Evra patch. Contraceptive or contraceptive patch evra (evra): principle of action, instructions, side effects, price Is it possible to remove the euro patch

Evra patch- a contraceptive, transdermal system (TTS), which delivers hormones to the dermis and hypodermis, which enter the body through the bloodstream. The delivered hormones cause changes in the body, preventing pregnancy. The active substances of the patch inhibit pituitary activity in relation to the synthesis of gonadotropic hormones. Under the influence of the drug, the follicle does not mature and ovulation does not occur. The drug creates artificial temporary anovulatory infertility. In addition, the drug causes thickening of the cervical mucus, which impairs the penetration of sperm into the uterus. In addition, changes occur in the endometrium, and it becomes resistant to blastocyst transplantation. Contraception using the Evra transdermal system is highly reliable (99.4%).

Indications for use

Transdermal system Evra used for contraception in women 18-45 years old.

Mode of application

Evra patch sticks only to intact healthy skin. The place for attaching the TTS must be dry, clean, and free of hair. For gluing, it is necessary to choose an area of ​​the body that is not subject to constant mechanical stress from dense, rubbing clothing. Do not apply TTC to the folded surfaces of the skin. To reduce the likelihood of irritation, do not stick the patches on the same place several times in a row. Ideal areas for adhesion are: stomach, shoulders, back, buttocks. Gluing to the chest area is unacceptable.

The TTS is carefully removed from the packaging and glued evenly and tightly. Folding, bending of the patch, or incomplete adherence of the TTS to the skin is unacceptable. The tightness of the fit must be monitored daily, since the amount of hormones entering the blood depends on it. Since the drug strictly doses hormones, the use of several patches at the same time is prohibited.

When using Evra from the first day of menstruation, the following scheme is used: the patch is glued on the first day of the cycle, on the eighth day it is replaced with a new one, on the fifteenth day it is replaced again. On the twenty-second day, the TTC is removed from the skin and a seven-day break is taken. On the 29th day, a new TTS is applied and the cycle repeats (regardless of the absence or presence of menstruation). The patch change day always falls on the same day of the week. When starting to use TTC on a day other than the first day of the cycle, sticking is carried out according to the same scheme, but in the first week of use additional methods of barrier contraception (BC) are used or sexual intercourse is excluded. There should be no delay in changing the patch.

Methods of using the Evra transdermal system depending on the situation:
Delay in changing the patch for more than 48 hours in the first week of the cycle
They stick on a new TTS as soon as they remember. On a normal replacement day, a new one is glued on. It is necessary to use additional BC methods during the week.

Delay in changing the patch for more than 48 hours in the second or third week of the cycle
The patch is applied as soon as they remember and this day is considered the beginning of a new four-week cycle. BC required within a week.

TTS was not deleted on the 22nd day
Must be removed as soon as possible. A new cycle begins on the usual start day (day 28). No additional bookmaker is required.

The day of starting the use of TTC in the new cycle has been missed
TTC Evra is applied as soon as the patient remembers. Now the first day of replacement will be a different day of the week. Be sure to use BC for a week.

Delay in changing the patch for more than 7 days and presence of sexual intercourse during this period
TTC is not used until the possibility of pregnancy has been ruled out.

Switching from oral contraceptives with a combined composition to TTC Evra
TTC is applied on the first day of menstruation. If it does not start, exclude pregnancy and only then begin using the drug Evra.

Switching from progestogen drugs to TTC Evra
TTC is applied after stopping the use of progestogens on any day. During the first week, additional BC is used.

After an abortion (spontaneous or medical before the 20th week)
TTS Evra is pasted on the same day.

After an abortion (spontaneous or medical after 20 weeks)
TTC Evra begins to be used from the 21st day after an abortion or on the first day of menstruation.

Postpartum contraception
The first Evra patch is applied no earlier than 28 days after birth or on the first day of menstruation.

Side effects

Because Evra patch affects the central nervous system, dizziness, migraines, convulsive manifestations, depressive states, irritability, anxiety, sleep disturbances, asthenia, changes in appetite, hearing impairment, and coordination of movements may be observed. Tachycardia, edema syndrome, and hypertensive manifestations may occur. If symptoms of uncontrolled hypertension appear, the drug is discontinued.
Inflammation of the gastrointestinal mucosa (gastritis, gastroenteritis), dyspepsia (flatulence, constipation, diarrhea, nausea, vomiting) may occur.

The drug sometimes provokes the development of varicose veins and hemorrhoids. Hormonal changes under the influence of TTC components lead to vaginitis, dysmenorrhea, enlarged mammary glands, the appearance of discharge from the nipples, changes in sexual desire, dyspareunia, mastitis, fibroadenomatous lesions of the mammary glands, and cystic lesions of the ovaries.
Skin reactions are common: rashes, including bullous, acne, itching, urticaria, eczema. In rare cases, hair loss. Sometimes photosensitivity reactions and changes in skin color develop. Rare cases of conjunctivitis and visual impairment have been identified. Asthmatic manifestations, shortness of breath, muscle weakness, pain in the limbs, back, tendon changes - all these side effects are extremely rare. The use of TTC Evra can provoke hypertriglyceridemia, increased thrombus formation, and affect weight. There is a risk of developing embolism and deep vein thrombosis during drug therapy.

Contraindications

:
TSS Evra do not use for: a tendency to thrombosis (including if there is a family history of cases); thrombophlebitis; hemorrhoids; organic heart lesions; systemic lupus erythematosus; ulcerative lesions of the gastrointestinal tract; the presence of precursors of thrombosis (atrial fibrillation, ischemic heart disease, angina pectoris, cerebrovascular accidents); hypersensitivity to the components of TTS Evra; severe hypertension; genetically determined dyslipoproteinemia; diabetes mellitus; prolonged immobilization; obesity with a BMI over 30; migraines; a history of liver dysfunction when taking contraceptives during pregnancy; oncological gynecological diseases (estrogen-dependent tumors); tumor damage to the liver; suspected pregnancy; uterine bleeding.
Typically, TTC is not used for contraception in girls under 18 years of age, and women over 45. The use of Evra during lactation, in the first four postpartum weeks, is prohibited.

Pregnancy

:
TTS Evra It is not advisable to use in pregnant women. It is unacceptable to use the patch if there is a theoretical possibility of pregnancy.

Interaction with other drugs

Reduce hormone activity TTS Evra the following drugs: barbiturates, anticonvulsants, ritonavir, phenylbutazone, modafinil, griseofulvin. The decrease in contraceptive reliability occurs due to increased metabolism of the active components of TTC Evra as a result of the induction of liver enzymes by the above drugs.
Additional contraception is used during the course of treatment and during another menstrual cycle. For a long course of treatment, there is no standard seven-day break between two courses using TTC Evra.
The simultaneous use of the Evra patch and cyclosporine is unacceptable. There is a loss of contraceptive effect when using TTC Evra with St. John's wort preparations. Some antibiotics can reduce the activity of hormones by accelerating their metabolism. When used with insulin medications, unpredictable changes in sugar levels are possible.

Overdose

:
In case of overdose, bleeding similar to menstrual bleeding and dyspepsia are observed.
Evra patch removed, symptomatic therapy is carried out. There is no specific antidote to the components of the drug.

Storage conditions

Keep TTS Evra follows as list B drugs. Before use, the patch must be in its original packaging. Freezing is unacceptable. Storage at temperatures below 15 degrees Celsius is prohibited. The storage temperature of TTS Evra is 15-25 degrees Celsius.

Release form

Drug Evra Available on the market in two forms:
- a package of three patches, each of which is in an individual package made of foil and laminated paper. Three patches are additionally protected by a common package made of polymer material;
- a package of nine patches, which contains three bags of three patches each.

Compound

:
Active components TTS Evra: norelgestromin 6 mg, ethinyl estradiol 600 mcg. The adhesive layer applied to polyester contains: crospovidone, lauryl lactate, polybutene.

