Dionelle

Overdose

Symptoms: no serious side effects from overdose have been reported. Nausea, vomiting, and small vaginal bleeding or spotting may occur.

Treatment: there is no specific antidote, symptomatic treatment should be carried out.

Contraindications

Janine® it should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be discontinued immediately:

hypersensitivity to any of the components of the drug Janine®,

thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders),

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) currently or in the anamnesis,

migraine with current or a history of focal neurological symptoms,

diabetes mellitus with vascular complications,

multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart,

uncontrolled arterial hypertension,

serious surgical intervention with prolonged immobilization,

smoking over the age of 35,

pancreatitis with severe hypertriglyceridemia currently or in the anamnesis,

liver failure and severe liver diseases (before normalization of liver tests),

liver tumors (benign or malignant) currently or in the anamnesis,

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspected of them,

vaginal bleeding of unknown origin,

pregnancy or suspected pregnancy,

breast-feeding period.

WITH CAUTION

The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors:

risk factors for thrombosis and thromboembolism: smoking, obesity (dyslipoproteinemia), hypertension, migraine, valvular heart disease, prolonged immobilization, serious surgery, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives),

other diseases that may cause peripheral circulatory disorders: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins,

hereditary angioedema,

hypertriglyceridemia,

liver diseases,

diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder diseases, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham chorea),

the postpartum period.

Dionelle® it should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking the drug, the drug should be discontinued immediately:

hypersensitivity to any of the components of the drug Dionelle®,

thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders),

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) currently or in the anamnesis,

migraine with current or a history of focal neurological symptoms,

diabetes mellitus with vascular complications,

multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart,

uncontrolled arterial hypertension,

serious surgical intervention with prolonged immobilization,

smoking over the age of 35,

pancreatitis with severe hypertriglyceridemia currently or in the anamnesis,

liver failure and severe liver diseases (before normalization of liver tests),

liver tumors (benign or malignant) currently or in the anamnesis,

identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspected of them,

vaginal bleeding of unknown origin,

pregnancy or suspected pregnancy,

breast-feeding period.

WITH CAUTION

The potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors:

risk factors for thrombosis and thromboembolism: smoking, obesity (dyslipoproteinemia), hypertension, migraine, valvular heart disease, prolonged immobilization, serious surgery, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives),

other diseases that may cause peripheral circulatory disorders: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins,

hereditary angioedema,

hypertriglyceridemia,

liver diseases,

diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder diseases, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham chorea),

the postpartum period.

The drug Dionelle® it should not be used in the presence of any of the conditions / diseases listed below. If any of these conditions develops for the first time while taking it, the drug should be immediately discontinued.

hypersensitivity to any of the components of the drug Dionelle®,

thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction),

conditions preceding thrombosis (including angina pectoris) currently or in the anamnesis,

cerebrovascular disease: stroke, transient ischemic attacks currently and in history,

multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries of the heart, severe dyslipoproteinemia, uncontrolled arterial hypertension, serious surgery, prolonged immobilization, surgical interventions on the lower extremities and pelvic organs, neurosurgical interventions, smoking over the age of 35 years,

congenital or acquired predisposition to arterial or venous thrombosis (resistance to activated protein C (including Leyden factor 5), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, presence of antibodies to phospholipids (anticardiolipin, lupus anticoagulant),

migraine with current or a history of focal neurological symptoms,

diabetes mellitus with vascular complications,

pancreatitis with severe hypertriglyceridemia currently or in the anamnesis,

liver failure and severe liver diseases (before normalization of liver enzymes), including Rotor and Dubin-Johnson syndromes,

liver tumors (benign or malignant) currently or in the anamnesis,

identified hormone-dependent malignancies (including those of the genitals or mammary glands) or suspected of them,

vaginal bleeding of unknown origin,

pregnancy or suspected pregnancy,

breastfeeding period,

galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (the drug contains lactose),

obesity (body mass index greater than 30 kg / m2),

extensive trauma,

the drug Dionelle® not intended for use in men.

With caution: The potential risk and expected benefit of COC use should be carefully weighed in each individual case in the presence of the following diseases/conditions and risk factors.

risk factors for thrombosis and thromboembolism: smoking, obesity (body mass index greater than 30 kg / m2), dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives),

other diseases that may cause peripheral circulatory disorders: diabetes mellitus, cancer, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins,

hereditary angioedema,

hypertriglyceridemia,

diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder diseases, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham chorea),

the postpartum period.

