Dimia last 4 pills. Video about hormonal birth control

Drospirenone + ethinyl estradiol tablets

Composition per 1 tablet:

active ingredients: drospirenone 3.000 mg, ethinylestradiol 0.020 mg;

Excipients: lactose monohydrate 48.530 mg, corn starch 16.600 mg, pregelatinized corn starch 9.600 mg, macrogol and polyvinyl alcohol copolymer 1.450 mg, magnesium stearate 0.800 mg.

film sheath (Opadry II white * 2.000 mg): polyvinyl alcohol 0.880 mg, titanium dioxide 0.403 mg, macrogol-3350 0.247 mg, talc 0.400 mg, soy lecithin 0.070 mg.

*code 85G18490

placebo pills

Composition per 1 tablet:

microcrystalline cellulose 42.39 mg, lactose 37.26 mg, pregelatinized corn starch 9.00 mg, magnesium stearate 0.90 mg, colloidal silicon dioxide 0.45 mg.

film sheath (Opadry II green** 3.0000 mg): polyvinyl alcohol 1.2000 mg, titanium dioxide 0.7086 mg, macrogol-3350 0.6060 mg, talc 0.4440 mg, indigo carmine0.0177 mg, quinoline yellow dye 0.0177 mg, iron oxide black dye 0.0030 mg; dye sunset yellow 0.0030 mg.

** code 85F21389

For drospirenone + ethinyl estradiol tablets: round, biconvex, white or off-white film-coated tablets, marked "G73" on one side of the tablet, embossed. In cross section, the nucleus is white or almost white.

For placebo pills: To round, biconvex, green film-coated tablets. In cross section, the nucleus is white or almost white.

Dimia® is a combined monophasic oral contraceptive (COC) containing drospirenone and. According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid effect. The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. The Pearl Index, an indicator that reflects the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive, is less than 1.

Drospirenone

Suction

When taken orally, drospirenone is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration of drospirenone in serum - about 38 ng / ml - is reached approximately 1-2 hours after a single dose.

Bioavailability 76-85%. Simultaneous administration with food does not affect the bioavailability of drospirenone.

Distribution

After oral administration, plasma concentrations of drospirenone decreased with a terminal half-life of 31 hours. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. The increase in SHBG induced by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The mean apparent volume of distribution of drospirenone is 3.7±1.2 L/kg.

Metabolism

Drospirenone is extensively metabolized after oral administration. The main metabolites in blood plasma are the acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both are formed without the participation of the P450 system. Drospirenone is metabolized to a small extent by cytochrome P450 3A4 and is able to inhibit this enzyme, as well as cytochrome P450 1A1, cytochrome P450 2C9 and cytochrome P450 2C19 in vitro.

breeding

The renal clearance of metabolites of drospirenone in blood serum is 1.5 ± 0.2 ml / min / kg. Drospirenone is excreted only in trace amounts unchanged. Drospirenone metabolites are excreted by the kidneys and through the intestines with an excretion ratio of about 1.2:1.4. The half-life of metabolites by the kidneys and through the intestines is about 40 hours.

Equilibrium concentration

During the treatment cycle, the maximum equilibrium concentration of drospirenone in blood plasma is about 70 ng / ml, it is reached after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of the terminal half-life and dosing interval.

Suction

When taken orally, it is absorbed quickly and completely. The maximum concentration in blood serum - about 33 pg / ml - is reached within 1-2 hours after a single oral administration. Absolute bioavailability as a result of first-pass conjugation and first-pass metabolism is approximately 60%. Simultaneous food intake reduced the bioavailability of ethinylestradiol in approximately 25% of the examined patients; there were no other changes.

Distribution

Serum concentrations of ethinylestradiol decreased biphasically, in the final distribution phase, the half-life is approximately 24 hours. binds well but non-specifically to serum albumin (approximately 98.5%) and induces an increase in serum SHBG concentrations. The apparent volume of distribution is about 5 l/kg.