Additionally

:
Transdermal contraception has no clinically proven safety priority over oral contraceptive pills.
If you are prone to hyperpigmentation, you should refrain from visiting a solarium or tanning while using the drug.
Stop using TTC 4 weeks before planned surgery. Contraceptive protection is resumed using TTC after full restoration of the full ability to move.
It is recommended to take folic acid during periods of TTC use and after their termination.
If a woman weighs more than 90 kg, a different type of protection against unwanted pregnancy should be chosen, since contraceptive effectiveness in this case may be reduced.
At the beginning of treatment, spotting may appear. This is the norm.
If the Evra patch partially peels off, you must try to reattach it tightly. For this purpose, you cannot use additional plasters or adhesive tapes. If the adhesive properties of TTC are damaged, the patch is replaced with a new one. The next transdermal system is applied on the standard replacement day. If it is unclear how long the patch has been peeled off, then additional BC methods are needed. In order for the patch to adhere well, you should not use cosmetics at the sites where the TTC is planned to be applied.
TTS is not thrown into the sewer or toilet. The bag containing the patch is not thrown away. After using the patch, it is glued to a special area of ​​the bag and only then disposed of.

The Evra contraceptive patch is a very thin and smooth adhesive plaster (20cm2) that is used to prevent pregnancy. The patch is applied once every 7 days and provides a reliable effect with a minimum of effort. The reliability of the patch is 99.4%.

The Evra patch daily releases 20 mcg of ethinyl estradiol and 150 mcg of norelgestromin, which, after attaching the patch, penetrate the skin into the blood and block ovulation, that is, the ovary does not release eggs that can be fertilized. The patch also causes changes in the cervical mucus, making it difficult for sperm to enter the uterine cavity. Thus, maximum protection against unplanned pregnancy is achieved.

ATTENTION!!!
The Evra contraceptive patch does not protect against sexually transmitted diseases. Therefore, a prerequisite for its use is the presence of one permanent sexual partner, and the absence of sexually transmitted infections in both of you.

Benefits of the Evra contraceptive patch

This method of contraception is beginning to become an increasingly popular method. Its main advantage is that it eliminates the “forgetting effect” that causes a lot of trouble when using oral contraceptive pills. If patch replacement is delayed for up to 48 hours, the use of additional contraceptives is not required.

The Evra contraceptive patch is very simple and comfortable to use - it attaches securely to the skin and does not come off during water procedures or exposure to the sun. You don't have to change your daily activities while using the patch. You can shower, sunbathe, swim, use the sauna and exercise.

Like other hormonal contraceptives, the patch has medicinal properties: when used, there is practically no intermenstrual bleeding, menstrual pain occurs much less frequently, and PMS develops less frequently.

Side effects and contraindications of the Evra patch

The contraceptive patch contains the same substances as most oral contraceptives (a combination of progestin and estrogen). The side effects of the Evra patch are the same as when using other forms of microdose hormonal contraception. Most of them are mild to moderate, which does not limit the possibility of using the patch. In addition, side effects often go away within 2-3 months of starting use.

You should not use the contraceptive patch if you have: thrombosis, an established or suspected diagnosis of a malignant tumor, a history of stroke or myocardial infarction, or during pregnancy or lactation. Contraindicated for use in women over 35 years of age who smoke more than 15 cigarettes per day.

When can I start using the Evra patch?

1. You can start using the patch on the first day of your menstrual cycle, i.e. The first patch should be applied on the first day of menstruation. In this case, additional contraception is not required.
2. You can start using the patch on any day of the week you choose, for example, on Monday: attach the first patch on the first Monday after the start of your period. In this case, during the first 7 days you will need to use additional non-hormonal contraceptives (, or).

How to apply the Evra patch?

The Evra contraceptive patch can be worn discreetly on one of four areas of the body:

Before you start using the patch, be sure to carefully study it, or ask your gynecologist to teach you how to apply the patch correctly.

ATTENTION!!!
Always apply the patch to clean, dry skin. Do not use creams, lotions, oils, powders or other skin care products in the area where the patch is attached to prevent it from coming off.

The patch should not be placed on red, irritated or damaged skin. Only one patch can be used at a time. Each subsequent patch can be applied to the same anatomical area, but try not to apply the patch to exactly the same place as the previous one. For example, if you applied the patch to the right side of your abdomen, then next time apply it to the left.

When should I replace the patch with a new one?

One strip of the Evra contraceptive patch is applied to the skin once a week. To avoid mistakes, follow a simple pattern:

• Day 1 – attach the patch
• Day 8 - replace the patch
• Day 15 - replace the patch
• Day 22 - remove the patch (7 days break).

These days will always coincide with the same day of the week (for example, you always change the patch on Mondays), so it will be easy for you to follow the pattern.

The patch can be changed at any time of the day during the scheduled day of the change. During the fourth week, the patch is not used, starting from the 22nd day. Usually your period should begin around this time. Be sure to reapply a new patch after one week. Do not take a break from wearing the patch for more than 7 days.

How can I change the day I change the patch?

During the 4th week, when the patch is not used, you can choose any new day to change the patch, applying a new patch on the day of the week that is more convenient for you, and the period without the patch should not be more than 7 days.

What to do if you forget to change the patch?

If you forget to change the contraceptive patch at the beginning of your cycle for more than one day (first week/1 day):

• attach the first patch of the new period as soon as you remember;
• this day is considered the new day for changing the patch and the new 1st day of the cycle;
• To exclude unplanned pregnancy, non-hormonal methods of contraception must be used in the first 7 subsequent days of the new cycle.

If you forgot to change the patch in time in the middle of the cycle (second week/8 day or third week/15 day):

• if one or two days are missed (up to 48 hours), you just need to attach a new patch. The next patch should be applied on your regular patch change day. The use of additional methods of contraception is not required;
• If you miss more than two days (48 hours or more): remove the used patch and apply a new one as soon as you remember. This day is considered the new 1st day of the cycle and the new day for changing the patch;
• it is necessary to use non-hormonal methods of contraception for the next 7 days of the new cycle to avoid unplanned pregnancy.

If you forget to remove the patch at the end of the cycle (week four/day 22):

• if the patch is not removed, it must be removed;
• the next cycle should begin on the usual day of changing the patch;
• the use of additional methods of contraception is not required.

What to do if the Evra patch comes off?

The Evra contraceptive patch adheres well to the skin. More than 70,000 patches have been tested. If you follow all the rules for gluing and wearing, no problems should arise. Nevertheless:

• If the patch has partially come off:
  Press the patch firmly with your palm for 10 seconds to make sure the patch sticks well again. Run your fingers along the edges of the patch for better adhesion. If the patch does not stick, replace it with a new one.
• If the patch comes off completely:
  Less than one day (up to 24 hours): it should be reattached to the same place or replaced with a new patch. The use of additional methods of contraception is not required. The next patch should be applied on your regular patch change day.

  For more than one day (24 hours or more) or if you do not know when the patch came off, you may not be protected from pregnancy. It is necessary to glue a new patch and consider this day the first day of the menstrual cycle. At the same time, in the first 7 days of a new cycle, it is necessary to use additional non-hormonal methods of contraception.

The Evra patch is a square-shaped transdermal therapeutic system (TTS), with a beige matte backing, rounded corners, a colorless adhesive layer and a transparent protective film; the inscription "EVRA" is embossed on the backing. Pack of 3 pieces.

Active substance:
1 TTC contains norelgestromin 6 mg, ethinyl estradiol 600 mcg (releases norelgestromin 203 mcg, ethinyl estradiol 33.9 mcg within 24 hours).

Excipients:
Composition of the TTC base: an outer layer of pigmented low-density polyethylene and an inner layer of polyester. Composition of the TTC middle layer: adhesive mixture of polyisobutylene-polybutene, crospovidone, polyester non-woven material, lauryl lactate. Composition of the removable protective layer of TTS: polyethylene terephthalate film, polydimethylsiloxane coating.

pharmachologic effect

Contraceptive agent for transdermal use. Inhibits the gonadotropic function of the pituitary gland, suppresses the development of the follicle and interferes with the ovulation process. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl index – 0.90.

The pregnancy rate does not depend on factors such as age, race and increases in women weighing more than 90 kg.

Pharmacokinetics

After application of the Evra patch, norelgestromin and ethinyl estradiol quickly appear in the serum, reaching a plateau after approximately 48 hours, and remain in equilibrium concentrations throughout the period of wearing the patch. This eliminates the daily rise and fall in serum hormone levels that occurs with oral contraceptives. The study examined the pharmacokinetics of norelgestromin and ethinyl estradiol in 37 women when the Evra patch was applied to the skin of the abdomen, buttocks, arms or back for 7 days. In all three studies, serum concentrations of norelgestromin and ethinyl estradiol remained within the target range throughout the entire period of wearing the Evra patch, regardless of application site. Absorption of norelgestromin when applied to all sites - buttocks, arm and torso - was therapeutically equivalent.

