Dienogest, Ethinyl Estradiol

Denovel 30 is a combined oral contraceptive (CPC) with ethinyl estradiol and the Dienogest progestogen.

The contraceptive effect of the drug Denovel 30 is based on the interaction of various factors, the most important of which are suppression of ovulation and a change in cervical secretion.

In clinical studies, the following Pearl index was calculated:

• Unadjusted Pearl Index: 0.454 (upper 95% confidence interval (CI): 0.701)
• Pearl adjusted index: 0.182 (upper 95% confidence interval: 0.358).

Dienogest is a derivative of nortestosterone with an in vitro affinity for progesterone receptors, 10-30 times less than in other synthetic progestogens. In vivo data in animals indicate strong progestogen activity and antiandrogen activity. Dienogest does not show significant androgenic, mineralocorticoid, or glucocorticoid activity in vivo.

The dose of dienogest, which leads to the suppression of ovulation, is 1 mg / day.

When used in high CPC (50 μg ethinyl estradiol), the risk of endometrial and ovarian cancer is reduced. The CCPs concerns, remains unclear.

Indications for use

Oral contraception

Contraindications

Combined oral contraceptives (CPC) should not be used in the presence of one of the following conditions. If any of these conditions or diseases occurs for the first time during the use of CPC, the drug should be stopped immediately.

• The presence of risk factors for venous thromboembolism (VTE):
• venous thromboembolism - the presence of VTE at present (with the use of anticoagulants) or in the anamnesis (for example, deep vein thrombosis (DVT) or pulmonary embolism (pulmonary embolism)
• hereditary or acquired tendency to venous thromboembolism is known, such as resistance to activated protein C (including Leiden factor V), antithrombin III deficiency, protein C deficiency, protein S deficiency;
• large surgical interventions with prolonged immobilization (see section "Features of use");
• high risk of venous thromboembolism due to the presence of many risk factors (see section "Peculiarities of use").
• The presence of risk factors for arterial thromboembolism (ATE):
• arterial thromboembolism - the presence of present arterial thromboembolism, a history of arterial thromboembolism (for example, myocardial infarction) or a prodromal condition (for example, angina pectoris);
• cerebrovascular disease - a current stroke, a history of stroke or a prodromal condition (e.g., transient ischemic attack (TIA)
• hereditary or acquired tendency to arterial thromboembolism is known, such as hyperhomocysteinemia and the presence of antibodies to phospholipids (antibodies to cardiolipins, lupus anticoagulant)
• the presence of a history of migraine with focal neurological symptoms;
• high risk of arterial thromboembolism due to the presence of many risk factors (see section "Peculiarities of use") or the presence of one of the risk factors, such as:
• diabetes mellitus with vascular symptoms;
• severe hypertension
• severe dyslipoproteinemia.
• Pancreatitis, including a history if it is associated with severe hypertriglyceridemia.
• The presence at present or in the history of severe liver disease, while liver function indicators are not normal.
• The presence at present or in the history of liver tumors (benign or malignant).
• Or suspected malignant neoplasms (e.g., genital organs or mammary glands) that are affected by sex steroid hormones.
• Established or suspected pregnancy.
• Undiagnosed vaginal bleeding.
• Concomitant use with medicines containing ombitasvir / paritaprevir / ritonavir and dazabuvir (seeSections "Interaction with other drugs and other types of interactions." And “Application Features”).
• Hypersensitivity to active substances or to any of the components of the drug.

Dosage and administration

For oral use.

Dosage

How to take Denovel 30

Take 1 tablet per day for 21 consecutive days at about the same time, washing down with a small amount of liquid if necessary, in the order defined on the package. Reception of tablets from each subsequent package should begin after the end of a seven-day break in taking the drug, during which withdrawal bleeding should occur. As a rule, withdrawal bleeding begins on the 2-3rd day after taking the last pill and may not end before taking the tablets from the next pack.

How to start treatment with Denovel 30

• If hormonal contraceptives in the previous period (last month) were not used

Pills should be started on the first day of the natural cycle (i.e., on the first day of menstrual bleeding).