Incompatibilities

Some drugs may reduce the effectiveness of the drug Dionelle®. These include drugs used for the treatment of:

- epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) - it is necessary to use barrier methods of contraception during the entire cycle of therapy and for another 28 days after its end,

- tuberculosis (e.g. rifampicin, rifabutin) and HIV infections (e.g. ritonavir, nevirapine) - it is necessary to use barrier methods of contraception during the entire cycle of therapy and for another 28 days after its end,

- antibiotics for the treatment of some other infectious diseases (e.g. penicillin, tetracyclines, griseofulvin) - it is necessary to use barrier methods of contraception during the entire cycle of therapy and for another 7 days after its end,

- Drugs based on St. John's wort (used for the treatment of depressive states) - it is necessary to use barrier methods of contraception during the entire cycle of therapy and for another 28 days after its end. The drug Dionelle® it can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.

Some drugs can affect the metabolism of the active components of the drug Dionelle®. These include:

- antifungal drugs (e.g. ketoconazole),

- N2- blockers for the treatment of gastric and duodenal ulcer (e.g. cimetidine),

- some drugs for the treatment of arterial hypertension (for example, verapamil, diltiazem),

- antibiotics for the treatment of bacterial infections (macrolides, such as erythromycin),

- antidepressants,

- grapefruit juice.

You should always tell your doctor what medications (including herbal medicines) the woman is taking or has recently taken. It is also necessary to inform any doctor, including a dentist who prescribes other drugs, as well as the pharmacist who sells the drug, that the patient is taking the drug Dionelle®.

In some cases, the doctor may recommend that the woman additionally use a barrier method of contraception (condom).

Undesirable effects

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

Against the background of taking the drug Janine® in women, other undesirable effects were observed, as indicated in the table below. Within each group, allocated according to the frequency of the undesirable effect, the undesirable effects are presented in descending order of severity.

By frequency, adverse effects are divided into frequent (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), and rare (≥1/10000 and <1/1000). For additional undesirable effects identified only in the course of post-marketing observations and for which it is not possible to estimate the frequency, "frequency unknown" is indicated.

The following adverse effects have been reported in women receiving CCP (see also section " Special instructions»):

- venous thromboembolic complications,

- arterial thromboembolic complications,

- cerebrovascular complications,

- hypertension,

- hypertriglyceridemia,

- changes in glucose tolerance or effects on peripheral tissue insulin resistance,

- liver tumors (benign or malignant),

- impaired liver function,

- chloasma,

- in women with hereditary angioedema, exogenous estrogens can cause an exacerbation of symptoms,

- the occurrence or aggravation of conditions for which the relationship with the use of PDA is not clearly proven: jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham chorea, herpes of pregnant women, otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

In women who use PDAs, there is a very small increase in the frequency of detection of breast cancer. Since breast cancer rarely occurs in women under 40, given the overall risk of developing breast cancer, the additional number of cases is very small. The relationship with the use of PDA is not known. For more information, see the sections "Contraindications" and "Special instructions".

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

Against the background of taking the drug Dionelle® in women, other undesirable effects were observed, as indicated in the table below. Within each group, allocated according to the frequency of the undesirable effect, the undesirable effects are presented in descending order of severity.

By frequency, adverse effects are divided into frequent (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), and rare (≥1/10000 and <1/1000). For additional undesirable effects identified only in the course of post-marketing observations and for which it is not possible to estimate the frequency, "frequency unknown" is indicated.

The following adverse effects have been reported in women receiving CCP (see also section " Special instructions»):

- venous thromboembolic complications,

- arterial thromboembolic complications,

- cerebrovascular complications,

- hypertension,

- hypertriglyceridemia,

- changes in glucose tolerance or effects on peripheral tissue insulin resistance,

- liver tumors (benign or malignant),

- impaired liver function,

- chloasma,

- in women with hereditary angioedema, exogenous estrogens can cause an exacerbation of symptoms,

- the occurrence or aggravation of conditions for which the relationship with the use of PDA is not clearly proven: jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham chorea, herpes of pregnant women, otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

In women who use PDAs, there is a very small increase in the frequency of detection of breast cancer. Since breast cancer rarely occurs in women under 40, given the overall risk of developing breast cancer, the additional number of cases is very small. The relationship with the use of PDA is not known. For more information, see the sections "Contraindications" and "Special instructions".

