Evra contraceptive patch: composition, application, advantages, analogues, price, reviews. Evra patch (Evra) Evra transdermal therapeutic system

Evra: instructions for use and reviews

Latin name: Evra

ATX code: G03AA13

Active substance: Norelgestromin + Ethinylestradiol (Norelgestromin + Ethinylestradiol)

Manufacturer: LTC Lohmann Therapie-Systems AG (Germany)

Description and photo update: 11.07.2018

Name: Evra (Evra).

Release form:

Transdermal patch or transdermal therapeutic system (TTS).

ATX code: G03AA13

Compound:

1 patch contains: norelgestromin 6 mg and ethinylestradiol 0.6 mg;

pharmachologic effect

The drug inhibits the gonadotropic function of the pituitary gland, inhibits the development of the follicle and interferes with the process of ovulation. The contraceptive effect is enhanced by increasing the viscosity of the cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl index - 0.90.

Indications for use

Contraception.

Dosage and administration

Applied externally.

TTC Evra should be applied to clean, dry, intact and healthy skin of the buttocks, abdomen, outer surface of the upper shoulder or upper body with minimal hair growth, in areas where it will not come into contact with tight-fitting clothing.
Each used patch is removed and immediately replaced with a new one on the same day of the week (the so-called "replacement day") on the 8th and 15th days of the menstrual cycle (2nd and 3rd week). The patch can be changed at any time on the replacement day. During the 4th week, from the 22nd to the 28th day of the cycle, TTS is not used. A new contraceptive cycle begins the day after the end of the 4th week (i.e. 7 days after the removal of the last third patch); the next TTS should be pasted, even if there was no menstruation or it did not end.

To achieve the maximum contraceptive effect, the drug must be used in strict accordance with the instructions. Only one Evra TTS can be used at a time.

Side effects

From the side of the central nervous system: dizziness, migraine, emotional lability, depression, anxiety, insomnia, drowsiness.

From the peripheral nervous system: paresthesia, hypoesthesia, convulsions, tremor,

From the side of the cardiovascular system: high blood pressure, tachycardia, edematous 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, asthma.

From the reproductive system: pain during intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, breast enlargement, menstrual irregularities (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation that occurs outside of 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), tendiosis (tendon changes), muscle weakness.

From the skin and its appendages: pruritus, urticaria, skin rash, contact dermatitis, bullous rash, acne, discoloration of the skin, eczema, increased sweating, alopecia, photosensitivity, dry skin.

Contraindications

• Hypersensitivity to Evra components;
• Thrombosis, venous (deep veins, pulmonary thromboembolism) and arterial (heart, brain, etc.), including history.
• The presence of serious or multiple risk factors for arterial thrombosis (severe arterial hypertension - blood pressure more than 160/100 mm Hg; diabetes mellitus with vascular damage; hereditary dyslipoproteinemia);
• Hereditary predisposition to venous or arterial thrombosis, such as activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and the presence of antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
• Migraine with aura;
• Confirmed or suspected breast cancer;
• Endometrial cancer and confirmed or suspected estrogen-dependent tumors;
• Adenoma and carcinoma of the liver;
• genital bleeding;
• Postmenopausal period;
• Age up to 18 years;
• Postpartum period (4 weeks);
• lactation period and pregnancy.

Impact on driving:

Does not affect.

special instructions

It is unacceptable to use on the area of ​​​​the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

Before starting or resuming the use of TTC Evra, it is necessary to conduct a complete medical examination and exclude pregnancy.

How do I change the patch day?
During the 4th week when the patch is not used, you can choose any new patch change day by applying a new patch on the day of the week that is most convenient for you, while the period without a patch should not be more than 7 days.
What to do if you forget to change your 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 patch change day and the new 1st day of the cycle;
• to exclude an unplanned pregnancy, non-hormonal methods of contraception must be used in the first 7 subsequent days of a new cycle.

If you forget to change the patch in time in the middle of the cycle (2nd week / 8th day or 3rd week / 15th 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 the normal 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 day 1 of the cycle and the new patch change day;
• it is necessary to use non-hormonal methods of contraception for the next 7 days of the new cycle in order to avoid an unplanned pregnancy.

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

• if the patch is not removed, then it must be removed;
• the next cycle should be started on the normal patch change day;
• the use of additional methods of contraception is not required.

What to do if the Evra patch is peeled off?