Metabolism

Ethinylestradiol is a substrate for presystemic conjugation in the mucosa of the small intestine and in the liver. It is primarily metabolized by aromatic hydroxylation, resulting in a wide range of hydroxylated and methylated metabolites, which are present both in free form and in the form of conjugates with glucuronic acid. The renal clearance of ethinylestradiol metabolites is approximately 5 ml/min/kg.

breeding

Unchanged is practically not excreted from the body. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. The half-life of the metabolite is about 24 hours.

Equilibrium concentration

The equilibrium concentration occurs in the second half of the treatment cycle, and the serum concentration of ethinylestradiol increases by 2.0-2.3 times.

Pharmacokineticsat special patient groups

In case of impaired renal function

The equilibrium concentration of drospirenone in plasma in women with mild renal insufficiency (creatinine clearance (CC) 50-80 ml / min) was comparable to the corresponding values ​​in women with normal renal function (CC > 80 ml / min). In women with moderate renal insufficiency (CC from 30 ml / min to 50 ml / min), the plasma concentration of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. Drospirenone did not have a clinically significant effect on the content of potassium in the blood serum. Pharmacokinetics in severe renal insufficiency has not been studied.

In violation of liver function

Drospirenone is well tolerated by patients with mild to moderate liver failure (Child-Pugh class B). Pharmacokinetics in severeliver failure has not been studied.

Oral contraception.

Dimia®, like other combined oral contraceptives (COCs), is contraindicated in any of the following conditions:

Thrombosis (arterial and venous) and thromboembolism at present or in history (including thrombosis, deep vein thrombophlebitis; pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders). Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

Multiple or severe risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, cerebrovascular or coronary artery disease; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35, obesity with a body mass index > 30 kg/m2;

Hereditary or acquired predisposition to venous or arterial thrombosis, for example, resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

Pregnancy and suspicion of it;

lactation period;

Pancreatitis with severe hypertriglyceridemia at present or in history;

Existing (or history of) severe liver disease, provided that liver function is not currently normal;

Severe chronic or acute renal failure;

Current or history of liver tumor (benign or malignant);

Hormone-dependent malignant neoplasms of the genital organs or breast at present or in history;

Bleeding from the vagina of unknown origin;

Migraine with a history of focal neurological symptoms;

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency;

Hypersensitivity to the drug or any of the components of the drug.

Risk factors for the development of thrombosis and thromboembolism: smoking before the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the next of kin); diseases in which peripheral circulatory disorders can occur: diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; hereditary angioedema, hypertriglyceridemia, severe liver disease (before normalization of liver function tests); diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in history, minor chorea (Sydenham's disease), chloasma, postpartum period.

Dimia® is contraindicated during pregnancy.

If pregnancy occurs while using Dimia®, it should be discontinued immediately. Extended epidemiological studies have found neither an increased risk of birth defects in children born to women who took COCs before pregnancy, nor a teratogenic effect of COCs when taken unintentionally during pregnancy.

According to preclinical studies, undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components cannot be ruled out.

The drug Dimia® can affect lactation: reduce the amount of milk and change its composition. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk while taking COCs. These amounts may affect the child. The use of the drug Dimia® during breastfeeding is contraindicated.

Mode of application: for intake.

How to take Dimia®

The tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet per day. Taking pills from the next pack begins after taking the last pill from the previous pack. "Withdrawal" bleeding usually begins 2-3 days after the start of placebo tablets (last row) and does not necessarily end by the start of the next pack.

How to start taking Dimia®

Hormonal contraceptives have not been used in the last month

Dimia® is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is also possible to start taking it on the 2nd-5th day of the menstrual cycle, in which case additional use of a barrier method of contraception is necessary during the first 7 days of taking the tablets from the first package.

Switching from other combined contraceptives (combined oral contraceptive pills, vaginal ring, or transdermal patch)

Dimia® should be started the next day after taking the last inactive tablet (for preparations containing 28 tablets) or the day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for preparations containing 21 tablets per package. In the case of a woman using a vaginal ring or transdermal patch, it is preferable to start taking Dimia® on the day of their removal or, at the latest, on the day when a new ring or patch is planned to be inserted.

Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from a progestogen-releasing intrauterine system (IUD)

A woman can switch from taking a mini-pill to taking Dimia® on any day (from an implant or from an IUD on the day they are removed, from injectable forms of drugs on the day the next injection was due), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

Dimia® can be started on the day of termination of pregnancy as prescribed by the doctor. In this case, the woman does not need to take additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy

A woman is recommended to start taking the drug on the 21-28th day after childbirth (provided that she is not breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia®. With the resumption of sexual activity (before taking Dimia®), pregnancy should be excluded.

Taking missed pills

Missing a placebo tablet from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.

If the delay exceeds 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:

1. Taking pills should never be interrupted for more than 7 days;

2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous tablet intake are required.

Accordingly, women can be given the following recommendations:

-Days 1-7

A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then she should take her tablets at the usual time. Also, a barrier method such as a condom should be used for the next 7 days. If sexual intercourse has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.

- Days 8-14

The woman should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take her tablets at the usual time. If during the 7 days preceding the first missed pill, the woman took the pills as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier - for example, a condom) is needed for 7 days.

- Days 15-24

The reliability of the method inevitably declines as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If one of the two schemes described below is followed, and if the woman has observed the drug regimen in the previous 7 days before skipping the pill, there will be no need to use additional contraceptive measures. If this is not the case, she must complete the first of the two regimens and use additional precautions for the next 7 days.

1. A woman should take the last missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then she should take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Most likely, there will be no "withdrawal" bleeding until the end of the second pack, but there may be "spotting" spotting or "withdrawal" bleeding on the days of taking the drug from the second pack.

2. A woman can also stop taking active tablets from the started package. Instead, she should take the placebo pills from the last row for 4 days, including the days she skipped pills, and then start taking the pills from the next pack.

If a woman misses a pill and does not subsequently experience "withdrawal" bleeding in the placebo pill phase, the possibility of pregnancy should be considered.

The use of the drug in gastrointestinal upset

In case of severe gastrointestinal disturbances (eg, vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3-4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for missing tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.

Postponement of menstrual bleeding "withdrawal"

To delay bleeding, the woman should skip the placebo pills from the pack she started and start taking the pills from the new pack. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic copious or "spotting" bleeding from the vagina. Regular intake of Dimia® is resumed after the placebo phase.

To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that a woman will not have menstrual-like “withdrawal” bleeding, but will have acyclic copious or “spotting” vaginal bleeding on the next pack (same as with lengthening the cycle).

The following adverse events have been reported while taking Dimia®:

The following serious adverse events have been reported in women using COCs:

Venous thromboembolic diseases;

Arterial thromboembolic diseases;

Tumors of the liver;

Occurrence or exacerbation of conditions for which the connection with COC use has not been proven: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes during a previous pregnancy, rheumatic chorea, hemolytic uremic syndrome, cholestatic jaundice;

Chloasma;

Acute or chronic liver disease may necessitate discontinuation of COC use until liver function tests return to normal;

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate the symptoms of angioedema.

There have been no cases of overdose of Dimia® yet. Based on general experience with combined oral contraceptives potential overdose symptoms may be: nausea, vomiting, slightly pronounced bleeding from the vagina.

There are no antidotes. Further treatment should be symptomatic.

Note: before taking concomitant drugs, you should read the instructions for use of the drug to identify potential interactions.

Effects of other medicinal products on Dimia®

Interactions between oral contraceptives and other medicinal products may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature. The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and St. John's wort (hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.

Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.

Women with short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (during the period of simultaneous use of other drugs and for another 7 days after its completion), in addition to COCs, barrier methods of contraception.

Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and the tablets from the next package should be started immediately.

If a woman is constantly taking microsomal liver enzyme inducers, she should use other reliable non-hormonal methods of contraception.

The main metabolites of drospirenone in human plasma are formed without the participation of the cytochrome P450 system. Cytochrome P450 inhibitors are therefore unlikely to interfere with the metabolism of drospirenone.

Effect of Dimia® on other medicinal products

Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).

Based on inhibition studies in vitro and interactions in vivo in female volunteers who took, and as a substrate, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.

