined hormonal contraceptives carries an increased risk of VTE. The use of preparations containing levonorgestrel, norgestimate (including Elin) or norethisterone is associated with a lower risk of developing VTE. The decision to use the preparation should be made after discussing the issue with the patient in order to make sure that the patient understands the risk of VTE, how the current risk factors affect the risk of VTE, and the risk of VTE is higher in the first year of application. There is also some evidence that this risk is increased when the use of a combined hormonal contraceptive is resumed after an interval of at least 4 weeks. The risk of developing VTE with the norgestimate containing agents is similar to the risks associated with the use of levonorgestrel-containing agents. In patients using combined hormonal contraceptives, cases of thrombosis in other vascular beds, such as the venous and arterial blood vessels of the liver, mesentery, kidneys, brain or retina, are very rarely described. The use of the preparation is contraindicated in women who coexist with several risk factors for venous thrombosis. If a woman has more than one risk factor, it is possible that the resultant risk is greater than it would result from a simple summation of individual risk factors - in this case, the total risk of VTE should be assessed. If the balance of benefits and risks is considered negative, then the combined hormonal contraceptive should not be prescribed. Risk factors for venous thromboembolism: obesity (body mass index above 30 kg / m²) - as the BMI increases, the risk increases significantly (this issue is particularly important if other risk factors coincide with it); prolonged immobilization (including flight over the course of more than 4 hours), passing a major surgical procedure, passing any surgical procedure in the lower limbs or pelvis, going through a neurosurgical procedure or experiencing any major trauma - it is recommended to discontinue the use of contraceptive pills (at least 4 weeks) before the planned surgery), the use can be resumed at the earliest 2 weeks after the patient is completely started, in order to avoid unintentional pregnancy, another method of contraception should be used (temporary immobilization, including air travel> 4 h, may also be a risk factor for venous thromboembolism , especially in women with other concomitant risk factors); family burden (VTE with a brother, sister or parent, especially in a relatively young age, eg before the age of 50) - if genetic predisposition is suspected, the patient should be referred to a specialist for advice before deciding whether to start using the product; other diseases associated with VTE (malignant tumor, systemic lupus erythematosis, haemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle-cell disease (Sickle Cell Syndrome); age - especially at the age of over 35 years. Opinions are divided as to the possible role of varicose veins and thrombophlebitis of superficial veins in contributing to the development or progression of venous thrombosis. The increased risk of thromboembolic complications during pregnancy and in the 6th week should be taken into account postpartum period. Epidemiological studies have demonstrated a relationship between the use of combined hormonal contraceptives and an increased risk of arterial thromboembolism (myocardial infarction) or an increased risk of cerebrovascular events (transient ischemic attack, stroke).The use of the preparation is contraindicated in women who have one serious risk factor or have several risk factors for arterial thromboembolism which expose them to an increased risk of arterial thrombosis. If a woman has more than one risk factor, it is possible that the resultant risk is greater than that resulting from a simple summation of individual risk factors - in this case, the total risk of arterial thromboembolism should be assessed. If the balance of benefits and risks is considered negative, then the preparation should not be prescribed. Risk factors for arterial thromboembolism: advanced age - especially age over 35 years; smoking - women should be strongly advised not to smoke if they are intending to use a combined hormonal contraceptive (women over 35 who do not express the will to stop smoking, another method of contraception should be strongly recommended); hypertension; obesity (index above 30 kg / m)²) - as BMI increases, the risk increases significantly, especially in women who have additional risk factors; Family burden (arterial thromboembolism in a brother, sister or parent, especially at a relatively young age, e.g. before the age of 50) - if you suspect hereditary predispositions, you should refer to a specialist for advice before deciding to start treatment any combined hormonal contraceptive; migraine - an increase in the frequency or severity of migraine during use (which may herald a cerebrovascular event) may be the reason for the immediate withdrawal of the preparation; other diseases associated with vascular adverse events (diabetes, hyperhomocysteinemia, cardiac valvulopathy and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus). The results of some epidemiological studies have indicated that long-term use of oral contraceptives (over 5 years) is associated with an increased risk of cervical cancer, but there is still no consensus to what extent this is related to the effects of sexual behavior and other factors such