The Evra contraceptive patch adheres well to the skin. Over 70,000 patches have been tested. Subject to all the rules of gluing and wearing, no problems should arise. Nevertheless:
If the patch is partially peeled off:
Press firmly on the patch with the palm of your hand for 10 seconds and check that the patch is well-adhered 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 has come off completely:
Less than one day (up to 24 hours): It should be reattached in 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 the normal patch change day.

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

Package:

It is in a sachet of combined material, in a transparent bag of polymer film 3 sachets; in a pack of cardboard 1 or 3 bags of polymer film (containing 3 or 9 TTS) along with special stickers on the calendar to mark the expiration date.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 0 C.

Best before date - 3 years

Description:

Modern combined hormonal contraceptive (patch) for transdermal use.

Manufacturer:
Janssen-Cilag (Belgium).

Composition and form of release

Transdermal Therapeutic System (TTS) square shape, with a beige matte backing, rounded corners, a colorless adhesive (adhesive) layer and a transparent protective film; the inscription "EVRA" is embossed on the backing.

Active ingredient: 1 TTC contains norelgestromin 6 mg, ethinylestradiol 600 mcg (releasing norelgestromin 203 mcg, ethinylestradiol 33.9 mcg within 24 hours).

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

pharmachologic effect

Contraceptive for transdermal use. It inhibits the gonadotropic function of the pituitary gland, inhibits the development of the follicle and prevents the process of ovulation. The contraceptive effect is enhanced by increasing the viscosity of the cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl Index - 0.90.

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

Pharmacokinetics

After attaching the Evra patch, norelgestromin and ethinylestradiol rapidly appear in the serum, reaching a plateau in approximately 48 hours, and remain at equilibrium concentration throughout the entire period of wearing the patch. This eliminates the daily rises and falls in serum hormone levels that occur with the use of oral contraceptives. In the course of the studies, the pharmacokinetics of norelgestromin and ethinylestradiol were studied 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 ethinylestradiol remained within the specified range during the entire period of wearing the Evra patch, regardless of the site of attachment. The absorption of norelgestromin when attached in all places - on the buttocks, arm and trunk - was therapeutically equivalent.

Evra allows continuous administration of norelgestromin and ethinyl estradiol into the systemic circulation and inhibits follicle development for an additional two full days after the recommended 7-day patch period has been completed. Even after a 2-day delay in patch replacement, the serum concentration of the two hormones remains within the specified range. Since norelgestromin and ethinylestradiol continue to provide a contraceptive effect during this 2-day period, there is no need for additional contraception if up to 2 days are missed. During each of the three 7-day Evra 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 both. In a study exposed to heat, humidity, cold and/or exercise in a fitness club, only one (1.1%) of 87 patches completely peeled off on its own. The values ​​of the maximum concentration of norelgestromin and ethinylestradiol in serum indicates that in none of the listed conditions there was a sudden release of an excess amount 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 the maximum contraceptive effect, it is necessary to strictly follow the instructions for using TTS 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 the 8th and 15th days of the menstrual cycle (2nd and 3rd week). TTS can be changed at any time on the replacement day. During the 4th week, from the 22nd to the 28th day of the cycle, TTS is not used. A new contraceptive cycle begins the next day after the end of the 4th week; the next TTS should be pasted, even if there was no menstruation or it did not end.

Under no circumstances should a break in the application of TTC Evra be more 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 that the recommended duration of the period free from the use of TTS is exceeded. In the case of sexual intercourse during such an extended period, the probability of conception is very high.

Start of application of TTS Evra

If during the previous menstrual cycle a woman did not use a hormonal contraceptive
Contraception using TTC Evra begins on the first day of menstruation. One Evra TTC is glued to the skin and used all week (7 days). The day of gluing the first TTC Evra (1st day/day of start) determines the subsequent replacement days. The day of replacement will fall on the same day of each week (8th and 15th days of the cycle). On the 22nd day of the cycle, TTS is removed, and from the 22nd to the 28th day of the cycle, the woman does not use Evra TTS. The next day is considered the first day of a new contraceptive cycle. If a woman starts using TTS Evra not from the first day of the cycle, then barrier methods of contraception should be used simultaneously during the first 7 days of the first contraceptive cycle.
If a woman switches from using a combined oral contraceptive to using TTS Evra
TTC Evra should be glued 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 excluded before starting the use of TTS Evra.

