Model trend pills 3mg + 0.02mg №28

Indications

- contraception;

- contraception and treatment of moderate acne (acne vulgaris);

- contraception and treatment of severe premenstrual tension syndrome.

Dosage and administration

The pills are taken orally in the order indicated on the packaging, every day at about the same time, with a small amount of water. It should be taken on 1 tab. / Day continuously for 28 days. Taking the pills from the next pack should be started the next day after taking the last pill from the previous pack.

Withdrawal bleeding, as a rule, begins on the 2-3rd day after the start of taking inactive pills and may not end before taking the pills from a new package.

Start taking the drug

In the absence of taking any hormonal contraceptives in the previous month use of the drug begins on the 1st day of the menstrual cycle (ie, on the 1st day of menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.

Transition from other combined hormonal contraceptive drugs (PDA, vaginal ring or contraceptive patch)

It is preferable to start taking the drug Modell Trend the next day after taking the last active pill from the previous package, but in no case later than the next day after taking the last inactive pill (for drugs containing 28 pills per pack). Acceptance of the drug Modelle should be started on the day of removal of the vaginal ring or patch, but no later than the day when a new patch is to be inserted or a new patch is pasted.

Transition from contraceptives containing progestogens only ("mini-pili", injection forms, implant or intrauterine system (IUD) with controlled release of progestogen)

You can switch from taking mini-drank to Modell Trend on any day (without a break), from an implant or an IUD with a progestogen on the day it was removed, from an injection contraceptive on the day when the next injection should be given. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

After abortion in the first trimester of pregnancy.

You can start taking the drug immediately - on the day of the abortion. Subject to this condition, the woman does not need additional methods of contraception.

After childbirth or abortion in the II trimester of pregnancy

It is recommended to start taking the drug on the 21-28th day after birth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills.However, if a woman has already lived sexually, before taking the drug Modell Trend, pregnancy should be excluded or it is necessary to wait for the first menstruation.

Acceptance of missed pills

Skipping inactive pills can be ignored. However, they should be thrown away in order not to accidentally extend the intake of inactive tablets. The following recommendations apply only to skipping active pills. If the delay in taking the drug was less than 24 h, contraceptive protection is not reduced. You should take the missed pill as soon as possible, and take the next one at the usual time. If the delay in taking the pills was more than 24 hours, contraceptive protection can be reduced. The more pills are missed and the closer the skipping of pills to the intake phase of inactive pills, the greater the likelihood of pregnancy. In this case, you can follow the following two basic rules:

- The drug should never be interrupted for more than 4 days;

- to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of tablets.

Accordingly, if the delay in taking active pills was more than 24 hours, we can recommend the following.

The first week of the drug

You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time).The next pill is taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used within the next 7 days. If sexual contact occurred within 7 days before the pill was missed, the likelihood of pregnancy should be considered.

The second week of the drug

You must take the last missed pill as soon as possible as soon as the woman remembers this (even if you need to take two pills at the same time). The next pill is taken at the usual time. Provided that the woman took the pills correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of the drug

The risk of pregnancy increases due to the intake of inactive tablets. It should strictly adhere to one of the following two options. Moreover, if within the 7 days preceding the first missed pill, all pills were taken correctly, there is no need to use additional contraceptive methods. Otherwise, you must use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) within 7 days.

one.You should take the last missed pill as soon as possible as soon as the woman remembers it (even if it means taking two pills at the same time). The following pills are taken at the usual time until the active pills in the package run out. Four inactive pills should be thrown away and immediately start taking the pills from the next package. Withdrawal bleeding is unlikely until the active pills in the second package run out, but there may be spotting and breakthrough bleeding while taking the pills.

2. You can also stop taking the pills from the current package. Then the woman should take a break of no more than 4 days, including the days of missing pills, and then start taking the drug from a new package.

If a woman missed active pills, and while taking inactive pills, the withdrawal did not occur, it is necessary to exclude pregnancy.

Recommendations in case of disorders of the gastrointestinal tract

In the event of severe gastrointestinal disorders (vomiting, diarrhea), absorption may be incomplete, therefore additional contraceptive methods should be used. If vomiting occurs within 4 hours after taking the active pill, refer to the recommendations for skipping pills. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, an additional active pill should be taken from another package.

Change the day of the onset of menstrual bleeding

In order to delay the onset of menstrual bleeding, a woman should continue taking the pills from the next package of the drug Modell Trend, skipping the inactive pills from the current package. Thus, the cycle can be extended at will for any period until the active pills from the second package run out. While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Regular intake of the drug Modell Trend resumes after the end of the phase of inactive tablets.