When taking the drug Dionelle® irregular bleeding (spotting spotting or breakthrough uterine bleeding) may occur, especially during the first months of use.

Against the background of taking the drug Dionelle® other undesirable effects may also occur, although their occurrence is not necessarily in all patients.

Serious adverse effects. Cm. "With caution» and "Special Instructions". You should read these sections carefully and consult your doctor if you experience any adverse effects, including serious reactions associated with the use of the drug.

Side effects identified during the administration of the active substances of the drug. Side effects detected during the administration of the active substances of the drug Dionelle®, are given with a distribution by frequency of development and by organ systems. The frequency of side effects was classified as follows: very common (>1/10), common (>1/100, <1/10), infrequent (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000, including individual cases), unspecified frequency.

Infectious and parasitic diseases: infrequently-vaginitis, vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections, rarely-salpingoophoritis (adnexitis), urinary tract infections, mastitis, cervicitis, fungal infections, herpetic lesions of the oral cavity, influenza, bronchitis, sinusitis, upper respiratory tract infections, viral infection.

Benign, malignant, and unspecified neoplasms (including cysts and polyps): infrequently-ovarian cysts, rarely-cysts of the uterus appendages, uterine fibroids, breast lipoma, breast cysts, fibrocystic mastopathy.

From the blood and lymphatic system: rarely-anemia.

On the part of the immune system: rarely-allergic reactions.

From the endocrine system: rarely-virilism.

From the side of metabolism and nutrition: rarely-increased appetite, rarely-anorexia.

Mental disorders: rarely-depression, very rarely-mood changes, unspecified frequency-decreased mood, insomnia, sleep disorders, aggression.

From the nervous system: often-headache, infrequently-dizziness, migraine, rarely-ischemic stroke, cerebrovascular disorders, dystonia.

On the part of the visual organ: rarely-dryness of the eye mucosa, irritation of the eye mucosa, oscillopsia, unspecified frequency-intolerance to contact lenses (unpleasant sensations when wearing them).

On the part of the organ of hearing and labyrinth disorders: rarely-sudden hearing loss, tinnitus, dizziness, hearing impairment.

From the heart: rarely-cardiovascular disorders, tachycardia.

From the side of the vessels: infrequently-increase, decrease in blood pressure, rarely-venous and arterial thrombosis and thromboembolism, thrombophlebitis, increased diastolic pressure, orthostatic circulatory dystonia, "hot flashes", varicose veins, venous diseases, pain along the veins.

From the respiratory system, chest and mediastinal organs: rarely-bronchial asthma, hyperventilation.

From the gastrointestinal tract: infrequently-abdominal pain, discomfort, bloating, nausea, vomiting, diarrhea, rarely — gastritis, enteritis, dyspepsia.

From the skin and subcutaneous tissues: infrequently-acne, alopecia, rash, including macular rash, itching (including generalized itching), rarely-allergic dermatitis, atopic dermatitis, neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, hyperpigmentation, seborrhea, dandruff, hirsutism, skin reaction-cellulite, vascular asterisks, unspecified frequency-urticaria, erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue disorders: rarely-back pain, discomfort in the muscles and skeleton, myalgia, pain in the extremities.

From the genitals and breast: often-pain in the mammary glands, a feeling of discomfort, infrequently-changes in the duration and volume of menstrual-like bleeding, including heavy menstrual-like bleeding, scanty menstrual-like spotting and the absence of menstrual-like spotting, acyclic bleeding, in t.tsch. vaginal bleeding and metrorrhagia, breast enlargement, swelling and swelling in the breast, breast edema, painful menstrual-like spotting, vaginal discharge, pelvic pain, rarely-cervical epithelial dysplasia, dyspareunia, galactorrhea, unspecified frequency-discharge from the mammary glands, decreased libido, increased libido

General disorders and disorders: infrequently-fatigue, asthenia, poor health, changes in body weight (increase, decrease and fluctuations in body weight), rarely-chest pain, peripheral edema, flu-like phenomena, fever, irritability, unspecified frequency-fluid retention.

Influence on the results of laboratory and instrumental studies: rarely-hypertriglyceridemia, hypercholesterolemia.

The following serious adverse events have been reported in women using COC (which includes Dionelle®):

- venous thromboembolic disorders,

- arterial thromboembolic disorders,

- stroke,

- increased blood pressure,

- hypertriglyceridemia,

- impaired glucose tolerance or effects on peripheral insulin resistance,

- liver tumors (benign and malignant),

- violation of the functional parameters of the liver,

- chloasma,

- in women with hereditary angioedema, exogenous estrogens can cause or exacerbate the symptoms of angioedema.

