Index of drugs

Contraception. The vaginal therapeutic system is intended for women of childbearing age. The safety and efficacy of the system was assessed in the group of women aged 18 to 40. The decision to prescribe a therapeutic system should be made on the basis of an individual assessment of risk factors in women, especially the risk of venous thromboembolism and the risk of venous thromboembolism associated with the use of the therapeutic system with respect to other combined hormonal contraceptives.

The vaginal therapeutic system contains 11.7 mg of etonogestrel and 2.7 mg of ethinyl estradiol. The vaginal therapeutic system releases etonogestrel and ethinyl estradiol in an average amount of 0.120 mg and 0.015 mg, respectively, within 24 h, for a period of 3 weeks.

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 for venous thromboembolic disease, eg resistance to active C protein (APC) (including Leiden V factor), antithrombin III deficiency, protein C deficiency, protein S deficiency; 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 (eg angina pectoris); cerebrovascular diseases - active stroke, previous stroke or prodromal symptoms (eg transient ischemic attack, TIA); confirmed hereditary or acquired tendency to occur in arterial thromboembolic disorders, eg hyperhomocysteinemia and the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant); migraine with focal neurological symptoms in an interview; 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. Inflammation of the pancreas now or in the past if co-occurs with severe hypertriglyceridaemia. Severe liver disease now or in the past, as long as liver function parameters do not return to normal. Current or previous liver cancer (benign or malignant). Presence or suspicion of malignant tumors of reproductive organs or breasts dependent on sex hormones. Bleeding from the vagina of unknown etiology.

The preparation is not indicated for use during pregnancy. If the patient becomes pregnant during the use of the vaginal therapeutic system, the vaginal therapeutic system should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children whose mothers used concomitant hormonal contraceptives prior to pregnancy or the teratogenic effects of these products used unconsciously in early pregnancy. A clinical trial conducted in a small group of women showed that the concentration of sex hormones in the uterine cavity in patients using Circlet is close to that observed in patients using combined oral hormonal contraceptives despite vaginal use. So far, there are no data on the results of termination of pregnancy in patients using Circlet. The risk of venous thromboembolism in women in the postpartum period should be taken into account when deciding whether to restart the treatment. The use of estrogen can affect breastfeeding, reducing the amount of food and changing its composition. For these reasons, the Circlet is not recommended until breastfeeding is completely stopped.A small amount of sex hormones and / or their metabolites can be secreted in breast milk, but there is no evidence that this could have an adverse effect on the health of the child.

Common: vaginitis, depression, decreased sex drive, headache, migraine, abdominal pain, nausea, acne, breast tenderness, pruritus of female genitalia, dysmenorrhea, pelvic pain, vaginal discharge, weight gain, discomfort associated with the use of the system therapeutic vaginal, prolapse of the vaginal therapeutic system. Uncommon: cervicitis, cystitis, urinary tract infection, increased appetite, mood changes, mood instability, sudden mood changes, dizziness, hypoaesthesia, visual disturbances, hot flushes, bloating, diarrhea, vomiting, constipation, alopecia, eczema, pruritus, rash, low back pain, muscle cramps, pain in the limb, impaired urination, urinary urgency, pollakiuria, amenorrhea, breast tenderness, breast enlargement, lump in the breast, cervix polyp, bleeding during intercourse, dyspareunia, curl cervical fibrocystic breasts, hemorrhagic menstruation, uterine hemorrhage, pelvic discomfort, premenstrual syndrome, uterine contraction, burning sensation in the vagina, unpleasant odor from the vagina, vaginal pain, discomfort of the vulva and vagina, dryness of the vulva and vagina Fatigue , irritability, malaise, edema, feeling of the presence of a foreign body, zw increased blood pressure, complications related to the contraceptive, damage to the vaginal therapeutic system. Rare: venous thromboembolism, arterial thromboembolic events, galactorrhoea. Not known: hypersensitivity, chloasma, urticaria, penile complaints. There are reports of cancers dependent on sex hormones (eg liver, breast cancer). in patients taking combined hormonal contraceptives.