Other interactions

In patients without renal insufficiency, concomitant use of drospirenone and angiotensin-converting enzyme (ACE) inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) does not significantly affect the content of potassium in the blood serum. But still, the simultaneous use of Dimia® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.

Laboratory tests

The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (transporter) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism and blood coagulation parameters and fibrinolysis. In general, the changes remain within the range of normal values. Drospirenone is the cause of an increase in plasma renin activity and - due to a small amineralocorticoid activity - reduces the concentration of aldosterone in plasma.

If there are any of the conditions/risk factors mentioned below, the benefits of taking COCs should be assessed individually for each woman and discussed with her before starting use. If an adverse event worsens or if any of these conditions or risk factors appear, the woman should contact her doctor. The doctor must decide whether to stop taking the COC.

Circulatory disorders

Taking any combined oral contraceptive increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of a woman's use of a combined oral contraceptive.

Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (< 0,05 мг этинилэстрадиола) в составе комбинированного перорального контрацептива, составляет примерно 20 случаев на 100000 женщин-лет (для левоноргестрелсодержащих КОК “второго поколения”) или 40 случаев на 100000 женщин-лет (для дезогестрел/гестоденсодержащих КОК “третьего поколения”). У женщин, не пользующихся КОК, случается 5-10 ВТЭ и 60 беременностей на 100000 женщин-лет. ВТЭ фатальна в 1-2% случаев.

Data from a large, prospective, 3-way study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism who used the combination of ethinylestradiol and drospirenone, 0.03 mg + 3 mg, coincided with the frequency of VTE in women who used levonorgestrel-containing oral contraceptives and other COCs. The degree of risk of venous thromboembolism when taking Dimia® has not yet been established.

Epidemiological studies have also revealed an association between COC use and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).

Very rarely, thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidneys, brain or retina, has occurred in women taking oral contraceptives. There is no consensus regarding the relationship of these phenomena with the use of hormonal contraceptives.

Symptoms of venous or arterial thrombotic / thromboembolic events or acute disorders of cerebral circulation:

Unusual unilateral pain and / or swelling of the lower extremities;

Sudden severe chest pain, whether it radiates to the left arm or not;

sudden shortness of breath;

Sudden onset of cough;

any unusual severe prolonged headache;

Sudden partial or complete loss of vision;

Diplopia;

Impaired speech or aphasia;

Vertigo;

Collapse with or without partial epileptic seizures;

Weakness or very noticeable numbness, suddenly affecting one side or one part of the body;

Movement disorders;

- "acute" abdomen.

A woman should consult with a specialist before taking COCs.

The risk of venous thromboembolic disorders when taking combined oral contraceptives (COCs) increases with:

Increasing age;

Hereditary predisposition (venous thromboembolism has ever happened to siblings or parents at a relatively early age);

Prolonged immobilization, advanced surgery, any surgical intervention on the lower extremities or major trauma. In such situations, it is recommended to stop taking the drug (in the case of a planned surgical intervention, at least four weeks in advance) and not resume until two weeks after the full restoration of mobility. If the drug has not been discontinued in advance, anticoagulant treatment should be considered;

Lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.

The risk of arterial thromboembolic complications or acute cerebrovascular accident when taking combined oral contraceptives (COCs) increases with:

Increasing age;

Smoking (women over 35 are strongly advised to stop smoking if they want to take COCs);

Dyslipoproteinemia;

arterial hypertension;

Migraines without focal neurological symptoms;

Obesity (body mass index over 30 kg/m2);

Hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult a specialist before starting a COC. damage to the heart valves; atrial fibrillation.

The presence of one major risk factor for venous disease or multiple risk factors for arterial disease may also be a contraindication. Anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COC use should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy (indirect anticoagulants - coumarin derivatives).

An increased risk of thromboembolism in the postpartum period should be taken into account. Other medical conditions associated with adverse vascular events include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency or severity of migraine while taking COCs may be an indication for the immediate abolition of combined oral contraceptives.