If the use of Evra begins later than the 1st day of menstruation, then within 7 days it is necessary to simultaneously use barrier methods of contraception. If more than 7 days have passed since taking the last contraceptive pill, then a woman may experience ovulation, and therefore she should consult a doctor before starting to use TTC Evra. Sexual intercourse during this extended pill-free period can lead to pregnancy.
If a woman switches from using progestogen-only preparations to using TTC Evra
A woman can switch from using a progestogen-only drug 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 TTS 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 start using TTS Evra. If a woman starts using TTS Evra immediately after an abortion or miscarriage, then additional methods of contraception are not required. A woman should know that ovulation can occur within 10 days of an abortion or miscarriage. After an abortion or miscarriage at the 20th week of pregnancy or later, the use of Evra TTS can be started on the 21st day after the abortion or miscarriage, or on the 1st day of the first menstruation.
After childbirth
Women who are not breastfeeding should start using TTC Evra no earlier than 4 weeks after childbirth. If a woman starts using TTS Evra later, then during the first 7 days she must additionally use a barrier method of contraception. If sexual intercourse has taken place, then pregnancy must be excluded before starting the use of TTC Evra, or the woman must wait for the first menstruation.

With full or partial peeling off of TTS Evra

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

With partial peeling off for more than a day (24 hours or longer), and also if a woman does not know exactly when Evra TTS partially or completely peeled off, pregnancy is possible. A 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 must immediately glue the new Evra TTS. Do not use additional adhesive tapes or dressings to hold TTC Evra in place.

If the next days of replacing TTS Evra are missed

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

With an increased risk of pregnancy, a woman should glue the first Evra TTS of a 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 the case of sexual intercourse during such an extended period without the use of TTC Evra, conception may occur.

Mid cycle (week 2/day 8 or week 3/day 15):
if 1 or 2 days have passed since the day of replacement (up to 48 hours): the woman should immediately glue a new TTS. The next TTC must be glued on the normal "replacement day". If during the 7 days preceding the first missed day of TTS attachment, the use of TTS 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 must stop the current contraceptive cycle and immediately start a new 4-week cycle by gluing 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 soon as possible. The next cycle of contraception 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 delay menstruation for one cycle, a woman must stick a new Evra TTC at the beginning of the 4th week (day 22), thereby skipping the period free from the use of Evra TTC. Intermenstrual bleeding or spotting may occur. After 6 consecutive weeks of TTS use, there should be a 7-day TTS-free interval. After the end of this interval, the regular use of the drug is resumed.

If on the day appointed for this during the week free from use, the woman wants to change the day of replacement, she must complete the current cycle by removing the third Evra TTC; a woman can choose a new replacement day by gluing the first Evra TTC 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 period, and during the next contraceptive cycle, intermenstrual bleeding or spotting may occur.

How to stick TTS Evra correctly

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

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

TTS 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 TTS Evra, make-up, creams, lotions, powders and other local products should not be applied to those areas of the skin where it is glued or will be glued.

A woman should inspect the Evra TTC daily in order to be sure of its strong attachment.

Used TTS must be carefully disposed of in accordance with the instructions.

Side effect

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

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

From the side of the cardiovascular system: increased blood pressure, palpitations, edematous 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 intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, breast enlargement, menstrual irregularities (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation that does not occur 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: pruritus, urticaria, skin rash, contact dermatitis, bullous rash, acne, discoloration of the skin, eczema, increased sweating, alopecia, photosensitivity, dry skin.

From the side of the organs of vision: conjunctivitis, visual impairment.

From the side of metabolism: weight gain, hypertriglyceridemia, hypercholesterolemia.
Other flu-like syndrome, fatigue, allergic reactions, chest pain, asthenic syndrome, syncope, anemia, abscesses, lymphadenopathy.

Rarely (with a frequency of >0.01% to<0.1%) гипертонус или гипотонус мышц, нарушение координации движений, дисфония, гемиплегия, невралгия, ступор, повышение либидо, деперсонализация, апатия, паранойя, доброкачественные опухоли молочных желез, рак шейки матки in situ, боль в промежности, изъязвление гениталий, атрофия молочных желез, cнижение АД, энантема, сухость во рту или усиленное слюноотделение, колит, боль при мочеиспускании, гиперпролактинемия, меланоз, нарушения пигментации кожи, хлоазма, ксерофтальмия, снижение массы тела или ожирение, воспаление подкожной клетчатки, непереносимость алкоголя, холецистит, холелитиаз, нарушение функции печени, пурпура, "приливы" крови к лицу, тромбоз (в т.ч. тромбоз глубоких вен, тромбоз легочной артерии), тромбофлебит поверхностных вен, боль в венах, эмболия легочной артерии.

