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Modelle Pro tabs 3mg + 0.03mg #21

Modelle Pro tabs 3mg + 0.03mg #21

$35.44

(In stock)

  • Modelle Pro tabs 3mg + 0.03mg #21 Modelle Pro tabs 3mg + 0.03mg #21

Modelle Pro tabs 3mg + 0.03mg #21

Quick Overview

Modelle PRO - Monophasic oral contraceptive with anti-mineralocorticoid and anti-androgenic properties.The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in the properties of the cervical secretion, as a result of which it becomes less permeable to sperm.If used correctly, the Pearl Index (the number of pregnancies per 100 women per year) is less than 1. If you skip pills or use it incorrectly, the Pearl Index may increase.In women taking combined oral contraceptives, the menstrual cycle becomes more regular, less frequent painful menstruation, decreases the intensity of bleeding, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of combined oral contraceptives reduces the risk of developing endometrial cancer and ovarian cancer.Drospirenone contained in the drug Modelle PRO, has antimineralocorticoid action. Prevents weight gain and edema associated with estrogen-induced fluid retention, which ensures a very good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). Clinical efficacy of Jess in alleviating the symptoms of severe PMS, such as severe psycho-emotional disorders, breast engorgement, headache, muscle and joint pain, weight gain, and other symptoms associated with the menstrual cycle, is shown.Drospirenone also has antiandrogenic activity and helps reduce acne, oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body.Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this combination with anti-mineralocorticoid and anti-androgenic effects provides Drospirenone with a biochemical and pharmacological profile similar to natural progesterone.

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pharmachologic effect

Modelle PRO - Monophasic oral contraceptive with anti-mineralocorticoid and anti-androgenic properties.The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in the properties of the cervical secretion, as a result of which it becomes less permeable to sperm.If used correctly, the Pearl Index (the number of pregnancies per 100 women per year) is less than 1. If you skip pills or use it incorrectly, the Pearl Index may increase.In women taking combined oral contraceptives, the menstrual cycle becomes more regular, less frequent painful menstruation, decreases the intensity of bleeding, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of combined oral contraceptives reduces the risk of developing endometrial cancer and ovarian cancer.Drospirenone contained in the drug Modelle PRO, has antimineralocorticoid action. Prevents weight gain and edema associated with estrogen-induced fluid retention, which ensures a very good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). Clinical efficacy of Jess in alleviating the symptoms of severe PMS, such as severe psycho-emotional disorders, breast engorgement, headache, muscle and joint pain, weight gain, and other symptoms associated with the menstrual cycle, is shown.Drospirenone also has antiandrogenic activity and helps reduce acne, oily skin and hair. This action of drospirenone is similar to the action of natural progesterone produced by the body.Drospirenone does not have androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. All this combination with anti-mineralocorticoid and anti-androgenic effects provides Drospirenone with a biochemical and pharmacological profile similar to natural progesterone.

In combination with ethinyl estradiol, drospirenone has a favorable effect on the lipid profile, characterized by an increase in HDL.

Modelle Pro, indications for use- contraception.

Contraindications

Carefully

The ratio of the potential risk and the expected benefit of using the drug Modelle Pro in each individual case should be assessed with the following diseases / conditions and risk factors:- Risk factors for thrombosis and thromboembolism: smoking, obesity (IMT2), dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, antifastoma, and hemorrhage of the heart), hereditary predisposition to thrombosis (thrombosis, antifastoma, and hemorrhoids), hereditary predisposition to thrombosis (thrombosis, hemorrhoids, hemorrhoids - from close relatives)- other diseases in which disorders of the peripheral circulation can be noted: diabetes mellitus without diabetic angiopathy, SLE, hemolytic uremic syndrome, Crohns disease and 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.

Dosage and administration

The drug is taken orally. Tablets should be taken in the order indicated on the packaging, every day at about the same time, with a small amount of water. Should take 1 tab. continuously for 21 days. Taking the pills from the next package begins after a 7-day break, during which menstrual-like bleeding is usually observed (withdrawal bleeding). As a rule, it starts 2-3 days after taking the last pill and may not end before taking the pills from a new pack.

Start taking the drug Modelle Pro

In the absence of taking any hormonal contraceptives in the previous month, use of the drug Modelle Pro should be started 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 tablets 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 Modelle Pro the next day after taking the last pill from the previous package, but in no case no later than the next day after the usual 7-day break. Acceptance of the drug Modelle Pro 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 “mini-drank” to taking the drug Modelle Pro on any day (without a break), from the implant or IUD - on the day of their removal, from the injection contraceptive - on the day when the next injection should be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.After an 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 21-28 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. If sexual intercourse has occurred, then before taking the drug Modelle Pro, pregnancy should be excluded or it is necessary to wait for the first menstruation.

