Instruction for use: MODELL MAM

Active substance Desogestrel

ATX code G03AC09 Desogestrel

Pharmacological group

Estrogens, gestagens; Their homologues and antagonists

Nosological classification (ICD-10)

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition

Tablets, coated with a film membrane 1 tab.

active substance:

Desogestrel 75 μg

Auxiliary substances: lactose monohydrate - 54.345 mg (the amount of lactose monohydrate depends on the actual purity of desogestrel); Corn starch - 6.5 mg; Povidone K30 - 2.4 mg; Stearic acid - 800 mcg; Α-tocopherol - 80 μg; Silicon dioxide colloidal - 800 mcg

Film coating: film coating "Tabcoat TC-white" (hypromellose - 55%, macrogol - 15%, talc - 10%, titanium dioxide - 20%) - 2,275 mg

Description of dosage form

The tablets covered with a film cover: white or almost white color, round, biconcave.

On the kink, the core is white or almost white.

pharmachologic effect

The pharmacological action is contraceptive, gestagenic.

Pharmacodynamics

Gestagen-containing oral contraceptive. Like other gestagen-containing oral contraceptives, Modell Mam 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 Modell Mam is achieved mainly by suppressing ovulation, as well as increasing the viscosity of the secretion of cervical mucus. When using Modell Mam in the first 56 days, the frequency of ovulation does not exceed 1%, after stopping the 56-day drug, ovulation occurs after 7-30 days (an average of 17 days).

The index of Pearl of the drug Modell 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 COC index in the general population of those taking the drugs.

Reception of the drug Modell 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, clinically significant changes from carbohydrate, lipid metabolism and hemostasis were not detected.

Pharmacokinetics

Suction. After taking the drug inwards, desogestrel is rapidly absorbed and converted into an active metabolite, ethonogestrel. Cmax in the blood serum is achieved after 1.8 hours. The absolute bioavailability of etonogestrel is approximately 70%.

Distribution. Css (equilibrium concentration) in the blood serum is achieved after 4-5 days of the drug. Binding to blood plasma proteins etonogestrel is 95,5-99%, mainly with albumin and to a lesser extent with SHBG (globulin, binding sex hormones).

In lactating mothers, etonogestrel is excreted in breast milk in the ratio of milk / blood serum 0.37: 0.55, therefore, with an approximate volume of milk consumed by the mother, 150 ml / kg / day, the newborn can receive 0.01-0.05 μg / kg / day Etonogestrel.

Metabolism. Desogestrel is converted by hydroxylation and dehydrogenation into the active metabolite ethonogestrel. Ethonogestrel is 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. T1 / 2 etonogestrel is approximately 30 hours as a single or repeated intake of the drug.

Indications

Contraception.

Contraindications

Hypersensitivity to desogestrel or any of the components of the drug;

Established or suspected pregnancy;

Presence at the moment or in an anamnesis of venous thromboembolism (including deep vein thrombosis of the lower extremities, thromboembolism of the pulmonary artery);

Prolonged immobilization associated with surgical intervention, disease or trauma;

Presence at the moment or in an anamnesis of severe liver disease (before the normalization of indicators of functional liver samples);

Hepatic insufficiency, incl. In the anamnesis;

Established or suspected malignant hormone-dependent tumors (including breast cancer);

Bleeding from the vagina of an unclear etiology;

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

With caution: uncontrolled arterial hypertension, developing against the background of taking the drug Modell Mam, or in the ineffectiveness of antihypertensive therapy; Porphyria SLE; Chloasma (especially in the presence of chloasma in pregnancy in the anamnesis); Diabetes mellitus (due to the possible effect of progestogens on peripheral insulin resistance and glucose tolerance); Herpes of pregnant women in the anamnesis; Benign or malignant liver tumors.

pregnancy and lactation

The use of the drug Modell Mam during pregnancy is contraindicated.

