1 film-coated tablet contains:
Desogestrel 0.075 mg.
Silicon dioxide colloidal;
Charozetta is a gestagen-containing oral contraceptive containing gestagen 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 contraceptive use) of Charozet was 0.4 in the group of all patients included in the study.
The Charlotte Pearl Index is comparable to the Pearl 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.
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 proteins, lactose or fats) of breast milk. However, small amounts of etonogestrel are excreted in breast milk. As a result, 0.01-0.05 micrograms of etonogestrel per kg of body weight per day can be delivered to the child (based on consumption of 150 ml / kg / day of breast milk).
There is limited evidence of long-term follow-up of children whose mothers started taking Charozet during the 4-8th week after 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.
Hypersensitivity to the active substance or any excipient of the drug.
Established or suspected pregnancy.
The presence at the moment 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 serious liver disease (until the indicators of liver function are normalized).
Hepatic failure, including in the anamnesis.
Established or suspected malignant hormone-dependent tumors.
Vaginal bleeding of unknown etiology.
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
If any of the following conditions / risk factors are present, the benefits of using gestagen and the possible risks for each individual woman should be weighed. This should be discussed with the woman before 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 feasibility of further use of the Charozet drug):
Persistent hypertension, developing while taking Charozetta, or with the ineffectiveness of antihypertensive therapy.
Thromboembolic disorders, including a history of: a woman should be warned about the possibility of relapse.
Long-term immobilization associated with surgery or with a 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.
The most common adverse effect reported in clinical trials 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 having an established, probable or possible relationship with the use of the drug.
In the event that any of the following conditions / risk factors is observed, it is necessary to carefully weigh the expected benefits and risk of using a contraceptive when consulting with your doctor throughout 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 connection with the administration of gestagens has not been established, cholestatic jaundice, pruritus, cholelithiasis, chorea, pregnant herpes, otosclerosis, deafness, and the development of hemolytic-uremic syndrome are possible with their administration.
The interaction between oral contraceptives and other drugs can lead to breakthrough bleeding and / or to 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 oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin and drugs containing St. John's wort (Hypericum perforatum)).
Women who use 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, the use of a non-hormonal method of contraception should be considered.
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 can 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, you should read the instructions for use of these drugs.
How to take, course of administration and dosage
The drug should be taken 1 tablet / day, daily, at the same time, for 28 days, in the order indicated on the package. Acceptance of each subsequent package should begin immediately after the previous one, without any interruption. The taken tablet can be washed down with a small amount of liquid.
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 the day after taking the last active pill of the combined oral contraceptive (the 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 tablets, a patch, a ring, or on the day after taking a placebo of the tablets 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): 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 the 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 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 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.
There are no reports of any serious complications of 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.