as human papilloma virus (HPV). Women who currently take combined oral contraceptives have a slightly higher risk of developing breast cancer. This increased risk gradually disappears within 10 years after discontinuing treatment. If the patient using oral contraceptive develops severe epigastric pain, enlargement of the liver or symptoms of abdominal haemorrhage, liver cancer should be considered during the differential diagnosis. The use of complex oral contraceptives with a higher dose of the active substance (50 μg ethinylestradiol) is associated with a lower risk of endometrial cancer and ovarian cancer. So far, it has not been confirmed whether this also applies to complex oral contraception with a reduced dose. In patients who are is equal to or greater than 90 kg, the contraceptive effectiveness of the agent may be reduced. Patients with hypertriglyceridaemia or a family history in this direction may be at increased risk of pancreatitis. Although many women taking hormonal contraceptives had a slight increase in blood pressure, clinically significant cases were rare. Discontinuation of combined oral contraceptives is only justified in these rare cases. If, during the use of a combined hormonal contraceptive in patients with prior hypertension, continuously elevated blood pressure values ​​or significantly elevated blood pressure do not decrease as a result of antihypertensive therapy, the combined hormonal contraceptive should be discontinued. If antihypertensive therapy restores normal blood pressure, treatment can be resumed. During pregnancy and the use of complex oral contraceptives, the existing conditions mentioned herein have been found or exacerbated, but evidence of a connection with the use of combined oral contraceptives is not conclusive: jaundice and / or pruritus associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenham chorea, herpes of pregnant women, hearing loss associated with otosclerosis. In women with congenital angioedema, estrogens of external origin may cause or exacerbate symptoms of angioedema. acute or chronic liver dysfunction may lead to discontinuation of combined hormonal contraceptives until liver function returns to normal.Recurrence of pruritus caused by cholestasis, which occurred during the last pregnancy or prior use of sex hormones, necessitates discontinuation of the preparation. Patients with diabetes should be closely monitored, especially at the beginning of the treatment. Increased endogenous depression, epilepsy, Crohn's disease and ulcerative colitis have been reported with the use of complex oral contraceptives. Chloasma may occur occasionally, especially in patients with a history of chloasma during pregnancy. Women with a tendency to chloasma while taking complex oral contraceptives should avoid exposure to the sun or ultraviolet radiation. The efficacy of combined oral contraceptives can be reduced if tablets with active substance are omitted, gastrointestinal disorders are taken while taking tablets, or concomitant use of other medications. In women taking combined hormonal contraceptives, especially in the initial months of their use, irregular bleeding may occur (spotting or intermenstrual bleeding). Due to this medical opinion about irregular bleeding will only be important after the period of adaptation, lasting about 3 cycles. If irregular breakthrough bleeding persists or appears after previous, regular cycles, and the preparation is taken according to the recommended schedule, a reason other than that resulting from the use of combined oral contraceptives should be considered. Non-hormonal causes should be investigated and, if necessary, appropriate diagnostics should be performed to exclude organic disease or pregnancy. Diagnostic tests may include curettage of the uterine cavity. Some women may not have withdrawal bleeds when they are taking their tablets. If the preparation was used as prescribed, the pregnancy is unlikely. However, if it has not been used as prescribed before the first absence of withdrawal bleed or if the woman does not have two consecutive withdrawal bleeds, pregnancy should be excluded before continuing. In some patients, a lack of or scanty menstruation may occur after discontinuation of hormonal contraception, especially if it was earlier. Do not use herbal remedies containing St John's wort while taking the product. The product contains lactose - should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The product contraindicated during pregnancy. Stop suspected pregnancy before stopping the preparation. The increased risk of VTE should be considered when resuming use in the puerperium period. Steroids contained in contraceptives and / or their metabolites may be excreted in milk. The use of the preparation is contraindicated in lactating women who gave birth less than 6 weeks ago; use in lactating women between 6 weeks and 6 months after delivery must be clinically warranted. Breast-feeding women, instead of using compound tablets that reduce lactation, should be advised to use "mini-pills" (containing only progestogen). Norgestimate, used in monotherapy and in combination with ethinyl estradiol, is an effective anti-ovulatory agent. After the oral contraceptive is finished, the patient should refrain from pregnancy until at least one natural menstruation occurs so that the age of the pregnancy can be determined. During this period, another method of contraception should be used.

