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Modelle Pure is a modern contraceptive that eliminates the effects of hormonal imbalance caused by hyperandrogenism: hirsutism, acne, and seborrhea, thereby restoring natural beauty and health to the skin and hair.Modelle Pure improves the condition of the skin with acne, can significantly reduce excessive growth of hair on the face and body in 95% of cases, reduces greasiness of the scalp and hair, reduces greasiness of the scalp and hair, protects against unwanted pregnancy in more.Monophasic combined contraceptive drug with antiandrogenna activity.It blocks the androgen receptors, inhibits the pituitary secretion of gonadotropic hormones.The mechanism of action is due to its constituent antiandrogen steroid cyproterone acetate and oral estrogen - ethinyl estradiol. Tsiproteron has the ability to competitively bind to the receptors of natural male sex hormones - androgens (testosterone, dihydroepiandrosterone, androstenedione, etc.), which are formed in small amounts in the body of women, mainly in the adrenal glands, ovaries and skin. By blocking androgen receptors in target organs, it reduces the effects of androgenization in women (due to the disruption of processes mediated by hormone-receptor complexes at the level of the main intracellular mechanisms). Along with antiandrogenic properties, it has a gestagen activity, imitating the properties of the hormone of the corpus luteum. Tsiproteron, possessing gestagennoe activity, inhibits the secretion of pituitary gonadotropic hormones and inhibits ovulation, which causes its contraceptive effect. Ethinyl estradiol enhances the central and peripheral effects of cyproterone on ovulation, retains a high viscositycervical mucus, which complicates the penetration of spermatozoa into the uterine cavity and contributes to ensuring a reliable contraceptive effect.
Tsiproterona acetate: completely absorbed after ingestion. After taking 1 tablet of the drug Modelle Pure, the maximum serum concentration is 15 ng / ml and is created after 1.6 hours. Almost completely bound to plasma albumin.During the course of treatment, the drug is cumulated: its serum concentration increases from 15 ng / ml on the first day of treatment to 21 ng / ml at the end of the 1st cycle and to 24 ng / ml at the end of the 3rd cycle of treatment.The area under the curve of concentration versus time increases by 2.2 times (the end of the 1st cycle) and 2.4 times (the end of the 3rd cycle).Equilibrium concentration is created about 16 days after the start of treatment.Bioavailability is 88% of the injected dose.The half-life of plasma is two-phase: the first phase is 0.8 hours, the second phase is 2.3 days.Total clearance is 3.6 ml / min / kg. It is metabolized in the liver through various reactions, including hydroxylation and conjugation. The main metabolite is 15-hydroxy-cyproterone.Part of the dose administered is excreted by the bile unchanged the main method of excretion is by the kidneys, in the form of metabolites. The half-life of the kidneys and bile is 1.9 days.Ethinyl estradiol: after oral administration, it is quickly and completely absorbed.After taking 1 tablet of the drug Modelle Pure, the maximum serum concentration is 80 pg / ml and is created after 1.7 hours. The half-life of plasma is two-phase: the first phase is 1-2 hours, the second phase is 20 hours.The apparent volume of distribution is 5 l / kg, plasma clearance - 5 ml / min / kg.Almost completely binds to plasma proteins. During absorption and first passage through the liver it is metabolized, which leads to a decrease in bioavailability.Equilibrium concentration is created 3-4 days after the start of treatment.Excreted in the form of metabolites through the intestines and kidneys (4: 6 ratio), the half-life is about 1 day.
Indications for use of the drug Modelle Pure are:- Contraception in women with androgenization phenomena.- Treatment of androgen-dependent diseases / conditions in women ("vulgar" acne (acne papulopustulosa, acne nodulocystica) seborrhea androgenetic alopecia hirsutism).