- the onset or deterioration of conditions for which there is a connection with the use of COC (which includes the drug Dionelle®) is not indisputable: jaundice and / or itching associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham chorea, herpes during previous pregnancy, hearing loss associated with otosclerosis, Crohn's disease, ulcerative colitis, cervical cancer,

- visual impairment,

- vertigo,

- pancreatitis,

- cholecystitis.

The frequency of breast cancer diagnosis in women using COC (which includes the drug Dionelle®), increased very slightly. Breast cancer is rarely seen in women under 40 years of age, the excess frequency is insignificant in relation to the overall risk of breast cancer.

The causal relationship of the occurrence of breast cancer with the use of COC has not been established. For more information, see "Contraindications" and "Special instructions".

If you notice any undesirable effects that are not listed in the description, you should inform your doctor.

Therapeutic indications

Contraception.

Contraception.

contraception (prevention of unwanted pregnancy),

treatment of mild to moderate acne in women who need contraception, with the ineffectiveness of other treatment methods (local treatment or the use of systemic antibiotics).

Pharmacotherapeutic group

• Combined contraceptive (progestogen estrogen) [Estrogens, progestogens, their homologs and antagonists in combinations]

Pharmacodynamic properties

The contraceptive effect of Janine® It is carried out through various complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, as a result of which it becomes impervious to sperm.

When used correctly, the Perl index (a measure that reflects the number of pregnancies in 100 women taking the contraceptive during the year) is less than 1. If you skip the tablets or use them incorrectly, the Pearl index may increase.

The gestagenic component of Janine® - dienogest-has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of HDL).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, the intensity and duration of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases. In addition, there is evidence of a reduced risk of endometrial cancer and ovarian cancer.

The contraceptive effect of Dionellea® It is carried out through various complementary mechanisms, the most important of which are the suppression of ovulation and the change in the viscosity of the cervical mucus, as a result of which it becomes impervious to sperm.

When used correctly, the Perl index (a measure that reflects the number of pregnancies in 100 women taking the contraceptive during the year) is less than 1. If you skip the tablets or use them incorrectly, the Pearl index may increase.

The progestogenic component of Dionellea® - dienogest-has antiandrogenic activity, which is confirmed by the results of a number of clinical studies. In addition, dienogest improves the blood lipid profile (increases the amount of HDL).

In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, the intensity and duration of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases. In addition, there is evidence of a reduced risk of endometrial cancer and ovarian cancer.

The drug Dionelle® - low-dose monophasic oral combined estrogen-gestagenic contraceptive drug.

The contraceptive effect of the drug Dionelle® It is based on the combined action of various factors, the most important of which is the suppression of ovulation and an increase in the viscosity of the secret of the cervix.

Progestogenic component of Dionelle® - dienogest-is a derivative of nortestosterone and has an antiandrogenic effect. Dienogest also has a beneficial effect on the lipid profile, increasing the HDL content.

In women taking COC, the cycle becomes more regular, painful menstruation is less frequent, and the intensity and duration of bleeding decreases.

Pharmacokinetic properties

Dienogest

Absorption. After oral administration, dienogest is rapidly and almost completely absorbed. Cmax in the blood plasma (51 ng / ml) is reached in (2.4±1.4) hours after taking a single dose. Bioavailability in combination with ethinyl estradiol is about 96%.

Distribution. Dienogest binds to serum albumin (90%) and does not bind to specific transport proteins — SHBG and corticosteroid-binding globulin (CSG). Any effect on the physiological transport processes of endogenous steroids is unlikely. The increase in the concentration of SHBG induced by ethinylestradiol does not affect the binding of dienogest to serum proteins.

Metabolism. Dienogest is metabolized primarily by hydroxylation, but also by hydrogenation, conjugation, and aromatization to form inactive metabolites. The total clearance after taking a single dose is 3.6 l/h.

Output. T1/2 dienogest is 8.5-10.8 hours. A small amount of dienogest is excreted unchanged by the kidneys. Its metabolites are excreted by the kidneys and with bile in a ratio of 3:1. T1/2 the total number of metabolites is 14.4 hours.

