Denovel 30, 21 tablets — Made in Germany — Free Delivery
(Denovel 30)
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Description Denovel 30, 21 tablets — Made in Germany — Free Delivery
Product description
Denovel 30 is a combined oral contraceptive (CPC) with ethinyl estradiol and the progestogen Dienogest.
The contraceptive effect of the preparation Denovel 30 is based on the interaction of various factors, the most important of which are ovulation suppression and changes in cervical secretion.
In the course of clinical studies, the following Pearl index was calculated:
- unadjusted Pearl index: 0.454 (upper 95% confidence interval (CI): 0.701)
- adjusted Pearl index: 0.182 (upper 95% confidence interval: 0.358).
Dienogest is a nortestosterone derivative with an in vitro affinity for progesterone receptors, 10-30 times less than other synthetic progestogens. In vivo data in animals indicate strong progestogen activity and antiandrogen activity. Dienogest does not exhibit 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 COCs (50 micrograms of ethinyl estradiol), the risk of endometrial and ovarian cancer is reduced. As far as this CCP is concerned, it remains unclear.
Indications for use
oral contraception.
Contraindications
Combined oral contraceptives (COCs) should not be used if one of the following conditions is present. If any of these conditions or diseases occurs for the first time during the use of COCs, the preparation should be stopped immediately.
The presence of risk factors for venous thromboembolism (VTE):
- venous thromboembolism - current (when using anticoagulants) or history of VTE (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE)
- known hereditary or acquired predisposition to venous thromboembolism, such as resistance to activated protein C (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency;
- major surgical interventions with prolonged immobilization (see section "Peculiarities of application");
- high risk of venous thromboembolism due to the presence of many risk factors (see section "Peculiarities of use").
Presence of risk factors for arterial thromboembolism (ATE):
- arterial thromboembolism - the presence of arterial thromboembolism at present, the presence of arterial thromboembolism in history (for example, myocardial infarction) or a prodromal condition (for example, angina pectoris);
- cerebrovascular disease - current stroke, history of stroke, or prodromal condition (eg, transient ischemic attack (TIA)
- known hereditary or acquired tendency to arterial thromboembolism, such as hyperhomocysteinemia and the presence of antibodies to phospholipids (anti-cardiolipin antibodies, lupus anticoagulant)
- 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 history, if associated with severe hypertriglyceridemia.
Current or history of severe liver disease, while liver function tests are not normal.
Current or history of liver tumors (benign or malignant).
Or suspected malignant neoplasms (for example, of the genitals or mammary glands) that are affected by sex steroid hormones.
Established or suspected pregnancy.
Undiagnosed vaginal bleeding.
Simultaneous use with preparations containing ombitasvir / paritaprevir / ritonavir and dazabuvir (see Sections "Interaction with other medicinal products and other forms of interaction." And "Peculiarities of use").
Hypersensitivity to the active substances or to any of the components of the preparation.
Dosage and administration
For oral use.
Dosage
How to take Denovel 30
Take 1 tablet daily for 21 consecutive days at approximately the same time, with a small amount of liquid as needed, in the order indicated on the package. Taking tablets from each subsequent package should be started after the end of the seven-day break in taking the preparation, 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 pills from the next pack.
How to start treatment with Denovel 30
If hormonal contraceptives were not used in the previous period (last month)
Tablets 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 pill of the previous COC, but no later than the next day after the usual break in taking the tablets or after taking the placebo tablets of the previous COC.
Switching from a 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.
Switching from a progestogen-only method (mini-pills, injections, implants) or a progestogen intrauterine system
You can start taking the preparation Denovel 30 on any day after stopping the "mini-pili" (in the case of using an implant or intrauterine system - on the day of their removal, in the case of an injection - instead of the next injection). However, in all cases, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the preparation.
After an abortion in the first trimester of pregnancy
You can start taking the preparation immediately. In this case, there is no need to use additional contraceptives.
After childbirth or abortion in the second trimester
It is recommended to start taking the preparation from the 21-28th day after childbirth or abortion in the second trimester of pregnancy. With a later start of taking the tablets, it is recommended to additionally use a 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 COCs, 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 preparation is not reduced. The missed tablet should be taken as soon as it is found out. The next tablet in this pack should be taken at the usual time.
If the delay in taking the pill exceeds 12:00, contraception may decrease. In this case, two basic rules can be followed.
A break in taking pills can never be more than 7 days.
Adequate inhibition of the hypothalamic-pituitary-ovarian system by continuous intake of tablets for 7 days.
Accordingly, the following recommendations should be followed in daily 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 taking the tablets at the usual time. In addition, you must use a barrier method of contraception, such as a condom, for the next 7 days. If sexual intercourse took place in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer the break in taking the preparation, 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 taking the tablets at the usual time. Provided that the tablets are taken correctly within 7 days before the pass, there is no need to use additional contraceptives. However, if more than one tablet is missed, it is recommended to additionally use other methods of contraception for 7 days.