Tumors

The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of combined oral contraceptives, but conflicting opinions remain as to the extent to which these findings relate to concomitant factors, such as testing for cervical cancer or the use of barrier methods of contraception.

A meta-analysis of the results of 54 epidemiological studies found a small increase in the relative risk (RR = 1.24) of breast cancer in women who currently take COCs. The risk gradually decreases over 10 years after stopping COC use. Since breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of developing breast cancer. These studies did not find sufficient evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both. Diagnosed breast cancer in women who have ever taken COCs was clinically less severe, due to the early diagnosis of the disease.

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have occurred in women taking COCs. In some cases, these tumors were life-threatening due to intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Other

The progestogen component of Dimia® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in potassium is not expected. However, in a clinical study in some patients with mild to moderate kidney disease who were taking potassium-sparing drugs, serum potassium increased slightly while taking drospirenone. Therefore, it is recommended to monitor serum potassium levels during the first cycle of treatment in patients with renal insufficiency in whom serum potassium levels were at the upper limit of normal before treatment and, especially, while taking potassium-sparing drugs.

In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis may be increased when taking COCs.

Although a small increase in blood pressure has been observed in many women taking combined oral contraceptives (COCs), clinically significant increases have rarely occurred. Only in these rare cases is immediate discontinuation of COC use justified. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure (BP) constantly increases, or significantly elevated pressure cannot be corrected by antihypertensive drugs, COC use should be discontinued. After normalization of blood pressure with antihypertensive drugs, COC use can be resumed.

The following diseases appeared or worsened both during pregnancy and when taking COCs, but the evidence for their relationship with taking COCs is inconclusive: jaundice and / or itching associated with cholestasis, gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; rheumatic chorea (Sydenham's chorea); herpes during pregnancy; otosclerosis with hearing loss.

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of edema.

Acute or chronic liver disease may be an indication to stop taking COCs until liver function tests return to normal. Recurrence of cholestatic jaundice and/or cholestasis-associated pruritus, which developed during a previous pregnancy or with earlier use of sex hormones, is an indication for discontinuation of COCs.

Although COCs may affect peripheral insulin resistance and glucose tolerance, changing the treatment regimen in patients with diabetes mellitus while taking COCs with low hormone levels (containing< 0,05 мг этинилэстрадиола) не показано. Однако следует внимательно наблюдать женщин с сахарным диабетом, особенно на ранних стадиях приема КОК.

Exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis was observed during COC use.

Chloasma may occur from time to time, especially in women who have a history of chloasma of pregnancy. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet light while taking COCs.

Coated tablets contain 48.53 mg lactose monohydrate, placebo tablets contain 37.26 mg anhydrous lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should not take this medicine.

Women who are allergic to soy lecithin may experience allergic reactions. The efficacy and safety of Dimia® as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years, the efficacy and safety of the drug are similar to those in women after 18 years. The use of the drug before the establishment of menarche is not indicated.

Medical examinations

Before you start taking or re-using the drug Dimia, you should collect a complete medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure, conduct a medical examination, guided by contraindications and precautions. A woman needs to be reminded of the need to carefully read the instructions for use and adhere to the recommendations indicated in it. The frequency and content of the survey should be based on existing practice guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least once every 6 months.

Women need to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced, for example, by missing pills, gastrointestinal disturbances during the period of taking the pills, or concomitant use of other drugs.

Insufficient cycle control

As with other COCs, women may experience acyclic bleeding ("spotting" or "withdrawal" bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed after a three-month adjustment period.

If acyclic bleeding recurs or begins after several regular cycles, the possibility of developing non-hormonal disorders should be considered and measures should be taken to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity.

Some women do not experience "withdrawal" bleeding during the placebo phase. If the COC was taken in accordance with the instructions for use, then it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like "withdrawal" bleeding, or if two bleedings were missed, pregnancy should be excluded before continuing to take COCs.

Film-coated tablets [set], 3 mg + 0.02 mg.

24 tablets each of drospirenone + ethinyl estradiol and 4 tablets of placebo in a PVC/PE/PVDC aluminum foil blister.