Inside, on 1 tablet of Modelle Pure per day, without chewing and washing down with a small amount of liquid. Reception should be made daily at the same selected hour, preferably after breakfast or dinner.Acceptance of the drug Modelle Pure begin on the 1st day of the menstrual cycle (ie, on the first day of menstrual bleeding), using a pill of the corresponding day of the week from the calendar package.A daily intake of the drug is carried out using a tablet from a calendar package sequentially in the direction of the arrow printed on the foil, until all the tablets are taken.After all 21 tablets are taken from the calendar package, a break in the intake of the drug for 7 days is made, during which menstrual-like bleeding occurs.After 28 days from the start of taking the drug (21 days of intake and 7 days off), i.e. on the same day of the week as at the beginning of the course, continue taking the drug from the next package.When switching from 21-day combined oral contraceptives (CCP), taking Modelle Pure should be started the next day after taking the last tablet of the previous drug, but in no case later than the next day after the usual 7-day break in reception. Further, as described above. The use of additional contraception is not required.When switching from the 28-day PDA, taking the drug Modelle Pure should be started the next day after taking the last active pill. Further, as described above.The use of additional contraception is not required.When switching from contraceptives containing only gestagens ("mini-pili"), the drug Modelle Pure should be used without interruption. Further, as described above.The use of additional contraception is not required.When using injectable forms of contraceptives, the Modelle Pure drug is started to be taken from the day when the next injection should be given. When moving from the implant - on the day of its removal. In all cases, you must use an additional barrier method of contraception (condom) during the first 7 days of taking pills.After an abortion in the first trimester of pregnancy, a woman can start taking the drug immediately.In this case, the woman does not need additional methods of contraception.After childbirth or abortion in the second trimester of pregnancy, the drug should be started on the 21-28th day. If reception is started later, it is necessary to use an additional barrier method of contraception (condom) during the first 7 days of taking the pills.If a woman lived sexually between the birth or abortion and the start of the drug Modelle Pure, then pregnancy should be excluded first or you should wait for the first menstruation.A woman should take the missed pill as soon as possible, the next pill is taken at the usual time. With a delay of less than 12 hours, the reliability of contraception is not reduced.If the delay in taking the pill is more than 12 hours, the reliability of contraception can be reduced.It should be borne in mind that taking the pill should never be interrupted for more than 7 days, and that 7 days of continuous taking the pill is required to achieve adequate suppression of the function of the hypothalamic-pituitary-ovarian system.Therefore, if the delay in taking the pill was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours) during the first and second week of taking the drug, the woman should take the last missed pill as soon as she can (even if it means taking two tablets at the same time).The next pill is taken at the usual time. Additionally, you should use a barrier method of contraception (condom) for the next 7 days.If the delay in taking the pill was more than 12 hours (the interval since taking the last pill is more than 36 hours) during the third week of taking the drug, the woman should take the missed pill as soon as she remembers (even if it means taking two tablets at the same time) . The next pill is taken at the usual time. In addition, taking the pill from a new pack should be started as soon as the current pack is finished, i.e. without a 7 day break. Additionally, you should use a barrier method of contraception (condom) for the next 7 days. Most likely, the woman will not have withdrawal bleeding until the end of the second package, but she may have spotting or breakthrough uterine bleeding on the days of taking the pills.If you skip taking 3 or more tablets, you should contact your doctor.If a woman had vomiting or diarrhea within 3 to 4 hours after taking Modelle Pure, the absorption of the active substances may be incomplete. In this case, you need to focus on the recommendations when skipping the pill. If a woman does not want to change the normal mode of taking the drug, she should take an additional pill (or several pills) from another package if necessary.In order to delay the onset of menstruation, a woman should continue taking the pills from the new package of the drug Modelle Pure immediately after all the pills from the previous one are taken, without interruption in the intake. Tablets from this new package can be taken as long as the woman wants (until the package is finished). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking the drug Modelle Pure from the new package should be after the usual 7-day break.In order to postpone the start of menstruation to another day of the week, a woman should shorten the next break in the pill for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and in the future there will be spotting and breakthrough bleeding while taking the second package (just as if she would like to delay the onset of menstruation).In the treatment of hyperandrogenic conditions, the duration of treatment is determined by the severity of the disease.After the disappearance of symptoms, it is recommended to take the drug Modelle Pure for at least another 3-4 months. In the event of a relapse within a few weeks or months after completion of the course, it is possible to carry out repeated therapy with Modelle Pure.