Evra allows for continuous delivery of norelgestromin and ethinyl estradiol into the systemic circulation and inhibits follicular development for an additional two full days after completion of the recommended 7-day period of wearing the patch. Even after a 2-day delay in patch replacement, serum concentrations of the two hormones remained within the target range. Because norelgestromin and ethinyl estradiol continue to provide contraceptive effect during this 2-day period, additional contraception is not necessary if up to 2 days are missed. During each of Evra's three 7-day attachment periods, 30 women wore the patch on their abdomen in one of six different conditions: normal activity, sauna, hydromassage, treadmill, cool water immersion, or a combination of these. During the study, under the influence of elevated temperature, humidity, cold and/or exercise in a fitness club, only one (1.1%) of 87 patches completely came off on its own. The values ​​of the maximum serum concentrations of norelgestromin and ethinyl estradiol indicate that in none of these conditions there was a sudden release of excess amounts of hormones.

Indications for use

• contraception (prevention of unwanted pregnancy) in women.

Mode of application

The patient should be informed that in order to achieve maximum contraceptive effect, it is necessary to strictly follow the instructions for use of TTC Evra. Only one TTS can be used at a time.

Each used TTC is removed and immediately replaced with a new one on the same day of the week (“replacement day”) on days 8 and 15 of the menstrual cycle (weeks 2 and 3). TTS can be changed at any time on the day of replacement. During the 4th week, from the 22nd to 28th day of the cycle, TTC is not used. A new contraceptive cycle begins the day after the end of the 4th week; the next TTS should be stuck on, even if there was no menstruation or it has not ended.

Under no circumstances should a break in the application of TTC Evra be longer than 7 days, otherwise the risk of pregnancy increases. In such situations, it is necessary to simultaneously use a barrier method of contraception for 7 days, because the risk of ovulation increases with each day the recommended duration of the period free from TTC use is exceeded. In case of sexual intercourse during such an extended period, the probability of conception is very high.

Starting to use the Evra patch

• If the woman did not use hormonal contraception during the previous menstrual cycle
  Contraception with TTC Evra begins on the first day of menstruation. One TTC Evra is glued to the skin and used for the whole week (7 days). The day of gluing the first TTS Evra (1st day/start day) determines the subsequent days of replacement. The replacement day will fall on the same day of each week (8th and 15th days of the cycle). On the 22nd day of the cycle, TTC is removed, and from the 22nd to 28th day of the cycle the woman does not use TTC Evra. The next day is considered the first day of the new contraceptive cycle. If a woman does not start using TTC Evra from the first day of the cycle, then she should simultaneously use barrier methods of contraception during the first 7 days of the first contraceptive cycle.
• If a woman switches from using a combined oral contraceptive to using TTC Evra
  TTC Evra should be applied to the skin on the 1st day of menstruation, which began after stopping the combined oral contraceptive. If menstruation does not begin within 5 days after taking the contraceptive pill, then pregnancy must be ruled out before starting to use TTC Evra.

  If the use of Evra begins after the 1st day of menstruation, then for 7 days it is necessary to simultaneously use barrier methods of contraception. If more than 7 days have passed since the last contraceptive pill, a woman may be ovulating and should therefore consult a doctor before starting to use TTC Evra. Sexual intercourse during this extended period without taking contraceptive pills can lead to pregnancy.

• If a woman switches from using progestogen-only medications to using TTC Evra
  A woman can switch from using a drug containing only a progestogen at any day (on the day the implant is removed, on the day the next injection is due), but during the first 7 days of using TTC Evra, a barrier method should be used to enhance the contraceptive effect.
• After an abortion or miscarriage
  After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin using TTC Evra. If a woman begins to use TTC Evra immediately after an abortion or miscarriage, then no additional methods of contraception are required. A woman should know that ovulation can occur within 10 days after an abortion or miscarriage. After an abortion or miscarriage in the 20th week of pregnancy or later, the use of TTC Evra can be started on the 21st day after the abortion or miscarriage, or on the 1st day of the first menstrual period.
• After childbirth
  Women who are not breastfeeding should start using TTC Evra no earlier than 4 weeks after birth. If a woman starts using TTC Evra later, then during the first 7 days she must additionally use a barrier method of contraception. If sexual intercourse has taken place, pregnancy must be excluded before starting the use of TTC Evra, or the woman must wait until her first menstruation.

When the Evra patch comes off completely or partially

If TTS Evra has completely or partially peeled off, then an insufficient amount of its active ingredients enters the blood. Even if the TTS Evra is partially peeled off in less than a day (up to 24 hours): the TTS Evra should be re-glued in the same place or immediately replaced with a new TTS Evra. Additional contraception is not required. The next TTS Evra must be glued on the usual “replacement day”.

If partial peeling occurs for more than 24 hours (24 hours or longer), and if the woman does not know exactly when the TTC Evra partially or completely peeled off, pregnancy may occur. The woman should immediately start a new cycle by gluing a new Evra TTC and consider this day the first day of the contraceptive cycle. Barrier methods of contraception should be used simultaneously only in the first 7 days of a new cycle.

You should not try to re-glue TTS Evra if it has lost its adhesive properties; instead, you need to immediately glue the new TTS Evra. Do not use additional adhesive tapes or bandages to hold the Evra TTS in place.

If the next days of replacing the Evra patch are missed

At the beginning of any contraceptive cycle (1st week/1st day)

If there is an increased risk of pregnancy, a woman should glue the first TTC Evra of the new cycle as soon as she remembers it. This day is considered the new "1st day" and a new "replacement day" is counted. Non-hormonal contraception should be used simultaneously during the first 7 days of a new cycle. In case of sexual intercourse during such an extended period without the use of TTC Evra, conception may occur.

In the middle of the cycle (2nd week/8th day or 3rd week/15th day):

• if 1 or 2 days have passed since the date of replacement (up to 48 hours): the woman should immediately glue a new TTS. The next TTS must be glued on the usual “replacement day”. If during the 7 days preceding the first missed day of TTC attachment, the use of TTC was correct, then additional contraception is not required;
• if more than 2 days (48 hours or more) have passed since the date of replacement: there is an increased risk of pregnancy. The woman should stop the current contraceptive cycle and immediately begin a new 4-week cycle with a new Evra TTC. This day is considered the new "1st day" and a new "replacement day" is counted. Barrier contraception should be used simultaneously during the first 7 days of a new cycle;
• at the end of the cycle (4th week/22nd day): if the TTC is not removed at the beginning of the 4th week (22nd day), then it should be removed as quickly as possible. The next contraceptive cycle should begin on the usual “replacement day,” which is the day after the 28th day. Additional contraception is not required.

Changing the replacement day

In order to postpone menstruation by one cycle, a woman must apply a new TTC Evra at the beginning of the 4th week (22nd day), thereby skipping the period free from the use of TTS Evra. Intermenstrual bleeding or spotting may occur. After 6 consecutive weeks of TTC use, there should be a 7-day TTC-free interval. After this interval ends, regular use of the drug is resumed.

If, on the designated day during the week free from use, a woman wants to change the day of replacement, she must complete the current cycle by removing the third TTC Evra; a woman can choose a new day of replacement by gluing the first TTC Evra of the next cycle on the selected day. The period free from the use of TTS Evra should in no case be more than 7 days. The shorter this period, the higher the likelihood that a woman will not have another menstruation, and during the next contraceptive cycle, intermenstrual bleeding or spotting may occur.

How to apply the Evra patch correctly

TTC Evra should be applied to clean, dry, intact and healthy skin of the buttocks, abdomen, outer upper arm or upper torso with minimal hair growth, in areas where it will not come into contact with tight-fitting clothing.

To avoid possible irritation, each subsequent TTC Evra must be glued to a different area of ​​the skin; this can be done within the same anatomical area.

TTC Evra must be pressed tightly so that its edges are in good contact with the skin. To prevent a decrease in the adhesive properties of TTC Evra, you should not apply makeup, creams, lotions, powders and other local products to those areas of the skin where it is or will be glued.

A woman should inspect the Evra TTC daily to ensure that it is firmly attached.

Used TTS must be disposed of carefully according to instructions.

Side effect

When using TTC Evra, the following side effects may occur:

From the central nervous system and peripheral nervous system
dizziness, migraine, paresthesia, hypoesthesia, convulsions, tremor, emotional lability, depression, anxiety, insomnia, drowsiness.

