Active substanceDesogestrelDesogestrel
Similar drugsTo uncover
  • Diamill®
    pills inwards 
  • Lactinet®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • MODELL MAM
    pills inwards 
  • Charozette®
    pills inwards 
    Organon, N.V.     Netherlands
  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains: active substance: desogestrel (in terms of 100% substance) 0.075 mg;

    auxiliary matter: lactose monohydrate 54,345* mg, starch corn 6,500 mg, povidone TO-30 2,400 mg, stearic acid acid 0,800 mg, alpha- tocopherol 0,080 mg, silicon dioxide colloidal 0.800 mg;

    film shell: film coating "Tabcoat TS-white" (hypromellose 55.00%, macrogol 15.00%, talc 10.00%, titanium dioxide 20.00%) 2.275 mg.

    * - the amount of lactose monohydrate depends on the actual purity of desogestrel.
    Description:Round biconvex tablets covered with a film coat of white or almost white color. At the break of the tablet, the core is seen white or almost white.

    Pharmacotherapeutic group:Gestagen
    ATX: & nbsp

    G.03.A.C   Progestogens

    G.03.A.C.09   Desogestrel

    Pharmacodynamics:

    The MODEL MAM preparation is a gestagen-containing oral contraceptive whose active ingredient is desogestrel. Like other gestagen-containing oral contraceptives, the MODEL MAM preparation is indicated for use during breastfeeding and for women who are contraindicated or who do not want to take estrogens. Unlike other gestagen-containing drugs, the contraceptive effect of MODEL MAM is achieved mainly by suppressing ovulation, as well as increasing the viscosity of the secretion of the cervix.

    When MODEL MAM is used, the frequency of ovulation does not exceed 1% in the first 56 days, after stopping the 56-day course of the drug, ovulation occurs after 7-30 days (an average of 17 days).

    The PERL Index of MODEL MAM (the indicator reflecting the frequency of pregnancy in 100 women during the year of use of the contraceptive) is 0.4, which is comparable to the Perl index of combined oral contraceptives (COCs) in the general population taking oral contraceptive drugs. Receiving MODEL MAM leads to a decrease in the concentration of estradiol in the blood plasma to values ​​corresponding to the early follicular phase.At the same time, there were no clinically significant changes in the carbohydrate, lipid metabolism and hemostasis parameters.

    Pharmacokinetics:

    Suction. After oral administration desogestrel quickly absorbed and converted to an active metabolite etonogestrel. The maximum concentration of etonogestrel in plasma is reached after 1.8 hours. The absolute bioavailability of etonogestrel is approximately 70%.

    Distribution. Equilibrium concentration in blood plasma is achieved after 4-5 days of admission. The association of blood plasma proteins etonogestrel is 95.5-99%. mainly with albumin and to a lesser extent - with globulin binding sex hormones.

    Metabolism. Desogestrel is converted by hydroxylation and dehydrogenation to an active metabolite etonogestrel. Etonogestrel metabolized by the formation of sulfate and glucuronide conjugates.

    Excretion. Etonogestrel and its metabolites are excreted by the kidneys and through the intestine (in a ratio of 1.5: 1) in the form of free steroids and conjugates.

    The half-life of etonogestrel is approximately 30 hours, as with a single, repeated and repeated administration of the drug.

    Nursing mothers etonogestrel e stands breast milk in a ratio of milk / blood plasma 0.37: 0.55, so the amount exemplary mother milk consumed 150 ml / kg / day newborn can receive 0.01-0.05 .mu.g etonogestrel per kg body weight per day.

    Indications:Contraception.
    Contraindications:

    - Hypersensitivity to the active substance or any auxiliary substance of the drug.

    - An established or suspected pregnancy.

    - The presence at the time of venous thromboembolism.

    - Presence at the moment or in an anamnesis of severe liver disease (as long as the parameters of the liver function are normalized).

    - Established or suspected malignant hormone-dependent tumors.

    - Bleeding from the vagina of an unclear etiology.

    - Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Carefully:Uncontrolled hypertension, which develops in patients receiving the drug MODELL MAM or the ineffectiveness of antihypertensive therapy; porphyria; systemic lupus erythematosus (SLE); Chlamydia, especially in the presence of chloasma during pregnancy in history; diabetes mellitus (because of the possible effect of progestogens onperipheral insulin resistance and glucose tolerance); herpes during the preceding pregnancy; benign or malignant liver tumors.