Acceptance of missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. You should take a pill as soon as possible, the next pill is taken at the usual time. If the delay in taking the drug was more than 12 hours, contraceptive protection may be reduced. The more pills missed and the closer the pass to the 7-day break in taking 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 the pills was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours), the woman should follow the recommendations given below.

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, you should use a barrier method of contraception (for example, a condom) for the next 7 days. If sexual intercourse took place during the week 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 upcoming break in taking pills. 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.1. 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 following tablets are taken at the usual time until the tablets in the current packaging run out. The next package should start immediately without a break. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking the pills.2. You can also stop taking the pills from the current package, thus starting the 7-day break (including the day you miss the pills), and then start taking the pills from the new package.If a woman misses taking pills, and then during a break in reception she has no withdrawal bleeding, 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 pill, you should follow the recommendations when skipping pills.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, it is necessary to continue the further intake of tablets from the new package Modelle Pro without a 7-day break. Tablets from the new packaging can be taken as long as necessary, including until the packaging is over. While taking the drug from the second package, spotting blood from the vagina or breakthrough uterine bleeding is possible. Regular intake of Modelle Pro from regular packaging should be resumed after the usual 7-day break. In order to postpone the onset of menstruation to another day of the week, a woman should reduce the closest interruption in taking the pills for the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and later there will be spotting and breakthrough bleeding while taking the second package (just like when she would like to delay the onset of menstruation).

Additional information for specific patient categories

The efficacy and safety of the drug as a contraceptive studied in women of reproductive age. It is assumed that the efficacy and safety of the drug in post-pubertal age up to 18 years of age are similar to those in women over 18 years of age. The use of the drug before the onset of menarche is shown.After menopause, the drug Modelle Pro is not shown.The use of the drug is contraindicated in the presence or present of a history of severe liver disease (before normalization of liver function tests), the presence or history of benign or malignant liver tumors.The drug is contraindicated in case of acute renal failure and severe severe renal insufficiency.

Use during pregnancy and lactation

Pregnancy

If pregnancy is detected while taking Modelle Pro, 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 by negligence 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 identified, 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 women taking 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, it is impossible to exclude the possibility of the development of undesirable effects caused by the hormonal activity of active substances in humans. 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 Modelle Pro 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 newborn. There are currently no significant epidemiological data available.

Lactation period

The drug is contraindicated during breastfeeding. It can reduce the amount of breast milk and change its composition, therefore, the use of the drug is not recommended until the cessation of breastfeeding. A small amount of sex hormones and / or their metabolites can be excreted in breast milk, but there is no evidence of their negative impact on the health of the child.

Side effects

The frequency of adverse reactions that were identified during the use of the drug is determined as follows: often (≥1 / 100-On the part of the immune system: rarely - bronchial asthma, hypersensitivity reactions.On the part of the nervous system: often - a headache.Mental disorders: often - depressive state Infrequently - a change in libido.On the part of the organ of hearing: rarely - hearing loss.Since the cardiovascular system: often - migraine infrequently - increase in blood pressure, decrease in blood pressure rarely - thromboembolism.On the part of the digestive system: often - nausea infrequently - vomiting, diarrhea.From the skin and subcutaneous tissues: infrequently - acne, eczema, itching rarely, erythema nodosum, erythema multiforme.On the part of the reproductive system and the mammary gland: often - menstrual disorders, acyclic hemorrhages, breast tenderness, increased sensitivity of the mammary gland, leucorrhea, vulvovaginal candidiasis infrequently - an increase in the mammary gland, vaginitis rarely - discharge from the mammary glands.Other: infrequently - fluid retention, change in body weight.The following serious adverse events have been reported in women taking CPC: venous thromboembolism arterial thromboembolism increased blood pressure liver tumors the emergence or worsening of conditions whose connection with the admission of CPC is not definitively established (Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine fibroids, porphyria, SLE, herpes during a previous pregnancy, Sydenhem’s chorea, hemolytic uremic syndrome, cholestatic jaundice) chloasmaIn women with hereditary angioedema, the use of estrogen may cause or aggravate its symptoms.

special instructions

Before starting or resuming use of the drug, Modelle Pro, it is necessary to familiarize with the history of life, family history of a woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, BMI) and gynecological examination, including the examination of the mammary glands and cytological examination of scraping from the cervix (test on ), 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 Modelle Pro 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

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 the result of careful observation and earlier diagnosis of breast cancer in women using CPC. Women who have ever used CCP, are detected earlier stages of breast cancer than women who have never used them.In rare cases, against the background of the use of PDA, the development of benign, and in extremely rare cases, malignant tumors of the liver, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In the event of severe pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis.

