Index of drugs

Hormonal contraception. Treatment of moderate acne in women who are not contraindicated to use oral contraceptives, and the appropriate local treatment was ineffective. The decision to prescribe the preparation should be made on the basis of an individual assessment of risk factors in women, in particular the risk of venous thromboembolism and the risk of venous thromboembolism associated with the use of the preparation in relation to other combined hormonal contraceptives.

1 tabl powl. contains 2 mg dienogest and 0.03 mg ethinyl estradiol. The preparation contains lactose.

A complex oral contraceptive with antiandrogenic properties. The contraceptive effect is based on the interaction of various factors, the most important of which is inhibition of ovulation and cervical secretion. The antiandrogenic effect of the combined use of ethinylestradiol / dienogest is, inter alia, to reduce serum androgen levels. The preparation causes a significant improvement of mild to moderate acne symptoms and has a beneficial effect on the symptoms of seborrhoea. Orally administered ethinyl estradiol undergoes rapid and complete absorption. The maximum serum concentration is about 1.5-4 h after taking the tablet. It is largely metabolised during absorption and as a result of the first-pass effect in the liver, whereby its average bioavailability after oral administration is approximately 44%. Ethinylestradiol is extensively (around 98%) but unspecifically bound to serum albumin and causes increased serum-binding globulin binding hormones (SHBG). Ethinyl estradiol undergoes pre-systemic coupling in the mucous membrane of the small intestine and liver. It is metabolized mainly by aromatic hydroxylation, which results in different hydroxylated and methylated metabolites, detected in the serum as free metabolites or conjugated glucuronides or sulfates. Ethinylestradiol undergoes enterohepatic circulation. The concentration of ethinyl estradiol in the serum decreases in two phases, determined by T_0,5 approximately 1 h and 10-20 h. Ethinylestradiol is not excreted unchanged. Metabolites are excreted in urine and bile in a ratio of 4: 6. Dienogest administered orally is rapidly and practically completely absorbed. After a single administration of the tablet, the maximum serum concentration occurs after about 2.5 hours. The absolute bioavailability of dienogest with ethinyl estradiol is approximately 96%. Dienogest binds to serum albumin and is not associated with SHBG and corticosteroid binding globulin (CBG). Approx. 10% of total active substance concentration in the serum is in the form of an unrelated steroid. 90% bind nonspecifically to albumin. Dienogest is mainly metabolised by hydroxylation and coupling to metabolites that are essentially inactive and are rapidly removed from the plasma. The concentration of serum dienogest decreases from T_0,5 amounting to approx. 9 h. Only small amounts are excreted unchanged by the kidneys. After an oral dose of 0.1 mg / kg, the ratio of urinary excretion to urine in the faeces is 3: 2.

Hypersensitivity to the active substances or to any of the excipients. Occurrence or risk of venous thromboembolism (VTE): venous thromboembolism - active (treated with anticoagulants) or history of venous thromboembolism, e.g. deep vein thrombosis (DVT), pulmonary embolism (PE); known hereditary or acquired predisposition to venous thromboembolic disease, eg resistance to active C protein (APC) (including Leiden V factor), antithrombin III deficiency, protein C deficiency, protein S deficiency or other coagulopathy, valvular heart disease, arrhythmias accompanied by an increased risk of blood clots; extensive surgery associated with long-term immobilization; high risk of venous thromboembolism due to multiple risk factors. Occurrence or risk of arterial thromboembolism (ATE): arterial thromboembolic events - active (eg myocardial infarction) or prodromal symptoms (e.g.angina pectoris); cerebrovascular diseases - active stroke, previous stroke or prodromal symptoms (eg transient ischemic attack, TIA); confirmed hereditary or acquired propensity for arterial thromboembolic events, e.g. hyperhomocysteinemia and the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant); migraine with focal neurological symptoms in an interview; high risk of arterial thromboembolic events, due to the presence of multiple risk factors or the presence of one of the major risk factors, such as: diabetes with vascular complications, severe hypertension, severe dyslipoproteinaemia. Smoking tobacco. Occurrence of pancreatitis with or without severe hypertriglyceridemia. Occurring or past liver dysfunction, unless liver function returns to normal (including Dubin-Johnson syndrome and Rotor syndrome). Presence or history of liver cancer. Diagnosis or suspicion of malignant tumors dependent on sex hormones (eg breast cancer or endometrium). Bleeding from the vagina of unexplained etiology. Amenorrhea with unexplained etiology.