Css. The pharmacokinetics of dienogest are not affected by the concentration of SHBG. After taking a daily dose, the concentration of the drug in the blood plasma increases approximately 1-5 times, and equilibrium is achieved after taking about 4 daily doses.

Ethinyl Estradiol

Absorption. After oral administration, ethinylestradiol is rapidly and completely absorbed. Cmax in blood plasma (67 ng / ml) is reached within 1.5-4 hours. During absorption and first passage through the liver, ethinylestradiol is metabolized, resulting in an average oral bioavailability of 44%.

Distribution. Ethinylestradiol is almost completely (98%), although non-specifically, bound by albumin. Ethinylestradiol induces the synthesis of SHBG. Fixed Vd ethinyl estradiol is 2.8–8.6 l/kg.

Metabolism. Ethinylestradiol undergoes presystemic conjugation both in the mucosa of the small intestine and in the liver. The main pathway of metabolism is aromatic hydroxylation, followed by conjugation with glucuronic and / or sulfuric acids. The rate of metabolic clearance from blood plasma is 2.3–7 ml/min/kg.

Output. The concentration of ethinyl estradiol in the blood plasma decreases, and the decrease is biphasic, the first phrase is characterized by T1/2 about 1 hour, the second — 10-20 hours. In an unmodified form is not displayed. Ethinylestradiol metabolites are excreted by the kidneys and liver in a ratio of 4: 6, with T1/2 for about 24 hours.

Css. It is achieved during the second half of the treatment cycle, when the levels of the drug in the serum become 2 times higher compared to a single dose.

Name of the medicinal product

Dionelle

Qualitative and quantitative composition

Dienogest, Ethinyl Estradiol

Dosage (Posology) and method of administration

Inside, with a small amount of water, daily at about the same time of day, in the order indicated on the package. Take 1 tablet per day, continuously for 21 days. The next package begins after a 7-day break in the intake of pills, during which there is usually a withdrawal bleeding. Bleeding usually begins on the 2-3-th day after taking the last dragee and may not end before the start of taking a new package.

Zhanin's reception® they start:

- in the absence of taking any hormonal contraceptives in the previous month. Zhanin's reception® it begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills from the first package,

- when switching from other combined oral contraceptives (from the vaginal ring, transdermal patch). It is preferable to start taking Janine® the day after taking the last active dragee from the previous package, but in no case later than the day after the usual 7-day break (for drugs containing 21 dragees), or after taking the last inactive dragee (for drugs containing 28 dragees in the package). When switching from the vaginal ring, transdermal patch, it is preferable to start taking Janine® on the day of removal of the ring or patch, but not later than the day when a new ring should be inserted or a new patch applied,

- when switching from contraceptives containing only progestogens ("mini-pili", injectable forms, implants), or an intrauterine contraceptive releasing progestogen (Mirena). A woman can switch from "mini-pili" to Janine® on any day (without a break), from the implant or intrauterine contraceptive with gestagen - on the day of its removal, from the injection form-from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills,

- after an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection,

- after childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking the drug on the 21st-28th day after delivery or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. If the woman has already lived a sexual life, before the start of taking Zhanin® pregnancy should be excluded or it is necessary to wait for the first menstruation.

Reception of missed pills. If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. The woman should take the pills as soon as possible, the next one is taken at the usual time.

If the delay in taking pills was more than 12 hours, contraceptive protection may be reduced. In this case, you can follow the following two basic rules:

- the drug should never be interrupted for more than 7 days,

- to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous intake of pills are required.

If the delay in taking the pills was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), the following tips can be given.

The first week of taking the drug

A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) should be used for the next 7 days. If sexual intercourse took place within a week before skipping the pills, it is necessary to take into account the probability of pregnancy. The more pills missed and the closer the break in the intake of active substances, the greater the likelihood of pregnancy.

The second week of taking the drug

A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time.

Provided that the woman took the pills correctly during the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of a decrease in reliability is inevitable due to the upcoming break in the intake of pills.

A woman should strictly adhere to one of the following two options (if in the 7 days preceding the first missed pill, all the pills were taken correctly, there is no need to use additional contraceptive methods):

1. A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time, until the dragees from the current package run out. The next package should be started immediately. Withdrawal bleeding is unlikely until the second package is finished, but spotting and breakthrough bleeding may occur while taking pills.

2. A woman can also stop taking pills from the current package. Then she should take a break for 7 days, including the day of skipping the pills, and then start taking a new package.