All women taking combined oral contraceptives are at increased risk of thrombosis and thromboembolism, a slight increase in the risk of the occurrence and worsening of other diseases (see the “Precautions” section). When combined oral contraceptives are taken, irregular (acyclic) vaginal bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.Often - more than 1/100 and less than 1/10 infrequently - more than 1/1000 and less than 1/100 rarely more than 1/10000 and less than 1/1000.Often: nausea, abdominal pain, weight gain, headache, depression, mood changes, pain in the mammary glands, engorgement of the mammary glands.Infrequently: vomiting, diarrhea, fluid retention, migraine, decreased libido, skin rash, urticaria, breast hypertrophy.Rarely: intermenstrual bleeding, oligomenorrhea, increased libido, weight loss, deterioration of the tolerance of contact lenses, allergic reactions, erythema nodosum, erythema multiforme with prolonged use - chloasma.
Contraindications to the use of the drug Modelle Pure are: pregnancy and lactation thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, thromboembolism of the pulmonary artery), coronary heart disease, stroke.- The states preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history.- Complicated lesions of the valvular apparatus of the heart (pulmonary hypertension, atrial fibrillation, subacute bacterial endocarditis in history).- Uncontrolled arterial hypertension (systolic blood pressure above 160 mm Hg or diastolic blood pressure above 100 mm Hg).- Serious surgical intervention with prolonged immobilization.- Diabetes with vascular complications.- Multiple or expressed risk factors for venous or arterial thrombosis, including vascular diseases of the brain or coronary arteries, arterial hypertension, middle-aged.- Liver failure and severe liver disease (until normalization of liver tests) active viral hepatitis, cirrhosis of the liver in art.decompensation idiopathic jaundice or itching during a former pregnancy congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes) liver tumors (benign or malignant) now or in history.- Migraine with focal neurological symptoms now or in history.- Smoking over the age of 35 years.- Pancreatitis with severe hypertriglyceridemia now or in history.- Identified hormone-dependent malignant diseases (including breast cancer and endometrium) or suspicion of them.- Bleeding from the vagina of unknown origin.- Sickle cell anemia, otosclerosis with deterioration during pregnancy, herpes during pregnancy in history.- Hypersensitivity to any of the components of the drug.Carefully
The potential risk and the expected benefit of using combined oral contraceptives in each individual case should be carefully weighed in the presence of the following diseases / conditions and risk factors:Risk factors for thrombosis and thromboembolism: smoking obesity dyslipoproteinemia, arterial hypertension migraine valvular heart disease prolonged immobilization, serious surgery, extensive trauma hereditary predisposition to thrombosis (thrombosis, blood clotting disorders, myocardial infarction or cerebral circulation at a young age in one of the closest relatives).Diseases in which there may be violations of the peripheral circulation: diabetes mellitus (or predisposition, for example, unexplained glucosuria) systemic lupus erythematosus tetany, renal failure, hemolytic uremic syndrome Crohns disease and ulcerative colitis varicose veins, phlebitis of superficial veins.Hypertriglyceridemia, liver disease, breast cancer in the family history or a benign breast tumor in the personal history, diagnosed depression in the personal history, uterine fibroids, gallstone disease, intolerance to contact lenses.Diseases that first appeared or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cholelithiasis, porphyria, Sydenhamma chorea, chloasma)Pregnancy
The drug Modelle Pure is contraindicated during pregnancy and lactation.
Impact on hepatic metabolism: the use of drugs that induce microsomal liver 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, and possibly oxcarbazepine, topiramate, felbamate, griseofulvin, andpreparations containing St. John's wort.HIV proteases (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), and combinations thereof, also have the potential to affect hepatic metabolism.During the taking of drugs that affect microsomal enzymes, and within 28 days after they are canceled, you should additionally use a barrier method of contraception.Effects on the intestinal-hepatic circulation: Some antibiotics (for example, penicillins and tetracyclines) can decrease the hepatic-hepatic circulation of estrogens, thereby lowering the concentration of ethinyl estradiol.When taking antibiotics (such as penicillins and tetracyclines) and for 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of use of the barrier method of protection ends later than the pills in the package, you need to proceed to the next package of the drug Modelle Pure without the usual interruption in taking the pills.Oral combined contraceptives can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine), their concentration in plasma and tissues.May require correction dosage regimen hypoglycemic drugs.
Symptoms of an overdose of the drug Modelle Pure: nausea, vomiting, bleeding when discontinuing the drug.Treatment is symptomatic. There is no specific antidote.Storage conditions
Store at a temperature not higher than 30 ° C. Keep out of the reach of children.