The preparation should be immediately discontinued in the following cases: beginning or suspected pregnancy; first signs of phlebitis or symptoms suggestive of thrombosis (including retinal thrombosis), embolism or myocardial infarction; constantly increased blood pressure to above 140/90 mmHg (re-use of combined oral contraceptives may be considered as soon as blood pressure values ​​return to normal as a result of antihypertensive treatment); planned surgery (at least 4 weeks earlier) and / or long-term immobilization (eg after accidents) - for at least 2 weeks after full recovery of physical fitness should not be returned to the use of tablets; occurrence for the first time or worsening of migraine; the occurrence of very frequent, prolonged or severe headaches or sudden development of neurological focal symptoms (these may be the first signs of stroke); acute epigastric pain, enlarged liver or symptoms of abdominal bleeding (these may be signs of liver cancer); the onset of jaundice, hepatitis, generalized pruritus, cholestasis and abnormal values ​​of liver parameters, deterioration of steroid hormone metabolism as a result of hepatic impairment; acute decompensation of diabetes; occurrence for the first time or a return of porphyria. Disorders / risk factors requiring special medical supervision: heart and kidney disorders resulting from the action of the active substance ethinylestradiol, which can lead to fluid retention in the body; superficial vein inflammation, significant tendency to varicose veins, peripheral circulatory disorders (because they may be associated with the onset of thrombosis); increase in blood pressure (up to 140/90 mmHg or above), disorders of lipid metabolism (in patients with lipid metabolism disorders, ethinylestradiol may lead to significant increase in triglycerides in the plasma, followed by pancreatitis and other complications); sickle cell disease; history of liver disease; disorders of the gallbladder; migraine; depression (it should be stated whether depression is related to the use of the preparation, if necessary, other non-hormonal methods of contraception should be used); decreased Glucose tolerance or diabetes (the need for insulin or other antidiabetic agents may change); smoking tobacco; epilepsy (if epileptic seizures develop during treatment with the product, other methods of contraception should be considered); lower chorea (Sydenhama); chronic inflammatory bowel disease (Leśniowski-Crohn's disease, ulcerative colitis); haemolytic-uremic syndrome; uterine fibroids; otosclerosis; long-term immobilization; obesity; systemic lupus erythematosus; age 40 or more. The use of any combined hormonal contraceptive is associated with an increased risk of venous thromboembolism compared to when the therapy is not used. The use of preparations containing levonorgestrel, norgestimate or norethisterone is associated with the lowest risk of venous thromboembolism. The risk of Dorin has not yet been established in comparison with these low-risk medicines.The decision to use the preparation from outside the group of preparations known for the lowest risk of venous thromboembolism should only be taken after talking to the patient, to ensure that she understands the risk of venous thromboembolism, how current risk factors affect this risk, and that the risk of venous thromboembolism is the highest in the first year of use. There is some evidence that the risk increases when combined hormonal contraceptives are taken again after an interruption of 4 weeks or longer. In patients using combined hormonal contraceptives, cases of thrombosis in other blood vessels, such as the hepatic, mesenteric, renal, or retinal veins and arteries, have been reported very rarely. Risk factors for venous thromboembolism: obesity (BMI body mass index over 30 kg / m²) - the risk increases significantly with the increase in BMI, this is especially important for women who also have other risk factors; long-term immobilization, extensive surgery, any surgical operation in the lower limbs or pelvis, neurosurgical surgery or serious trauma - it is recommended to stop using the tablets for at least 4 weeks before the planned surgery and not to resume use within 2 weeks from the time of return for motor function (another method of contraception should be used), anticoagulant therapy should be considered if the preparation has not been discontinued early (temporary immobilization, including air travel> 4 h, may also be a risk factor for venous thromboembolism, especially in women with co-existing other risk factors); positive family history (occurrence of venous thromboembolism in siblings or parents, especially at a relatively young age, e.g. before 50) - if genetic predisposition is suspected, a woman should be referred for a decision to use a combined hormonal contraceptive consultation with a specialist; other diseases associated with venous thromboembolism (cancer, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases (eg Crohn's disease or ulcerative colitis) and sickle-cell anemia); age - especially at the age of over 35 years. If the patient has several VTE risk factors at the same time, the use of the preparation is contraindicated. If a woman has more than one risk factor, it is possible that the risk increase is greater than the sum of the single factors - in this case, the overall risk of venous thromboembolism should be assessed. If the