Description
Release form
Film-coated tablets.
Packing
84 pcs.
Pharmacological action
Charozetta is a progestogen-containing oral contraceptive containing progestogen desogestrel. Like other gestagen-containing oral contraceptives ( mini-drank ), Charozetta is best suited for use during breastfeeding and for women who are contraindicated or who do not want to take estrogen. Unlike mini-drank , the contraceptive effect of Charozet s drug is achieved mainly due to the suppression of ovulation. Other effects include increased viscosity of cervical mucus.
When using the Charozet drug in the first 56 days, the frequency of ovulation does not exceed 1%, after stopping the 56-day intake of the drug, ovulation occurs after 7-30 days (on average after 17 days). In a comparative study of efficacy (in which it was allowed to take missed tablets for a maximum of 3 hours), the general Perl index (an indicator that reflects the pregnancy rate in 100 women during the year of using the contraceptive) of Charozet was 0.4 in the group of all patients included in the study.
The Perl index of Charozette is comparable to the Perl index of combined oral contraceptives in the general population taking oral contraceptives. Taking Charozetta leads to a decrease in serum estradiol to the values characteristic of the early follicular phase. There were no clinically significant changes in carbohydrate, lipid metabolism and hemostasis.
Indications
Contraception.
Contraindications
Hypersensitivity to the active substance or any excipient of the drug.
Established or suspected pregnancy.
The presence at present or in the history of venous thromboembolism (including deep vein thrombosis of the leg, thromboembolism of the pulmonary artery).
The presence at the moment or in the anamnesis of a severe liver disease (until the liver function indicators normalize).
Hepatic failure, including in the anamnesis.
Identified or suspected malignant hormone-dependent tumors.
Vaginal bleeding of unknown etiology.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Caution
If you have any of the following conditions / risk factors, you should weigh the benefits of using gestagen and the possible risks for each individual woman. This should be discussed with the woman before how she decides to start taking the drug. In the event of a worsening, exacerbation of the disease or the occurrence of any of these conditions, a woman should first consult a doctor. The doctor should decide on the appropriateness of further use of the Charozet drug):
Persistent hypertension that develops while taking the Charozet drug, or with ineffective antihypertensive therapy.
Thromboembolic disorders, including a history of: a woman should be warned about the possibility of relapse.
Prolonged immobilization associated with surgery or disease.
Since it is impossible to exclude the biological effect of gestagens on the development of liver cancer, an individual assessment of the benefit-risk ratio should be made when prescribing the drug to women with liver cancer.
Chloasma, especially in women with a history of chloasma during pregnancy: women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation while using Charozet.
Use during pregnancy and lactation
During pregnancy, the use of the drug is contraindicated. Preclinical studies have shown that very high doses of gestagens can cause masculinization of the female fetus. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children whose mothers took oral contraceptives before pregnancy, nor a teratogenic effect in case of unintentional use of oral contraceptives in early pregnancy.
The drug does not affect the quantity or quality (concentration of protein, lactose or fat) of breast milk. However, small amounts of etonogestrel are excreted in breast milk. As a result, a child may receive 0.01 – 0, 05 μg etonogestrel per kg body weight per day (based on consumption of 150 ml / kg / day of breast milk).
There is limited evidence for long-term follow-up of children whose mothers started taking Charozet within 4-8 weeks after giving birth. The duration of breastfeeding was 7 months, and the children were monitored until they reached the age of 1.5 (n = 32) or 2.5 years (n = 14). Assessment of growth, physical and psychomotor development did not reveal any differences with babies whose mothers used copper intrauterine devices. Available data say that Charozetta can be used during lactation. Nevertheless, it is necessary to carefully monitor the development and growth of the infant whose mother is using Charozet.
Special instructions
Medical examinations / consultations: Before prescribing the drug, a woman should have a thorough medical history and a thorough gynecological examination to rule out pregnancy. Before prescribing the drug, the cause of menstrual irregularities, for example, oligomenorrhea and amenorrhea, should be established. The interval between control medical examinations is determined by the doctor in each individual case (the frequency of examinations is at least 1 time per year). If the prescribed drug can affect a latent or existing disease, an appropriate schedule of follow-up medical examinations should be made.
Despite taking Charozett regularly, occasional spotting may occur. If bleeding is very frequent and irregular, consider using another method of contraception. If the above symptoms are persistent, then in this case it is necessary to exclude organic pathology. The tactics for amenorrhea during the use of the drug depend on whether the tablets were taken in accordance with the instructions, and may include a pregnancy test. In case of pregnancy, the drug should be discontinued. In case of acute or chronic violations of liver function, a woman should consult a specialist for examination and consultation. Women should be informed that Charozetta does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Decreased efficacy: The effectiveness of gestagen-containing oral contraceptives may be reduced if you miss a pill, have a gastrointestinal upset, or take other medications.