• Switching from another PDA

It is advisable to start taking Denovel 30 tablets the next day after taking the last hormone tablets of the previous PDA, but no later than the next day after the usual break in taking the tablets or after taking the placebo tablets of the previous PDA.

• Transition from the vaginal ring or transdermal patch

Preference should be given to the use of Denovel 30 on the day of removal of the vaginal ring or transdermal patch, but no later than the day when subsequent use of these agents is necessary.

• Transition from a method based on the use of only a progestogen (mini-pills, injections, implants) or an intrauterine system with a progestogen

You can start taking Denovel 30 any day after you stop taking the "mini-pill" (in the case of using an implant or intrauterine system - on the day of their removal, in the case of injection - instead of the next injection). However, in all cases, it is recommended to additionally use the barrier method of contraception during the first 7 days of taking the drug.

• After an abortion in the first trimester of pregnancy

You can start taking the drug right away. In this case, there is no need to use additional contraceptives.

• After childbirth or abortion in the II trimester

It is recommended to start taking the drug from the 21-28th day after childbirth or abortion in the second trimester of pregnancy. At a later start of taking the tablets, it is recommended to additionally use the barrier method of contraception during the first 7 days of taking the tablets. However, if sexual intercourse has already taken place, then before starting the use of CPC, it is necessary to exclude pregnancy or wait for the onset of the first menstruation.

What to do if you miss a pill

If the delay in taking the pill does not exceed 12:00, the contraceptive effect of the drug does not decrease. A missed pill should be taken as soon as it turns out. The next tablet from this package must be taken at the usual time.

If the delay in taking the pill exceeds 12:00, contraception may decrease. In this case, you can follow two basic rules.

1. A break in taking pills can never be more than 7 days.
2. Adequate inhibition of the hypothalamus-pituitary-ovary system by continuous administration of tablets for 7 days.

In accordance with this, you should be guided by the following recommendations in everyday life:

§ 1st week

You should take the last missed tablet as soon as possible, even if you have to take two tablets at the same time. After that, continue to take the pill at the usual time. In addition, over the next 7 days it is necessary to use a barrier method of contraception, such as a condom.If sexual intercourse took place in the previous 7 days, the possibility of pregnancy should be considered. The more tablets missed and the closer the break in taking the drug, the higher the risk of pregnancy.

§ 2nd week

You should take the last missed tablet as soon as possible, even if you have to take two tablets at the same time. After that, continue to take the pill at the usual time. If you take the tablets correctly for 7 days before skipping, there is no need to use additional contraceptives. However, when skipping more than one tablet, it is recommended to additionally use other methods of contraception for 7 days.

§ 3rd week

The risk of a decrease in reliability increases with the approach of a seven-day interval in taking pills. However, if you follow the pill regimen, you can avoid a decrease in contraceptive protection. If you adhere to one of the following two options, then there will be no need for the use of additional contraceptives, provided that the tablets are taken correctly within 7 days before skipping. Otherwise, it is recommended to adhere to the first of the following options and use additional methods of contraception in the next 7 days.

1. You should take the last missed tablet as soon as possible, even if you have to take 2 tablets at the same time. After that, continue to take the pill at the usual time. Tablets from the next package should be taken immediately after the previous one, that is, there should not be a break between taking tablets from two packages. It is unlikely that a woman will have withdrawal bleeding before the end of taking the tablets from the second package, although spotting or breakthrough bleeding is possible while taking the tablets.
2. You can also stop taking pills from the current package. In this case, the break in taking the drug should be up to 7 days, including days of skipping pills; taking tablets should begin with the next package.

If, after skipping a pill, there is no expected withdrawal bleeding during the first habitual break in taking the drug, then probable pregnancy.

Recommendations for gastrointestinal disorders

In case of severe disorders of the gastrointestinal tract, incomplete absorption of the drug is possible; in this case, additional contraceptives should be used. If vomiting begins within 3-4 hours after taking the drug, it is more likely to take a new tablet. If it has passed more than 12:00, the recommendation given above in the section “Dosage and Administration”, sub-item “What to do if you miss a pill” is acceptable. If a woman does not want to change her schedule for taking pills, she needs to take an extra pill (s) with subsequent packaging.

