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Modelle Libera set of tabs #91

Modelle Libera set of tabs #91

$72.24

(In stock)

  • Modelle Libera set of tabs #91 Modelle Libera set of tabs #91

Modelle Libera set of tabs #91

Quick Overview

1 tablet of levonorgestrel and ethinyl estradiol contains:active substances: levonorgestrel 0.10 mg. ethinyl estradiol 0.02 mg;excipients (core): anhydrous lactose 58.00 mg. hypromellose 8.00 mg, microcrystalline cellulose 8.00 mg, corn starch 5.00 mg. magnesium stearate 0.88 mg;excipients (shell): opadry II orange (32К13357) 5.0 * mg (lactose monohydrate 40.0%, hypromellose 15cP 28.0%, titanium dioxide 22.5%. triacetin 8.0%. sun sunset yellow aluminum lacquer 1.5%) .1 tablet of ethinyl estradiol contains:active ingredients: ethinyl estradiol 0.01 mg;excipients (core): anhydrous lactose 69.20 mg. polacriline potassium 2.50 mg, microcrystalline cellulose 8.00 mg, magnesium stearate 0.29 mg;excipients (shell): opadry II white (Y-22-7719) 5.0 * mg (titanium dioxide 30.00%, polydextrose 24.00%, hypromellose CsR 18.00%, hypromellose 6cP 15.43%, triacetin 7.50%. hypromellose 50cP 2.57 %, macrogol 2.50%).* depending on the size of the series, the amount of coverage may vary.

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Composition

1 tablet of levonorgestrel and ethinyl estradiol contains:active substances: levonorgestrel 0.10 mg. ethinyl estradiol 0.02 mgexcipients (core): anhydrous lactose 58.00 mg. hypromellose 8.00 mg, microcrystalline cellulose 8.00 mg, corn starch 5.00 mg. magnesium stearate 0.88 mgexcipients (shell): opadry II orange (32К13357) 5.0 * mg (lactose monohydrate 40.0%, hypromellose 15cP 28.0%, titanium dioxide 22.5%. triacetin 8.0%. sun sunset yellow aluminum lacquer 1.5%) .1 tablet of ethinyl estradiol contains:active ingredients: ethinyl estradiol 0.01 mgexcipients (core): anhydrous lactose 69.20 mg. polacriline potassium 2.50 mg, microcrystalline cellulose 8.00 mg, magnesium stearate 0.29 mgexcipients (shell): opadry II white (Y-22-7719) 5.0 * mg (titanium dioxide 30.00%, polydextrose 24.00%, hypromellose CsR 18.00%, hypromellose 6cP 15.43%, triacetin 7.50%. hypromellose 50cP 2.57 %, macrogol 2.50%).* depending on the size of the series, the amount of coverage may vary.

Description

Levonorgestrel and ethinyl estradiol tablets 0.1 mg + 0.02 mg: round biconvex tablets, film-coated orange, with extruded inscription "455" on one side of the tablet and "T" on the other side.** in cross-section, the core of the tablet is from white to almost white. Ethinyl estradiol tablets 0.01 mg: round biconvex tablets, film-coated white, with extruded inscription "173" on one side of the tablet and "T" on the other side.Pharmacotherapeutic group:Combined contraceptive (estrogen + progestogen)ATH code:G03AB03

Pharmacodynamics

Modelle Libera - combined oral estrogen-progestin contraceptive drug for continuous long-term use for 91 days.The contraceptive effect of the drug is due to the complementary mechanisms of active substances, the most important of which include suppression of ovulation, an increase in the viscosity of the cervical secretions, which makes it difficult for sperm to enter the uterus, and changes in the endometrium that prevent implantation of a fertilized egg.When using the drug Modelle Libera, the number of menstrual bleeding decreases to four per year. In the last 7 days of a long-term administration of the drug (days 85-91) with the use of 10 μg of ethinyl estradiol instead of placebo, there is an increase in the suppression of the ovarian follicular apparatus and a decrease in the risk of ovulation skipping. Menstrual-like bleeding associated with discontinuation of the drug occurs due to the fact that there is no progestin effect on the endometrium, but in women there is a residual suppression of the hypothalamo-pituitary system due to taking a small dose of ethinyl estradiol to control the functional activity of the ovaries.Based on data from clinical studies, the Pearl index for the use of the drug Modelle Libera was 2.74. This Pearl index was calculated taking into account the pregnancies resulting from violations of the regimen of drug administration.