1 or 3 blisters in a cardboard box along with instructions for use. A cardboard flat case for storing the blister is enclosed in a cardboard bundle.

Dimia is a monophasic oral contraceptive.

Release form and composition

Produced in the form of tablets. 1 package contains two varieties:

• Tablets, film-coated, white or almost white, round, biconvex, marked "G73" on one side of the tablet, applied by embossing; on a cross section, the core is white or almost white (24 pieces in a blister).
• Placebo tablets, film-coated - green, round, biconvex; on a cross section, the core is white or almost white (24 pieces in a blister).

Indications for use

Oral contraception.

Contraindications

• arterial and venous thrombosis, thromboembolism (myocardial infarction, cerebrovascular disorders, stroke, pulmonary embolism, deep vein thrombophlebitis);
• conditions preceding thrombosis (transient ischemic attacks or angina pectoris);
• tendency to arterial or venous thrombosis;
• risk factors contributing to the development of venous or arterial thrombosis (cerebrovascular disease, obesity, damage to the valvular apparatus of the heart, arterial hypertension, etc.);
• severe liver disease;
• liver tumor;
• severe chronic or acute renal failure;
• hormone-dependent malignant tumors of the genital organs or mammary glands;
• pancreatitis with hypertriglyceridemia;
• migraine with focal neurological symptoms;
• bleeding from the vagina of unknown origin;
• lactose intolerance or lactase deficiency;
• hypersensitivity to the components of the drug;
• pregnancy or suspicion of it and the lactation period.

With great care, it is prescribed for such pathologies and conditions:

• diseases that contribute to impaired peripheral circulation (diabetes mellitus, phlebitis of superficial veins, systemic lupus erythematosus, hemolytic uremic syndrome, ulcerative colitis, sickle cell anemia, Crohn's disease);
• hereditary angioedema;
• hypertriglyceridemia;
• postpartum period;
• diseases that developed during pregnancy or while taking sex hormones (herpes, chorea, porphyria, jaundice, chloasma, atherosclerosis with hearing impairment).

Instructions for use Dimia (method and dosage)

The tablets should be taken daily, at about the same time, with a small amount of water, in the order indicated on the blister pack.

Tablets are taken continuously for 28 days, 1 tablet per day.

Taking pills from the next pack begins after taking the last pill from the previous pack. "Withdrawal" bleeding usually begins 2 to 3 days after the start of placebo tablets (last row) and does not necessarily end by the start of the next pack.

Admission procedure

If hormonal contraceptives have not been used in the last month, the drug is started on the 1st day of the menstrual cycle. The beginning of the reception is also possible on the 2nd - 5th day of the menstrual cycle, in this case, it is necessary to additionally use a barrier method of contraception during the first 7 days of taking the tablets from the first package.

Switching from other combined contraceptives (OC tablets, vaginal ring or transdermal patch). Reception should be started the next day after taking the last inactive tablet (for drugs containing 28 tablets) or the next day after taking the last active tablet from the previous package (possibly the next day after the end of the usual 7-day break) - for drugs, containing 21 tab. packaged. In the case of a woman using a vaginal ring or transdermal patch, it is preferable to start taking the drug on the day of their removal or, at the latest, on the day when a new ring or patch is planned to be inserted.

Switching from progestogen-only contraceptives (mini-pills, injections, implants) or from an intrauterine system (IUD) that releases progestogens. A woman can switch from taking a mini-pill to taking drugs on any day (from an implant or from an IUD - on the day they are removed, from injectable forms of drugs - on the day when the next injection was to be made), but in all cases it is necessary to use additionally barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy. Reception can be started according to the doctor's prescription on the day of termination of pregnancy. In this case, the woman does not need to take additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy. It is recommended to start taking the drug on the 21st - 28th day after childbirth (provided that she is not breastfeeding) or abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception during the first 7 days after starting Dimia. With the resumption of sexual activity, pregnancy should be excluded.

Taking missed pills

Skipping placebo tablets from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The indications below apply only to missed tablets containing the active ingredients.