Contraindications for use

Venous thrombosis incl. history (including deep vein thrombosis, pulmonary thromboembolism);
- Arterial thrombosis, incl. history (including acute cerebrovascular accident, myocardial infarction, thrombosis of the retinal arteries) 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 mm Hg), diabetes mellitus with vascular damage;
- Hereditary dyslipoproteinemia;
- Hereditary predisposition to venous or arterial thrombosis (for example, activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies - antibodies against cardiolipin, lupus anticoagulant);
- Migraine with aura;
- Confirmed or suspected breast cancer;
- Endometrial cancer and confirmed or suspected estrogen-dependent tumors;
- Aadenoma and carcinoma of the liver;
- Genital bleeding;
- Postmenopausal period;
- Age up to 18 years;
- Postpartum period (4 weeks);
- lactation period;
- Hypersensitivity to the components of the drug.

It is unacceptable to use on the area of ​​​​the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

Caution should be used when indicating 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 over 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 valvular apparatus of the heart; atrial fibrillation; diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease; ulcerative colitis; violations of liver function; hypertriglyceridemia (including family history); acute liver dysfunction during a previous pregnancy or previous use of sex hormones; with menstrual irregularities; impaired renal function.

The use of the drug Evra during pregnancy and lactation

Evra is contraindicated during pregnancy and lactation.

Use for violations of the liver and kidneys

Evra should be used with caution in violation of liver function; acute liver dysfunction during a previous pregnancy or previous use of sex hormones.
Caution should be used in violation of kidney function.

Use in children under 12 years of age

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 safer than oral contraceptives in any aspect.

Before starting or resuming the use of TTS Evra, it is necessary to collect 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 specialist advice before considering the use of hormonal contraception.

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

With prolonged immobilization, after extensive surgery on the lower extremities or severe trauma, it is recommended to stop using hormonal contraceptives (in case of a planned operation, 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.

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

Women with or a family history of hypertriglyceridemia may be at increased risk of pancreatitis when using combined hormonal contraceptives.

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

It has been reported that oral combined hormonal contraceptives may cause or exacerbate the following diseases, but there is no convincing evidence of their association with the use of combined oral contraceptives. These include: jaundice and/or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic erythematosis; hemolytic-uremic syndrome; chorea of ​​Sydenham; gestational herpes, otosclerosis-related hearing loss. Hormonal contraceptives can affect some endocrine parameters, markers of liver function and blood components:
increased concentrations of prothrombin and coagulation factors VII, VIII, IX and X; the level of antithrombin III decreases; the level of protein S decreases; increased platelet aggregation caused by norepinephrine;

the concentration of thyroxin-binding globulin increases, which causes an increase in the concentration of total thyroid hormone, which is measured by the content of iodine associated with protein, the content of T4 (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 thyroxin-binding globulin, the concentration of free T4 does not change. Serum concentrations of other binding proteins may be elevated;

increased concentrations of globulins that bind sex hormones, which leads to an increase in the concentration of total circulating endogenous sex hormones. However, the concentrations of free or biologically active sex steroids decrease or remain unchanged.

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

Hormonal contraceptives may cause a decrease in serum folate concentrations. This can have potentially clinically significant consequences if a woman becomes pregnant shortly after stopping the hormonal contraceptive. Currently, all women are advised to take folic acid during and after the end of hormonal contraception.

Combined hormonal contraceptives may affect peripheral tissue insulin resistance and glucose tolerance, but there is no evidence of the need to change the regimen of diabetes therapy during the use of combined hormonal contraceptives. At the same time, the condition of patients suffering from diabetes mellitus should be carefully monitored, especially at an 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 hyperpigmentation of the skin of the face during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while wearing TTC Evra. 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 drugs that induce microsomal enzymes (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 use 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 the withdrawal of microsomal enzyme inducers and within 7 days after stopping antibiotics. If the period of taking concomitant drugs exceeds the 3-week cycle of using TTS Evra, then a new contraceptive cycle should be started immediately after the end of the previous one, i.e. without the usual period free from the use of TTS. Women receiving long-term therapy with drugs that induce liver enzymes should choose another method of contraception.