The drug Modell Mam does not affect the quantity or quality of breast milk. However, a small amount of etonogestrel is excreted in breast milk. As a result, etonogestrel may be administered into the body of the baby in the amount of 0,01-0,05 mkg / kg / day (with the amount of breast milk consumed 150 ml / kg / day).

The drug Modell Mam can be used during breastfeeding. Nevertheless, it is necessary to carefully monitor the development and growth of the child during breastfeeding, if the woman uses the drug Modell Mam for the purpose of contraception.

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 can also be longer. After 2 months of using the drug, bleeding, as a rule, becomes less frequent. In clinical studies, the most frequent (> 2.5%) other side effects of desogestrel were: acne, mood changes, breast tenderness, nausea and weight gain.

Undesirable reactions are classified according to frequency as follows: often (≥1 / 100); Infrequently (≥1 / 1000, <1/100); Rarely (<1/1000). The undesirable effects presented below were evaluated by the investigators as having an established, probable and possible association with the administration of the drug.

Infections and invasions: infrequently - a vaginal infection.

From the nervous system: often - a headache.

Mental disorders: often - a change in mood, a decrease in libido.

From the side of the organ of vision: infrequently - intolerance of contact lenses.

From the digestive tract (gastrointestinal tract): often - nausea; Infrequently - vomiting.

From the skin and subcutaneous tissue: often - acne; Infrequently - alopecia; Rarely - redness of the skin, skin rash, hives, erythema nodosum.

From the reproductive system and the breast: often - breast tenderness, menstrual irregularity, amenorrhea; Infrequently - dysmenorrhea, ovarian cyst; Rarely - discharge from the breast, ectopic pregnancy.

Common disorders: often - weight gain; Infrequently fatigue.

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

Reliable connection with reception of gestagens is not established: jaundice and / or skin itching associated with cholestasis; The formation of gallstones; Porphyria; Systemic lupus erythematosus; Hemolytic-uremic syndrome; chorea; Herpes during anterior pregnancy; Hearing loss associated with otosclerosis; Hereditary angioedema.

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, including phenytoin, barbiturates (eg phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin, drugs, 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 efficacy may decrease. In this case, you should follow the recommendations for missed tablets taken with Modell Mam.

Hormonal contraceptive drugs can affect the metabolism of other drugs. Accordingly, concentrations of drugs (drug) in plasma and tissues can both increase (eg, cyclosporine) and decrease (eg lamotrigine). When used simultaneously with other drugs to identify possible interactions, you should read the instructions for the use of appropriate medications.

Dosing and Administration

Inside for 1 table / day, daily, at the same time, for 28 days. Tablets should be washed down with a small amount of liquid.

In the absence of a previous intake of hormonal contraceptives (during the last month). Reception of the drug Modell Mam should be started on the 1st day of the menstrual cycle (1st day of menstrual bleeding). You can start taking Modell Mam on the 2nd-5th days of the menstrual cycle, but then during the first cycle for the first 7 days of using the drug it is recommended to use an additional (barrier) method of contraception.

Transition from COC (combined oral contraceptives), vaginal ring or transdermal contraceptive patch. The administration of Modell 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. Reception of the drug Modell Mam can begin the day after the end of the usual interval in the intake of the previous oral contraceptive or the day after taking the placebo, the use of a contraceptive patch, the vaginal ring (ie 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 Modad Mam ii.

Transition from contraceptives containing only gestagens (mini-pili, injection, implant), or with the progestogen-releasing progestogen (IUD). When using a drug containing gestagen (mini-pili), you can go to the drug Modell Mam any day; When using an implant or IUD - on the day they are removed; 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 abortion, made in the first trimester, it is recommended to start using the drug Modell Mam immediately; An additional method of contraception is not required.

After childbirth or abortion, made in the II trimester. Reception of the drug Modell Mam is possible no earlier than 21-28 days after the abortion, made in the second trimester, and not earlier than the 6th week after childbirth. At the beginning of taking Modell Mam drug in later terms, it is necessary to additionally apply the barrier method of contraception during the first 7 days of taking the drug. In the case of a woman who has had sexual intercourse after giving birth or having an abortion before starting the drug, you should exclude pregnancy or wait for the first menstruation before starting the drug.