From the cardiovascular system
increased blood pressure, palpitations, edema syndrome, varicose veins.

From the digestive system
gingivitis, anorexia or increased appetite, gastritis, gastroenteritis, dyspepsia, abdominal pain, vomiting, diarrhea, flatulence, constipation, hemorrhoids.

From the respiratory system
upper respiratory tract infections, shortness of breath, bronchial asthma.

From the reproductive system
pain during sexual intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, enlarged mammary glands, menstrual irregularities (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation not occurring in connection with childbirth , ovarian dysfunction, mastitis, breast fibroadenomas, ovarian cysts.

From the urinary system
urinary tract infections.

From the musculoskeletal system
muscle cramps, myalgia, arthralgia, ostalgia (including back pain, pain in the lower extremities), tendinosis (tendon changes), muscle weakness.

Dermatological reactions
itching, urticaria, skin rash, contact dermatitis, bullous rash, acne, skin discoloration, eczema, increased sweating, alopecia, photosensitivity, dry skin.

From the side of the organ of vision
conjunctivitis, visual impairment.

Metabolism
weight gain, hypertriglyceridemia, hypercholesterolemia.

Others
flu-like syndrome, feeling tired, allergic reactions, chest pain, asthenic syndrome, fainting, anemia, abscesses, lymphadenopathy.

Rarely (with frequency from >0.01% to<0.1%)
hypertonicity or hypotonicity of muscles, impaired coordination of movements, dysphonia, hemiplegia, neuralgia, stupor, increased libido, depersonalization, apathy, paranoia, benign tumors of the mammary glands, cervical cancer in situ, pain in the perineum, ulceration of the genitals, atrophy of the mammary glands, decreased blood pressure , enanthema, dry mouth or increased salivation, colitis, pain when urinating, hyperprolactinemia, melanosis, skin pigmentation disorders, chloasma, xerophthalmia, weight loss or obesity, inflammation of the subcutaneous tissue, alcohol intolerance, cholecystitis, cholelithiasis, liver dysfunction, purpura , "flushes" of blood to the face, thrombosis (including deep vein thrombosis, pulmonary artery thrombosis), thrombophlebitis of the superficial veins, pain in the veins, pulmonary embolism.

Contraindications for use

• venous thrombosis, incl. history (including deep vein thrombosis, pulmonary embolism);
• arterial thrombosis, incl. history (including acute cerebrovascular accident, myocardial infarction, retinal artery thrombosis) or precursors of thrombosis (including angina pectoris or transient ischemic attack);
• the presence of serious or multiple risk factors for arterial thrombosis: severe arterial hypertension (more than 160/100 mmHg), diabetes mellitus with vascular damage;
• hereditary dyslipoproteinemia;
• hereditary predisposition to venous or arterial thrombosis (eg, activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies - anticardiolipin antibodies, lupus anticoagulant);
• migraine with aura;
• confirmed or suspected breast cancer;
• endometrial cancer and confirmed or suspected estrogen-dependent tumors;
• liver adenoma and carcinoma;
• genital bleeding;
• postmenopausal period;
• age under 18 years;
• postpartum period (4 weeks);
• lactation period;
• hypersensitivity to the components of the drug.

Do not use on the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

Carefully should be used when there is a family history of venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age; with prolonged immobilization; obesity (body mass index more than 30 kg/m2, calculated as the ratio of body weight in kilograms to the square of height in meters); thrombophlebitis of superficial veins and varicose veins; dyslipoproteinemia; arterial hypertension; lesions of the heart valve apparatus; atrial fibrillation; diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease; ulcerative colitis; liver dysfunction; hypertriglyceridemia (including family history); acute impairment of liver function during a previous pregnancy or previous use of sex hormones; for menstrual irregularities; renal dysfunction.

Use of the drug Evra during pregnancy and lactation

The drug Evra is contraindicated during pregnancy and lactation.

Use for liver and kidney dysfunctions

• Evra should be used with caution in case of liver dysfunction; acute impairment of liver function during a previous pregnancy or previous use of sex hormones.
• Use with caution in case of impaired renal function.

Use in children under 12 years of age

The transdermal contraceptive patch Evra is contraindicated in children and adolescents under 18 years of age.

special instructions

There is no clinical evidence that the transdermal contraceptive system is in any way safer than oral contraceptives.

Before starting or resuming the use of TTC Evra, it is necessary to obtain a detailed medical history (including family history) and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, taking into account contraindications and warnings.

If a hereditary predisposition to venous thromboembolism is suspected (if venous thromboembolism occurred in a brother, sister or parent at a relatively young age), the woman should be referred for consultation with a specialist before deciding on the use of hormonal contraception.

The risk of vascular complications is increased in women with thrombophlebitis of the superficial veins and varicose veins, as well as in obesity (body mass index more than 30 kg/m2).

In case of prolonged immobilization, after major surgery on the lower extremities or severe trauma, it is recommended to stop using hormonal contraceptives (for planned surgery, this should be done 4 weeks before it) and resume hormonal contraception no earlier than 2 weeks later. after complete remobilization.

Some epidemiological studies have found an increased risk of cervical cancer in women who use combined oral contraceptives for a long time.

Women taking combined oral contraceptives may develop liver tumors, which can cause life-threatening intra-abdominal bleeding. If women using TTC Evra experience severe pain in the upper abdomen, liver enlargement or symptoms of intra-abdominal bleeding, differential diagnosis should be carried out to exclude a possible liver tumor.

Women with hypertriglyceridemia or a family history of this disease may have an increased risk of pancreatitis when using combined hormonal contraceptives.

If pharmacologically uncontrolled arterial hypertension occurs in women while using combined hormonal contraceptives, the drug should be discontinued. The use of TTC Evra can be resumed after normalization of blood pressure.

The following conditions have been reported to occur or be aggravated by oral use of combined hormonal contraceptives, but there is no convincing evidence that they are associated with the use of combined oral contraceptives. These include: jaundice and/or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic erythematosis; hemolytic-uremic syndrome; Sydenham's chorea; gestational herpes, otosclerosis-related hearing loss. Hormonal contraceptives may affect some endocrine parameters, liver function markers, and blood components:

• concentrations of prothrombin and coagulation factors VII, VIII, IX and X increase; the level of antithrombin III decreases; protein S levels decrease; norepinephrine-induced platelet aggregation increases;
• the concentration of thyroxine-binding globulin increases, which causes an increase in the concentration of total thyroid hormone, which is measured by the content of protein-bound iodine, T4 content (determined using chromatography or radioimmunoassay); The binding of free T3 by the ion exchange resin decreases, as evidenced by an increase in the concentration of thyroxine-binding globulin, the concentration of free T4 does not change. Serum concentrations of other binding proteins may be increased;
• The concentrations of sex hormone-binding globulins increase, which leads to an increase in the concentrations of total circulating endogenous sex hormones. At the same time, the concentrations of free or biologically active sex steroids decrease or remain unchanged.

In women using TTC Evra, the concentrations of HDL-C, total cholesterol, LDL-C and TG may slightly increase, while the LDL-C/HDL-C ratio may remain unchanged.

Hormonal contraceptives may cause a decrease in serum folate concentrations. This may have potentially clinically significant consequences if a woman becomes pregnant soon after stopping hormonal contraception. It is currently recommended that all women take folic acid during and after stopping hormonal contraception.

Combined hormonal contraceptives may affect peripheral insulin resistance and glucose tolerance, but there is no evidence that changes in diabetes mellitus therapy are necessary while using combined hormonal contraceptives. At the same time, the condition of patients suffering from diabetes mellitus should be carefully monitored, especially at the early stage of using TTC Evra.

Exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported in women taking combined oral contraceptives.

Women who have experienced facial hyperpigmentation during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while wearing the Evra TTC. Often this hyperpigmentation is not completely reversible.

Women should be informed that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women taking microsomal enzyme-inducing drugs (hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil and phenylbutazone) and antibiotics (except tetracyclines) should temporarily use a barrier method of contraception in addition to TTS Evra or choose another method of contraception. The barrier method must be used during the course of treatment with the above drugs, as well as within 28 days after discontinuation of microsomal enzyme inducers and within 7 days after stopping antibiotics. If the period of taking concomitant medications exceeds the 3-week cycle of using TTC Evra, then a new contraceptive cycle must be started immediately after the end of the previous one, i.e. without the usual period free from TTC use. Women receiving long-term therapy with drugs that induce liver enzymes should choose another method of contraception.

