Ges, 3 mg+0.02 mg 28 pcs

Contraception

• Contraception
• Contraception and treatment of moderate acne (acne vulgaris)
• Contraception and treatment of severe premenstrual syndrome (PMS)

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Active ingredient

Drospirenone, Ethinylestradiol

How to take, the dosage

Tablets should be taken in the order listed on the package at approximately the same time every day with a small amount of water. The tablets are taken without interruption. It is necessary to take 1 tablet / day sequentially for 28 days. Each subsequent package should be started the day after taking the last tablet from the previous package. Withdrawal bleeding usually begins on the 2nd or 3rd day after the beginning of inactive (white) pills, and may not end until the beginning of the next package. The pills in the new pack should always be started on the same day of the week, and cancellation bleeding will occur on about the same days of each month.

The “flexible” regimen

The “flexible” regimen of Jes can only be used if you have a Clyk dispenser and flex cartridges. The drug should be taken 1 tablet daily at the same time, with a small amount of liquid. The tablets should be taken continuously for at least 24 days. Between 25 and 120 days of use of the drug Jes, a 4-day break in taking the pills may be taken at the discretion of the patient.

The pills should not be taken more than 4 days apart. A 4-day break from taking pills must be taken no later than 120 days of continuous use. After each 4-day break from taking the pills, a new cycle with a minimum duration of 24 days and a maximum duration of 120 days begins. Usually, bleeding withdrawal develops during the 4-day interval between pills, but may not end until the next pill needs to be taken. If you experience a mucous bloody discharge/vaginal bleeding for 3 consecutive days between days 25 and 120, it is recommended that you take a 4-day break from taking the pills. This will reduce the total number of days of bleeding.

The instructions for handling the package of Jes for the 24+4 regimen

The package of Jes contains a blister containing 24 active, hormone-containing light pink tablets and 4 inactive white, hormone-free tablets (last row). Also included in the package is a calendar of intake consisting of 7 self-adhesive strips with the names of the days of the week marked on them. You should choose the strip with the first day of the week on which you plan to start taking the pills. For example, if a woman starts pills on Wednesday, use the strip that starts with “Wed.

The strip should be glued along the top of the package so that the first day is above the pill with the “Start” arrow pointing to it. This way, you can see which day of the week each pill should be taken.

The Clyk Instructions for Use

Please read the detailed Instructions for Use carefully before starting and during use.

The general description of the Clyk pipette:

The side keys are the pressing area to receive the tablet;

The flex-cartridge eject button – Pressing this button ejects the flex-cartridge;

Pill dispensing area-the part of the dispenser where the dispensed pills appear;

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Pill timer-displays the time you took the pill;

The display shows the Home Screen and menu options;

The OK Button- Pressing the button confirms action, such as starting a 4-day pill pill pill fast and changing the reminder sound.

The most important functions

Activating a new pipette: The Flex Cartridge (containing 30 pills) should be removed from the packaging and immediately inserted into the pipette. The narrow end of the flex cartridge should be inserted into the pipette so that the dispenser window (and the pills in the flex cartridge) are clearly visible. The flex cartridge must be inserted all the way in.

The dispenser will automatically record the dispensing time of the first pill, setting this time as “Intake Time. Thus, the woman needs to:

– make sure she unpacks and inserts the flex cartridge on the day she plans to start taking pills;

– make sure the first pill dispensing time is convenient for her daily pill intake.

At 24-hour intervals, the dispenser display will alert you when it’s time to take your next pill.

Ejecting a pill

Push both side buttons simultaneously with one hand to remove the pill you are taking with the other.

Changing the Flex Cartridge

In normal use, the Flex Cartridge can only be removed if it is empty, otherwise follow the detailed operating instructions for the Clyk dispenser. The empty flex cartridge is ejected by pressing the flex cartridge eject button. The dispenser stores all information about the current cycle and a new filled flex cartridge should be inserted according to the instructions above.

You should carefully read the detailed instructions for use for the Clyk dispenser included in the product package before and during use.

To start taking the product

If you have not taken any hormonal contraceptive in the previous month

The use of Jez starts on day 1 of the menstrual cycle (i.e. on day 1 of the menstrual bleeding), in which case no additional contraceptive measures are required. It is allowed to start taking it on the 2nd to 5th day of a menstrual cycle, but in this case it is recommended to use additionally a barrier method of contraception during the first 7 days of taking tablets from the first package. Thereafter, the pills must be taken in the order specified for the 24+4 or “flexible” regimen.