Pharmacokinetics

Suction. Ethinyl estradiol and levonorgestrel are rapidly absorbed from the gastrointestinal tract, the maximum plasma concentration is achieved 2 hours after oral administration. Levonorgestrel is completely absorbed after oral administration (bioavailability of approximately 100%) and is not subject to presystemic metabolism.Ethinyl estradiol is completely absorbed from the gastrointestinal tract, but due to presystemic metabolism in the liver and intestinal mucosa, its bioavailability is approximately 43%.Distribution. The volume of distribution of levonorgestrel and ethinyl estradiol is 1.8 L / kg and 4.3 L / kg, respectively.97.5-99% of levonorgestrel binds to plasma proteins, mainly to sex hormone-binding globulin (SHBG), and to a lesser extent to albumin. Ethinyl estradiol does not bind to SHBG, but causes an increase in plasma SHBG concentration, with the result that the Levonorgestrel fraction associated with SHBG increases, while the fraction bound to albumin decreases. 97.5-99%. ethinyl estradiol binds to plasma albumin.As a result of continuous daily use of the drug Modelle Libera, the concentration of levonorgestrel and ethinyl estradiol in the blood plasma increases in comparison with the administration of a single dose of the drug.Metabolism. After absorption, levonorgestrel is metabolized to form glucuronides and sulfates, and glucuronides are conjugated in blood plasma. Ethinyl estradiol undergoes presystemic conjugation in the small intestinal mucosa and in the liver. The main pathway of metabolism is aromatic hydroxylation, thus forming a wide range of hydroxylated and methylated metabolites, which are present both as free metabolites and as conjugates with glucuronides and sulfates.Derivation. About 45% of levonorgestrel and its metabolites are excreted by the kidneys, and about 32% are excreted through the intestines, mainly in the form of glucuronide conjugates.Ethinyl estradiol is excreted by the kidneys and through the intestines in the form of conjugates of glucuronide and sulfate, and then undergoes enterohepatic recirculation.

Indications for use

Oral contraception.

Contraindications

Carefully

Use during pregnancy and during breastfeeding

The drug Modelle Libera is contraindicated during pregnancy and during breastfeeding.If pregnancy is detected while taking the drug Modelle Libera. the drug should be immediately withdrawn. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children from mothers who received COCs before pregnancy, or a teratogenic effect, if accidentally taken by COCs in the early stages of pregnancy.Taking COCs can reduce the amount of breast milk and alter its composition, therefore, their use is contraindicated until breastfeeding is stopped. A small amount of the active ingredients of COCs and / or their metabolites that enter breast milk may affect the baby.

Dosage and administration

The drug Modelle Libera is ingested continuously for 91 days, 1 tablet per day at the same time in the order indicated on the package (blister).To achieve the greatest contraceptive effect of the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours.Start taking the pills should be taken every day with a small amount of liquid. One orange tablet containing levonorgestrel and ethinyl estradiol is taken daily for 84 days, then one white tablet containing ethinyl estradiol is taken. for 7 days, during which the menstrual-like "withdrawal" bleeding occurs.Each subsequent cycle of taking the drug Modelle Libera lasting 91 days begins without interruption the next day after taking the last tablet from the previous package, adhering to the same order of administration.In the absence of taking any hormonal contraceptive drugs in the previous month.Taking the pills should begin on the first day of the menstrual cycle (i.e., on the first day of the menstrual bleeding). It is allowed to start taking on the 2-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills.In the transition from the use of other hormonal combined contraceptive drugs (COC, vaginal ring or transdermal patch).A woman should start taking the drug Modelle Libera on the next day after taking the last active tablet (the last tablet containing the active substances) of the previously used oral contraceptive drug. In the case of using a vaginal ring or transdermal patch, a woman should start taking the drug at the time a new ring is to be inserted or a new patch is pasted.In the transition from the use of contraceptives containing only gestagens ("mini-pili", injection forms, implant), or with a progestogen-releasing intrauterine contraceptive.You can switch from taking “mini-drank” to Modelle Libera on any day (without a break), from an implant or intrauterine contraceptive with a gestagen - on the day of its removal, from an injection form of a contraceptive - from the day. when the next injection should be done. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.After abortion in the first trimester of pregnancy.You can start taking the drug Modelle Libera immediately - on the day of abortion. Subject to this condition, the woman does not need additional contraception.After childbirth or abortion in the II trimester of pregnancy.To start taking the drug should be no earlier than 21-28 days after birth (in the absence of breastfeeding) or abortion in the second trimester of pregnancy. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. However, during sexual intercourse before taking the drug Modelle Libera, you should exclude pregnancy before taking the drug or wait for the first menstruation.