Other states

Clinical studies have shown no effect of drospirenone on serum potassium concentration in patients with mild to moderate renal insufficiency. Theoretically, there is a risk of hyperkalemia in patients with impaired renal function and the initial potassium content at the level of VGN or against the background of medication, leading to a delay of potassium in the body.Women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking PDA. Despite the fact that a slight increase in blood pressure has been described in many women taking CPC, clinically significant hypertension was rarely observed. However, if a persistent, clinically significant increase in blood pressure develops during CPA use, these drugs should be canceled and treatment of hypertension should begin. Reception of PDA can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.The following conditions have been reported to develop or worsen both during pregnancy and when taking PDA, but their relationship with taking PDA has not been proven: jaundice and / or itching associated with cholestasis the formation of gallstones porphyria SLE hemolytic uremic syndrome Chorea Sydenham herpes pregnant hearing loss associated with otosclerosis. Also described are cases of Crohn's disease or ulcerative colitis with PDA use.In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.In acute or chronic liver dysfunction, it may be necessary to discontinue the drug until liver function indicators return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or a previous intake of sex hormones, requires the discontinuation of PDA.Although KPC may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose KPC (containing less than 50 μg of ethinyl estradiol a). However, women with diabetes mellitus need careful control of the concentration of glucose in the blood during the use of the drug.With the use of the drug may develop chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking a PDA should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.The effectiveness of PDA can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions.

Effect on the menstrual cycle

Irregular (acyclic) bleeding (spotting or breakthrough bleeding) may occur on the background of PDA use, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant neoplasms or pregnancy.Some women may not develop withdrawal bleeding during a break in the pill. If taking the PDA was carried out in accordance with the instructions, then pregnancy is unlikely. However, if before taking CPC was performed irregularly or if there are no two withdrawal bleedings in a row, then pregnancy should be excluded before continuing to take the drug.

Impact on laboratory test scores

Acceptance of PDA may affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, the content of transport proteins in the blood plasma, carbohydrate metabolism, coagulation parameters and fibrinolysis. Changes usually do not go beyond the normal range. Drospirenone increases plasma renin and aldosterone activity, which is associated with its antimineralocorticoid effect.

Influence on ability to drive motor transport and control mechanisms

Studies on the effect of the drug on the ability to drive vehicles and mechanisms have not been conducted. The influence of the CCP on the ability to drive vehicles and mechanisms was not observed.

Interaction

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive reliability. Women taking such drugs should temporarily use barrier methods of contraception in addition to Modelle Pro, or choose another method of contraception.The interaction leading to a decrease in the effectiveness of the drug Modelle ProThe use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones, which, in turn, can lead to breakthrough bleeding or a decrease in contraceptive reliability. Such drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John's wort.During the taking of drugs that affect the microsomal liver enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be additionally used.HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), and combinations thereof, also have the potential to affect hepatic metabolism.Some antibiotics (for example, penicillins and tetracycline) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol. During the use of antibiotics (such as penicillins and tetracyclines) and within 7 days after their cancellation, an additional method of contraception should be used. If the period of use of the barrier method of protection ends later than the tablets in the package, you need to proceed to the next package of the drug Modelle Pro without the usual interruption in taking the tablets.

Other interaction

The major metabolites of drospirenone are formed in plasma without the participation of the cytochrome P450 system. Therefore, the effect of cytochrome P450 inhibitors on the metabolism of drospirenone is unlikely.PDA may affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in plasma and tissue concentrations.Based on in vitro interaction studies, as well as studies in female volunteers taking omeprazole, simvastatin and midazolam, it was found that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely.There is a theoretical possibility of increasing the serum potassium concentration in women receiving Modelle Pro along with other drugs that can increase the serum potassium concentration. These drugs include ACE inhibitors, angiotensin II receptor antagonists, some anti-inflammatory drugs, potassium-saving diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, there was no significant difference between the serum potassium concentration compared to placebo.

Overdose

No serious violations in overdose were reported.Symptoms: Based on the experience of using PDA in overdose, nausea, vomiting, spotting from the vagina or metrorrhagia may occur.Treatment: symptomatic therapy there is no specific antidote.Shelf life - 3 years.

Storage conditions

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.

Terms of sell

You can buy Modelle Pro without a prescription.

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Additional Information

SKU fh2662
The purpose of the medication Contraception
Weight kg. 0.05

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