How to delay withdrawal bleeding

To delay withdrawal bleeding, you should continue to take the drug tablets from the new package and not take a break in taking the drug. If you wish, the period of admission can be continued until the end of the tablets from the second package. In this case, breakthrough bleeding or spotting can be observed. The regular use of the drug Denovel 30 is restored after the usual seven-day break in taking the tablets.

To shift the time of withdrawal bleeding to another day of the week, it is recommended to shorten the break in taking the pills by as many days as desired. It should be noted that the shorter the break, the more often there is a lack of withdrawal bleeding and a greater risk of breakthrough bleeding or spotting during the administration of tablets from the second package (as in the case of delayed withdrawal bleeding).

Overdose

Acute toxicity with a combined overdose of dienogest and ethinyl estradiol is very low. The likelihood of symptoms of intoxication is low even in children, several tablets were accidentally taken.

In case of an overdose, nausea, vomiting, slight bleeding from the vagina are possible. Vaginal bleeding can occur even in girls before their first appearance of menstruation, if they accidentally take the drug

Treatment. No antidotes exist. SPECIAL.

Adverse reactions

Data on the frequency of adverse reactions to the drug, the occurrence of which was reported in clinical trials (N = 4.942) using ethinyl estradiol / dienogest as an oral contraceptive, are summarized in the following table. Within each frequency group, unwanted effects are presented in decreasing order of severity. The frequency is determined as follows: often (≥ 1/100 - <1/10), infrequent (≥ 1/1000 - <1/100) and rare (≥ 1/10 000 - <1/1 000). The list of additional adverse reactions to the drug that were found only during post-marketing surveillance and whose frequency of occurrence was not evaluated is given in the column “Frequency unknown”.

special instructions

Use during pregnancy

In case of pregnancy, the use of the drug must be stopped immediately.

The results of epidemiological studies do not indicate an increased risk of congenital malformations in children whose mothers took oral contraceptives before pregnancy, as well as the possibility of teratogenicity in the event of unintentional administration of oral contraceptives in early pregnancy.

Animal studies have revealed side effects during pregnancy and lactation. Given these data obtained in animal studies, side effects caused by the action of active compounds cannot be ruled out. But the general experience with CPC during pregnancy did not provide evidence of actual side effects in humans.

The increased risk of VTE in the postpartum period should be taken into account when restoring the drug Denovel 30 (see Sections "Method of application and dose" and "Features of use").

PDAs can affect lactation because they can reduce the amount and composition of breast milk. When using CPC, small amounts of birth control steroids and / or their metabolites can be excreted in milk. These amounts may affect the baby. Therefore, the drug Denovel 30 is not recommended to be used until the end of the lactation period.

Children

The drug is indicated for use only after the onset of menstruation.

The ability to influence the reaction rate when driving vehicles or other mechanisms

A study of the effect on the ability to concentrate when driving vehicles and operating machinery was not conducted. In persons taking PDAs, the effects of PDAs on the ability to concentrate while driving and operating machines and mechanisms were not noticed.

Interaction with other drugs and other types of interactions

Note: in order to identify possible types of interaction, you should familiarize yourself with the instructions for the use of drugs taken simultaneously with this drug.

The effect of other drugs on the drug Denovel 30

There may be an interaction with drugs that induce the activity of microsomal enzymes, which can lead to increased clearance of sex hormones and lead to intermenstrual bleeding and / or a decrease in the effectiveness of the contraceptive.

Structure

active substances: ethinyl estradiol, dienogest;

1 coated tablet contains 0.03 mg ethinyl estradiol and 2 mg dienogest

Excipients: lactose, corn starch, maltodextrin, magnesium stearate, a white coating shell for film coating (hypromellose, lactose, titanium dioxide (E171), macrogol 4000, sodium).

Storage conditions

Keep out of reach of children in the original packaging at a temperature not exceeding 30 ° C.

Shelf life is 3 years.