To transfer the onset of menstrual bleeding to another day of the week, a woman should cut the next phase of inactive pills for the desired number of days. The shorter the interval, the higher the risk that there will be no withdrawal bleeding, and later there will be spotting and breakthrough bleeding while taking the second package (just as if she would like to delay the onset of menstruation).

Additional information for specific patent categories

The efficacy and safety of the drug as a contraceptive studied in women of reproductive age. Drug use before the menarche not shown.

After menopause drug Model Trend is not shown.

The use of the drug is contraindicated in the presence or in the history severe liver disease (until normalization of functional liver samples and within 3 months after the return of these indicators to normal).

The drug Model Trend is contraindicated in acute renal failure and severe renal failure.

Side effect

I report on the following most common adverse reactions in women using the combination of drospirenone + ethinyl estradiol for "Contraception" and "Contraception and treatment of moderate acne (acne vulgaris)": nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the vagina of unspecified origin. These adverse reactions occurred in more than 3% of women. In women using Drospirenone + Ethinyl Estradiol, the following most common adverse reactions have been reported (in more than 10% of women): nausea, pain in the mammary glands, irregular uterine bleeding. Serious adverse reactions are arterial and venous thromboembolism.

The frequency of adverse reactions identified during clinical trials of the combination of drospirenone + ethinyl estradiol is determined as follows: often (≥1 / 100- <1/10); infrequently (≥1 / 1000- <1/100); rarely (≥1 / 10 000- <1/1000). For undesirable reactions detected only in the process of post-marketing observation, the frequency of which cannot be estimated, the “frequency is unknown” is indicated.

Infectious and parasitic diseases: rarely - candidiasis of the oral mucosa, candidal vulvovaginitis.

From the hemopoietic system: rarely - anemia, thrombocytopenia.

On the part of the immune system: rarely, allergic reactions; frequency is unknown - hypersensitivity reactions.

Metabolism and nutrition: rarely, increased appetite, anorexia, hyperkalemia, hyponatremia.

Mental disorders: often - emotional lability, depression / depressed mood; infrequently - decrease / loss of libido, drowsiness; rarely - anorgasmia, insomnia.

From the nervous system: often - headache; infrequently - dizziness, paresthesia; rarely - vestibular dizziness, tremor.

On the part of the organ of vision: rarely - conjunctivitis, dry eyes, blurred vision.

Since the cardiovascular system: infrequently - migraine, varicose veins, increased blood pressure; rarely - tachycardia, phlebitis, vascular disease, nosebleeds, syncope, venous or arterial thromboembolism *.

From the digestive system: often nausea; infrequently - abdominal pain, vomiting, dyspepsia , flatulence, gastritis, diarrhea; rarely - bloating, gastrointestinal upset, feeling of distention in the abdomen, hernia of the esophageal opening of the diaphragm, constipation, dry mouth, biliary colic, cholecystitis.

Skin and Subcutaneous Tissues: rarely - acne, itching, rash; rarely - chloasma, eczema, alopecia, acne-like dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis; frequency is unknown - erythema multiforme.

From the musculoskeletal system: infrequently - back pain, pain in the limbs, muscle spasms.

On the part of the reproductive system and the breast: often - breast tenderness, acyclic bleeding **, absence of menstrual-like bleeding; infrequently - pain in the pelvic area, enlargement of the mammary glands, fibrocystic mastopathy, discharge from the genitals, "hot flushes", vaginitis, painful menstrual-like bleeding, scanty menstrual-like bleeding, dryness of the mucous membrane of the vagina, pathological changes in the Pap smear; rarely - dyspareunia, vulvovaginitis, post-coital bleeding, breast cyst, breast hyperplasia, breast neoplasm, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.

Laboratory and instrumental data: infrequently - weight gain; rarely - weight loss.

Other: infrequently - asthenia, excessive sweating, edema (generalized edema, peripheral edema, swelling of the face); rarely - malaise.

* venous or arterial thromboembolism includes occlusion of peripheral deep veins; thrombosis and thromboembolism / occlusion of the pulmonary vessels; myocardial infarction, cerebral infarction and hemorrhagic stroke.