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

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

If during the use of TTS Evra in accordance with the recommendations, there is persistence of intermenstrual bleeding or such bleeding occurs after previous regular cycles, then reasons other than the use of TTS should be considered. The possibility of non-hormonal causes of menstrual irregularities should be kept in mind and, if necessary, an adequate diagnostic examination should be carried out to rule out an organic disease or pregnancy.

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

In some women, discontinuation of hormonal contraceptives can provoke the occurrence of amenorrhea or oligomenorrhea, especially if they are present before the start of hormonal contraception.

If the application of Evra TTC causes skin irritation, then you can stick a new TTC on another area of ​​\u200b\u200bthe skin and wear it until the next day of replacement.

In women weighing 90 kg or more, the effectiveness of contraception may be reduced.

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

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

The safety and efficacy of TTS Evra are established only for women from 18 to 45 years old.

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

Overdose

Symptoms: nausea, vomiting, vaginal bleeding.
Treatment: There is no specific antidote. TTS should be removed and symptomatic therapy should be carried out.

drug interaction

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 may be the cause of intermenstrual bleeding or ineffectiveness of hormonal contraception, i.e., the onset of unwanted pregnancy. The mechanism of interaction between these drugs and the active ingredients of TTC Evra is based on the ability of the above drugs to induce hepatic enzymes, with the participation of which sex hormones are metabolized. The maximum induction of enzymes 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 Evra TTS can lead to a loss of contraceptive effect. Women who take these herbal remedies may experience intermenstrual bleeding and unwanted pregnancies. This is due to the fact that St. John's wort induces enzymes that metabolize sex hormones. The inducing effect can persist for 2 weeks. after the abolition of the herbal preparation containing St. John's wort.

Loss of contraceptive effect can be caused by antibiotics (including ampicillin and tetracyclines). A pharmacokinetic interaction study showed that oral administration of tetracycline hydrochloride 3 days before and for 7 days during the use of TTC Evra does not significantly affect the pharmacokinetics of norelgestromin or ethinyl estradiol.

Terms and conditions of storage

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

The Evra hormonal contraceptive patch (another name for TTS is a transdermal therapeutic system) is a new method of protection against unwanted pregnancy, which has proven high efficiency and safety.

The patch, which is glued to the skin, releases a certain amount of hormones into the blood every day that change the functioning of the ovaries. Thanks to the Evra hormonal patch, ovulation is blocked in the ovaries, the mucus in the canal in the cervix becomes thicker, and the uterine mucosa becomes thinner, which prevents the penetration of spermatozoa into the uterus, fertilization and attachment of the embryo in the uterine cavity.

According to the manufacturer, the effectiveness of the hormonal patch is 99.4%, however, according to independent studies, its effectiveness is in the region of 92% and is comparable to the efficiency. All effects of the hormonal patch are temporary, and a woman's ability to become pregnant returns in the first months after stopping the use of the patch.

WARNING: The drug has contraindications. Do not start using this drug without first talking to your doctor.

Composition and form of release

Hormonal patch Evra is available in the form of a square flesh-colored patch 5x5cm in size.

One patch contains 600 micrograms of ethinylestradiol and 6 mg of norelgestromin. This is a fairly large dose of hormones, but it is designed not for one day, but for a week. Every day for a week, the patch releases a small dose of hormones into the blood: about 20 micrograms of ethinylestradiol and about 150 micrograms of norelgestromin.

One package contains 3 or 9 patches, designed for 1 or 3 months of use, respectively.

Benefits of the hormonal patch Evra

The Evra hormonal patch has several advantages over other methods of hormonal contraception:

Unlike birth control pills, which need to be taken every day, the hormone patch only needs to be changed once a week, which is much more convenient for most women.

Another advantage of the patch compared to birth control pills is that being up to 48 hours late in changing the patch does not reduce its contraceptive effect, while in the case of taking birth control pills, being 12-24 hours late can lead to unwanted pregnancy.

A third advantage compared to birth control pills is that the use of a hormonal patch is much less likely to cause bleeding in the middle of the cycle.

The contraceptive effect of the Evra hormonal patch does not decrease with digestive disorders (vomiting, diarrhea).

Your weight exceeds 90 kg.

You have or have had thyroid problems.

You have or have had gallbladder disease.

You suffer from epilepsy.

Do you have or have had diseases of the mammary glands (fibrocystic mastopathy, etc.)

Rules for the use of the hormonal patch Evra

Hormonal patch Evra should be glued to the skin once a week for 3 weeks in a row. The fourth week is the week of the break, when the patch is not applied, and the woman may begin menstrual-like bleeding ("menstruation").

