Oral contraception.
The current risk factors for an individual woman, especially the risk factors for venous thromboembolism (VTE), and the higher risk of VTE with Lindinet 30 compared with other combined hormonal contraceptives should be considered when deciding whether to prescribe Lindinet 30. and "Features of application").
Combined hormonal contraceptives (COCs) should not be used in the following cases. If any of these conditions occur during the use of the preparation, its use should be stopped immediately.
Hypersensitivity to the active substances or to any of the excipients.
Presence or risk of venous thromboembolism (VTE):
Presence or risk of arterial thromboembolism (ATE):
Presence of a history of pancreatitis or pancreatitis if it is associated with severe hypertriglyceridemia.
Presence of a history of severe or impaired liver function (until liver function is restored).
Presence of liver tumors (benign or malignant) or a history of such tumors.
Known or suspected steroid-dependent malignancies (eg, genitals, mammary glands).
Undiagnosed abnormal vaginal bleeding.
Co-administration of Lindinet 30 with ombitasvir / paritaprevir / ritonavir and dasabuvir is contraindicated (see sections “Special warnings and special precautions for use” and “Interaction with other medicinal products and other forms of interaction”).
active substances: ethinyl estradiol, gestodene;
1 tablet contains ethinyl estradiol 0.03 mg and gestodene 0.075 mg;
Excipients: sodium calcium edetate, magnesium stearate, colloidal anhydrous silica, povidone, corn starch, lactose monohydrate, quinoline yellow (E 104), titanium dioxide (E 171), macrogol 6000, talc, calcium carbonate, sacha.
The tablets should be taken at about the same time each day, in the order indicated on the blister pack. You should take 1 tablet per day (preferably at the same time of day) for 21 consecutive days. Then you should take a seven-day break from taking the tablets. During the seven-day break, menstrual-like bleeding should occur as a result of preparation withdrawal. Bleeding usually begins on the 2nd or 3rd day after the last tablet and may continue until the tablets from the next pack are used.
The next day after a seven-day break, you should start taking the tablets from the next pack, which contains 21 tablets.
The first dose.
Lindinet 30 should be started on the first day of the menstrual cycle.
The tablets can also be started from the 2nd to the 7th day of menstruation, but in this case it is necessary to use additional non-hormonal contraceptives (eg condoms, spermicide) during the first 7 days of use of the tablets.
Switch to Lindinet 30 from another combination contraceptive (combination oral contraceptives (PDAs), vaginal ring or transdermal patch).
The first tablet of Lindinet 30 should be taken after the last tablet from the previous pack of another combined oral contraceptive on the first day of menstrual bleeding, but no later than the next day after the usual break (or placebo) from the previous pack of oral contraceptives.
When switching to Lindinet 30 from a vaginal ring or transdermal patch, it is advisable to start taking Lindinet 30 on the day of removal of the vaginal ring or transdermal patch, but not later than the day of the planned use of a new vaginal ring or transdermal patch.
Switch to Lindinet 30 with progestogen-only preparations (mini-pills, injections, implants or the intrauterine system).
From the "mini-drink" you can switch to Lindinet 30 on any day of the menstrual cycle. From the implant, you can switch to Lindinet 30 on the day of removal of the implant or intrauterine system. When switching to Lindinet 30 injections, you should start taking the preparation on the day of the planned injection. In these cases, additional contraceptive methods should be used in the first 7 days.
Use of Lindinet 30 after abortion in the first trimester of pregnancy.
The preparation can be started immediately after abortion in the first trimester of pregnancy, in which case there is no need to use additional methods of contraception.
Use of Lindinet 30 after childbirth or abortion in the second trimester of pregnancy.
Information on the use of the preparation during breastfeeding is described in the section "Use during pregnancy or breastfeeding".
Because the postpartum period is associated with an increased risk of thromboembolism, Lindinet 30 can be started no earlier than 28 days after delivery in non-breastfeeding women or after an abortion in the second trimester. The woman should be advised to use an additional reserve non-hormonal method of contraception during the first 7 days of taking the pill. However, if you have already had sexual intercourse after childbirth or abortion, you must rule out pregnancy or wait for your first period before taking Lindinet 30 (see also Special Precautions and Use during Pregnancy or Breastfeeding).
Skip pills.
If the delay in taking the pill does not exceed 12 hours, the contraceptive effect of the preparation is not reduced. The missed pill should be taken as soon as it is clear. The next tablet in this pack should be taken at the usual time. If the delay in taking the pill exceeds 12 hours, contraceptive protection may be reduced. In this case, you must follow two basic rules:
The break in taking pills can never be more than 7 days.
Adequate suppression of the hypothalamic-pituitary-ovarian system is achieved as a result of continuous administration of the preparation for 7 days.
Accordingly, the following recommendations should be followed in everyday life:
1st week
The last missed tablet should be taken as soon as possible, even if you have to take two tablets at the same time. After that, you should continue to take the pills at the usual time. Also, use a barrier method of contraception, such as a condom, for the next 7 days. If sexual intercourse has taken place in the previous 7 days, the possibility of pregnancy should be considered. The more pills you miss and the closer you are to a seven-day break, the higher the risk of pregnancy.
2nd week
The last missed tablet should be taken as soon as possible, even if you have to take two tablets at the same time. After that, you should continue to take the pills at the usual time. If you take the pill correctly for 7 days before taking the pill, you do not need to use additional methods of contraception. Otherwise, or if you miss more than 1 pill, it is recommended to use a barrier method of contraception during
7 days.
3rd week
The risk of reduced contraceptive effect increases with the approach of a seven-day break in taking the preparation. However, by following the pill regimen, a reduction in contraceptive protection can be avoided. If you follow one of the following options, you will not need to use additional methods of contraception, provided you take the pill correctly for 7 days before skipping the pill. If this is not the case, follow the first of the following options and use additional methods of contraception for the next 7 days.
The last missed tablet should be taken as soon as possible, even if you have to take 2 tablets at the same time. After that, you should continue to take the pills at the usual time. The next pack of tablets should be started immediately after the previous one, ie there should be no break in the use of the preparation. Women are unlikely to start menstrual-like bleeding before taking the second pack of tablets, although smears or breakthrough bleeding may occur.
You can also stop taking the tablets from the current package. In this case, the break in the use of the preparation should be 7 days, including the days of skipping the tablets, after which you should start taking the tablets from the next package.
If there is no menstrual-like bleeding after taking the pill during the first normal pill break, the possibility of pregnancy should be considered.
Measures taken for vomiting and / or diarrhea.
If vomiting or diarrhea occurs within 4 hours after taking the preparation, it means that the active substance of the tablet could not be completely absorbed. In this case, you must act in accordance with the item "Skip the pill". If the patient does not want to deviate from the mode of administration, the missed tablets should be taken from the additional package.
Delayed or accelerated menstruation.
To delay menstruation, the tablets should be continued from the new package without a seven-day break in the use of the preparation. Menstrual bleeding can be delayed for as long as necessary until you have finished taking the tablets from the second pack. Bleeding or breakthrough bleeding may occur during delayed menstrual bleeding. Regular use of Lindinet 30 can be resumed after a regular seven-day break.
In order to accelerate the onset of menstrual bleeding, a seven-day break in the use of the preparation can be reduced to the desired number of days.
The shorter the break in the preparation, the higher the risk that menstrual bleeding will not occur or when taking pills from the next package will be observed smearing or breakthrough bleeding.
Children.
Lindinet 30 is indicated for use only after regular menstruation.
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