Modelle Pure - coated tablets.On 21 tablets in the blister from PVC / aluminum or PVC / PVDH / aluminum foil.1 or 3 blisters along with instructions for use in a carton box.
1 tablet Modelle Pure contains: active substances: cyproterone acetate micronized 2,000 mg, ethinyl estradiol micronized 0,035 mg.Excipients: lactose monohydrate 29.115 mg, corn starch 20,000 mg, povidone K25 2.100 mg, talc 1.650 mg, magnesium stearate 0.100 mg.Shell: sucrose 19.637 mg, calcium carbonate 8.402 mg, talc 4.095 mg, titanium dioxide 0.278 mg, povidone K90 0.200 mg, macrogol 6000 2.178 mg, glycerol 85% 0.139 mg, iron dye oxide 0.027 mg, mountain glycolic wax 0.044 mg.
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.In the event of a worsening, intensifying, or first manifestation of any of these conditions, diseases, or risk factors, the woman should consult withby your doctor, who may decide to discontinue the drug.Diseases of the cardiovascular system
There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary thromboembolism, myocardial infarction, stroke) when taking CPC. These diseases are rare.The risk of venous thromboembolism is maximum in the first year of taking such drugs. 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 further increases, especially in women over 35)in the presence of: an aggravated family history (for example, venous or arterial thromboembolism ever with close relatives or parents at a relatively young age). In case of hereditary predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking a PDA obesity (body mass index more than 30 kg / m2) dyslipoproteinemia hypertension migraine valvular heart disease atrial fibrillation prolonged immobilization, serious surgery, any surgery on the legs or extensive trauma. In these situations, it is advisable to stop using the PDA (in the case of the planned operation, at least four weeks before it) and not to resume reception within two weeks after the end of immobilization.The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.The increased risk of developing thromboembolism in the postpartum period should be considered.Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, tetany, 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 during the use of PDA (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.Tumors
An important risk factor for cervical cancer is the persistence of papillomavirus.The results of some epidemiological studies indicate an additional increase in this risk with long-term use of PDA, however, this statement remains controversial, because it is not fully established how the results of studies take into account associated risk factors, such as screening for cervical conditions and sexual behavior, including rarer use barrier contraceptive methods.The relationship between taking CPC and breast cancer has not been proven. There is a slightly increased relative risk of developing breast cancer diagnosed in women who are currently taking CCP. The increased risk gradually disappears within 10 years after discontinuation of these drugs. The observed increase in risk may be the result of careful observation and earlier diagnosis of breast cancer in women using PDA. In women who have ever used CCP, earlier stages of breast cancer are detected and clinically it is less pronounced than in women who have never used them.In isolated 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 abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding during differential diagnosis, the possibility of a liver tumor in patients taking PDA should be considered.Other states
Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of developing pancreatitis while receiving PDA.Although a slight increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking CPC, these drugs should be canceled and treatment of hypertension should begin. Acceptance of the PDA can be continued ifantihypertensive therapy achieved normal blood pressure values.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 systemic lupus erythematosus hemolytic uremic syndrome chorea herpes pregnant hearing loss associated with otosclerosis. Also described are cases of Crohn's disease and ulcerativecolitis on the background of the use of PDAs.In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.Acute or chronic abnormal liver function may require the abolition of the PDA until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or the previous administration 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 (<0.05 mg ethinyl estradiol). However, women with diabetes should be carefully monitored while taking CPC.Chloasma can sometimes develop, 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.Treatment (contraception) should be immediately stopped when pregnancy occurs, the development of migraine-like headaches (if they were not there before), the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or bloating of the veins in the legs), with the appearance of jaundice, visual disturbances, cerebrovascular disorders stabbing pains of unknown etiology when breathing or coughing, pain and chest tightness, with increasing blood pressure.Admission is also stopped 3 months before the planned pregnancy, 6 weeks before the planned surgical intervention and with prolonged immobilization. In case of diarrhea and vomiting, the contraceptive effect is reduced, therefore, without stopping taking the drug Modelle Pure, it is necessary to use additional non-hormonal methods of contraception.Terms of sell
The prescription is not required to buy Modelle Pure.'
|The purpose of the medication||Contraception|