    Pregnancy and lactation:

    The use of MODEL MAM during pregnancy is contraindicated.

    The MODEL MAM preparation does not affect the quantity or quality of breast milk.

    However, a small amount of etonogestrel is excreted in breast milk. As a result, the child's body can enter etonogestrel in the amount of 0.01-0.05 μg / kg / day (with the amount of breast milk consumed 150 ml / kg / day).

    There is limited data on long-term follow-up of children whose mothers started taking desogestrel during the 4-8th week after childbirth. The duration of breastfeeding was 7 months, and the children were monitored until they reached the age of 1.5 years (n= 32) or 2.5 years (n= 14). The evaluation of growth, physical and psychomotor development did not reveal any difference compared to children whose mothers used copper nonhormonal intrauterine devices (intrauterine contraceptive).

    The MODEL MAM preparation can be used during breastfeeding.Nevertheless, it is necessary to carefully monitor the development and growth of the child during breastfeeding, if a woman uses contraception for use preparation MODEL MAM.

    Dosing and Administration:The drug Modell MAM is taken orally 1 tablet daily, at the same time, for 28 days, with a small amount of liquid.

    In the absence of a previous intake of hormonal contraceptives (during the last month)

    Acceptance of MODEL MAM should be started on the 1st day of the menstrual cycle (1st day of menstrual bleeding).

    You can start taking MODEL MAM on the 2nd-5th day of the menstrual cycle, but then during the first cycle during the first 7 days of taking the drug it is recommended to use an additional (barrier) method of contraception.

    Transition from COC, vaginal ring or transdermal contraceptive patch

    Receiving MODEL MAM should be started the day after the last active KOC tablet (the last tablet containing the active substance) or on the day of removal of the vaginal ring or contraceptive patch.In these cases, there is no need for additional contraception.

    The reception of MODEL MAM can be started the day after the end of the usual interval in taking the previous oral contraceptive or the day after receiving the placebo, the use of a contraceptive patch, the vaginal ring (that is, the day when it would be necessary to start taking the tablets from the new packaging of COCs, introduce a new vaginal ring or glue a new contraceptive patch), but it is recommended to use an additional barrier method of contraception during the first 7 days of taking MODEL MDM ii.

    Transition from contraceptives containing only gestagens ("mini-pili", injectable forms, implant), or with the progestative-releasing progestin of the intrauterine contraceptive (IUD)

    When using a drug containing gestagen ("mini-pili"), you can go to the drug MODEL MAM any day; when using an implant or IUD - on the day of their removal; when using the injection contraceptive form - the day the next injection is to be made.

    In all these cases, an additional contraceptive method is not required.

    After the abortion, made in the I trimester, it is recommended to start taking MODEL MAM immediately; an additional contraceptive method is not required.

    After childbirth or abortion, made in the second trimester

    Acceptance of MODEL MAM is possible not earlier than 21-28 days after the abortion, made in the II trimester, and not earlier than 6 weeks after childbirth. At the beginning of taking MODEL MAM in later periods, the barrier method of contraception must be additionally applied during the first 7 days of taking the drug.

    If a woman after sex or abortion before starting the drug MODEL MAM had sex, before starting the drug should be excluded from pregnancy or wait for the first menstruation.

    Passing the next dose of MODEL MAM

    Contraceptive protection may decrease if the interval between taking two tablets of MODEL MAM is more than 36 hours. If the break in taking tablets is less than 12 hours. then the missed tablet should be taken immediately, as soon as a woman remembers it, and the next pill should be taken at the usual time. If the break in taking tablets is more than 12 hours, then the woman should follow the above recommendations, and also apply an additional contraceptive method within the next 7 days. If taking pills was missed in the first week of taking MODEL MAM and there was sexual contact during the week preceding the missed intake of tablets, pregnancy should be excluded.

    Recommendations in case of gastrointestinal disorders

    In the case of severe gastrointestinal disorders (vomiting, diarrhea), desogestrel absorption may be incomplete and additional contraceptive methods should be used in this case. If vomiting occurs within 3-4 hours after taking MODEL MAM, the absorption may be incomplete. In this case, it is necessary to be guided by the recommendations regarding the intake of missed tablets.

    Side effects:

    The most frequent undesirable effects in clinical studies were irregular spotting. They were observed in 50% of women taking desogestrel. Menstruation-like bleeding may also be longer. After 2 months of the drug, bleeding usually becomes less frequent.