Taking missed pills

Week 1 (Day 1- Day 7)

If one or more pills are missed during the first week, the risk of pregnancy increases because 7 days of continuous pills are required to suppress the hypothalamic-pituitary-ovarian regulation.If you miss the reception of one orange pill, you must take the missed orange 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.If you miss taking two orange pills, a woman needs to take two pills on the day she remembered the pass, and two more the next day. Subsequent tablets are taken at the usual time. Within 7 days, additional barrier methods of contraception should be used (for example, a condom).If you miss taking 3 orange tablets, they are not taken, and subsequent tablets are taken at the usual time as directed on the package. During the next week after skipping the pills, the woman may begin to stop bleeding. In any case, a barrier method of contraception (for example, a condom) should be used additionally within the next 7 days. If sexual intercourse took place during the week before the tablet is missed, the likelihood of pregnancy must be considered.

Week 2 - 12 (Day 8 - Day 84)

One missed orange tablet should be taken as soon as possible, even if you have to take two tablets at the same time. Subsequent tablets are taken at the usual time. The use of additional methods of contraception is not required.If you miss taking two orange pills, a woman needs to take two pills on the day she remembered the pass, and two more the next day. Subsequent tablets are taken at the usual time. Within 7 days, additional barrier methods of contraception should be used (for example, a condom).If you miss taking 3 orange tablets, they are not taken, and subsequent tablets are taken at the usual time as directed on the package. During the next week after skipping the pills, the woman may begin to stop bleeding.Within 7 days you should use additional barrier methods of contraception.

Missed taking white tablets containing ethinyl estradiol (Week 13)

Tablets that the patient forgot to take should be missed. Subsequent tablets must be taken at the usual time until the end of the package.Additional contraceptive methods are not required.If a woman did not have “withdrawal” bleeding during the 13th week (while taking white tablets containing ethinyl estradiol), you should exclude the possibility of pregnancy before starting a new 91-day course of taking the drug.

Recommendations for gastrointestinal disorders

In the event of serious disorders of the gastrointestinal tract (for example, vomiting or diarrhea in the period up to 3-4 hours after taking the pills), the absorption of the drug may be incomplete, and additional methods of contraception may be required.In these cases, you should focus on the above recommendations when skipping pills.

Side effect

Overdose

No serious side effects from overdose have been reported. Based on the experience of using COCs, symptoms that may occur during an overdose are identified: nausea, vomiting, vaginal bloody discharge or metrorrhagia.Treatment: conduct symptomatic therapy. There is no specific antidote.

Interaction with other drugs

The interaction of oral contraceptive drugs with other drugs can lead to "breakthrough" bleeding and / or a decrease in contraceptive reliability.The interactions leading to decrease in efficiency of the drug Modelle Libera. Effect on hepatic metabolism.The 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 decrease the reliability of contraception. Such drugs include phenytoin, bosentan, vemurafenib, barbiturates, primidone, carbamazepine. rifampicin. rifabutin. It is also possible oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort. The maximum induction of enzymes is reached after 10 days and lasts for 4 weeks after the end of the use of inducer drugs.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.Women undergoing a short course of treatment with any of the above drugs, with the exception of rifampicin. a barrier method of contraception should be used temporarily in addition to the oral contraceptive preparation, i.e. during the use of concomitant therapy and within 7 days after its completion.Women taking rifampicin and griseofulvin should use a barrier method of contraception in addition to an oral contraceptive when taking rifampicin and for 28 days after discontinuation.Women undergoing a long course of treatment with drugs containing active substances that induce liver microsomal enzymes are recommended to use a barrier method of contraception.