When prescribing drugs that are metabolized by isoenzymes CYP3A4 and CYP2C19, especially those with a narrow therapeutic index (for example, cyclosporine), during the use of TTC Evra, the possibility of a clinically significant interaction should be excluded.

When using any combined hormonal contraceptives, the menstrual cycle may be disrupted (spotting or intermenstrual bleeding), especially in the first months of using these drugs. The duration of the adaptation period is about three cycles.

If, while using TTC Evra in accordance with the recommendations, persistence of intermenstrual bleeding is observed or such bleeding occurs after previous regular cycles, then reasons other than the use of TTC should be taken into account. One should keep in mind the possibility of non-hormonal causes of menstrual irregularities and, if necessary, conduct an adequate diagnostic examination to exclude organic disease or pregnancy.

In some women, menstruation may not occur during the period free from the use of TTC Evra. If a woman did not follow the instructions for use in the period preceding the first missed menstruation, or if she did not have two menstruation after breaks from using TTC, then pregnancy must be excluded before continuing to use TTC Evra.

In some women, discontinuation of hormonal contraceptives may provoke the occurrence of amenorrhea or oligomenorrhea, especially if they were present before starting hormonal contraception.

If the application of TTC Evra causes skin irritation, then you can glue a new TTC to another area of ​​​​the skin and wear it until the next day of replacement.

In women weighing 90 kg or more, contraceptive effectiveness may be reduced.

If symptoms of liver dysfunction occur, the use of combined hormonal contraceptives should be discontinued until liver function markers normalize.

In case of recurrence of cholestasis-related itching that occurred during a previous pregnancy or previous use of sex hormones, combined hormonal contraceptives should be discontinued.

The safety and effectiveness of TTC Evra are established only for women from 18 to 45 years of age.

Immediately after removing the TTS from the bag, it should be firmly glued to the skin. After TTS is removed, it still contains significant amounts of active ingredients. Residual hormones can be harmful to the environment if released into water, and therefore used TTCs should be disposed of carefully. To do this, separate a special sticky film from the outside of the bag. Place the used TTC in the bag so that its sticky side faces the colored area on the bag, and press lightly to seal. The sealed bag is thrown away. Used TTS should not be thrown into the toilet or sewer.

Overdose

Symptoms: nausea, vomiting, vaginal bleeding.
Treatment: there is no specific antidote. The TTS should be removed and symptomatic therapy performed.

Drug interactions

Hydantoins, barbiturates, primidone, carbamazepine and rifampicin, as well as oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil and phenylbutazone, can cause an acceleration of the metabolism of sex hormones, which can cause intermenstrual bleeding or the ineffectiveness of hormonal contraception, i.e. the onset of unwanted pregnancy. The mechanism of interaction between these drugs and the active ingredients of TTS Evra is based on the ability of the above drugs to induce liver enzymes, with the participation of which sex hormones are metabolized. Maximum enzyme induction is usually achieved no earlier than 2-3 weeks, and may persist for at least 4 weeks after discontinuation of the corresponding drug.

Taking herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with the use of TTC Evra may lead to loss of contraceptive effect. Women who take such herbal remedies may experience intermenstrual bleeding and an unwanted pregnancy. This is due to the fact that St. John's wort induces enzymes that metabolize sex hormones. The inducing effect can last for 2 weeks. after discontinuation of a herbal preparation containing St. John's wort.

Antibiotics (including ampicillin and tetracyclines) can cause loss of contraceptive effect. A pharmacokinetic interaction study showed that oral administration of tetracycline hydrochloride 3 days before and for 7 days during use of TTC Evra does not have a significant effect on the pharmacokinetics of norelgestromin or ethinyl estradiol.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 15° to 25°C. Store in original packaging, do not store in refrigerator or freezer. Shelf life 2 years.

The Evra contraceptive patch was developed specifically for those women who do not want to take pills every day, but still dream of reliable contraception. The active ingredient of the drug penetrates immediately under the skin, inhibits ovulation and prevents possible fertilization. All you need to do is apply the patch strictly according to the instructions and enjoy your intimate life without the risk of unwanted pregnancy.

General characteristics: composition, description

The Evra patch is a modern contraceptive with combined action, used transdermally. Another name for the drug is transdermal therapeutic system (TTS). The patch is made in the shape of a square, has a matte light brown backing with an embossed EVRA inscription. The corners of the contraceptive product are rounded. On the reverse side there is a colorless adhesive layer with which the patch is fixed to the skin.

The product contains the following active ingredients:

• norelgestromin;
• ethinyl estradiol;

Auxiliary components are:

• TTC base: the outer layer contains pigmented low-density polyethylene, the inner layer contains polyester.
• The middle layer of TTC is made of an adhesive mixture consisting of polyisobutylene-polybutene, lauryl lactate, and non-woven polyester material.
• The removable protective layer of TTC includes a film of polyethylene terephthalate and a coating of polydimethylsiloxane.

Advantages: why do women choose the Evra system?

The advantages of a contraceptive include the following:

1. Simplicity and ease of use: a woman can independently install the patch on the skin.
2. High efficiency: protects against unwanted pregnancy in 99% of cases. Even if the schedule is off, the product continues to work for 1-2 days.
3. The contraceptive patch does not require placement on any specific area of ​​the body. If desired, it can be glued to any place suitable for a woman.
4. Strong fixation on the skin: TTC peeling off occurs quite rarely.
5. Reduced pain during menstruation.
6. Normalization of hormonal levels.
7. Reversible: The patch can be removed and fertility will be restored.
8. Ease of removal by a woman of the patch without causing any discomfort. If necessary, you can peel off the product with water.
9. The drug prevents the development of premenstrual syndrome.
10. Does not affect the quality of everyday life or sports. You can go to the pool or sauna with the patch.
11. Does not require dosage calculation: one contraceptive contains the required content of the medicinal substance for the onset of the contraceptive effect.
12. Time saving: you only need to use the Evra patch three times a month.
13. No interaction with other medications: the contraceptive can be used in conjunction with antibiotics and other medications.
14. The drug does not pass through the digestive tract and does not affect its functioning.
15. Acts faster than oral contraceptives.
16. Ensuring a constant concentration of the drug in the blood without hormonal fluctuations.

Note: it is better to apply the Evra patch on clean, dry skin with minimal hair growth and where the drug will not come into contact with thick clothing: buttocks, abdomen, outer surface of the shoulder.

Disadvantages: What to watch out for when using the birth control patch

As can be seen from the above, the hormonal drug has many advantages. However, any drugs also have their drawbacks. The Evra patch is no exception. Such negative qualities include:

The Evra patch does not protect against sexually transmitted infections, therefore it is recommended for use only if you have one regular partner.

Operating principle

The contraceptive patch has an inhibitory effect on the gonadotropic function of the pituitary gland, suppresses the maturation of follicles and prevents the onset of ovulation. The contraceptive effect is increased due to an increase in the viscosity of the mucus in the cervix and a decrease in the susceptibility of the uterine mucosa to the fertilized egg.

The onset of conception does not depend on age or race, but increases in women whose weight exceeds 90 kg.

Contraindications

The instructions for Evra say that it is not advisable to use the hormonal patch if you have the following conditions:

• Venous or arterial thrombosis, including hereditary predisposition to these diseases.
• Angina pectoris.
• Arterial hypertension (over 160/100 mm Hg).
• Diabetes mellitus with developed angiopathy.
• Hereditary dyslipoproteinemia.
• Migraine manifested by aura.
• Breast cancer or suspicion of it.
• Endometrial cancer, estrogen-dependent tumors, including suspicions of these neoplasms.
• Liver adenoma and carcinoma.
• Bleeding from the genital tract.
• Age under 18 years and postmenopausal period.
• Postpartum period (up to 6 weeks after birth).
• Individual intolerance to the components of the patch.

The contraceptive patch is strictly contraindicated during pregnancy and breastfeeding (lactation).

Side effects and complications

The use of TTS Evra may cause undesirable consequences. Let's take a closer look at them.