    In clinical studies, the most frequent (> 2.5%) other side effects of desogestrel were: acne, mood changes, breast pain, nausea and weight gain.

    The undesirable effects presented below in the table were evaluated by the researchers as having an established, probable and possible connection with the reception preparation.

    Systems

    Frequency of adverse reactions

    Often (not less than 1/100)

    Infrequently (not less than 1/100 (1 less than 1/100)

    Rarely (less than 1/1000)

    Infections and invasions


    vaginal infection


    From the nervous system

    headache



    Mental

    violations

    mood changes, decreased libido



    From the side of the organ of vision


    intolerance to contact lenses


    From the gastrointestinal tract

    nausea

    vomiting


    From the skin and subcutaneous tissue

    acne

    alopecia

    redness of the skin, skin rash, hives, erythema nodosum

    From the reproductive system and breast

    pain in the mammary gland, violation of the menstrual cycle, amenorrhea

    dysmenorrhea, ovarian cyst

    discharge from the breast, ectopic pregnancy

    Common violations

    weight gain

    fatigue


    In women who used (combined) oral contraceptives, seldom there were various serious undesirable effects: venous and arterial thrombosis and thromboembolism, hormone-dependent tumors (eg, breast cancer) and chloasma.

    A reliable connection with receiving gestagens is not established: jaundice and / or itching of the skin associated with cholestasis; the formation of gallstones; porphyria; SLE: hemolytic-uremic syndrome; chorea; herpes during the preceding pregnancy; hearing loss associated with otosclerosis; hereditary angioedema.
    Overdose:

    Symptoms: nausea, vomiting; in young girls - a slight vaginal bleeding.

    Treatment: there is no specific antidote. Symptomatic therapy.

    Interaction:

    The interaction between oral contraceptives (mainly combined and gestagen-containing) and other drugs can lead to "breakthrough" uterine bleeding and / or a decrease in contraceptive effectiveness.

    When used simultaneously with drugs that induce microsomal liver enzymes (hydantoin derivatives, incl. phenytoin; barbiturates (for example, phenobarbital); primidon; carbamazepine; rifampicin; oxcarbazepine; rifabutin; topiramate; felbamate; ritonavir; nelfinavir; griseofulvin; preparations containing St. John's wort pitted), it is possible to increase the clearance of sex hormones. Women using any of these drugs should temporarily use the barrier method in addition to desogestrel or choose another method of contraception. The barrier method of contraception should be used during the application of these drugs and within 28 days after discontinuation of their administration. For women receiving long-term treatment with inducers of microsomal liver enzymes, the possibility of using a non-hormonal contraceptive method should be considered.

    With the use of activated charcoal, desogestrel absorption may decrease and. consequently, contraceptive effectiveness may decrease. In this case, you should follow the recommendations for missed intake of MODEL MAM tablets.

    Hormonal contraceptive drugs can affect the metabolism of other medicines.Accordingly, the concentrations of the drug in the plasma and in tissues can both increase (for example, ciclosporin), and decrease (for example, lamotrigine).

    When using other drugs at the same time to identify possible interactions, you should familiarize yourself with the instructions for the use of these medications.

    Special instructions:

    Medical examinations

    Before using MODEL MAM, you should carefully collect the anamnesis and conduct a thorough gynecological examination to exclude pregnancy. Before the appointment of the drug should establish the cause of menstrual irregularities, for example, oligomenorrhoea and amenorrhea. The interval between the control medical examinations is determined by the doctor in each individual case (the frequency of the examinations is less than 1 time in 6 months). If the prescribed drug can affect the latent or existing disease, an appropriate schedule of control medical examinations should be made.

    Despite the regular administration of MODEL MAM, occasional spotting may occur.If bleeding is very frequent and irregular, consider using another method of contraception. If the above symptoms are stable, then in this case it is necessary to exclude organic pathology. Tactics in relation to amenorrhea during the application of MODEL MAM depends on whether the drug was taken in accordance with the instructions, and may include a pregnancy test. In case of pregnancy, the drug MODEL MAM should be stopped. With a significant increase in blood pressure or ineffectiveness of antihypertensive therapy with Modell MAM should stop taking the drug.

    If a liver function disorder occurs, a woman should consult a specialist for examination and counseling.

    Women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation during the application of MODEL MAM.