Effects on enterohepatic recirculation

Some antibiotics (for example, penicillins and tetracycline) can reduce the enterohepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol.COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) of their concentration in plasma and tissues.Women undergoing thyroid hormone replacement therapy may need to increase the dose of the thyroid hormone drug, since the concentration of globulin that binds the thyroid hormone in the blood plasma increases when taking the oral contraceptive drug.

special instructions

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

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism, such as deep vein thrombosis. pulmonary embolism, myocardial infarction, cerebrovascular diseases. The risk of venous thromboembolism (VTE) is especially high during the first year of COC use.The approximate frequency of VTE in women taking oral contraceptive drugs with a low dose of estrogen (less than 50 μg of ethinyl estradiol). ranging from 20 cases per 100,000 reproductive years for women (for drugs containing levonorgestrel) to 40 cases per 100,000 reproductive years for women (for preparations containing desogestrel / gestoden) compared to 5-10 cases for 100,000 reproductive years women for patients not taking COC, and 60 cases per 100,000 pregnancies. VTE is fatal in 1-2% of cases.In women taking COCs, extremely rare cases of thrombosis of other blood vessels are described, for example, hepatic, mesenteric, renal arteries and veins or veins and retinal arteries. The relationship of these cases with the reception of the COC is not proven.A woman should stop taking the drug and consult a doctor if symptoms of venous or arterial thrombosis develop, which may include one-sided pain in the lower limb and / or edema sudden severe chest pain, with or without irradiation to the left hand sudden shortness of breath sudden bouts of coughing any unusual, severe, prolonged headache increased frequency and severity of migraine sudden partial or complete loss of vision diplopia inarticulate speech or aphasia dizziness fainting with or without seizures weakness or a very significant loss of sensation, suddenly appearing on one side or in one part of the body movement disorders "Sharp" belly.The risk of thrombosis (venous and / or arterial) and thromboembolism increases: with age, in smokers (with an increase in the number of cigarettes smoked or an increase in age, the risk further increases, especially in women over 35 years old), with a family history or arterial thromboembolism ever in close relatives or parents at a relatively young age), obesity (body mass index more than 30 kg / m2), dyslipoproteinemia, arterial hypertension, valvular heart disease, prolonged immobilization, Foot surgery, any surgery to the legs, or major trauma, atrial fibrillation.The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. In the case of a planned operation, the drug should be discontinued at least 4 weeks before it and should not be resumed within 2 weeks after the end of immobilization. Consideration should be given to an increased risk of thromboembolism in the postpartum period. Peripheral circulatory disorders can also occur in diabetes mellitus, SLE, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.An increase in the frequency and severity of migraine attacks during the application of COCs (which may precede cerebrovascular disorders) should be the basis for the immediate cessation of these drugs.The presence of one pronounced risk factor or multiple risk factors is a contraindication to the use of an oral contraceptive drug. Should consider the possibility of anticoagulant therapy. You should choose a suitable alternative method of contraception. When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis.

Tumors

There are reports of some increase in the risk of cervical cancer with prolonged use of COC. However, the connection with the reception of the COC is not proven. There are contradictions regarding the extent to which these data are associated with screening for cervical pathology or with the characteristics of sexual behavior (more rare use of barrier methods of contraception). The most important risk factor for cervical cancer is persistent HPV infection. 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 COCs at present (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. For the reason that. 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 COCs recently is insignificant relative to the overall risk of the disease. The relationship between the development of breast cancer and COC is not proven. The observed increase in risk may be due not only to an earlier diagnosis of breast cancer in women using COCs. but also the biological effects of sex hormones or a combination of these two factors. Women who have ever applied COC. earlier stages of breast cancer are detected than in women who have never used them.In rare cases, 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 against the background of COCs. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, this should be considered when performing a differential diagnosis.