** In the process of continuous treatment, the bleeding irregularity usually decreases.

The following adverse reactions have been reported in women using PDA, with a very rare occurrence or delayed symptoms, which are believed to be associated with taking PDA:

- mammary cancer;

- liver tumors (benign and malignant);

- erythema nodosum;

- increase in blood pressure;

- pancreatitis in women with hypertriglyceridemia;

- the appearance or worsening of conditions whose connection with the admission of the CCP has not been definitively established: porphyria, SLE, pregnant herpes, chorea Sydenhem, hemolytic-uremic syndrome, cholestatic jaundice and / or itching associated with cholestasis ; cholelithiasis; otosclerosis with impaired hearing;

- abnormal liver function;

- change in glucose tolerance and the development of insulin resistance;

- chloasma;

- Crohn's disease, ulcerative colitis;

- hypersensitivity reactions (including skin rash, urticaria).

In women with hereditary angioedema, estrogen administration may cause or exacerbate its symptoms.

Contraindications

- thrombosis (venous and arterial) at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

- conditions preceding thrombosis (including transient ischemic attacks, atrial fibrillation, angina pectoris) now or in history;

- identified susceptibility to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

- migraine with focal neurological symptoms at present or in history;

- diabetes with vascular complications;

- Multiple or severe risk factors for venous or arterial thrombosis (including complicated lesions of the cardiac valve apparatus, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled arterial hypertension, prolonged immobilization, extensive surgical intervention, surgery on the lower extremities, extensive injuries, smoking over the age of 35, obesity with a BMI> 30 kg / m²);

- pancreatitis with severe hypertriglyceridemia now or in history;

- liver failure and severe liver disease (until normalization of functional liver tests and within 3 months after the return of these indicators to normal);

- liver tumors (benign or malignant) now or in history;

- acute renal failure or severe renal failure;

- identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

- bleeding from the vagina of unknown origin;

- pregnancy or suspicion of it;

- lactation period (breastfeeding);

- hereditary lactose intolerance , lactase deficiency or glucose-galactose malabsorption syndrome;

- hypersensitivity to the drug.

If any of the above diseases or conditions develop for the first time while taking the drug, it should be immediately canceled.

Carefully

The ratio of the potential risk and the expected benefit of the use of the drug Model Trend in each individual case should be assessed with the following diseases / conditions and risk factors:

- risk factors for thrombosis and thromboembolism: smoking, obesity (BMI <30 kg / m²), dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (adult thrombosis, myocardial infarction or impaired cerebral circulation in a young age in one of the next relatives), adolescents, adult myocardial infarction or cerebral circulation at a young age in one of the close relatives, adolescents women;

- other diseases in which disorders of the peripheral circulation can be observed: diabetes mellitus without diabetic angiopathy, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease or ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;

- hereditary angioedema;

- hypertriglyceridemia;

- liver disease, not related to contraindications;

- Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, pregnant herpes, Sydenhem chorea);

- postpartum period.

Use during pregnancy and lactation

Pregnancy

Use of the drug Modell Trend is contraindicated in pregnancy. If pregnancy is detected during the use of the drug Modell Trend, the drug should be immediately canceled. Extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenic effects in cases where sex hormones were taken carelessly in the early stages of pregnancy.

In animal studies, the effects of drospirenone and ethinyl estradiol have been associated with their pharmacological action. In particular, in reproductive toxicity studies in animals, an embryotoxic and fetotoxic effect was detected, but these effects were considered to be related to the specifics of a particular animal species. At exposure levels in animals exceeding the corresponding levels in patients receiving drospirenone and ethinyl estradiol, an effect was observed on the differentiation of the sex of rat embryos, which was absent in small monkeys. According to the data obtained in animal studies, the possibility of the development of undesirable effects caused by the hormonal activity of the active substances in humans cannot be excluded. However, the cumulative experience of the use of PDA during pregnancy did not provide evidence of the development of undesirable effects in humans. Data on the results of taking the drug Modell Trend during pregnancy is limited,which does not allow to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and the newborn. There are currently no significant epidemiological data available.

Lactation period

Use of the drug Modell Trend is contraindicated during breastfeeding. KPC can reduce the amount of breast milk and change its composition, therefore, their use is not recommended until the termination of breastfeeding. A small amount of sex hormones and / or their metabolites may be excreted in milk.

Application for violations of the liver

Contraindicated use of the drug for liver failure and severe liver disease (before normalization of functional liver samples and within 3 months after the return of these indicators to normal), liver tumors (benign or malignant) now or in history.

Precautions should be prescribed the drug for liver diseases, not related to contraindications.

Application for violations of kidney function

The drug is contraindicated in acute renal failure and severe renal failure.

Use in children

Drug use before the menarche not shown.