benefit-risk assessment is negative, no complex hormonal contraceptives should be prescribed. There was no consensus on the possible effect of varicose veins and thrombophlebitis on the occurrence or progression of venous thromboembolism. The increased risk of thromboembolism during pregnancy and in particular in the 6th week should be considered. postpartum period. Patients should be advised that if symptoms of venous thromboembolism occur, see a doctor immediately and tell the healthcare professional that they use a combined hormonal contraceptive. Epidemiological studies have shown a relationship between the use of hormonal contraceptives and an increased risk of arterial thromboembolism (myocardial infarction) or cerebrovascular events (eg, transient ischemic attack, stroke); cases of arterial thromboembolic events can be fatal. Risk factors for arterial thromboembolic events: age - especially those over 35 years of age; smoking - women should be carefully instructed not to smoke if they intend to use a combined hormonal contraceptive, women over the age of 35 who have not stopped smoking should be carefully instructed to use a different method of contraception; hypertension; obesity (body mass index (BMI) over 30 kg / m²) - the risk increases significantly with the increase in BMI, this is especially important for women who also have other risk factors; positive family history (occurrence of arterial thromboembolism in siblings or parents, especially at a relatively young age, e.g. before- if you suspect you have a genetic predisposition, a woman should be referred to a specialist before deciding whether to use a combined hormonal contraceptive; migraine - an increase in the frequency or severity of migraine during use of combined hormonal contraceptives (which may indicate the occurrence of a cerebrovascular event) may be a reason to discontinue use immediately; other conditions associated with adverse events within the vessels (diabetes, hyperhomocysteinemia, valvular heart disease, atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus). The use of the preparation is contraindicated if the patient has one serious or several risk factors for arterial thromboembolic events that place the patient at high risk of arterial thrombosis. If a woman has more than one risk factor, it is possible that the risk increase is greater than the sum of individual factors - in this case, the total risk should be assessed. If the benefit-risk assessment is negative, no complex hormonal contraceptives should be prescribed. Patients should be advised that if signs of arterial thromboembolism occur, immediately seek medical attention and tell the healthcare professional that they are using combined hormonal contraceptives. In women taking combined oral contraceptives, the risk of breast cancer slightly increases; this increased risk decreases within 10 years of discontinuation of these measures. Long-term use of hormonal contraceptives is a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV); the influence of other factors (eg different number of sexual partners and the use of mechanical contraception) on the development of these changes has not yet been clarified. Very rare reports of benign liver adenomas have been reported in women taking combined oral contraceptives. In individual cases, their cracks led to life-threatening haemorrhages to the abdominal cavity. In case of acute epigastric pain, hepatomegaly or abdominal haemorrhage in women using combined oral contraceptives, the liver tumor should be considered for differential diagnosis. Studies have shown an increased risk of developing hepatocellular carcinomas during long-term use of combined oral contraceptives; however, this type of tumor is extremely rare. For patients who have ever had diseases associated with hypertension or kidney problems, a different method of contraception is recommended. Women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation when taking combined oral contraceptives. In women with hereditary angioedema, the administration of exogenous estrogens may cause or worsen the symptoms of angioneurotic edema. In patients taking combined oral contraceptives, intermenstrual bleeding or spotting was observed, especially during the first few months of use - the assessment of intermenstrual bleeding is only important after approximately 3 months of use. If irregular bleeding persists or recurs after pre-existing menstrual cycles, non-hormonal causes should be considered and appropriate diagnostic tests performed to exclude malignancy and pregnancy. If both of these causes are ruled out, the preparation may be restarted or changed to another hormonal contraceptive. Intermenstrual bleeding may indicate a decreased contraceptive effectiveness. Some patients may not have withdrawal bleeding during the tablet-free period. If, prior to the first absence of withdrawal bleeding, the preparation was not taken as directed, or if the withdrawal bleeding did not occur in two consecutive menstrual cycles, make sure that you are not pregnant before continuing. The contraceptive effectiveness of the preparation may be reduced: if tablets are missed; if you have vomiting or diarrhea; if you are taking other medicines at the same time.When concomitant treatment with St. John's Wort is recommended, additional non-hormonal contraception is recommended. 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.

