Charozetta pills 0.075mg №28

Packaging

28 tablets

Mechanism of action

Charozetta is a gestagen-containing oral contraceptive containing progestogen desogestrel. Like other gestagenic oral contraceptives ("mini-pili") Charozetta is best suited for use during breastfeeding and for women who are contraindicated or who do not want to take estrogen. In contrast to the "mini-pili", the contraceptive effect of the drug Charozetta is achieved mainly due to the suppression of ovulation. Other effects include an increase in viscosity of the cervical mucus.
When using Charozetta in the first 56 days, the frequency of ovulation does not exceed 1%, after stopping the 56-day drug intake, ovulation occurs after 7-30 days (an average of 17 days). In a comparative efficacy study (in which missed pills were allowed to be taken for a maximum of 3 hours), the general Pearl index (indicator,reflecting the frequency of pregnancy in 100 women during the year of using the contraceptive) Charozetta drug was 0.4 in the group of all patients included in the study.
The Pearl Index of a Charozett's drug is comparable to the Pearl Index of combined oral contraceptives in the general population taking oral contraceptives. Taking Charozetta leads to a decrease in the level of estradiol in serum to values ​​characteristic of the early follicular phase. At the same time, no clinically significant changes in carbohydrate, lipid metabolism and hemostasis parameters were revealed.

Indications and usage

Contraception.

Contraindications

- Hypersensitivity to the active substance or any excipient of the drug.
- Established or suspected pregnancy.
- Presence or current history of venous thromboembolism (including deep leg vein thrombosis, pulmonary embolism).
- The presence at the moment or in the history of severe liver disease (as long as the indicators of liver function are not normalized).
- Hepatic failure, incl. in the anamnesis.
- Established or suspected malignant hormone-dependent tumors.
- Bleeding from the vagina of unknown etiology.
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
With caution (if any of the following conditions / risk factors are present, the benefits of using a progestogen should be weighed against the possible risks for each individual woman.This should be discussed with the woman before she decides to start taking the drug. In case of worsening, exacerbation of the disease or the occurrence of any of these conditions, for the first time, the woman should consult a doctor. The physician should decide on the appropriateness of further use of the drug Charozetta):
- Sustained hypertension, developing on the background of taking the drug Charozetta, or with the ineffectiveness of antihypertensive therapy.
- Thromboembolic disorders, including a history: 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 should be made of the ratio of benefits and risks when prescribing the drug to women with liver cancer.
- Chloasma, especially in women with chloasma during pregnancy in history: women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation while using the drug Charozetta.

Pregnancy and Breastfeeding

During pregnancy, the use of the drug is contraindicated. The results of preclinical studies have shown that very high doses of gestagens can cause masculinization of the female fetus. Extensive epidemiological studies have not revealed any increased risk of congenital developmental defects in children,mothers who took oral contraceptives before pregnancy, no teratogenic effect in case of unintentionally taking 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, 0.01 - 0.05 mcg of etonogestrel per kg of body weight per day (based on the consumption of 150 ml / kg / day of breast milk) can be taken to the baby.
There is limited evidence of long-term follow-up of children whose mothers started taking Charozetta during the 4th to 8th week after birth. The duration of breastfeeding was 7 months, and the children were under observation until they reached the age of 1.5 (n = 32) or up to 2.5 years (n = 14). Evaluation of growth, physical and psychomotor development did not reveal any differences with the babies whose mothers used copper intrauterine devices. Available data suggest that Charozetta can be used during lactation. However, it is necessary to carefully monitor the development and growth of the infant, whose mother uses the drug Charozetta.