Where can I stick the Evra hormonal patch?

The patch can be glued to the skin of the abdomen, buttocks, in the area of ​​the shoulder blade, as well as to the skin of the outer part of the shoulder. With experience in applying the patch, you will find the place that is most comfortable for you.

The most important thing when choosing a place for gluing a patch is to find a skin area that meets the following requirements:

the skin in this area should be dry and healthy (no scratches, rashes, etc.)

there should be no natural skin folds at the place where the patch is attached (for example, it is not recommended to glue the patch on the inner surface of the elbow joint)

there should be minimal hairiness at the place where the patch is attached (otherwise the patch may not adhere well, and at the moment the patch is peeled off, you will get a painful depilation effect)

the skin in this area should not be in close contact or rub against clothing (for example, a panty band or bra strap)

The patch should not be applied to the breast skin.

When changing the patch, do not stick it on the same place where the previous one was attached. Do not apply lotions, creams, oils, powders, or other cosmetics to the selected area of ​​skin before applying the patch.

If you have never used hormonal contraceptives before

Attach the Evra patch on the first day of menstruation and remember the day of the week on which this happened. All further patch changes will be done on the same day of the week.

The patch is used in four-week contraceptive cycles. Contraceptive cycle when using a hormonal patch:

Day 1 of the menstrual cycle: Attach the first patch

Day 8 of the menstrual cycle: replace the patch with a new one (second)

Day 15 of the menstrual cycle: change the patch for a new one (third)

Day 22 of the menstrual cycle: remove the third patch and do not apply a new one

Day 28 of the menstrual cycle is the beginning of a new contraceptive cycle: attach the first patch, etc.

When will the contraceptive effect come?

If you started using the Evra hormonal patch from the first day of menstruation, then the contraceptive effect occurs immediately, so you do not need to use other contraceptives.

If you did not attach the patch on the first day of your period, then its effect may be reduced, so you need to use additional contraceptives (for example,) during the week.

Will the contraceptive effect last during the break?

The contraceptive effect of the Evra hormonal patch is maintained for the duration of the 7-day break between the patches.

How to switch to the Evra hormonal patch from birth control pills?

If you took birth control pills last month, then it is recommended to attach the Evra patch on the first day of menstruation, which began after the cancellation of OK, but no later than 7 days after the cancellation of birth control pills.

If the patch was applied on the first day of menstruation, then the contraceptive effect occurs immediately, and you do not need to use additional contraceptives.

If the patch is not attached on the first day of menstruation, then the contraceptive effect may be reduced. In this situation, it is recommended to use additional contraceptives during the first 7 days after applying the patch.

If more than 7 days have passed since you stopped taking OCs, and you had unprotected intercourse on those days, you should make sure that you are not pregnant before applying the patch. To do this, you can do or pass.

Evra hormonal patch after childbirth

You can start using the patch no earlier than 4 weeks after giving birth. Keep in mind that you can become pregnant in the first weeks after giving birth, so be sure to use other barrier methods of contraception before using the patch. If you had unprotected intercourse before the patch was applied, first make sure you are not pregnant.

Is it possible to use the Evra hormonal patch for nursing mothers?

The hormones that the patch secretes penetrate into breast milk, so the Evra hormonal patch is contraindicated during breastfeeding.

How to start using the Evra hormonal patch after an abortion and miscarriage?

If the abortion or miscarriage occurred in the first trimester of pregnancy (before 12 weeks), then the first patch can be attached on the day of the abortion or curettage after the miscarriage. In this case, the contraceptive effect occurs immediately, and you do not need to use additional contraceptives.

If more than 5 days have passed after an abortion or miscarriage, then you can start using the patch from the first day of the next menstruation. Keep in mind that pregnancy can occur as early as the first weeks after an abortion or miscarriage. Condoms or other non-hormonal methods of contraception should be used before starting the patch.

If an abortion or miscarriage occurred later than 12 weeks of pregnancy, then you can start using the Evra hormonal patch no earlier than 4 weeks after cleaning.

Monthly and brown discharge while wearing the Evra patch

While wearing the Evra hormonal patch, more or less abundant brown (bloody) discharge is acceptable. Especially often such discharges are observed in the first 3 months after the start of using the patch. If the discharge is excessive, long lasting, or does not stop after 3 months of using the patch, consult your healthcare professional.

What should I do if I forgot to put on a new patch in time?