When switching from other combined oral contraceptives, the vaginal ring, or the contraceptive patch

. It is preferable to start Jes the day after taking the last active tablet from the previous package, but in no case later than the day after the usual 7-day interval (for products containing 21 pills) or after taking the last inactive tablet (for products containing 28 pills in a package). The intake of the medication Jes should be started on the day of removal of the vaginal ring or patch, but not later than the day when a new ring or a new patch is to be inserted.

When switching from contraceptives containing only gestagens (“mini-pills,” injectable forms, implant), or from a gestagen-releasing intrauterine contraceptive

A woman can switch from a “mini-pill,” injectable forms, or implant. A woman can switch from taking the “mini-pill” to Ges on any day (without a break), from the implant or intrauterine contraceptive with gestagen – on the day of its removal, from the injectable contraceptive – on the day when the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After a first trimester abortion

A woman can begin taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, the woman does not need additional contraceptive measures.

After delivery or after a second trimester abortion

The drug can be started 21 to 28 days after a spontaneous or medical abortion or after childbirth if breastfeeding is not present. If the use of the drug is started later, an additional barrier method of contraception should be used during the first 7 days of taking the pills. However, if sexual intercourse has already taken place, pregnancy must be ruled out before starting the use of Ges, or you must wait for your first menstrual period.

To stop taking Ges

Stopping taking Ges can be stopped at any time. If a woman is not planning a pregnancy, or if a woman is contraindicated because she is taking a potentially harmful drug for the fetus, you should discuss other methods of contraception with your doctor. If a woman is planning a pregnancy, it is recommended that she stop taking the medication and wait for her natural menstrual bleeding before trying to get pregnant. This will help to more accurately calculate the timing of pregnancy and the time of delivery.

Missing pills

Missing inactive pills on a 24+4 regimen can be ignored. However, they should be discarded to avoid inadvertently prolonging the period of inactive pills. The following recommendations apply only to skipping active (light pink) pills.

If it is less than 24 hours late, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible and take the next ones at the usual time.

If pills are missed for more than 24 hours, contraceptive protection may be reduced. The more pills you miss, and the closer the missed pills are to the inactive white pill phase of the 24+4 regimen or the pill-free period of the flexible pill regimen, the greater the chance of pregnancy.

The following two basic rules can guide this:

– taking the drug should never be interrupted for more than 7 days (note that the recommended interval for taking inactive pills is 4 days for the “24+4” regimen, and for the “flexible” regimen the interval without taking pills should not exceed 4 days);

The hypothalamic-pituitary-ovarian system requires 7 days of continuous pills to achieve adequate suppression.

The Clyk dispenser helps control the pills and alerts women to the need for an additional method of contraception. A warning exclamation point symbol appears on the display if you skip pills or take pills irregularly for more than 7 consecutive days. The “exclamation mark” disappears after 7 days of continuous dispensing of tablets by the dispenser. If more than one pill is missed, it is recommended that you consult your doctor.

In the case of the 24+4 regimen and the flexible regimen, if the information from the Clyk dispenser is not available or there are concerns about its accuracy, the following guidelines should be followed:

When missing pills during day 1 through day 7

The woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. In addition, an additional barrier method of contraception (e.g., a condom) should be used for the next 7 days. If sexual intercourse took place in the 7 days before skipping the pill, the possibility of pregnancy should be considered.

If you miss an absence between days 8-14 on the 24 + 4 pill or if you miss between days 8-24 on the flexible pill regimen, you should take the last pill you missed as soon as you remember it, even if that means taking two pills at once. She continues to take the next pill at the usual time.

As long as the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, and if two or more pills are missed, additional barrier methods of contraception (such as a condom) should be used for 7 days, and in “flexible” regimens, barrier methods of contraception should be used until the continuous period of taking the pills reaches 7 days.

If you miss between day 15 and day 24 on the 24+4 pill regimen or if you miss between day 25 and day 120 on the flexible regimen

If you miss between day 25 and day 120 on the flexible regimen. Risk of decreased reliability is inevitable due to the approaching phase of inactive white pills in the case of the 24+4 regimen or the pill-free period in the “flexible” regimen. One of the following two options must be strictly adhered to. In this case, if all pills were taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following regimens and additionally use a barrier method of contraception (such as a condom) for 7 days.