    Women should be informed that MODEL MAM does not protect against HIV infection and other sexually transmitted diseases.

    Decreased efficiency

    The effectiveness of gestagen containing oral contraceptives can be reduced if the drug is not taken, gastrointestinal disorders or when taking other medications.

    Effects on the menstrual cycle

    During the use of gestagen-containing contraceptives in some women, menstrual bleeding may become more frequent or more prolonged, while in others these bleeding may become more rare or even completely stop. These changes are often the reason that a woman refuses this method of contraception or ceases to strictly follow the doctor's instructions. With detailed consultation with women who decided to start taking MODEL MAM, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. The evaluation of irregular bleeding should be based on a clinical picture and may include an examination to exclude malignant neoplasms or pregnancy.

    Development of follicles

    With the intake of all low-dose hormonal contraceptives, follicles develop, and occasionally the size of the follicle can reach sizes larger than those in the normal cycle.These enlarged follicles disappear spontaneously, which often occurs without symptoms; only in some cases there is a slight pain in the lower abdomen. Surgical intervention is rarely required.

    Lab tests

    The data obtained with regard to COCs showed that the use of hormonal contraceptive drugs may affect the results of some laboratory tests, including indicators of liver, thyroid, adrenal and kidney function; the content of transport proteins in the blood plasma, for example, corticosteroid-binding globulin; lipid / lipoprotein fractions, carbohydrate metabolism and blood coagulation and fibrinolysis. Usually these changes remain within the normal range.

    Mammary cancer

    The risk of breast cancer increases with age. During the use of COC, the risk that a woman will be diagnosed with breast cancer increases slightly and gradually disappears within 10 years after cessation use of oral contraceptives, the risk of nc related duration application, and depends on the age of the woman during the application of COCs. Expected the number of diagnosed cases of breast cancer among 10,000 women who used COCs (within 10 years after discontinuation of their use), relative to women who have never taken medicines of this group for the same period are shown in the table below.

    Age group

    Expected number of cases among women using COCs

    Expected number of cases among women who did not use COCs

    16-19 years old

    4,5

    4

    20-24 years old

    17,5

    16

    25-29 years old

    48,7

    44

    30-34 years old

    110

    100

    35-39 years

    180

    160

    40-44 years

    260

    230

    The risk for women using oral contraceptive preparations containing only progestogen, for example, the MODEL MAM preparation, is similar to that of COCs.

    The risk of breast cancer associated with taking COC is insignificant.

    The increased risk of breast cancer in women using COCs may be due to earlier diagnosis, the biological effects of the drug, or a combination of these two factors.

    Venous thromboembolism

    In epidemiological studies, a link was established between the use of COCs and the increased incidence of venous thromboembolism (deep vein thrombosis and pulmonary embolism).Despite the fact that the clinical significance of these data for desogestrel as a contraceptive drug that does not contain estrogen is unknown, therapy with MODEL MDM should be discontinued in the case of thrombosis. Termination of MODEL MAM therapy should also be considered in the case of prolonged immobilization associated with an operation or disease.

    Diabetes

    The gestagens can affect peripheral insulin resistance and glucose tolerance, but there is no evidence that there is a need to change the therapeutic regimen in diabetics using gestagen containing oral contraceptives. Nevertheless, patients with diabetes should be carefully monitored during the first months of use of MODEL MAM.

    Mineral density of bone tissue

    When using the MODEL MAM preparation, the concentration of estradiol in the blood plasma can be reduced to the level corresponding to the early follicular phase.

    It is not known whether this reduction has any clinically significant effect on bone mineral density.

    Prevention of ectopic pregnancy

    Prevention of ectopic pregnancy with gestagen-containing oral contraceptives is not as effective as in the use of COCs, as ovulation often occurs during their use. Despite the fact that the MODEL MAM product effectively inhibits ovulation, in the case of amenorrhea or abdominal pain, differential diagnosis should exclude an ectopic pregnancy.

    Effect on the ability to drive transp. cf. and fur:The use of MODEL MAM does not affect the ability to perform actions that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets coated with a film coat, 0.075 mg.

    Packaging:For 28 tablets in a blister of PVC / Aluminum foil. 1, 3 or 6 blisters together with instructions for use in a cardboard box.
    Storage conditions:Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002412
    Date of registration:31.03.2014 / 16.11.2016
    Expiration Date:31.03.2019
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp16.11.2017
    Illustrated instructions
      Instructions
      Up