§ 3rd week
The risk of reduced reliability increases as the seven-day pill interval approaches. However, if the pill regimen is followed, a decrease in contraceptive protection can be avoided. If one of the following two options is followed, then there will be no need to use additional contraceptives, provided that the pills have been taken correctly within 7 days before the missed. Otherwise, it is recommended to stick to the first of the following options and use additional methods of contraception for the next 7 days.
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 taking the tablets at the usual time. Tablets from the next pack should be started immediately after the end of the previous one, that is, there should not be a break between taking the pills from two packs. It is unlikely that a woman will experience withdrawal bleeding before finishing her second pack of pills, although spotting or breakthrough bleeding may occur while taking the pills.
You can also stop taking the tablets from the current package. In this case, a break in taking the preparation should be up to 7 days, including the days of skipping tablets; taking the tablets should start with the next package.
If, after a missed tablet, there is no expected withdrawal bleeding during the first habitual break in taking the preparation, then pregnancy is likely.
Recommendations in case of disorders of the gastrointestinal tract
In case of severe disorders of the gastrointestinal tract, incomplete absorption of the preparation is possible, in which case additional contraceptives should be used. If vomiting began within 3-4 hours after taking the preparation, it is more likely to take a new pill. If more than 12:00 has passed, the recommendation given above in the section "Method of administration and doses", subparagraph "What to do in case of missing a pill" is acceptable. If a woman does not want to change her pill schedule, she needs to take an additional pill(s) from the next pack.
How to Delay the Onset of Withdrawal Bleeding
To delay withdrawal bleeding, you should continue to take the tablets of the preparation from the new package and do not take a break in taking the preparation. If there is a desire, the period of admission can be continued until the end of the tablets from the second package. This may result in breakthrough bleeding or spotting. Regular use of the preparation Denovel 30 is restored after the usual seven-day break in taking the tablets.
To shift the timing of withdrawal bleeding to another day of the week, it is recommended to shorten the pill break by as many days as desired. It should be noted that the shorter the break, the more often there is no withdrawal bleeding and a greater risk of breakthrough bleeding or spotting during the administration of tablets from the second pack (as in the case of delayed withdrawal bleeding).
Overdose
Acute toxicity with combined overdose of dienogest and ethinyl estradiol is very low. The likelihood of symptoms of intoxication is low even in children who have accidentally taken several pills.
In case of an overdose, nausea, vomiting, slight bleeding from the vagina are possible. Vaginal bleeding can even occur in girls before their first period if they accidentally take the preparation.
Treatment. There are no antidotes. SPECIAL.
Adverse reactions
Data on the frequency of adverse reactions to the preparation, the occurrence of which was reported in clinical studies (N = 4.942) using ethinylestradiol / dienogest as an oral contraceptive, are summarized in the following table. Within each frequency group, adverse effects are presented in descending order of their severity. The frequency is defined as follows: often (≥ 1/100 - <1/10), infrequent (≥ 1/1000 - <1/100) and rare (≥ 1/10000 - <1/1000). A list of additional adverse reactions to the preparation, which were found only during post-marketing surveillance and the frequency of which was not evaluated, is given in the "Frequency unknown" column.
special instructions
Use during pregnancy
In the event of pregnancy, the preparation should be discontinued 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 a teratogenic effect in case of inadvertent use of oral contraceptives in early pregnancy.
Animal studies have shown side effects during pregnancy and lactation. Given these data obtained in animal studies, side effects caused by the action of the active compounds cannot be ruled out. But overall experience with COC use during pregnancy has not provided evidence of actual side effects in humans.
The increased risk of VTE in the postpartum period should be taken into account when restoring the use of the preparation Denovel 30 (see Sections "Method of application and dose" and "Peculiarities of use").
COCs can affect lactation because they can reduce the amount and composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk when COCs are used. These amounts may affect the child. Therefore, the preparation Denovel 30 is not recommended to be used until the end of the period of breastfeeding.
Children
The preparation is indicated for use only after the onset of menstruation.
The ability to influence the reaction rate when driving vehicles or operating other mechanisms
A study of the effect on the ability to concentrate when driving vehicles and operating machines and mechanisms has not been conducted. In persons taking CPC, the effect of CPC on the ability to concentrate when driving vehicles and operating machines and mechanisms was not noticed.
Interaction with other medicinal products and other forms of interaction
Note: In order to identify possible types of interactions, you should read the instructions for use of preparations taken simultaneously with this preparation.
The effect of other preparations on the preparation Denovel 30
There may be an interaction with preparations 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.
Compound
active ingredients: ethinylestradiol, dienogest;
1 film-coated tablet contains ethinylestradiol 0.03 mg and dienogest 2 mg
Excipients: lactose, corn starch, maltodextrin, magnesium stearate, shell white mixture for film coating (hypromellose, lactose, titanium dioxide (E171), macrogol 4000, sodium).
Storage conditions
Keep out of the reach of children in the original packaging at a temperature not exceeding 30°C.
Shelf life - 3 years.
Tags: Denovel
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