1. The woman should take the last missed pill as soon as she remembers (even if this means taking two pills at once). For the 24+4 regimen: the next pills are taken at the usual time until the active light pink pills in the pack run out, the 4 inactive white pills should be discarded and the pills from the next pack should be started immediately. Bleeding cancellation is unlikely until the active light pink tablets in the second pack are finished, but there may be mucous discharge and/or breakthrough bleeding while taking the pills. If a “flexible” regimen is used, at least 7 pills (one pill daily) should be taken without interruption.

2. For the “24+4” regimen: the woman can also interrupt the active light pink pills from her current package. Then take a break of no more than 4 days, including the days the pills were missed, and then start the pills from the new package. If the woman skipped active light pink pills and no bleeding cancellation occurred while taking inactive white pills, pregnancy should be ruled out. For a “flexible” regimen: a woman can also take a 4-day break from taking the pills, including the day she missed the pill, to cause bleeding withdrawal and then start a new cycle of the medication. If a woman misses taking the pills and does not have a bleeding withdrawal during the next period of interruption, the possibility of pregnancy should be considered.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken.

If vomiting or diarrhea has occurred within 3-4 hours of taking the active light pink pill, the recommendations for skipping the pill should be followed. If a woman does not want to change her usual regimen and postpone the start of her menstruation to another day of the week, an additional active light pink pill should be taken.

How to change the timing of bleeding withdrawal or how to delay bleeding withdrawal on 24+4

To delay bleeding withdrawal, women must continue taking pills from the next package of Ges while skipping the inactive pills of the current package. In this way, the cycle can be prolonged, if desired, for as long as the active light pink pills of the second package last, which is about 3 weeks later than usual. If an earlier start of the next cycle is planned, you should stop taking the active light pink pills from the second pack at any time, discard the remaining active light pink pills and start taking the white inactive pills (for a maximum of 4 days), and then start taking the pills from the new pack. In this case, about 2-3 days after taking the last light pink tablet from the previous package, bleeding withdrawal should begin. Against the background of taking the drug from the second package, a woman may have masticatory discharge and/or breakthrough uterine bleeding. Regular use of Jes is then resumed after the period of inactive white pills has ended.

In order to postpone the start of withdrawal bleeding to another day of the week, a woman should shorten her next period of inactive white pills by the desired number of days. The shorter the interval, the higher the risk that she won’t have a bleeding withdrawal and will subsequently have masticatory discharge and/or breakthrough bleeding while taking the pills from the second pack.

Interaction

Influence of other drugs on the drug Ges

Special Instructions

If any of the conditions/risk factors listed below are currently present, the potential risks and expected benefits of combined oral contraceptives should be carefully weighed in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or first appear, the woman should consult her physician, who may decide if the drug should be discontinued.

Contraindications

Thrombosis and thromboembolism, as well as conditions preceding thrombosis, currently or in the history, cerebrovascular disorders; migraine with focal neurological symptoms, currently or in the history; diabetes mellitus with vascular complications; multiple or pronounced risk factors for venous or arterial thrombosis, including complicated heart valve lesions; atrial fibrillation; cerebral or coronary artery disease; uncontrolled arterial hypertension; major surgery with prolonged immobilization; smoking over the age of 35 pancreatitis with significant hypertriglyceridemia, current or history; liver failure and severe liver disease (until liver tests return to normal); liver tumors (benign or malignant), current or history; severe renal failure, acute renal failure adrenal insufficiency; revealed hormone-dependent malignant diseases (including reproductive organs or mammary glands) or suspicion of them; vaginal bleeding of unclear genesis; pregnancy or suspicion of it; breast-feeding period; hypersensitivity to any of components of the drug DES.

Side effects

The following most common adverse reactions have been reported in women taking Ges 24+4 for the indications “Contraception” and “Contraception and treatment of moderate acne (acne vulgaris)”: nausea, breast pain, irregular uterine bleeding, and genital bleeding of unspecified genesis. These adverse reactions occurred in more than 3% of women. The following most common adverse reactions (more than 10% of women) have been reported in patients using Ges for the indication “Contraception and treatment of severe premenstrual syndrome”: nausea, breast pain, irregular uterine bleeding.

Overdose

No serious disorders have been reported in case of overdose.

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