The patient places the Circlet in the vagina by herself. The doctor should instruct the patient on how to set up and remove the system. After installing the system, it stays in the vagina for 3 weeks. The presence of a vaginal therapeutic system in the vagina should be checked regularly. The system should be removed after 3 weeks of use, on the same day of the week in which it was installed. After a break in the application of a vaginal therapeutic system lasting one week, a new vaginal therapeutic system is assumed (eg if the system was put on Wednesday around 8 pm, it should also be removed on Wednesday, 3 weeks later, at about 22.00 hrs). the Next Wednesday a new vaginal therapeutic system should be established). The withdrawal bleeding usually occurs 2-3 days after the system is removed and may not completely resign until the new system is established.Start of application. In the previous cycle, no hormonal contraceptive was used. The system should be established on the first day of the natural cycle (ie on the first day of menstruation). You can also start using the Circulatory vaginal therapy system between the 2nd and 5th day of the cycle, but in this case, during the first cycle for the first 7 days of using the vaginal therapeutic system, it is recommended to use a contraceptive method at the same time.Hormone contraceptives have been used so far. The vaginal system should be established at the latest on the day following the discontinuance of the use of tablets or a transdermal patch, a pre-assembled hormonal contraceptive, or after the use of placebo-containing tablets. If the patient regularly and correctly used the previous method of contraception and if it is certain that she is not pregnant, she may change her current complex hormonal contraception to an intravaginal therapeutic system on any day of the cycle. The interruption in the use of the current contraceptive should never exceed the prescribed time.To date, contraception containing only progestin (minitabletka, implant or injections) or the progestin-releasing intrauterine therapy system (IUS) has been used. The use of a vaginal therapeutic system instead of a minitabletka can be started on any day (in the case of an implant and system - on the day of implant or system removal, in the case of injections - on the next scheduled injection), but in all of these cases, the first 7 days of using the vaginal additionally use mechanical methods of contraception.After a miscarriage in the first trimester of pregnancy. The use of the vaginal therapeutic system can be started immediately. There is no need for additional contraception at the same time. If it is not recommended to start using the vaginal therapeutic system immediately after a miscarriage, the patient should follow the instructions given in the section: In the previous cycle, no hormonal contraceptive was used. In the meantime, she should use a different method of contraception.After delivery or miscarriage in the second trimester of pregnancy. The use of the vaginal therapeutic system should commence 4 weeks after delivery or after miscarriage in the second trimester of pregnancy. If the therapeutic system is later started, the use of a mechanical contraceptive method should be recommended for the first 7 days of the vaginal therapy system. However, if there was a relationship at that time, the pregnancy should be excluded before the vaginal therapeutic system is started or the patient should wait for the first menstrual period.Proceedings in case of a longer break in the use of the vaginal therapeutic system. The patient should establish a new vaginal therapeutic system as soon as possible. Additionally, for the next 7 days should use a mechanical method of contraception, such as a condom. If an intercourse occurred during the interruption of the vaginal therapeutic system, make sure that the patient is not pregnant. The longer the interval in using the vaginal therapeutic system was longer, the higher the risk of pregnancy.Proceedings in the event of a vaginal therapeutic system falling out. The system should be in the scabbard continuously for a period of 3 weeks. If the intravaginal therapy system falls out spontaneously, it should be washed in cold or lukewarm (not hot) water and replaced as soon as possible. If the system was outside the vagina for less than 3 hours, this did not affect the contraceptive effectiveness. The patient should re-establish the vaginal therapy system as soon as possible, up to 3 hours after falling out. If the patient suspects or is certain that the system has been outside the vagina for more than 3 hours in the first or second week of use, the contraceptive efficacy of the vaginal delivery system may have decreased. The patient should re-establish the vaginal therapeutic system as soon as possible. Additionally, during the first 7 days of using the vaginal therapeutic system after re-insertion, mechanical contraception, such as a condom, should be used. The longer the system was out of the scabbard and the closer to the planned interruption in its use, the higher the risk of pregnancy. If the patient suspects or is sure that the system has been outside the vagina for more than 3 hours in the third week of use, the contraceptive effectiveness of the vaginal delivery system may have decreased. The patient should discard this intravaginal therapy system and choose one of the following two solutions: 1. Set up a new vaginal therapeutic system as soon as possible. Note: Setting up a new vaginal therapeutic system means starting the next three-week period of its use. This may result in a lack of expected withdrawal bleeding. However, spotting or intermenstrual bleeding may occur. 2. Wait for the withdrawal bleeding and establish a new vaginal therapeutic system, no later than 7 days (7x24 h) after removal or spontaneous withdrawal of the previous intravaginal vaginal system. Note: The above procedure can only be accepted if the intravaginal therapy system has been used continuously for the last 7 days.Proceedings for prolonged use of the vaginal therapeutic system. Although this is not the recommended procedure, if the vaginal therapeutic system has been used for no longer than 4 weeks, contraceptive effectiveness is maintained. The patient can do 1 week. break in its use, and then set up a new vaginal therapeutic system. If the vaginal therapeutic system has been used for more than 4 weeks, the contraceptive effectiveness may be reduced and a patient should be made sure that the patient is not pregnant before starting a new system. If the patient did not follow the recommended method of using the vaginal therapeutic system and in the next interruption of its use, the withdrawal bleeding did not occur, before establishing a new vaginal therapeutic system, it should be ensured that the patient is not pregnant.Proceedings to delay or postpone bleeding.In exceptional cases, to delay the onset of withdrawal bleeding, the patient may establish a new vaginal therapeutic system, leaving a week's interruption in its use. The new vaginal therapeutic system can be used for the next 3 weeks. During this time, intermenstrual bleeding or spotting may occur.After a week's break in the use of the vaginal therapeutic system, the vaginal therapeutic system is returned to normal. In order to postpone the occurrence of a withdrawal bleed to a different day of the week than the one to which the patient is accustomed, the patient may shorten another gap in the use of the vaginal therapeutic system by any number of days. The shorter the interval in using the vaginal therapeutic system is, the greater the likelihood of no withdrawal bleeding after its removal and intermenstrual bleeding or spotting during the use of the next intravaginal therapy system.