Use in elderly patients

After menopause drug Model Trend is not shown.

special instructions

Medical examinations

Before starting or resuming the use of the drug Modell Trend, it is necessary to read the historylife, family history of women, conduct a thorough general medical (including measurement of blood pressure, heart rate, definition of BMI) and gynecological examination, including examination of the mammary glands and cytological examination of the scraping from the cervix (Pap test), to exclude pregnancy. The amount of additional research and the frequency of control examinations are determined individually. Usually, control examinations should be carried out at least 1 time in 6 months.

A woman should be informed that the drug Model Trend does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

If any of the conditions, diseases, and risk factors listed below are present, then the potential risk and the expected benefits of using a PDA in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the drug. When weighting, amplification, or at the first manifestation of risk factors may require the abolition of the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of CPC and an increase in the incidence of venous and arterial thrombosis and thromboembolism, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disease. These diseases are rare.

The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs.The risk is especially high with the initial use of PDA or the resumption of the use of the same or different PDAs (after a break between taking the drug in 4 weeks or more). Data from a large prospective study involving 3 groups of patients show that the risk is greatest, mostly during the first 3 months.

The overall risk of VTE in women taking low-dose PDA (containing less than 50 μg of ethinyl estradiol) is 2–3 times higher than in non-pregnant women who do not take PDA, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth. VTE can be fatal (1-2% of cases).

VTE, which is manifested in the form of deep vein thrombosis or pulmonary thromboembolism (PE), can develop with the use of any PDA.

Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and retinal arteries or vessels, occurs extremely rarely with CPK. There is no consensus regarding the relationship between the occurrence of these events and the use of PDAs. Symptoms of deep vein thrombosis (DVT) include: one-sided swelling of the lower limb or along the vein on the lower limb, pain or discomfort in the lower limb only in a vertical position or when walking, local temperature increase in the affected lower limb, redness or change in skin color on the lower limbs.

The symptoms of pulmonary embolism are as follows: shortness of breath or rapid breathing; sudden cough, incl.with hemoptysis; acute pain in the chest, which may increase with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are nonspecific and may be misinterpreted as symptoms of other more or less serious events (for example, an infection of the respiratory tract).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensitivity of the face, limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one or two-sided vision loss; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without epileptic seizures. Other signs of vascular occlusion are: sudden pain, swelling and weak blueing of the extremities, the acute stomach symptom complex.

Symptoms of myocardial infarction include: pain; the discomfort; a feeling of pressure, heaviness, a feeling of constriction or fullness in the chest, in the arm or behind the sternum discomfort in the left half of the chest radiating to the back, cheekbone, larynx, arm, epigastric region; cold sweat, nausea, vomiting, or dizziness, severe weakness, anxiety, or shortness of breath; feeling of rapid or irregular heartbeat. Arterial thromboembolism can be life threatening or fatal.

The risk of thrombosis (venous and / or arterial) and thromboembolism increases:

- with age;

- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years old);

in the presence of:

- obesity (BMI> than 30 kg / m²);

- burdened family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age). In the case of hereditary or acquired predisposition, a woman should be sent to the appropriate specialist to decide on the possibility of using a PDA;

- prolonged immobilization, serious surgical intervention, any operation on the lower limbs or extensive trauma. In these situations, it is necessary to discontinue the use of PDA (in the case of the planned operation, at least 4 weeks before it) and not to resume reception within 2 weeks after the end of immobilization;

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- valvular heart disease;

- Atrial fibrillation.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

You should consider the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can also occur in diabetes mellitus, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine attacks during the use of PDA (which may precede cerebrovascular disorders) should be the basis for the immediate cessation of these drugs.

Biochemical indicators indicating hereditary or acquired susceptibility to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, deficiency of protein S, the presence of antibodies to phospholipids (an antibody to a cardiolipin III, a deficit of a word, and a drawstring; .

When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (containing less than 50 μg of ethinyl estradiol).

Drugs containing levonorgestrel, norgestimate or norethindrone have a low risk of developing venous thromboembolism. For drugs that include drospirenone, the risk of thromboembolic complications is 2 times higher, and therefore a woman should be warned about this increased risk before prescribing the drug Modell Trend.

Tumors

The most important risk factor for cervical cancer is persistent HPV infection.There are reports of some increase in the risk of developing cervical cancer with prolonged use of PDA. However, the connection with the admission of the PDA is not proven. Conflicting data remain on the extent to which these data are associated with screening for the identification of cervical pathology or sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women taking CPC at the present time (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely observed in women under 40 years of age, an increase in the number of breast cancer diagnoses in women who are currently taking or are taking CCP is insignificant relative to the overall risk of the disease. The relationship between the development of breast cancer and the intake of PDA has not been proven. The observed increase in risk may also be due to careful observation and earlier diagnosis of breast cancer in women.