Dosage and administration

Tablets should be taken orally in the order indicated on the package, every day at about the same time, if necessary with a small amount of liquid. Daily you need to take one pill for 28 days. Each subsequent packaging begins immediately after the completion of the previous packaging.
In the absence of previous use of hormonal contraceptives (within the last month) pills should be started on day 1 of the menstrual cycle (on day 1 of the menstrual bleeding). It is allowed to start the reception on the 2-5 day, but then during the first cycle during the first 7 days of taking the pills, it is recommended to use a barrier method of contraception.
Transition from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring or transdermal patch): A woman should start taking Charozetta, preferably the next day after taking the last active pill of the combined oral contraceptive (the last pill containing the active substance) or on the day of the removal of the vaginal ring or patch. In these cases, there is no need for additional contraception. At the latest, a woman may also start taking Charozetta the day after the usual interval for taking the pills, the patch, the ring, or the day after taking the placebo of the previous combined oral contraceptive pill (that is, the day when you would start using new packing a combined oral contraceptive, insert a new ring or stick a new patch), but during the first 7 days of taking the pills, it is recommended to use an additional barrier method of contraction ptsii.
Switching from other drugs that contain only progestogen ("mini-pili", injection, implant, or progestogen-releasing intrauterine system): a woman taking "mini-drank." may switch to taking Charozetta on any given day. A woman using an implant or intrauterine system is on the day they are removed. A woman who uses injectable contraceptive forms is on the day when the next injection is to be given. In all these cases, an additional method of contraception is not required.
After the first trimester abortionIt is recommended to start taking the drug immediately: an additional method of contraception is not required.
The drug can be taken no earlier than 21-28 days after an abortion in the second trimester, and not earlier than 6 weeks after delivery. When you start taking the drug at a later date, you must additionally use a barrier method of contraception during the first 7 days of taking the pills. However, if a woman after childbirth or abortion has already had sexual contact before taking the drug Charozetta, pregnancy should be excluded or the woman should wait until the first menstruation before using the drug.
What to do if you miss the next pill intake: contraceptive protection may be reduced if the interval between taking two pills is more than 36 hours. If the delay in taking the pill is less than 12 hours, then the missed pill should be taken 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 and also apply an additional method of contraception for the next 7 days. If the pills were missed in the very first week of taking the drug and sexual intercourse took place during the week preceding the skip of taking the pills, pregnancy should be excluded.
In case of severe gastrointestinal disorders (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 ingestion, absorption may not be complete. In this case, you should be guided by the recommendations regarding the administration of the missed pills.