Very common: headache, gastrointestinal disturbances, vomiting, diarrhea, nausea, menstrual disorders, uterine haemorrhage, abnormal withdrawal bleeding. Common: urinary tract infection, vaginal infection, hypersensitivity, fluid retention, mood changes, depression, nervousness, insomnia, migraine, dizziness, gastrointestinal pain, abdominal pain, bloating, constipation, winds, acne, rash, painful cramps muscle, pain in the limbs, back pain, lack of menstruation, vaginal discharge, breast pain, chest pain, swelling, weakness, weight gain.Uncommon: Cervical dysplasia, reduced or increased appetite, changes in body weight, anxiety, sex drive disorders, syncope, paresthesia, visual disturbances, dry eyes, palpitations, thrombosis, hypertension, hot flushes, shortness of breath, alopecia, hirsutism, urticaria , pruritus, erythema, skin discoloration, muscle pain, discharge from the breast, breast enlargement, ovarian cyst, dryness of the vulva and vagina, weight loss. Rare: breast cysts, loss of appetite, loss of libido, vertigo, tachycardia, venous thrombotic events or arterial thrombotic events, pancreatitis, hepatitis, severe sweating, hypersensitivity to light, vaginal discharge. Not known: liver adenomas, breast cancer, benign breast cancer, focal liver nodular hyperplasia, fibroadenoma, dyslipidemia, cerebrovascular incident, seizures, contact lens intolerance, retinal vein thrombosis, myocardial infarction, deep vein thrombosis, pulmonary embolism, edema vasomotor, erythema nodosum, night sweats, inhibition of lactation.

Orally. Adults. One table should be taken at a fixed time every day (preferably in the evening) for a continuous period of 21 days followed by a 7-day break in taking tablets. The Next package should start after the 7-day break. During this period, no additional contraceptives need to be used. During a break in taking tablets, bleeding usually occurs at the beginning of the 2nd to 4th day after taking the last tablet.Beginning of the preparation. Taking the tablets starts on the first day of the woman's natural menstrual cycle, the first day of bleeding.Transition from another contraceptive. Transition from a complex hormonal contraceptive (combined oral contraceptives, vaginal discs or transdermal patches): it is best to start taking the product on the day after the last active tablet (containing the active substance) of a combined oral contraceptive, but no later than the day after the usual interruption of previous tablets or after taking the last tablet containing the placebo previously used combined oral contraceptive. In case of using the vaginal disc or the transdermal patch in advance, it is best to start taking the product on the day of removal, but at the latest on the day of re-application.Transition from a method containing only progestagen (mini-pill, injection, implant or intrauterine contraceptive system secreting progestin): a woman can each day go from a mini-mouse to a product (from an implant or intrauterine system on the day of removal, from a drug injected - on the day of the next application), however in all cases, the use of an additional contraceptive barrier method should be recommended for the first 7 days of tablets.Administration of the preparation after delivery.After giving birth, oral contraceptives for non-feeding mothers can be started 21 days after delivery, if the patient is fully moving and has no postpartum complications. There is no need to use additional contraceptives. If the preparation is started later than 21 days after delivery, additional contraception is necessary for the first 7 days of taking the tablets. If a sexual intercourse has occurred after birth, one should withhold oral contraception until the first day of the first menstrual bleeding.The use of the preparation after removal of pregnancy or abortion. After removal of pregnancy in the first trimester: the product can be used immediately. In this case, no additional contraceptive measures are necessary.After delivery or removal of pregnancy in the second trimester of pregnancy: should be started on day 21 to 28 after delivery or removal of pregnancy in the second trimester. In the event of a later start for the first 7 days, an additional barrier method should be recommended. However, if the woman has already had sexual