• Nervous system: the appearance of migraine, dizziness, paresthesia, hypoesthesia, convulsions, tremor, anxiety, insomnia and drowsiness.
• Cardiovascular system: hypertension, tachycardia, edema syndrome, varicose veins.
• Gastrointestinal tract: gingivitis, anorexia or increased appetite, gastritis, dyspepsia, gastroenteritis, vomiting, diarrhea, bloating, hemorrhoids and constipation.
• Respiratory system: bronchial asthma, inflammation of the upper respiratory tract.
• Genitourinary system: painful sexual intercourse, decreased sexual desire, enlarged mammary glands, menstrual disorder, impaired secretion from the vagina, inflammation of the urinary tract, changes in the structure of cervical mucus, ovarian dysfunction, mastitis, ovarian cysts, breast fibroadenomas.
• Musculoskeletal system: cramps, myalgia, arthralgia, tendinosis and muscle weakness.
• Skin reactions: itching, urticaria-type rashes, contact dermatitis, bullous rashes, acne, eczema, increased sweating, alopecia, dry skin.
• Visual impairment.
• Other: asthenic syndrome, fainting, feeling of fatigue, chest pain, abscesses, lymphadenopathy.

Application diagram: how and when to apply the Evra patch

Contraception begins on the 1st day of menstruation. A woman sticks the Evra patch to her skin and does not remove it for 1 week, replacing it with a new one on the 8th and 15th day of the cycle. From the 22nd to the 28th day you should not use a contraceptive.

What to do if a woman does not apply TTC Evra on the first day of the cycle? It’s okay, you’ll just have to additionally use a barrier method of contraception (condoms) for a week.

If a girl decides to switch from oral contraceptives to a patch, the latter is attached to the skin on the 1st day of her period, which began after finishing taking COCs. A woman should be wary that menstruation does not begin after 5 days before the intended use of the contraceptive pill. This may indicate pregnancy. It is not recommended to apply the patch until it is clear whether the woman is pregnant or not.

If the last contraceptive pill was taken more than 7 days ago, ovulation may occur. Before using TTC, a woman should definitely consult a gynecologist. At this time, pregnancy may occur, so to avoid conception, it is necessary to use a condom every time you have sexual intercourse.

Timing of installation after childbirth and abortion

After termination of pregnancy before the 20th week, experts allow the use of the Evra patch immediately without the use of additional contraceptives. After the 21st week of gestation, TTS can be applied on the 21st day after the abortion or on the 1st day of menstruation.

How much does the Evra patch cost?

The drug is not cheap: its average price reaches 500 rubles. Since 3 TTS are required to be applied in 1 month, this method of contraception is considered expensive, but reliable. You can buy contraception at a pharmacy or online.

In contact with

Evra: instructions for use and reviews

Latin name: Evra

ATX code: G03AA13

Active substance: Norelgestromin + Ethinylestradiol

Manufacturer: LTC Lohmann Therapie-Systems AG (Germany)

Updating the description and photo: 11.07.2018

Evra is a combined contraceptive.

Release form and composition

The dosage form of Evra is a transdermal patch [transdermal therapeutic system (TTS)]: square, with perforation along the tear line, with a matte beige backing on which the inscription “EVRA” is embossed, with rounded corners, a colorless adhesive (adhesive) layer and a transparent protective film , size together with protective film – (51+1) mm x (51+1) mm (1 piece each in bags of laminated paper and aluminum foil, 3 bags each in transparent film bags, 1 or 3 film bags (3 or 9 patches, respectively) in a cardboard box complete with special calendar stickers to mark the dates of use of the patch).

Active substances in the patch:

• norelgestromin (NE) – 6 mg;
• ethinyl estradiol (EE) – 0.6 mg.

Over 24 hours, one patch releases 0.203 mg HE and 0.0339 mg EE.

The transdermal patch consists of the following layers:

• auxiliary components: adhesive mixture of polyisobutylene and polybutylene (221.4 mg), lauryl lactate (12 mg), crospovidone (60 mg);
• polyester non-woven fabric (34 mg);
• support film (110.7 mg);
• protective film (208.95 mg).

Pharmacological properties

Pharmacodynamics

The contraceptive effect of Evra is due to inhibition of the gonadotropic function of the pituitary gland, suppression of follicle development and obstruction of the ovulation process. The drug also increases the viscosity of cervical secretions and reduces the susceptibility of the endometrium to the blastocyst, thereby enhancing the contraceptive effect.

The Pearl index, which reflects the pregnancy rate in 100 women within 1 year of using the chosen method of contraception, is 0.9. At the same time, the frequency of pregnancy does not depend on the race and age of the woman, but increases with a body weight of more than 90 kg.

Pharmacokinetics

After application of TTS, the concentrations of active substances in the blood plasma reach steady-state values ​​after 48 hours and amount to 0.8 ng/ml HE and 50 pg/ml EE.

With long-term use of this contraceptive, the steady-state concentration (C ss) and the area under the concentration-time curve (AUC) increase slightly.

During physical exercise and various temperature conditions, there are no significant changes in C ss ethinyl estradiol, C ss and AUC of norelgestromin, and the AUC of ethinyl estradiol increases slightly with physical exercise.

The target values ​​of the equilibrium concentration of HE and EE are maintained for 10 days of using the patch, i.e., the contraceptive effect of Evra is maintained even if the woman replaces the patch 2 days later than the scheduled 7-day period.

Norelgestromin and its serum metabolite norgestrel are characterized by a high degree of binding to plasma proteins (> 97%). Norelgestromin binds to albumin, and norgestrel binds mainly to globulins that bind sex hormones. Ethinyl estradiol has a high degree of binding to plasma albumin.

NOT metabolized in the liver to form norgestrel, various conjugated and hydroxylated metabolites. EE is metabolized to various hydroxylated compounds and their sulfate and glucuronide conjugates.

In human liver microsomes, progestogens and estrogens inhibit many enzymes of the cytochrome P 450 system (including CYP3A4 and CYP2C19).

The half-life of HE is on average 28 hours, and that of EE is 17 hours. Their metabolites are excreted through the intestines and kidneys.

The C ss and AUC values ​​of Evra's active substances decrease slightly with increasing age, surface area or body weight.

Indications for use

Evra is a drug used for contraception (prevention of unwanted pregnancy).

Contraindications

Absolute:

• known or suspected pregnancy;
• postpartum period (4 weeks);
• breastfeeding period;
• migraine with focal neurological symptoms;
• diagnosed (including history) or suspected estrogen-dependent malignant tumors (for example, endometrial cancer);
• confirmed or suspected breast cancer;
• bleeding from the vagina of unknown etiology;
• cholestatic jaundice during a previous pregnancy or jaundice with previous use of hormonal contraceptives;
• benign or malignant liver tumors;
• acute or chronic liver disease with impaired liver function;
• diabetes mellitus with vascular damage;
• conditions preceding thrombosis (including transient ischemic attacks and angina), including a history of;
• thrombosis (arterial and venous) and thromboembolism (including thrombosis, deep vein thrombophlebitis, cerebrovascular disorders, pulmonary embolism, stroke, myocardial infarction) currently or in history;
• severe or multiple risk factors for venous or arterial thrombosis, including smoking over the age of 35 years, uncontrolled arterial hypertension, hereditary dyslipoproteinemia, cerebrovascular or coronary artery disease, complicated valvular heart disease, atrial fibrillation, subacute bacterial endocarditis, obesity [mass index body weight more than 30 kg/m2 – the ratio of body weight (in kilograms) to the square of height (in meters)], extensive surgery with prolonged immobilization;
• hereditary predisposition to venous or arterial thrombosis, including the presence of antibodies to phospholipids (anticardiolipin antibodies, lupus anticoagulant), antithrombin III deficiency, protein S deficiency, activated protein C resistance, hyperhomocysteinemia and protein C deficiency;
• age under 18 years;
• hypersensitivity to the components of the drug.

Relative (for the following diseases/conditions, Evra can be used only after a thorough assessment of the expected benefits and possible risks):

• herpes during a previous pregnancy;
• Crohn's disease;
• ulcerative colitis;
• hemolytic-uremic syndrome;
• systemic lupus erythematosus;
• family history of cholestatic jaundice (for example, Rotor, Dubin-Johnson syndromes);
• chronic idiopathic jaundice;
• multiple sclerosis;
• diabetes mellitus without vascular complications;
• thrombophlebitis of superficial veins and varicose veins;
• venous or arterial thromboembolism in close relatives (parents, brothers, sisters) at a relatively young age;
• breast cancer in first-degree relatives;
• severe depression, including a history of depression;
• cholelithiasis, including a history;
• chorea;
• otosclerosis;
• hypertriglyceridemia;
• uterine fibroids and endometriosis;
• chloasma;
• controlled arterial hypertension;
• porphyria;
• acute liver dysfunction during a previous pregnancy or previous use of sex hormones;
• severe migraine without focal neurological symptoms.