Medical examinations / consultations: Before prescribing the drug, a history should be carefully collected from the woman and a thorough gynecological examination should be carried out to exclude pregnancy. Before the appointment of the drug should establish the cause of menstrual disorders, for example, oligomenorrhea and amenorrhea. The interval between the control medical examinations is determined by the doctor in each individual case (the frequency of examinations - 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 the regular intake of the drug Charozetta, sometimes irregular spotting may occur. If the bleeding is very frequent and irregular, you should consider using another method of contraception. If the above symptoms are persistent, then in this case it is necessary to exclude organic pathology. Tactics in relation to amenorrhea during the use of the drug depends on whether the pills were taken in accordance with the instructions, and may include a pregnancy test. In the case of pregnancy, the drug should be discontinued. In the event of acute or chronic liver dysfunction, the 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 effectiveness: The effectiveness of gestagen-containing oral contraceptives can be reduced in the case of skipping pills, gastrointestinal disorders, or when taking other drugs.
Changes in the nature of menstruation: during the use of progestogen-containing contraceptives in some women, vaginal bleeding may become more frequent or longer, while in other women these bleeding may become more rare or even stop.These changes are often the reason that the woman refuses this method of contraception, or ceases to strictly follow the instructions of the doctor. With detailed consultation with women who decide to start taking Charozetta, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. Evaluation of vaginal bleeding should be based on the clinical picture and may include a survey to exclude malignant neoplasms or pregnancy.
Follicular development: when all low-dose hormonal contraceptives are taken, follicles develop, and occasionally the size of the follicle may reach sizes larger than those in the normal cycle. In general, these enlarged follicles disappear spontaneously. Often, this proceeds without symptoms; in some cases, mild pain in the lower abdomen. Surgical intervention is rarely required.
Lab tests: data obtained on combined oral contraceptives have shown that the use of hormonal contraceptives can influence the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, serum protein levels, such as globulin, binding corticosteroids, lipid / lipoprotein fractions, carbohydrate metabolism and blood clotting and fibrinolysis.Usually these changes remain within the normal range. It is not known to what extent this also applies to contraceptives containing only gestagen.
Mammary cancer: The risk of breast cancer increases with age. During the use of combined oral contraceptives, the risk that a woman will be diagnosed with breast cancer increases slightly. This increased risk gradually disappears within 10 years after discontinuation of oral contraceptives, it is not associated with the duration of use, but depends on the age of the woman during the use of combined oral contraceptives.
The risk in women using oral contraceptives that contain only progestogen, for example, Charozetta, may be similar to that when using combined oral contraceptives. However, data for oral contraceptives containing only gestagen are not so specific. Compared with the risk of breast cancer throughout life, the increase in the risk associated with taking combined oral contraceptives is small. Breast cancer diagnosed in women using combined oral contraceptives tends to be less clinically developed than cancer diagnosed in women who have never used the combined oral contraceptive.The increased risk in women using combined oral contraceptives may be due to an earlier diagnosis, the biological effects of the drug, or a combination of these two factors.
Venous thromboembolism: epidemiological studies have established a link between the use of combined oral contraceptives and an 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 Charozetta should be discontinued in the event of thrombosis. Consideration should be given to discontinuing Charozetta's drug in the event of prolonged immobilization associated with an operation or a disease.
Diabetes: Although progestogens may affect peripheral tissue insulin resistance and glucose tolerance, there is no evidence that there is a need to change the therapeutic regimen in diabetics who use oral gestagenous contraceptives. However, women with diabetes should be monitored closely during the first months of use.
Bone mineral density: the use of Charozetta leads to a decrease in the level of estradiol in serum to a level corresponding to the early follicular phase.To date, it is not known whether this reduction has any clinically significant effect on bone mineral density.
Prevention of ectopic pregnancy traditional gestagens containing oral contraceptives ("mini-pili") are not as effective as with combined oral contraceptives, because when using the "mini-pili" often ovulation occurs. Despite the fact that Charozetta effectively suppresses ovulation, in case of amenorrhea or abdominal pain, ectopic pregnancy should be excluded during differential diagnosis.
Charozetta's drug contains no more than 65 mg of lactose, therefore women with rare hereditary disorders associated with galactose intolerance, Lappa lactase deficiency, or glucose-galactose malabsorption should refrain from taking the drug.
Influence on ability to drive motor transport 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.

The interaction between oral contraceptives and other drugs can lead to breakthrough bleeding and / or to a decrease in contraceptive efficacy. The following interactions have been reported in the literature (mainly with combined contraceptives, but sometimes also reported for progestin-containing contraceptives).
Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, resulting in increased clearance of sex hormones (for example, hydantoins (for example, phenytoin), barbiturates (for example, phenobarbital), primidone, Carbamazepine, rifampicin; and probably oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, Griseofulvin, and preparations containing Hypericum perforatum (Hypericum perforatum)).
Women using any of these medications should temporarily use a barrier method in addition to Charozetta or choose another method of contraception. Barrier contraception method should be used during the use of these drugs and within 28 days after the termination of their admission. For women receiving long-term treatment with hepatic enzyme inducers, the possibility of using a non-hormonal method of contraception should be considered.
With the use of Activated carbon, the absorption of deogestrel in a pill may decrease and, therefore, contraceptive efficacy may decrease. In this case, you should proceed in accordance with the recommendations regarding the missed tablets.
Hormonal contraceptives can affect the metabolism of other drugs. Accordingly, drug concentrations in plasma and in tissues can both increase (for example, cyclosporin) or decrease.
To identify possible interactions, you should read the instructions for use of these medicines.

There are no reports of any serious complications in overdose of Charozetta.
Possible: nausea, vomiting, in young girls - slight vaginal bleeding.
Treatment: there is no specific antidote, and further treatment should be symptomatic.

Store in a dry, dark place at temperatures from 2 ° C to 30 ° C.