If a woman has missed taking pills and then during a break in taking pills she does not have withdrawal bleeding, it is necessary to exclude pregnancy.

Advice in case of vomiting and diarrhea

If a woman has had vomiting or diarrhea within up to 4 hours after taking active pills, absorption may be incomplete, and additional contraceptive measures should be taken. In these cases, you should follow the recommendations when skipping taking pills.

Changing the day of the beginning of the menstrual cycle

In order to delay the start of menstruation, a woman should continue taking pills from a new package of Zhanin® immediately after taking all the pills from the previous one, without a break in the reception. The pills from this new package can be taken for as long as the woman wants (until the package is finished). Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. To restart Janine® from the new pack follows after the usual 7-day break.

In order to move the day of the beginning of menstruation to another day of the week, a woman should be recommended to shorten the nearest break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding during the second package (as well as in the case when she would like to delay the start of menstruation).

Additional information for special categories of patients

Children and teenagers. The drug Zhanin® it is shown only after the onset of menarche.

Elderly patients. Not applicable. The drug Zhanin® it is not indicated after the onset of menopause.

Patients with disorders of the liver. The drug Zhanin® it is contraindicated in women with severe liver diseases until the liver function indicators return to normal (see also the section "Contraindications").

Patients with kidney disorders. The drug Zhanin® It has not been specifically studied in patients with renal impairment. The available data do not suggest a change in treatment in such patients.

Inside, with a small amount of water, daily at about the same time of day, in the order indicated on the package. Take 1 tablet per day, continuously for 21 days. The next package begins after a 7-day break in the intake of pills, during which there is usually a withdrawal bleeding. Bleeding usually begins on the 2-3-th day after taking the last dragee and may not end before the start of taking a new package.

Dionellea Reception® they start:

- in the absence of taking any hormonal contraceptives in the previous month. Dionellea Reception® it begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills from the first package,

- when switching from other combined oral contraceptives (from the vaginal ring, transdermal patch). It is preferable to begin receiving Dionellea® the day after taking the last active dragee from the previous package, but in no case later than the day after the usual 7-day break (for drugs containing 21 dragees), or after taking the last inactive dragee (for drugs containing 28 dragees in the package). When switching from the vaginal ring, transdermal patch, it is preferable to start taking Dionellea® on the day of removal of the ring or patch, but not later than the day when a new ring should be inserted or a new patch applied,

- when switching from contraceptives containing only progestogens ("mini-pili", injectable forms, implants), or an intrauterine contraceptive releasing progestogen (Mirena). A woman can switch from "mini-pili" to Dionelle® on any day (without a break), from the implant or intrauterine contraceptive with gestagen - on the day of its removal, from the injection form-from the day when the next injection should have been made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills,

- after an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection,

- after childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking the drug on the 21st-28th day after delivery or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. If the woman has already lived a sexual life, before taking Dionellea® pregnancy should be excluded or it is necessary to wait for the first menstruation.

Receiving missed pills. If the delay in taking the drug was less than 12 hours, the contraceptive protection is not reduced. The woman should take the pills as soon as possible, the next one is taken at the usual time.

If the delay in taking pills was more than 12 hours, contraceptive protection may be reduced. In this case, you can follow the following two basic rules:

- the drug should never be interrupted for more than 7 days,

- to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation, 7 days of continuous intake of pills are required.

If the delay in taking the pills was more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), the following tips can be given.

The first week of taking the drug

A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) should be used for the next 7 days. If sexual intercourse took place within a week before skipping the pills, it is necessary to take into account the probability of pregnancy. The more pills missed and the closer the break in the intake of active substances, the greater the likelihood of pregnancy.

The second week of taking the drug

A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time.

Provided that the woman took the pills correctly during the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more pills, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

The third week of taking the drug

The risk of a decrease in reliability is inevitable due to the upcoming break in the intake of pills.

A woman should strictly adhere to one of the following two options (if in the 7 days preceding the first missed pill, all the pills were taken correctly, there is no need to use additional contraceptive methods):

1. A woman should take the last missed dragee as soon as possible (even if this means taking two dragees at the same time). The next dragee is taken at the usual time, until the dragees from the current package run out. The next package should be started immediately. Withdrawal bleeding is unlikely until the second package is finished, but spotting and breakthrough bleeding may occur while taking pills.

2. A woman can also stop taking pills from the current package. Then she should take a break for 7 days, including the day of skipping the pills, and then start taking a new package.