Skipping the next dose of the drug. Contraceptive protection may decrease if the interval between taking two tablets of Modell Mam is more than 36 hours. If the break in taking the tablets is less than 12 hours, then the missed tablet should be taken as soon as the woman remembers it, and the next pill should be taken into the usual time. If the break in taking the tablets is more than 12 hours, it is necessary to follow the above recommendations, as well as to apply an additional contraceptive method within the next 7 days. If taking pills was missed in the first week of using Modell 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 Modemell Mam, the absorption may be incomplete. In this case it is necessary to be guided by the recommendations concerning the intake of missed tablets.

Overdose

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

Treatment: symptomatic therapy; There is no specific antidote.

special instructions

Medical examinations. Before prescribing the drug Modell Mam should carefully collect anamnesis and conduct a thorough gynecological examination to exclude pregnancy. Before the appointment of the drug should determine the cause of menstrual irregularities, such as oligomenorrhoea or amenorrhea. The interval between the control medical examinations is determined by the doctor in each individual case (the frequency of the examinations is at least 1 time in 6 months). If the prescribing drug can affect the latent or existing disease, an appropriate schedule of follow-up medical examinations should be drawn up.

Despite the regular administration of Modell 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. The tactic for amenorrhoea during the application of Modell Mam depends on whether the drug was taken according to the instructions and may include a pregnancy test. In case of pregnancy, taking Modell Mam should be stopped. With a significant increase in blood pressure or ineffectiveness of antihypertensive therapy with Modell Mam should stop taking the drug.

In case of violations of liver function, a woman should consult a specialist for examination and consultation. Women with a predisposition to chloasma should avoid exposure to sunlight or UV radiation during the application of the drug Modell Mam.

A woman should be informed that the drug Modell Mam does not protect against HIV infection and other sexually transmitted diseases.

Decreased efficiency. The effectiveness of gestagen-containing oral contraceptives can be reduced in case of skipping of the drug, gastrointestinal disorders or when taking other drugs.

Influence 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 the drug Modell Mam, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. 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 globulin, binding corticosteroids; 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 insignificantly and gradually disappears within 10 years after discontinuation of oral contraceptives, the risk is not related to the duration of use, but depends on the age of the woman during the use of COCs. The estimated number of diagnosed breast cancers among 10,000 women using COCs (within 10 years of discontinuation) and women who have never taken medications of this group during the same period

The risk for women using oral contraceptive preparations containing only progestogen, for example, the Modell 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 PE). Although the clinical significance of this data for desogestrel as a contraceptive without estrogen is unknown, therapy with Modell Mam should be discontinued in the case of thrombosis. The termination of therapy with Modell Mam should also be considered in the case of prolonged immobilization associated with an operation or disease.

Diabetes. The gestagens can influence the resistance of peripheral tissues to insulin and glucose tolerance, but there is no evidence that there is a need to change the therapeutic regimen in diabetic patients using gestagen containing oral contraceptives. However, patients with diabetes mellitus should be closely monitored during the first months of use of Modell Mam.

BMD. When using Modell Mam, 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 BMD.

Prevention of ectopic pregnancy. Prevention of ectopic pregnancy with gestagen containing oral contraceptives is not as effective as when using COCs, because ovulation often occurs when they are used. Despite the fact that the drug Modell Mam effectively suppresses ovulation, in the case of amenorrhea or abdominal pain, differential diagnosis should exclude an ectopic pregnancy.

Influence on the ability to drive vehicles and mechanisms. The use of Modell Mam does not affect the ability to perform actions that require an increased concentration of attention and speed of psychomotor reactions.

Form of issue

Film-coated tablets. In the blister is 28 pcs. 1, 3, 6 bl. Are placed in packs cardboard.

Terms of leave from pharmacies

On prescription.

storage Conditions

At temperatures not higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date stated on the package