Instructions for use of Evra: method and dosage

To achieve maximum contraceptive effect, Evra must be used in strict accordance with the recommendations described below.

One patch is designed for 7 days of use, after this period it should be immediately replaced with a new one, on the same day of the week - that is, on the 8th and 15th day of the drug use cycle (the so-called replacement days). From 22 to 28 days of the cycle there is a break, during which menstrual-like withdrawal bleeding is observed. After which a new contraceptive cycle is started, even if the withdrawal bleeding has not stopped by this time.

Under no circumstances should you take a break from wearing the patch for more than 7 days, as the risk of reducing the effectiveness of the drug and, as a result, pregnancy increases. If the break has been exceeded, it is necessary to additionally use barrier contraceptives for 7 days, since with each overdue day the likelihood of ovulation increases.

Mode of application

The Evra transdermal patch must be applied, pressing firmly, onto healthy, clean, dry, intact skin of the outer surface of the upper arm, abdomen, buttocks, upper torso with minimal hair growth - in areas where it will not come into contact with tight-fitting clothing. To avoid possible irritation, it is recommended to apply each new patch to a different area of ​​the skin, including within the same anatomical area. It is strictly forbidden to use TTC on the mammary gland area. To avoid reducing the adhesive properties of the patch, do not apply powder, cream, lotion or any other local product to the skin where it will be glued.

Every day a woman should inspect the patch to be sure that it is firmly attached.

Used patches still contain a significant amount of the active substances of the drug, so they should be disposed of correctly: remove the special adhesive film from the outside of the bag, place the TTS, facing its sticky side towards the colored area on the bag and lightly pressing to seal, then throw it in the trash bucket. Do not throw into drains or toilets.

Starting to use the transdermal patch

If a woman did not use a hormonal contraceptive in the previous menstrual cycle, Evra should be applied on the first day of menstruation. Exactly after 7 and 14 days - on days 8 and 15 of the cycle, respectively - the patch is replaced with a new one. On the 22nd day of the cycle, TTC must be removed and taken a break until the 28th day of the cycle. Day 29 – the first day of a new contraceptive cycle, etc.

In cases where a woman does not start using the patch on the first day of the cycle, an additional barrier method of contraception must be used over the next 7 days.

When switching to Evra from a combined oral contraceptive (COC), the patch must be applied on the first day of menstrual bleeding that occurs after stopping the COC. If this recommendation is followed, the pronounced effect of the drug is maintained, otherwise it is necessary to additionally use a barrier method of contraception for 7 days. However, if there is a break of more than 7 days, ovulation is possible, so before using the transdermal patch, a woman should consult a doctor. Sexual contact at this time can lead to pregnancy. If withdrawal bleeding does not begin within 5 days after taking the last active tablet of an oral contraceptive, pregnancy should also be excluded before starting to use Evra.

When switching to Evra from drugs containing only progestogen, you can start using the patch on the day the implant is removed or the day when the next injection is due, but during the first 7 days you should additionally use a barrier method of contraception.

After giving birth, non-breastfeeding women can start using the transdermal patch 4 weeks after delivery. If later, an additional barrier method must be used within 7 days. Women who had sexual intercourse during this period should first exclude pregnancy or wait until their first menstruation.

After an abortion or miscarriage before the 20th week of pregnancy, you can start using Evra immediately, then additional contraception is not required.

After an abortion or miscarriage at 20 weeks of pregnancy or later, you can start using the drug on the 21st day or on the first day of the first menstruation (whichever comes first).

Missed doses

In cases where the patch partially or completely peels off, an insufficient amount of active contraceptive substances enters the bloodstream.

If less than 24 hours have passed after the TTC has been peeled off (even partially), it is necessary to re-stick the patch in the same place or immediately replace it with a new one and continue to adhere to the usual regimen of using Evra. Additional contraceptive protection is not required.

If more than 24 hours have passed since the TTC came off (even partially), or the woman does not know exactly when the patch came off, she must immediately start a new cycle, i.e., stick on a new patch and continue to consider this day the first day of the contraceptive cycle. In the first 7 days, it is recommended to additionally use a barrier method of contraception.

You should not try to re-glue a patch that has lost its adhesive properties. In this case, you must use a new one. Do not use adhesive tapes or bandages to hold the TTC in place.

Missed patch replacement days

After a 7-day break from using the patch, you need to apply a new one. In cases where a woman forgets to do this, the recommendations described below should be followed.

If this happened at the beginning of the contraceptive cycle (first week/first day), it is necessary to stick the patch on as soon as the woman remembers this, and consider this day as the first day of the contraceptive cycle, accordingly the day of replacement will also shift. You must additionally use a barrier method of contraception for 7 days. In case of sexual intercourse during this extended period, conception is possible.

If this happened in the middle of the cycle (second week/eighth day or third week/fifteenth day), then:

• no more than 48 hours have passed since the day of replacement (the day when it was necessary to replace the TTS), a new patch must be applied immediately, and the next one on the usual day of replacement. Women who used their previous TTC correctly during the 7 days preceding the first missed day of attaching a new patch do not require additional contraception;
• If more than 48 hours have passed since the day of replacement, you must immediately apply a new patch, consider this day the first day of the new contraceptive cycle and count the new days of replacement from there. You should additionally use a barrier method of contraception for 7 days.

In cases where a woman forgot to remove the patch on the 22nd day of the cycle, it should be removed as soon as possible, and the next cycle should begin on the usual day of replacement (day 29 of the cycle). Additional methods of contraception are not required.

Changing the replacement day

To move your period forward by one cycle, you need to apply a new patch on day 22 of your cycle, thereby skipping the standard 7-day withdrawal period. However, it should be borne in mind that in this case, spotting or intermenstrual bleeding may occur. After 6 weeks of consistent use of Evra, you should definitely take a break from using the drug, and then resume its regular use.

Women who wish to reschedule the replacement day should complete the current contraceptive cycle, i.e., remove the third patch, and, having chosen a new replacement day, stick on the first patch of the next contraceptive cycle. It is important to take into account that the period of interruption in the use of Evra should not exceed 7 days. You should also know that the shorter this period, the higher the likelihood of the absence of another menstrual-like bleeding, and during the next contraceptive cycle, scanty or heavy acyclic bleeding may occur.

Side effects

According to clinical trials, the most common adverse reactions of Evra are: discomfort in the mammary glands, local reactions, headache, nausea.

The frequency of side effects is classified as follows: very often - ≥ 1/10, often - from ≥ 1/100 to< 1/10, нечасто – от ≥ 1/1000 до < 1/100, редко – от ≥1 /10 000 до < 1/1000, очень редко – < 1/10 000, включая отдельные сообщения.

Possible side effects:

• local reactions: often - reactions on the skin at the site of application of the patch, such as peeling, dryness, burning, swelling, hematomas, crusting, thickening, inflammation, atrophy, discharge, infection, formation of nodules and pustules, scars, loss of sensitivity, unpleasant odor , erosion, ulcer, excoriation, eczema, abscess, bleeding, paresthesia, photosensitivity, tumor growth; infrequently - irritation;
• general disorders: often – malaise, fatigue; uncommon – peripheral edema, hypersensitivity reactions;
• from the cardiovascular system: infrequently – arterial hypertension; rarely – thrombophlebitis of the veins of the extremities, venous thrombosis; very rarely - arterial thrombosis and thromboembolism, myocardial infarction, hypertensive crisis;
• from the gastrointestinal tract: very often – nausea; often - bloating, abdominal pain, diarrhea, vomiting; very rarely - colitis;
• from the side of metabolism and nutrition: often – weight gain; very rarely - increased appetite, hyperglycemia, insulin resistance;
• from the musculoskeletal system: often – muscle cramps;
• from the central and peripheral nervous system: very often – headache; often – migraine, dizziness; very rarely - subarachnoid hemorrhage, migraine with focal neurological symptoms, dysgeusia, cerebrovascular accidents (including transient cerebrovascular accidents, occlusion and stenosis of cerebral vessels, ischemic and hemorrhagic strokes);
• from the psyche: often - aggressiveness, tearfulness, affect, anxiety, emotional instability, depression; infrequently – insomnia, changes in libido; very rarely – frustration, anger;
• from the hepatobiliary system: infrequently – cholecystitis, cholelithiasis; very rarely - liver damage, cholestasis, cholestatic jaundice;
• infections and infestations: often - fungal infections of the vagina; very rarely - pustular rashes;
• on the part of the visual organs: very rarely - intolerance to contact lenses;
• on the part of the skin and subcutaneous tissues: often – skin reactions, itching, acne; uncommon – allergic dermatitis, urticaria, eczema, erythema, photosensitivity reactions, alopecia, chloasma; rarely - itchy rash, erythematous rash, generalized itching; very rarely - erythema nodosum, erythema multiforme, seborrheic dermatitis, exfoliative rash, angioedema;
• benign, malignant and neoplasms of uncertain etiology: rarely - uterine leiomyoma; very rarely - breast fibroadenoma, cervical cancer, breast cancer, liver tumors, liver adenoma;
• from the reproductive system and mammary glands: very often - fibrocystic changes in the mammary glands, pain, swelling, swelling, discomfort, increased sensitivity and enlargement of the mammary gland; often – vaginal discharge, uterine spasm, painful menstrual-like bleeding; infrequently - discharge from the genital tract, dryness of the mucous membrane of the vagina and vulva, galactorrhea, breast tumors; rarely - rare menstrual-like bleeding or its absence; very rarely - acyclic, scanty or heavy bleeding, cervical dysplasia, suppression of lactation;
• laboratory parameters: very rarely - an increase in the concentration of low-density lipoproteins, a change in the concentration of glucose in the blood, a change in the concentration of cholesterol in the blood.

Overdose

In case of overdose, the following symptoms are observed: bleeding from the vagina, nausea, vomiting. In this case, the TTS should be removed as quickly as possible and symptomatic therapy performed. There is no specific antidote.

special instructions

The Evra patch can be used only after consultation with a doctor, who must rule out pregnancy and assess the advisability of using the drug by collecting a detailed medical history about the patient and her immediate family, including data on heredity. A gynecological and general examination is also required (including breast examination, mammography, blood pressure measurement). If a hereditary predisposition to venous thromboembolism is suspected (for example, if parents, sister or brother have this disease), the woman is referred for additional consultation to an appropriate specialist.

Evra does not protect against sexually transmitted infections. Every woman should be warned about this when prescribing the drug.

If any symptoms appear during use of Evra that may indicate the occurrence of thromboembolic complications, it is necessary to immediately stop using TTC. The risk of vascular complications is increased with obesity, varicose veins and thrombophlebitis of the superficial veins.

Also, the risk of developing venous thromboembolic complications increases with prolonged immobilization and surgical interventions on the lower extremities. For this reason, 4 weeks before elective surgery, within 2 weeks after emergency surgery, and during and after prolonged immobilization, the use of hormonal contraceptives is not recommended.

According to some epidemiological studies, long-term use of combined hormonal contraceptives at a young age (before the first pregnancy) increases the risk of developing breast cancer. Some studies have shown that taking hormonal contraceptives is associated with an increased risk of developing cervical tumors, including cancer.

Due to the risk of benign liver adenomas, if you experience severe pain in the upper abdomen, symptoms of intra-abdominal bleeding or liver enlargement, you should consult a doctor for differential diagnosis and to exclude a liver tumor.

In case of pharmacologically uncontrolled arterial hypertension, the drug should be discontinued. You can resume use only after normalization of blood pressure.

According to the instructions, Evra can affect some indicators of functional tests. In particular, while using the transdermal patch:

• glucose tolerance decreases;
• concentrations of prothrombin and coagulation factors VII, VIII, IX and X increase;
• platelet aggregation increases;
• protein S levels decrease;
• concentrations of triglycerides, total cholesterol, high-density lipoprotein cholesterol (HDL-X) and low-density lipoprotein cholesterol (LDL-X) increase, while the LDL-C/HDL-C ratio may remain unchanged;
• antithrombin III levels decrease;
• The content of thyroxine-binding globulin increases, as a result of which the concentration of total thyroid hormone increases. The binding of free triiodothyronine (T3) by the ion exchange resin is reduced, as evidenced by an increase in the concentration of thyroxine-binding globulin. The concentration of free thyroxine (T4) does not change. Increased concentrations of other binding proteins are also possible;
• Serum folate concentrations decrease, which is why there is a risk of clinically significant consequences if pregnancy occurs soon after discontinuation of the contraceptive (it is currently recommended that all women with folic acid deficiency take folic acid in early pregnancy);
• The concentrations of globulins that bind sex hormones increase, resulting in an increase in the concentrations of total circulating endogenous sex hormones. In this case, the concentrations of biologically active or free sex hormones decrease or remain unchanged.

Hormonal contraceptives can cause thrombosis of retinal vessels. In the following cases, you should immediately stop using Evra and consult a doctor for diagnostic and therapeutic measures:

• unexpected transient, partial or complete loss of vision;
• attacks of blurred vision;
• diplopia;
• swelling of the papilla;
• violation of the integrity of retinal vessels.

While using the transdermal patch, women are advised to avoid exposure to sunlight or artificial ultraviolet light, as there is a risk of skin hyperpigmentation, which may not be completely reversible.

In women weighing ≥ 90 kg, contraceptive effectiveness may be reduced.

Women who smoke have an increased risk of developing side effects from the cardiovascular system, and therefore it is strongly recommended to refrain from smoking.

During the period of use of Evra, women should regularly undergo preventive medical examinations, the volume and frequency of which should be selected individually by a doctor depending on the clinical picture, but at least once every six months.

The transdermal patch should not be cut or damaged, as this may reduce its contraceptive effectiveness.

Impact on the ability to drive vehicles and complex mechanisms

Eura has no or negligible effect on psychomotor and cognitive functions.

Use during pregnancy and lactation

Evra is contraindicated for women during these periods of life.

Use in childhood

The effectiveness and safety of Evra are established for women from 18 years of age until the onset of menopause, therefore the drug is not prescribed to adolescents under 18 years of age.

For impaired renal function

Evra should be used with caution in case of renal impairment.

For liver dysfunction

Evra should be used with caution in the following cases: impaired liver function, acute functional impairment of the liver during a previous pregnancy or previous use of sex hormones.

Drug interactions

Antibiotics, certain drugs and herbal medicines that induce liver microsomal enzymes (including CYP3A4) that metabolize contraceptive hormones reduce the effectiveness of Evra. In this case, during the period of taking such drugs and for 7 days after their discontinuation (when taking rifampicin and St. John's wort preparations - for 28 days after discontinuation), it is necessary to additionally use a barrier method of contraception. If therapy with such drugs is long-term (more than 3 weeks), a new contraceptive cycle should be started without a withdrawal period. Drugs that may reduce the effectiveness of Evra include: griseofulvin, bosentan, barbiturates, modafinil, rifampicin and rifabutin, aprepitant (fosaprepitant), some HIV protease inhibitors or combinations thereof (eg, ritonavir, nelfinavir), St. John's wort, some non-nucleoside reverse transcriptase inhibitors (for example, nevirapine), some antiepileptic drugs (for example, felbamate, rufinamide, eslicarbazepine acetate, phenytoin, carbamazepine, topiramate, oxcarbazepine).

The following drugs may increase plasma ethinyl estradiol levels: etoricoxib, ascorbic acid, paracetamol, HMG-CoA reductase inhibitors (including rosuvastatin and atorvastatin), CYP3A4 inhibitors (including grapefruit juice, fluconazole, ketoconazole, itraconazole, voriconazole), certain non-nucleosides reverse transcriptase inhibitors (for example, etravirine), some HIV protease inhibitors (for example, indinavir, atazanavir).

With simultaneous use, Evra may increase (due to CYP inhibition) plasma concentrations of the following drugs: selegiline, omeprazole, tizanidine, cyclosporine, voriconazole, theophylline, prednisolone.

In the case of combined use, Evra can reduce (due to the induction of glucuronidation) the plasma concentrations of the following drugs: lamotrigine, temazepam, paracetamol, morphine, clofibrate, salicylic acid. Due to a decrease in the levels of these substances in the blood, undesirable reactions may develop, so adjustment of their doses is required.

It is recommended that you consult your physician before taking any medication while using this TTC.

Analogs

There is no information about analogues of Evra.

Terms and conditions of storage

Store in original packaging at temperatures up to 30 °C out of the reach of children.

Shelf life – 2 years.