Do not use during pregnancy. Before using the preparation, make sure that the patient is not pregnant. If the patient becomes pregnant while using the preparation, stop using it immediately. The results of extensive epidemiological studies did not show an increase in the risk of birth defects in children whose mothers took combined oral contraceptives before pregnancy, and the majority of epidemiological studies conducted so far have not shown a teratogenic effect on the fetus in the event of accidental intake of oral contraception during early pregnancy. These types of studies have not been carried out with Dorin. The risk of venous thromboembolism in women in the postpartum period should be taken into account when deciding whether to restart the treatment. Do not use the product during breastfeeding, because it can reduce the amount of milk produced, and the active substances in small amounts can pass into human milk.

Common: headache, breast pain (including discomfort and breast tenderness). Uncommon: vaginitis or vaginitis, vaginal candidiasis or fungal vaginal and vulvar infections, increased appetite, depressed mood, dizziness, migraine, hypertension, hypotension, abdominal pain (including epigastric pain and abdominal pain) abdomen, bloating), nausea, vomiting, diarrhea, acne, baldness, rash (including a spotted rash), pruritus (including pruritus of the whole body), irregular withdrawal bleeding (including menorrhagia, scant and short-lasting menstruation, sporadic menstruation and lack of menstruation), intermenstrual bleeding (including vaginal bleeding and uterine bleeding), breast enlargement (including congestion and / or breast swelling), breast swelling, dysmenorrhea, changes in vaginal secretions, ovarian cysts, pelvic pain, fatigue ( including weakness and malaise), changes in body weight. Rare: inflammation of the ovaries and fallopian tubes, urinary tract infection, cystitis, mastitis, cervicitis, fungal infections, candidiasis, oral herpes, influenza, bronchitis, sinusitis, upper respiratory tract infections, viral infections, uterine smooth myoma , breast lipoma, anemia, hypersensitivity, virilysis, anorexia, depression, mental disorders, insomnia, sleep disorders, aggression, ischemic stroke, cerebrovascular disorders, dystonia, dry eyes, eye irritation, oscillation, visual impairment, sudden hearing loss, noise ear, dizziness, hearing loss, cardiovascular disorders, tachycardia (including accelerated heart rate), venous thromboembolism / arterial thromboembolism, thrombophlebitis, diastolic hypotension, orthostatic disorders, hot flushes, varicose veins, ailments on the part of veins, venous pain, asthma, hyperventilation posterior, gastritis, enteritis, dyspepsia, allergic dermatitis, atopic dermatitis and / or neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorders and / or severe pigmentation, seborrhea, dandruff, hirsutism, skin changes , skin reactions, "orange peel (cellulite)," vascular "vaginas, back pain, musculoskeletal disorders, muscle pain, limb pain, cervical dysplasia, adnexal cysts, appendage pain, breast cysts, fibrocystic cysts, pain during sexual intercourse, galactorrhea, menstrual disorders, the occurrence of an additional mammary gland (without clinical symptoms), chest pain, peripheral edema, flu-like disorders, inflammation, fever, irritability, increased triglycerides in the blood, hypercholesterolemia. Not known: mood changes, decreased libido, increased libido, contact lens intolerance, urticaria, erythema nodosum, erythema multiforme, breast discharge, fluid retention.Severe side effects seen in women taking combined oral contraceptives: hypertension; hypertriglyceridemia; changes in glucose tolerance or effects on peripheral insulin resistance; liver cancer (benign and malignant); liver dysfunction; chloasma; in women with hereditary angioedema, the use of exogenous estrogens may reveal or exacerbate its symptoms; onset or worsening of diseases that have not been elucidated with the use of COCs: jaundice and / or pruritus associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenham chorea, herpes simplex, hearing loss associated with otosclerosis, Leśniowski-Crohn's disease, ulcerative colitis, cervical cancer. The incidence of breast cancer detection is slightly increased in women using oral contraception (a causal relationship with the use of COCs is unknown). In women using combined hormonal contraceptives, there is an increased risk of venous and arterial thrombosis and thromboembolic events, including myocardial infarction, stroke, transient ischemic attack, venous thrombosis and pulmonary embolism.