Changes in the nature of menstruation: during the use of gestagen-containing contraceptives in some women, vaginal bleeding may become more frequent or longer, while in other women these bleeding may become rarer or even stop. These changes are often the reason that a woman refuses this method of contraception, or ceases to strictly follow the doctor ² ¢s instructions. With detailed consultation with women who decide to start taking Charozet, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. Assessment of vaginal bleeding should be based on the clinical picture and may include examination to exclude malignant neoplasms or pregnancy.
Follicular development: when all low-dose hormonal contraceptives are taken, follicles develop, sometimes the size of the follicle can reach sizes that exceed those in the normal cycle. In general, these enlarged follicles disappear spontaneously. Often, this occurs without symptoms, in some cases there is mild pain in the lower abdomen. Surgical intervention is rarely required.
Laboratory tests: data on combined oral contraceptives have shown that hormonal contraceptives may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, and (transport) protein levels in serum, for example, corticosteroid binding globulin, lipid / lipoprotein fractions, carbohydrate metabolism, and blood coagulation and fibrinolysis. Typically, these changes remain within normal values. It is not known to what extent this also applies to contraceptives containing only gestagen.
Breast cancer: The risk of breast cancer increases with age. During the use of combined oral contraceptives, the risk of that a woman will be diagnosed with breast cancer is slightly increasing. This increased risk gradually disappears within 10 years after stopping the use of oral contraceptives, it is not associated with the duration of use, and depends on the age of the woman during the use of combined oral contraceptives.
The risk in women using oral contraceptives containing only a progestogen, such as Charozet ² ¢s drug, is probably similar to that when using combined oral contraceptives. However, the data for oral contraceptives containing only gestagen are not so certain. Compared to the risk of developing breast cancer throughout life, the increase in risk associated with taking combined oral contraceptives is small. Mammary cancer, diagnosed in women using combined oral contraceptives tends to be less clinically developed than cancer diagnosed in women who have never used combined oral contraceptives. The increased risk in women using combined oral contraceptives may be due to earlier diagnosis, biological effects of the drug, or a combination of these two factors.
Venous thromboembolism: epidemiological studies have found a link between the use of combined oral contraceptives and the increased incidence of venous thromboembolism (VTE, deep vein thrombosis and pulmonary embolism). And although the clinical significance of these data for desogestrel, as a contraceptive that does not contain an estrogen component, is unknown, the use of Charozet should be discontinued in case of thrombosis. Consideration should be given to discontinuing Charozet’s administration in the event of prolonged immobilization associated with surgery or disease.
Diabetes mellitus: although progestogens may affect peripheral tissue resistance to insulin and glucose tolerance, there is no evidence that there is a need to change the therapeutic regimen in patients with diabetes using gestagen-containing oral contraceptives. However, women with diabetes should be closely monitored during the first months of the drug.
Bone mineral density: the use of Charozetta leads to a decrease in serum estradiol to a level corresponding to the early follicular phase. Until now, it is not known whether this decrease has any clinically significant effect on bone mineral density.
Prevention of ectopic pregnancy with traditional gestagen-containing oral contraceptives (“mini-pill”) is not as effective as with combined oral contraceptives, since ovulation often occurs with the use of “mini-pill”. Despite the fact that Charozetta effectively suppresses ovulation, in the case of amenorrhea or abdominal pain, an ectopic pregnancy should be excluded during the differential diagnosis.
Charozetta contains not more than 65 mg of lactose, so women with rare hereditary disorders associated with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should refrain from taking the drug.
Influence on the ability to drive vehicles and control mechanisms: based on the pharmacodynamic profile, it is believed that the drug does not affect the ability to drive vehicles and work with mechanisms.
Composition of
In 1 film-coated tablet contains:
Desogestrel 0.075 mg.
Excipients:
Corn starch
Povidone
? -tocopherol
Stearic acid
Silicon dioxide colloidal
Lactose monohydrate.
Shell composition:
Hypromellose
Macrogol 400
Talc
Titanium dioxide.
Dosage and administration
Tablets should be taken orally in the order indicated on the package, every day at approximately the same time, if necessary, washed down with a small amount of liquid. Daily, take one tablet for 28 days. Each subsequent packaging begins immediately after completion of the previous packaging.
In the absence of previous use of hormonal contraceptives (during the last month), tablets should be taken on the 1st day of the menstrual cycle (on the 1st day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day, but then during the first cycle during the first 7 days of taking the tablets it is recommended to additionally apply the barrier method of contraception.
Switching from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring or transdermal patch): a woman should start taking Charozet preferably on the day after taking the last active pill of the combined oral contraceptive (last pill containing the active substance) or on the day the vaginal ring is removed or patch. In these cases, there is no need for additional contraception. At the latest, a woman can also start taking Charozet on the day after the usual interval in taking pills, a patch, a ring, or on the day after taking a placebo tablet of the previous combined oral contraceptive (i.e., on the day when it would be necessary to start using a new packaging a combined oral contraceptive, introduce a new ring or stick a new patch), but during the first 7 days of taking the tablets it is recommended to use an additional barrier method of contraception .