If you are late in taking the pill less than 12 hours, contraceptive protection is not reduced. The woman should take the missed pill as soon as possible (as soon as she remembers) and the next pill at the usual time.

If you are late in taking the pill for more than 12 hours, contraceptive protection may be reduced. In this case, two basic rules can be followed: pills should never be interrupted for more than 7 days, and 7 days of continuous pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.

Accordingly, women can be given the following recommendations:

• Days 1–7. You must take the missed tablet as soon as you remember it, even if it means taking 2 tablets at the same time. Then take the tablets at the usual time. In addition, for the next 7 days, a barrier method, such as a condom, should be used. If sexual intercourse has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills missed and the closer this pass is to the 7-day break in taking the drug, the higher the risk of pregnancy.
• Days 8–14. You must take the missed tablet as soon as you remember, even if it means taking 2 tablets at the same time. Then take the tablets at the usual time. If during the 7 days preceding the first missed tablet, the tablets were taken as expected, there is no need for additional contraceptive measures. However, if more than 1 tablet is missed, an additional method of contraception (barrier, such as a condom) is required for 7 days.
• Days 15–24. The reliability of the method inevitably declines as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If one of the two schemes described below is followed, and if the regimen of taking the drug has been observed in the previous 7 days before skipping the pill, there will be no need to use additional contraceptive measures. If this is not the case, the first of the two regimens must be followed and additional precautions taken for the next 7 days.

Take the last missed tablet as soon as you remember, even if it means taking 2 tablets at the same time. Then take the tablets at the usual time until the active tablets run out. 4 placebo tablets from the last row should not be taken, you must immediately start taking the tablets from the next blister pack. Withdrawal bleeding may not occur until the end of the second pack, but spotting or withdrawal bleeding may occur on the days of taking the second pack.

If necessary, you can stop taking active tablets from the started package. Instead, take the placebo pills from the last row for 4 days, including the days you missed pills, and then start taking the pills from the next pack.

If there is no withdrawal bleeding in the placebo tablet phase after missed pills and subsequently, the possibility of pregnancy should be considered.

The use of the drug in gastrointestinal upset

In case of severe gastrointestinal disorders (eg vomiting or diarrhea), the absorption of the drug will be incomplete and additional contraceptive measures will be required. If vomiting occurs within 3 to 4 hours after taking the active tablet, a new (replacement) tablet should be taken as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time. If more than 12 hours have passed, it is recommended to proceed according to the instructions for skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from another pack.

Delay menstrual-like withdrawal bleeding

To delay bleeding, the woman should skip the placebo pills from the pack she started and start taking the pills from the new pack. The delay can be extended until the active tablets in the second pack run out. During the delay, a woman may experience acyclic profuse or spotting bleeding from the vagina. Regular intake of the drug is resumed after the placebo phase. To shift bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When the cycle is shortened, it is more likely that the woman will not have menstrual-like withdrawal bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (same as with lengthening the cycle).

Side effects

Dimia can provoke the following side effects:

• from the nervous system: tremor, dizziness, insomnia, paresthesia, drowsiness, headaches, depression, decreased libido, vertigo, anorgasmia;
• from the hematopoietic system: anemia or thrombocytopenia;
• from the side of the cardiovascular system: migraines, tachycardia, arterial hypertension, fainting, varicose veins, epistaxis;
• on the part of metabolism: increased appetite, hyperkalemia, anorexia, hyponatremia, weight loss/increase;
• from the reproductive system: no bleeding, vaginitis, chest pain, vaginal discharge, breast enlargement, pelvic pain, dryness of the vaginal mucosa, scanty or heavy bleeding, cervical polyps, hyperplasia or breast cyst;
• from the musculoskeletal system: pain in the back and limbs, muscle cramps;
• from the liver and biliary tract: pain in the gallbladder or cholecystitis;
• from the digestive system: abdominal pain, nausea, diarrhea, vomiting; infections: candidiasis;
• on the part of the skin, such as rash, eczema, skin striae, itching, contact dermatitis and dry skin.

Overdose

Cases of overdose have not been registered.