If a woman has missed taking pills and then during a break in taking pills she does not have withdrawal bleeding, it is necessary to exclude pregnancy.

Advice in case of vomiting and diarrhea

If a woman has had vomiting or diarrhea within up to 4 hours after taking active pills, absorption may be incomplete, and additional contraceptive measures should be taken. In these cases, you should be guided by the recommendations when skipping the intake of pills.

Changing the day of the beginning of the menstrual cycle

In order to delay the start of menstruation, a woman should continue taking pills from a new package of Dionellea® immediately after taking all the pills from the previous one, without a break in the reception. The pills from this new package can be taken for as long as the woman wants (until the package is finished). Against the background of taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume receiving Dionellea® from the new pack follows after the usual 7-day break.

In order to move the day of the beginning of menstruation to another day of the week, a woman should be recommended to shorten the nearest break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and will continue to have spotting and breakthrough bleeding during the second package (as well as in the case when she would like to delay the start of menstruation).

Additional information for special categories of patients

Children and teenagers. The drug Dionelle® it is shown only after the onset of menarche.

Elderly patients. Not applicable. The drug Dionelle® it is not indicated after the onset of menopause.

Patients with disorders of the liver. The drug Dionelle® it is contraindicated in women with severe liver diseases until the liver function indicators return to normal (see also the section "Contraindications").

Patients with kidney disorders. The drug Dionelle® It has not been specifically studied in patients with renal impairment. The available data do not suggest a change in treatment in such patients.

When and how to take Dionelle®

The drug Dionelle® take inside one tablet a day, without chewing and drinking a small amount of water, at the same time every day. Tablets are taken for 21 days without a break according to the scheme indicated on the blister. Each blister contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken. For the next 7 days, the tablets are not taken. During this period, menstrual-like bleeding (withdrawal bleeding) should begin. It usually begins 2-3 days after taking the last tablet of the drug Dionelle®.

After a 7-day break, on the 8th day, start taking tablets from a new package (if the package contains 21 tablets) or a blister (if the package contains 63 tablets), even if the bleeding has not stopped yet. This means that the patient will always start a new package (blister) on the same day of the week and every month the withdrawal bleeding will occur on about the same day.

How to start taking Dionelle®

In the absence of taking any hormonal contraceptives in the previous month. Taking the drug Dionelle® start on the first day of the natural menstrual cycle (i.e., on the first day of menstrual bleeding). Take a pill marked with the corresponding day of the week. For example, if menstruation begins on a Friday, take a pill marked with letters denoting Friday. Then continue to take the pills on the following days in the prescribed manner. It is also acceptable to start taking it from the 2nd-5th day of the cycle, but in this case it is recommended to additionally use a barrier method of contraception (condom) during the first 7 days of taking tablets from the first package (blister).

When switching from other COCs, a contraceptive vaginal ring, or a contraceptive patch. You can start taking the drug Dionelle® the day after taking the last tablet from the previous package of COC (i.e. without a break in the reception). If the previous package also contained inactive tablets (without the active substance), you can start using the drug Dionelle® the day after taking the last active pill. You can also start taking it later, but in no case later than the next day, after the usual break in the reception (a break of 7 days for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in the package).

In the case of using a contraceptive patch or a contraceptive vaginal ring, take the drug Dionelle® you should start on the day of their removal, but not later than the day when a new ring should be inserted or a new patch applied.

When switching from oral contraceptives containing only progestogen (mini-pili). The patient can stop taking the mini-pili any day and start taking the drug Dionelle® the next day, at the same time. During the first 7 days of taking the pills, it is also necessary to use an additional barrier method of contraception.

When switching from an injectable contraceptive, implant, or intrauterine contraceptive (intrauterine device) that releases progestogen. Start taking Dionelle® on the day when the next injection should be made or on the day of removal of the implant or intrauterine contraceptive. During the first 7 days of taking the pills, it is also necessary to use an additional barrier method of contraception.

After giving birth. Immediately after the birth of the child, the doctor may recommend that the patient wait until the end of the first normal menstrual cycle before starting the drug Dionelle®. Sometimes, on the recommendation of a doctor, you can start taking the drug earlier.

After a spontaneous miscarriage or abortion in the first trimester of pregnancy. You should consult your doctor. It is usually recommended to start taking the drug immediately.

If you miss taking the drug Dionelle®.

If the delay in taking the next pill is less than 12 hours, the contraceptive effect of the drug Dionelle® saved. You should take the pill as soon as the patient remembers about it. Take the next pill at the usual time.