Late replacement of the patch by less than 48 hours does not reduce its contraceptive effect. In this case, apply the patch as soon as possible. No additional precautions are required.

If you are late for 2 days or more, then the contraceptive effect may decrease. Your next steps will depend on which patch you forgot to stick on time:

If you forgot to stick a new Evra patch after a week break (the first patch or the first week of the cycle), then stick it on as soon as you remember about it. Remember this day of the week, as you will perform all subsequent patch changes on this day. To avoid unwanted pregnancy, use additional contraception (such as condoms) for 7 days after applying the patch. If you had unprotected intercourse before the patch was applied, there is a risk of pregnancy.

If you forget to apply the second or third patch (second or third week of the cycle), then apply the patch as soon as possible and remember the day of the week on which this happened. From this day on, you need to start a new contraceptive cycle (change the patch for the next 3 weeks and take a break on the fourth week). Use additional contraception for another 7 days.

What should I do if I forgot to peel off the third patch in time?

Nothing bad will happen. Peel off the third patch as soon as possible and start a new contraceptive cycle on your usual day of the week. The contraceptive effect in this situation will not decrease.

What to do if the Evra hormonal patch is peeled off?

If the hormonal patch has peeled off (completely or partially), then the contraceptive effect may be reduced. If less than 24 hours have passed from the moment of peeling off, then replace the peeled off patch with a new one. Change your next patch on your usual day of the week. Additional contraception is not required in this situation.

If more than 24 hours have passed since the patch was peeled off, or if you do not know when the patch peeled off, you should immediately replace it with a new one and note the day of the week on which this happened. From this day on, you should start a new contraceptive cycle (change the patch for 3 weeks and take a break on the fourth week). To avoid an unplanned pregnancy, use additional contraception for another 7 days.

How to postpone menstruation with the Evra hormonal patch?

You can delay unwanted periods for up to a month with a hormonal patch. To do this, after removing the third patch, you do not need to take a 7-day break, but instead you should stick a new (fourth in a row) patch. After the fourth, the fifth and sixth patches follow, and at week 7 you should take a break.

If you skip the 7-day break, you may experience bloody (brown) discharge of varying degrees of profusion. It is not dangerous and does not reduce the contraceptive effect. Despite these discharges, continue to use the patch as usual.

What to do if there is no period in the 7-day break?

If, against the background of the use of the Evra hormonal patch, menstruation did not occur in a 7-day break, then you need to remember if there were any episodes in the past month that reduce the effect of the patch. If there were no such episodes (the patch did not come off, you did not forget to change it in time, etc.), then you can continue using the patch even if your period has not come.

If you have had episodes in the last month that could reduce the effect of the hormone patch, then you should stop using the patch again and not restart until pregnancy has been ruled out.

Consult a doctor if, against the background of the use of TTS Evra, menstruation is absent for 2 cycles in a row or more.

What factors can reduce the contraceptive effect of the Evra hormonal patch?

Some drugs and medicinal herbs can reduce the contraceptive effect of the Evra hormonal patch. Before starting treatment with this or that medicine, be sure to consult your doctor.

What should I do if pregnancy occurs during the use of the Evra hormonal patch?

If you find out you are pregnant, stop using the hormone patch immediately (peel off the existing patch and do not put on a new one). The use of a hormonal patch in early pregnancy does not increase the risk of abnormalities in the unborn child, so the pregnancy can be saved.

Planning for pregnancy after canceling the Evra hormonal patch

If you are planning to become pregnant, complete the current cycle of the hormone patch and do not start a new cycle after a 7-day break. Start taking folic acid at least 1 month before you expect to conceive.

The contraceptive patch "Evra" is a very smooth and fairly thin adhesive plaster, which is used as a protection against sticking the product only once every seven days. This allows you to get a reliable effect, while spending a minimum of effort. It is worth noting that the Evra adhesive plaster protects by 99.4%.

How the product works

"Evra" (patch), reviews of which are mostly positive, releases 150 micrograms of norelgesromine and 20 micrograms of ethinyl estradiol. These substances enter the bloodstream through the skin. After that, ovulation is blocked. In other words, the ovary stops releasing an egg that can already be fertilized. In addition, the drug causes mucosal changes in the uterus. As a result, this makes it difficult for sperm to enter the uterine cavity. It is thanks to this action of the product that protection against pregnancy is achieved.

However, when using this drug, one should not forget that the Evra hormonal contraceptive patch is not able to protect a woman from certain sexually transmitted diseases. It is for this reason that a prerequisite for its use is the presence of only one permanent partner. At the same time, a man and a woman should not have any infections transmitted during intercourse.

