1 tabl fructose contains 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol.
Action:
Monophasic, oral contraceptive. Ethinyl estradiol is a synthetic estrogen with a much stronger but similar to natural estradiol action and use. Norgestrel is a Progestin-like progestogen. It inhibits ovulation more strongly than norethisterone and shows androgenic properties. Ethinyl estradiol is rapidly and completely absorbed from the gastrointestinal tract; bioavailability is 40-60%, maximum blood concentration is achieved after 1-2 h. In 98% it binds to albumin and induces an increase in serum SHBG. Metabolism occurs in the liver, excreting in the faeces and urine. T0,5 after repeated administration it is about 16-18 h. Levonorgestrel is rapidly and completely absorbed after oral administration; bioavailability is almost 100%. It is highly associated with sex hormone binding globulin (SHBG). It is completely metabolised, and excretion occurs in the urine and feces. T0,5 after repeated administration it is 21-26 hours.
Contraindications:
Hypersensitivity to the components of the preparation. Current or past thrombosis of deep veins. Current or past thromboembolism. Cerebrovascular disease or coronary heart disease. Presence of risk factors for thromboembolism (valvular heart valve and arrhythmias increasing the risk of thrombosis). Hereditary or acquired propensities for venous or arterial thrombosis, or signs that herald (eg angina and transient cerebral ischemia). Headache with focal neurological symptoms such as aura. Diabetes with vascular changes. Uncontrolled overpressure. Diagnosis or suspected malignant breast cancer or other estrogen-dependent cancer. Adenomas or hepatocellular malignancies or active liver dysfunction until normal liver function parameters are obtained. Bleeding from the vagina of undetermined etiology. Pancreatitis with severe hypertriglycaemia (active or history). Diagnosis or suspicion of pregnancy.
Precautions:
Particularly cautiously use in the case of depression, hypertension, cholestasis, reduced Glucose tolerance or diabetes, increased triglycerides in the blood. The use of the preparation should be discontinued in the event of visual disturbances, exophthalmos or double vision, congestive disc, retinal vascular changes, significant increase in blood pressure, occurrence or exacerbation of migraine or long-term or severe recurrent headache, recurrent depression. The preparation increases the risk of thromboembolic vein and artery disease - be careful. Factors that increase the risk of these disorders are: obesity, surgery or injury, the period after childbirth or abortion in the second trimester of pregnancy, longer immobility period, advanced age. The preparation should be discontinued 4 weeks before the planned surgery, 2 weeks after surgery and during a long immobilization period. Do not use after 28 days after giving birth to women who are not breastfeeding or after a miscarriage. The use of combined oral contraceptives in women suffering from migraine (in particular in the case of migraine aura) increases the risk of stroke. The risk of cardiovascular disorders (eg stroke, myocardial infarction) increases with age and in women who smoke (especially over 35 years of age) - women who smoke the product are advised not to smoke cigarettes. Due to the lactose and sucrose content, the preparation should not be used in patients with galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucrase-isomaltase deficiency, malabsorption of glucose-galactose.
Pregnancy and lactation:
The preparation is contraindicated in pregnancy and breast-feeding.
Side effects:
Very common: headache, migraine, intermenstrual bleeding, spotting.Common: vaginitis, including yeast infection, weight gain or loss, mood changes (including depression), changes in libido, nervousness, dizziness, nausea, vomiting, abdominal pain, acne, pain or tenderness in the breast, breast enlargement, discharge from the breast, painful menstruation, change in menstrual bleeding, change in the image of the erosion, change in vaginal discharge, lack of menstruation, fluid retention, edema. Uncommon: increased or decreased appetite, stomach cramping, bloating, diarrhea, rash, chloasma that may persist or melanoderma, hirsutism, alopecia, elevated blood pressure, changes in blood lipids (including hypertriglyceridaemia). Rare: anaphylactic or anaphylactoid reactions (including very rarely urticaria, angioneurotic edema and severe reactions with respiratory and cardiovascular symptoms), glucose intolerance, contact lens intolerance, erythema nodosum, cholestatic jaundice, decreased folate in blood, discharge. Very rare: increased systemic lupus erythematosus, worsening of porphyria, exacerbation of chorea, optic neuritis, retinal thrombosis, enlargement of varicose veins, pancreatitis, ischemic colitis, cholecystitis, including cholelithiasis, erythema multiforme, haemolytic-uremic syndrome. In addition: inflammatory bowel disease (Crohn's disease, ulcerative colitis), damage to liver cells (eg hepatitis, abnormal liver function). Some studies suggest that the use of combined contraceptives increases the risk of intraepithelial or invasive cervical cancer and breast cancer. Likewise, in very rare cases, these preparations may be associated with the presence of hepatic adenomas and primary hepatocellular carcinoma.
Dosage:
Orally. The preparation should be started on the first day of the cycle. Take 1 tabl. daily, at the same time of the day, for 21 days. Then take a 7-day break, during which there is a withdrawal bleed (usually after 2-3 days). The Next pack should be started after a 7-day break, even if bleeding continues. Patients who have previously received other two-part contraceptives who start using the product should take the first tablet the day after the end of taking the contraceptive pill containing active substances, or at the latest on the day after the 7-day tablet-free interval or after taking the contraceptive tablets without active substances. When switching from a progestogen-only preparation, the first tablet of the preparation should be taken the day after the last mini-pill. If the patient previously used a subcutaneous implant, the tablet should be taken the day after the implant is removed. When using injections, the preparation should start on the day on which the next injection should be taken. In all cases, additional contraceptive methods are recommended for the first 7 days of use. In the event of a miscarriage in the first trimester of pregnancy, the use of the preparation can be started immediately. In the event of delivery or miscarriage in the second trimester of pregnancy, the use of the preparation may begin no earlier than 28 days after delivery or abortion; for the first 7 days of taking the preparation it is recommended to use additional methods of contraception. If you miss a tablet, if it is no more than 12 hours, take it as soon as possible and take your tablets at the usual time (the effectiveness of the preparation is preserved). If you miss a tablet, if more than 12 hours have passed, take it as soon as possible, even if it means taking two tablets and take the next tablet at the usual time; additional contraceptive methods should be used for the next 7 days; If the packaging ends in these 7 days, the next one should begin without the usual break. If tabl. omitted during the last 7 days of taking the preparation, the next pack should be started after the adoption of the last tabl. from the previous packaging, without the usual break. If vomiting or diarrhea occurs within 4 hours of taking the tablet, proceed as if you missed the tablet.In order to delay menstruation, do not take a 7-day break in the use of tablets, but start using tablets with a new pack. Bleeding should occur after the completion of the tablets from the second pack. In the meantime, intermenstrual bleeding or spotting may occur.