Analogues

Analogues for the ATX code: Anabella, Vidora, Jess, Leia, Midian.

Do not make the decision to change the drug yourself, consult your doctor.

pharmachologic effect

Dimia is a contraceptive drug that has a pronounced antiandrogenic and moderate antimineralocorticoid effect on the woman's body, without showing estrogenic, glucocorticoid and antiglucocorticoid activity. The contraceptive effect is based on the ability to delay the onset of ovulation, change the properties of the endometrium and increase the viscosity of the cervical secretion.

special instructions

• Taking any OC increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of COC use by a woman. Therefore, before starting to take drugs, a woman should consult a specialist.
• Rarely, benign liver tumors and even more rarely, malignant liver tumors occurred in women taking OCs. In some cases, these tumors were life-threatening (due to intra-abdominal bleeding). This should be taken into account when making a differential diagnosis in case of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.
• In a clinical study in some patients with mild to moderate kidney disease, serum potassium increased slightly while taking drospirenone. It is recommended to monitor the content of potassium in the serum during the first cycle of treatment.
• In women with hypertriglyceridemia or a hereditary predisposition, the risk of pancreatitis may be increased when taking OCs.
• In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of edema.
• Acute or chronic liver disease may be an indication to stop taking OCs until normalization of liver function tests.
• Exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis was observed during COC use.
• In rare hereditary diseases, such as galactose intolerance, lactase deficiency or malabsorption of glucose-galactose, the drug is not recommended.
• Women who are allergic to soy lecithin may experience allergic reactions.
• The efficacy and safety of the drug as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years, the efficacy and safety of the drug are similar to those in women after 18 years. The use of the drug before the establishment of menarche is not indicated.
• Before initiation or re-use, a complete medical history (including family history) should be taken and pregnancy excluded. The frequency and content of the survey should be based on existing practice guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least once every 6 months.
• Women need to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
• The effectiveness of OCs may be reduced, for example, by missing pills, gastrointestinal disorders, or while taking other drugs.
• A woman may experience acyclic bleeding (spotting or withdrawal bleeding), especially in the first months of taking. Therefore, any irregular bleeding should be assessed after a three-month adjustment period.
• If acyclic bleeding recurs or begins after several regular cycles, the possibility of developing non-hormonal disorders should be considered and measures should be taken to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity.
• Some women do not experience withdrawal bleeding during the placebo phase. If OK was taken in accordance with the instructions for use, then it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like withdrawal bleeding or two bleedings were missed, pregnancy should be excluded before continuing to take COCs.

During pregnancy and breastfeeding

Prohibited during pregnancy and breastfeeding. If pregnancy occurs during the use of the drug, it should be stopped immediately.

In childhood

Application before the establishment of menarche is not indicated.

In old age

Designed for women of childbearing age.

For impaired renal function

In severe chronic or acute renal failure is contraindicated.

For impaired liver function

Contraindicated in existing severe liver disease (or history) provided that liver function is not currently normalized; with a liver tumor (benign or malignant) at present or in history.

drug interaction

• Interactions between oral contraceptives and other medicinal products may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.
• The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations of St. John's wort (Hypericum perforatum) is based on the ability of these active substances to induce microsomal liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.
• Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is not clear.
• Women with short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (during the period of simultaneous use of other drugs and for another 7 days after its completion), in addition to PDA, barrier methods of contraception.
• Women receiving rifampicin therapy, in addition to taking COCs, should use a barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medications last longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and the drospirenone + ethinyl estradiol tablets from the next package should be started immediately.
• If a woman is constantly taking drugs - inducers of microsomal liver enzymes, she should use other reliable non-hormonal methods of contraception.
• Oral contraceptives may affect the metabolism of some other active substances. Accordingly, plasma or tissue concentrations of these substances may either increase (eg, cyclosporine) or decrease (eg, lamotrigine).
• In patients without renal insufficiency, the simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the content of potassium in the blood serum. But still, the simultaneous use with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, during the first cycle of treatment, it is necessary to control the concentration of serum potassium.

Terms of dispensing from pharmacies

Released by prescription.