Product Benefits

Recently, this method of protection against pregnancy has become much more popular than other contraceptives. Its main advantage lies in the fact that when it is used, the so-called forgetting effect, which causes a lot of trouble when using oral contraceptive pills, is excluded. It should be noted that even if the replacement of the patch is delayed for several days, additional contraceptives are not required.

"Evra" (patch), reviews of which indicate its effectiveness, is quite comfortable and easy to use. The product adheres well to the skin. At the same time, it does not peel off even when exposed to the sun and during water procedures. There is also no need to change your daily routine and reduce daily activity. The use of such a contraceptive allows you to sunbathe, shower, swim, engage in various physical exercises, visit a sauna or a bath.

In addition, the patch has a therapeutic effect on the body. Like many hormonal drugs, this product eliminates spotting that occurs between periods. With its use, pain in the lower abdomen rarely occurs. In addition, the patch prevents the development of premenstrual syndrome.

Contraindications and side effects

"Evra" (patch), reviews of which will be useful to many, has the same side effects as many hormonal birth control pills. Many of them are expressed, as a rule, in a moderate or mild degree. This, in turn, does not limit the use of this product. It is worth noting that many side effects disappear after a few months after the start of use.

Plaster "Evra" can not be used for:

1. lactation.
2. Pregnancy.
3. Having a myocardial infarction or stroke in the past.
4. Suspected or already established diagnosis of a malignant tumor.
5. Thrombosis.

Also, the patch should not be used by women over 35 and those who smoke more than 15 cigarettes during the day.

When to start using the product

When can I start using "Evra" (patch)? Reviews show that this product can be used on the first day of the onset of menstruation. Use of additional contraceptives in this case is not necessary.

You can also start using the patch any day of the week. For example, on Monday. The first patch should be applied on the same day after the onset of menstruation. In this case, additional contraceptives will need to be used during the first week. They must be non-hormonal, such as a diaphragm, chemical or condoms.

How to glue the drug

The patch "Evra", the price of which is relatively low, can be worn unnoticed by other people on four parts of the test:

• Lower belly.
• On the buttock.
• On the shoulder blade.
• On the outside of the shoulder.

As the reviews show, before attaching the patch, you should carefully study the instructions. You need to fix the product on dry and clean skin. Also, do not use powder, oils, lotions, creams and other caring cosmetics exactly where the patch is glued. This will prevent the product from peeling off.

In addition, the reviews indicate that you should not attach the patch to damaged, irritated and reddened areas of the skin. You can not glue several pieces to a rhinestone. You can attach the patch to the same area several times. Of course, there are a few rules. Experts recommend not to stick it constantly in the same place.

When to change the patch

Hormonal patch "Evra" should be glued once a week. Many women advise, in order not to get confused, to follow the following scheme:

1. On the first day, you need to attach the tool.
2. On the eighth day, the patch should be replaced.
3. On the 15th day, you need to change the remedy again.
4. On day 22, the patch should be removed.
5. The next seven days require a break.

It is worth noting that all these days will coincide with a specific day of the week. Therefore, using the patch according to this scheme is very simple. Replacing funds can be done at any time of the day. The patch can not be used from 22 days during the week. It is during this period that menstruation begins. Experts do not recommend taking a break for more than seven days.

What to do if the day of the shift is missed?

It is better to change the Evra patch on time. If the replacement of the agent occurred later a day at the beginning of the cycle, then:

1. Attach the patch as soon as you remember. From that day on, a new cycle will begin.
2. To avoid pregnancy, non-hormonal contraceptives should be used in the first week of a new cycle.

If it was not possible to replace the patch on the 8th or 15th day, then:

If the patch was not removed at the end of the cycle, then:

• First of all, the patch must be removed if it has not been done before. After that, a new cycle must be started on the day that will correspond to the scheme.
• It is not necessary to use additional non-hormonal remedies in this case.

If the product peels off

If the Evra patch, the price of which is from 690 to 850 rubles per pack, has partially peeled off, then you need to press it strongly with your palm and hold it for 10 seconds. It should reattach firmly. After that, you should run your fingers along the edges of the patch. If it does not stick, then it should be replaced.

If the patch is completely peeled off and less than 24 hours have passed, then you should try to stick it back in the same place. If this is not possible, then you need to replace it. There is no need to take additional protective equipment.