If the delay in taking the pills was more than 12 hours, contraceptive protection may be reduced. The more consecutive pills are missed and the closer this pass is to the beginning of the reception or to the end of the reception, the higher the risk of pregnancy.

In this regard, you can follow the following rules:

- skipped more than 1 table. from the package (blister). You should consult your doctor,

- missed 1 table. in the 1st week of taking the drug. Take the missed pill as soon as possible, as soon as the patient remembers (even if this means taking 2 tablets at the same time). Take the next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse was within a week before skipping the pill, you need to consider the likelihood of pregnancy. Consult your doctor immediately,

- missed one tablet in the 2nd week of taking the drug. Take the missed pill as soon as possible, as soon as the patient remembers (even if this means taking 2 tablets at the same time). Take the next pill at the usual time. If the patient took the pills correctly during the 7 days preceding the first missed pill, the contraceptive effect of the drug Dionelle® it persists, and the woman does not need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception for 7 days.

- missed one tablet on the 3rd week of taking the drug. If all the pills were taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods if the patient will adhere to any of the following two options.

1. Take the missed pill as soon as possible, as soon as the woman remembers (even if this means taking 2 tablets at the same time). Take the next pill at the usual time. Start the next package (blister) immediately after the end of taking the tablets from the current package (blister), so there will be no break between packages (blisters). Withdrawal bleeding is unlikely until you run out of tablets from the 2nd package (blister), but there may be spotting or breakthrough uterine bleeding on the days of taking the drug.

2. Stop taking the tablets from the current package (blister), take a break for 7 or less days (including the day of skipping the pill) , and then start taking the tablets from the new package (blister). If there is no expected menstrual-like bleeding after the pill break, the woman may be pregnant. You should consult your doctor before you start taking tablets from a new package (blister).

In situations where a woman is advised to stop taking Dionelle® or its reliability may be reduced, you should refrain from sexual contact or use non-hormonal contraceptive methods (for example, a condom or other barrier methods). You should not use the rhythm or temperature methods. These methods may be unreliable, as taking COC leads to changes in basal temperature and cervical mucus.

In case of discontinuation of the drug Dionelle®

You can stop taking the drug Dionelle® anytime. If you stop taking it due to the desire to become pregnant, it is usually recommended to wait for the first normal menstruation and only then try to get pregnant. With this method, it is easier to set the date of birth.

Recommendations for gastrointestinal disorders

In case of vomiting or diarrhea, the active ingredients of the drug Dionelle® may not be fully absorbed. If vomiting continues for 3-4 hours after taking a contraceptive pill, the result may be the same as if you skip taking the pill. You should act as recommended if you miss taking the pill. In case of severe diarrhea, you should consult your doctor.

Delaying the onset of menstrual-like bleeding

You can delay the onset of menstrual bleeding if you start taking pills from the next package (if the package contains 21 tablets) or a blister (if the package contains 63 tablets).) immediately after the end of the current package (blister). You can take the pills for as long as the woman wants, or until the pills in the package (blister) run out. If it is necessary for the withdrawal bleeding to begin, you should simply stop taking the pills. While taking Dionelle tablets® from the new package (blister), heavy or smearing spotting may appear. Start taking tablets from the next package (blister) after the usual 7-day interval.

Changing the day of onset of menstrual-like bleeding

If a woman takes the pills, strictly following all the recommendations, menstrual-like bleeding occurs approximately on the same days every 4 weeks. If you need to change these days, you should simply shorten (but in no case extend) the next interval without taking the pills. For example, bleeding begins on Fridays, and it is necessary that it begins on Tuesdays (3 days earlier), then you need to start taking tablets from a new package (blister) 3 days earlier than usual. If the interval without taking the pills is too short, bleeding may not occur at all in this interval. However, while taking tablets from a new package (blister), there may be abundant or smearing spotting

Additional information for individual patient groups

Children and teenagers. The drug Dionelle® it is shown only after the onset of menarche.

Elderly patients. Not applicable. The drug Dionelle® it is not indicated after the onset of menopause.

Patients with impaired liver function. The drug Dionelle® is contraindicated in women with severe liver disease as long as liver function tests have not come back to normal (also see "Contraindications").

Patients with impaired renal function. Application of the drug Dionelle® it has not been specifically studied in patients with impaired renal function. The available data do not suggest a change in the dosage regimen in such patients.