intercourse, pregnancy should be ruled out before starting the use of a combined oral contraceptive or until the first menstrual bleeding occurs.Proceedings to delay menstruation. To delay the onset of menstruation, a woman should start a new pack on the day after the end of the current pack, without taking a break in the use of the tablets. Taking tablets should continue in the usual way. When taking the tablets from the second packet, you may have slight spotting or intermenstrual bleeding, but this does not reduce contraceptive protection unless you take any tablets. The next pack should be started after an ordinary 7-day break in taking the tablets, even if the menstrual period is still present.Proceeding in case of skipping tablets. If the delay in taking the tablet does not exceed 12 hours, the degree of protection against pregnancy will remain unchanged. The woman should then take the tablet as soon as possible, and the next dose should take at the usual time. If the delay in taking the tablet exceeds 12 h, the degree of protection against pregnancy may be reduced. If you forget to take tablets, follow these basic rules: 1. Never stop taking tablets for more than 4 days; 2. The proper inhibition of the hypothalamo-pituitary-ovary axis requires continued intake of tablets for 7 days. Therefore, the following procedure should be recommended:days 1-7. - the patient should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, continue taking your tablets at the usual time. Additionally, for the next 7 days she should use a barrier method, e.g. a condom. If there has been sexual intercourse during the week preceding the omission of the tablet, the possibility of pregnancy should be considered. The more tablets omitted, and the shorter the interval to the period of tablet use, the greater the risk of becoming pregnant;days 8-14. - the patient should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, continue taking your tablets at the usual time. If the woman took tablets correctly for the period of 7 days preceding the first omission of the tablet, there is no need to use additional contraceptive precautions. However, if a woman omitted more than 1 tablet, additional precautions should be recommended for 7 days;days 15-21. - the risk of reduced effectiveness is imminent due to the upcoming 7-day break in taking tablets. However, reducing contraceptive protection can be prevented by adjusting the pattern of taking tablets. If a woman adheres to one of two recommendations, there is no need to use additional contraceptive precautions, as long as she took the tablets correctly for the period of 7 days preceding the first omission of the tablet. In another case, the patient should follow the first of two options, and in addition for the next 7 days should use additional contraceptive protection. 1. The patient should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. Then, continue taking your tablets at the usual time. The next pack should be started immediately after the end of taking the tablets from the last pack, i.e. without the period of interruption in taking the tablets. In this case, withdrawal bleeding is unlikely until the end of the second pack, but spotting or breakthrough bleeding may occur while taking the tablets. 2. You can also stop taking the tablets from the current pack. Then the woman should start a 7-day break in taking the tablets, covering the days when the tablets have been missed, and then should start taking the tablets from the next pack. If a woman skips a few tablets and subsequently does not experience withdrawal bleeding during the first regular tableting break, you should consider the possibility of getting pregnant. In case ofsevere gastrointestinal disorders (eg, vomiting or diarrhea), active substances may not be fully absorbed, therefore additional contraception should be used.If vomiting or severe diarrhea occurs within 3-4 hours after taking the tablet, immediately take a new tablet (spare). The new tablet, if possible, should be taken no later than within 12 hours of the usual time of reception. After more than 12 hours, follow the instructions for dealing with missed tablets. If a woman does not want to change the usual pattern of taking tablets, she must take an additional tablet (s) from another pack.