Orally. 1 tabl daily for 21 consecutive days. The tablet should be swallowed whole (not chewed) daily, more or less at the same time each day, with a small amount of liquid if necessary. The first tablet should be taken out of the place on the blister marked on the day of the week in which tablets are started. The Next tablets should be taken in the direction of the arrows, until the tablets are blister. During the follow-up after a 21-day, 7-day tablet-free interval, discontinuation bleeding occurs usually within 2-4 days after taking the last tablet. After a 7-day tablet-free interval, continue taking the tablets from the next blister pack, regardless of whether the withdrawal bleed is over or continues. The contraceptive action also applies to the 7-day break in taking tablets.Beginning of the preparation. No hormonal contraception last month: tablets should be started on Day 1 of the cycle (1st day of menstrual bleeding). If the preparation is taken correctly, contraceptive protection occurs from the first day of taking tablets. If tablets are started between the 2nd and 5th day, an additional, non-hormonal method of contraception (barrier method) should be used for the first 7 days of taking the tablets.A change from another combined hormonal contraceptive (combined oral contraceptive, intravaginal therapy system, transdermal patch): depending on the type of oral COC, the preparation should be started either on the day following the usual tablet-free interval (after taking the last tablet containing active substances) or on the day following the last tablet containing the active ingredients of the previous combined oral contraceptive. If a vaginal or transdermal patch system has been used, the preparation should be started on the day following the usual discontinuation of the intravaginal or transdermal system.Change from a preparation containing only progestagen (mini-tablet, implant, injection) or from the intrauterine therapy system: if the patient was taking mini-tablets, the change of treatment can take place on any given day; in the case of a change from an implant or intrauterine therapy system, it should take place on the day of removal, and in case of a change from the injection, on the day on which the next injection should be made. In all these cases, non-hormonal contraception (barrier method) should additionally be used during the first 7 days of the preparation.After a miscarriage in the first trimester of pregnancy: the preparation can be started immediately. In this case, there is no need for an additional method of contraception.After delivery or miscarriage in the second trimester of pregnancy: because the risk of thromboembolic events increases immediately after delivery, patients after delivery (not breastfeeding) or after a miscarriage in the second trimester of pregnancy should not initiate oral contraception for at least 21 to 28 days. During the first 7 days of taking tablets, an additional non-hormonal method of contraception (barrier method) should be used. If you have had sexual intercourse, make sure you are not pregnant or wait until the first menstrual bleeding occurs before taking the medicine.Proceeding in case of skipping tablets. Irregular drug intake may reduce its contraceptive effectiveness. If the patient forgets to take the tablet, but takes it within 12 hours after the usual time of use, the contraceptive effectiveness will not be reduced. Then return to taking all subsequent tablets at the usual time. If more than 12 hours have passed since the planned adoption of the tablet, the contraceptive effectiveness is not fully ensured. The shorter the interval between the missed tablet taking and the interruption in the use of tablets, the greater the likelihood of getting pregnant. If the usual dose of withdrawal bleeds does not appear after the missed dose, make sure that you are not pregnant before starting a new blister. The procedure for omitting the tablet should be in accordance with the following two basic principles: 1. Do not stop taking tablets for more than 7 days. 2. At least 7 days of regular tablet intake are required to effectively inhibit the hypothalamo-pituitary-ovary axis. This results in the following recommendations in the case of omitting the tablet: take the last missed tablet as soon as possible, even if it means taking 2 tablets on one day. The next tablets should be taken at the usual time. In addition, non-hormonal contraception should be used for the next 7 days. If you have missed the tablet one time in the second week of taking it, you do not need to use additional methods of contraception. If more than one tablet is missed, an additional non-hormonal contraceptive should be used until the next regular withdrawal bleed. 1. If less than 7 days remain between the missed dose and the last tablet from the current blister, start taking the tablets from the next blister the day after taking the last tablet from the current blister (without interruption in taking tablets). In this case, it is likely that no withdrawal bleeding will occur until the end of the second pack. However, severe bleeding and / or staining may occur. 2. You can also stop taking the tablets from the current packaging immediately and start taking a break before taking the tablets. After a break in taking the tablets, no longer than 7 days, also taking into account the day the tablet is missed, start taking the tablets from the next pack.Proceedings in case of vomiting or diarrhea. If vomiting or severe diarrhea occurs in the first 4 hours after taking the product, the active substances may not be completely absorbed, therefore additional contraceptive measures should be taken. In addition, follow the instructions as if you missed taking the tablet once. If you need to keep your usual tablet-taking schedule, take an extra tablet from another blister. If gastrointestinal disturbances persist for several days or when they recur, use additional non-hormonal methods of contraception and inform your doctor.Delay of withdrawal bleeding. To delay the onset of withdrawal bleed, continue taking the tablets from the next blister without any interruption in the use of the tablets. The withdrawal bleed may be delayed as long as the patient wishes, but not longer than until the second blister pack is used. During this period, severe bleeding or staining may occur. After the Next, ordinary 7-day tablet-free period, you can continue to take the medicine as usual.