Other states

Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking COCs.Although a slight increase in blood pressure has been described in many women taking COCs. clinically significant hypertension was rarely observed. However, if a persistent, clinically significant increase in blood pressure develops while taking COCs, stop taking the drug and begin treatment of arterial hypertension. Receiving COC 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 during both pregnancy and COC. but their association with COC is not proven: jaundice and / or pruritus. associated with cholestasis gallstones formation: porphyria SLE hemolytic-uremic syndrome: Sydengham's chorea: herpes during pregnancy hearing loss associated with otosclerosis.There were reports of worsening of the course of endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis while taking COCs.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 remove the drug before normalizing the liver function tests. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or a previous intake of sex hormones, requires discontinuation of COC. Although COCs can influence insulin resistance and glucose tolerance, as a rule, correction of the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus is not required. However, women with diabetes mellitus need careful control of the concentration of glucose in the blood during the use of the drug.When using the drug may develop chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking COCs should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Reduced efficiency

The effectiveness of COCs can be reduced by skipping tablets, vomiting and diarrhea, or as a result of drug interactions with concomitant medications.

Medical examinations

Before starting or resuming use of the drug Modelle Libera, you should familiarize yourself with the history of life, family history of the woman, conduct a thorough general medical (including blood pressure, heart rate, body mass index) and gynecological examinations, including breast examination and cytological examination of scraping cervix (Papanicolaou test), exclude pregnancy. The amount of additional research and the frequency of control examinations is determined individually. Usually control tests should be carried out at least 1 time in 6 months.A woman should be informed that Modelle Libera does not protect against HIV infection (Acquired Immune Deficiency Syndrome - AIDS) and other sexually transmitted diseases.

Influence of the menstrual cycle

Irregular (acyclic) bleeding ("spotting" bleeding or "breakthrough" bleeding) may occur on the background of COC use, especially during the first 3 months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.In the course of clinical studies of the drug Modelle Libera, the planned menstrual bleeding (“withdrawal” bleeding) and / or the appearance of “bloody” bleeding remained relatively constant, lasting an average of three days during each 91-day cycle. The frequency of unplanned “withdrawal” bleeding and unplanned “spotting” bleeding decreased during a 91-day cycle. A woman should be warned that in the event of "bloody" bleeding or the appearance of unplanned bleeding, one should still adhere to the same mode of administration of the drug Modelle Libera. If the bleeding is constant or lasts too long, the woman should consult a doctor.If the woman did not have a "stop" bleeding during the 13th week (when taking white tablets containing ethinyl estradiol). the possibility of pregnancy should be excluded.

Impact on laboratory test scores

Acceptance of COCs may affect the results of some laboratory tests, including indicators of liver function, kidney, thyroid, adrenal glands, concentration of transport proteins in plasma, indicators of carbohydrate metabolism, coagulation parameters and fibrinolysis. Changes usually do not go beyond the normal range.

Conditions requiring medical advice

Influence on ability to drive vehicles and mechanisms

No effect of the drug on the ability to drive vehicles and mechanisms.

Release form

A set of film-coated tablets. 0.1 mg + 0.02 mg and 0.01 mg.2 PVC / TE / PVDC / Aluminum foil blisters of 28 tablets of levonorgestrel and ethinyl estradiol and 1 PVC / TEH of PVDH / Aluminum foil blister of 28 tablets of levonorgestrel and ethinyl estradiol and 7 tablets of ethinyl estradiol, tightly coated with cardboard blister. together with the adsorbent in a foil bag. 1 foil bag along with instructions for use and a card with stickers in a carton box.

Storage conditions

Store at a temperature not exceeding 25 ° C, protected from light and moisture.Keep out of the reach of children.Shelf life - 3 years. Do not use after the expiration date.

Pharmacy sales terms

You don't need a prescription to buy Modelle Libera.

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Additional Information

SKU fh2677
The purpose of the medication Contraception
Weight kg. 0.05

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