Switching from other drugs containing only gestagen (mini-pill, injection, implant, or gestagen-releasing intrauterine system): a woman taking a mini-pill. may switch to taking Charozet on any day. A woman using an implant or intrauterine system – on the day they are removed. A woman who is using injectable contraceptives on the day the next injection is due. In all these cases, an additional method of contraception is not required.
After an abortion in the first trimester, it is recommended to start taking the drug immediately: an additional method of contraception is not required.
Acceptance of the drug is possible not earlier than 21-28 days after an abortion, an additional method of contraception is not required.
Acceptance of the drug is possible not earlier than 21-28 days after an abortion, an additional method of contraception is not required.
Acceptance of the drug is possible not earlier than 21-28 days after an abortion,made in the second trimester, and not earlier than 6 weeks after birth. When you start taking the drug at a later date, you must additionally apply the barrier method of contraception during the first 7 days of taking the tablets. However, if a woman had already had sexual intercourse after giving birth or abortion before taking Charozet, she should be excluded from pregnancy or the woman should wait for her first menstruation.
What to do if you miss the next pill: contraceptive protection may be reduced if the interval between taking two tablets is more than 36 hours. If the delay in taking the pill is less than 12 hours, then the missed pill should be taken immediately as soon as the woman remembers this, and the next pill should be taken at the usual time. If the delay in taking the pill is more than 12 hours, then the woman should follow the above recommendations, as well as apply an additional method of contraception for the next 7 days. If the tablets were missed in the very first week of taking the drug and there was sexual intercourse during the week preceding the missed tablets, pregnancy should be excluded.
In case of severe gastrointestinal upsets (vomiting, diarrhea), absorption may be incomplete and in this case additional methods of contraception should be used. If vomiting occurs within 3-4 hours after administration, then absorption may not be complete. In this case, it is necessary to be guided by the recommendations regarding the intake of missed tablets.
Side effects of
The most common adverse effect reported in clinical studies was irregular menstruation. Up to 50% of women who used desogestrel noted acyclic spotting: in 20-30% of women, menstruation became more frequent, while in other 20%, more rare or even completely stopped. Menses may also become longer.
After several months of taking the drug, menstruation tends to become less frequent. Informing the doctor, monitoring by the doctor, as well as the use of the menstrual diary can increase compliance with treatment with the drug.
The following are undesirable effects that have an established, probable, or possible association with the use of the drug.
In that case if any of the following conditions / risk factors is observed, you should carefully weigh the expected benefits and risk of using a contraceptive when consulting with your doctor over the entire period of contraception. If any of the following conditions / risk factors appears, intensifies, changes, the patient should immediately consult a doctor to decide on the possibility of further use of the drug.
Often – acne, nausea, mood changes, decreased libido, breast tenderness, menstrual irregularities, headache, weight gain.
Infrequently – alopecia, fatigue, vomiting, discomfort when wearing contact lenses, vaginitis, dysmenorrhea, ovarian cysts.
Rarely – redness of the skin, rash, urticaria, erythema nodosum.
Although a reliable association with the administration of gestagens has not been established, cholestatic jaundice, pruritus, cholelithiasis, chorea, herpes in pregnant women, otosclerosis, deafness, and the development of hemolytic-uremic syndrome are possible with their administration.
Drug Interactions
The interaction between oral contraceptives and other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive effectiveness. The following interactions have been reported in the literature (mainly with combined contraceptives, but sometimes also reported with gestagen-containing contraceptives).
Hepatic metabolism: interactions with microsomal enzyme-inducing drugs can occur, leading to increased clearance of sex hormones (e.g. hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin and probably also oxcarbaz rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and drugs containing St. John’s wort (Hypericum perforatum)).
Women using any of these medicines should temporarily use the barrier method in addition to Charoset’s or choose another method of contraception. The barrier method of contraception should be used during the use of these drugs and within 28 days after stopping their use. For women receiving long-term treatment with inducers of liver enzymes, Consideration should be given to using a non-hormonal method of contraception.
When using activated charcoal, the absorption of desogestrel in the tablet may decrease and, therefore, contraceptive effectiveness may decrease. In this case, you should act in accordance with the recommendations regarding missed tablets.
Hormonal contraceptives may affect the metabolism of other drugs. Accordingly, the concentration of the drug in the plasma and in the tissues can both increase (for example, cyclosporine) and decrease.
To identify possible interactions, read the instructions for use of these medicines.
Overdose
There are no reports of any serious complications with an overdose of Charozetta.
Possible: nausea, vomiting, in young girls – slight vaginal bleeding.
Treatment: There is no specific antidote and further treatment should be symptomatic.
Storage Conditions
Store in a dry, dark place at 2 ° C to 30 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Desogestrel
Prescription conditions from
pharmacies prescription
Dosage PMA
Prescribing
Prescribing
For women of childbearing age, Adults n the value of physician
N.V. Organon, the Netherlands
