Dimia, pills 3mg+0.02mg, 28pcs

Composition

Ethinyl estradiol+drospirenone tablets

1 tablet contains:

active ingredients:

ethinyl estradiol 0.02 mg,

rospirenone 3 mg,

excipients:

lactose monohydrate — 48.53 mg;

corn starch-16.6 mg;

pre-gelatinized corn starch-9.6 mg;

macrogol and polyvinyl alcohol copolymer-1.45 mg;

magnesium stearate-0.8 mg,

 film shell:

Opadry II white 85G18490 (polyvinyl alcohol-0.88 mg, titanium dioxide-0.403 mg, macrogol 3350-0.247 mg, talc-0.4 mg, soy lecithin-0.07 mg) — 2 mg

Placebo tablets

1 tablet contains:

MCC-42.39 mg;

lactose-37.26 mg;

pregelatinized corn starch-9 mg;

magnesium stearate-0.9 mg;

colloidal silicon dioxide-0.45 mg,

 film shell:

Opadry II green 85F21389 (polyvinyl alcohol 1.2 mg, titanium dioxide — 0,7086 mg, macrogol 3350 — 0,606 mg, talc — 0,444 mg, Indigo — 0,0177 mg, quinoline yellow dye — 0,0177 mg, dye iron oxide black — 0,003 mg dye “sunset” yellow — 0,003 mg) — 3 mg.

Pharmacological action

Medication Dimia is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol.

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 cervical secretions and changes in the endometrium.

The Perl index, an indicator that reflects the frequency of pregnancy in 100 women of reproductive age during the year of contraceptive use, is less than 1.

Indications

Oral contraception.

Contraindications

The drug Demia like other COC, is contraindicated in any condition listed below:

• hypersensitivity to the drug or any component of the drug;
• thrombosis (venous and arterial) and thromboembolism in the present or in history (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders). Status, previous thrombosis (including transient ischemic attack, angina), currently or in history;
• multiple or severe risk factors for venous or arterial thrombosis, including the complicated lesions of valvular apparatus of the heart, atrial fibrillation, vascular diseases of the brain or coronary arteries; uncontrolled hypertension, body surgery with prolonged immobilization, Smoking at the age of 35 years, obesity with a body mass index >30;
• hereditary or acquired predisposition for venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, deficiency of protein C, protein S deficiency, hyperhomocysteinemia and antibodies against phospholipids (antibodies to phospholipids antibodies to cardiolipin, lupus anticoagulant);
• pregnancy and suspected it;
• lactation;
• pancreatitis with severe hypertriglyceridemia now or in history;
• the existing (or in history) severe liver disease, provided that the function of the liver and is currently not normalized;
• severe chronic or acute renal failure;
• liver tumor (benign or malignant) at present or in the anamnesis;
• hormone-dependent malignant tumors of the genital or breast cancer now or in history;
• vaginal bleeding of unknown origin;
• migraine with focal neurological symptoms in history;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lactase deficiency Lappa.

With caution:  risk factors for thrombosis and thromboembolism — smoking under the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraines without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulatory disorders at a young age in one of the closest relatives); diseases in which peripheral circulatory disorders may occur (diabetes mellitus). diabetes without vascular complications, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia, superficial venous phlebitis); hereditary angioedema; hypertriglyceridemia; severe liver diseases (before normalization of liver function tests); diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and/or pruritus associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, a history of herpes simplex during pregnancy, chorea minor (Sydenham’s disease); chloasma; postpartum period.

Side effects

Frequency: often (more than 1/100, less than 1/10); infrequently (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000). From the genitourinary system: acyclic vaginal bleeding (spotting spotting or breakthrough bleeding); often-engorgement, soreness of the mammary glands, infrequently-hypertrophy of the mammary glands, decreased libido, rarely-changes in the nature of vaginal secretion, discharge from the mammary glands, increased libido. From the nervous system: often-headache, decreased mood, emotional lability, infrequently-migraine. From the cardiovascular system: rarely-thrombosis (venous and arterial), thromboembolism. From the digestive system: often – nausea, abdominal pain, infrequently-vomiting, diarrhea. From the skin: infrequently-skin rash. Allergic reactions: infrequently-urticaria, rarely-erythema nodosum, erythema multiforme. Other: often-weight gain, infrequently-fluid retention, rarely-poor tolerance to contact lenses, weight loss; chloasma, especially if there is a history of chloasma in pregnant women.

Interaction

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

The effect of other drugs on Dimia®. Interactions between oral contraceptives and other medications may result in acyclic bleeding and / or ineffective contraception. The interactions described below are reflected in the scientific literature.

The mechanism of interaction with gidantoin, 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 then persists for at least 4 weeks after discontinuation of drug therapy.

Ineffectiveness of contraception was also observed when taking antibiotics, such as ampicillin and tetracycline. The mechanism of this phenomenon is unclear. Women with short-term treatment (up to one week) with any of the above groups of drugs or monopreparations should temporarily use barrier methods of contraception (during the period of simultaneous use of other drugs and for another 7 days after its end), in addition to COCs.

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

If a woman is constantly taking drugs that induce microsomal liver enzymes, 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 affect drospirenone metabolism.

Effect of Dimia® to other BOS. Oral contraceptives may affect the metabolism of some other active substances. Accordingly, the concentrations of these substances in blood plasma or tissues can either increase (for example, cyclosporine) or decrease (for example, lamotrigine). Based on studies of in vitro inhibition and in vivo interactions in female volunteers taking omeprazole, simvastatin and midazolam 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 ACE inhibitors or NSAIDs does not significantly affect the serum potassium content. However, the concomitant 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 monitor the concentration of serum potassium.

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

How to take, course of use and dosage

Inside, every day, at approximately 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 each. per day. Taking tablets from the next package begins after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after starting placebo tablets (last row) and does not necessarily end by the beginning of the next pack.

Procedure for taking Dimia®

No hormonal contraceptives have been used in the last month. Dimia® begins on the 1st day of the menstrual cycle (i. e., on the 1st day of menstrual bleeding). It is also possible to start taking it on the 2nd-5th day of the menstrual cycle, in this case, additional use of a barrier method of contraception is necessary during the first 7 days of taking tablets from the first package.

Switching from other combined contraceptives (COCs as tablets, a vaginal ring, or a transdermal patch). Start taking Dimia® it is necessary the next day after taking the last inactive tablet (for preparations 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 preparations containing 21 tablets in a package. If a woman uses a vaginal ring or transdermal patch, take Dimia® it is preferable to start on the day of their removal or, at the latest, on the day when a new ring or patch replacement is planned.

Switch from progestogen-only contraceptives (mini-pills, injections, implants), or an intrauterine system (IUD) that releases progestogens. A woman can switch from taking a mini-pill to taking Dimia® on any day (from the implant or IUD-on the day of their removal, from injectable forms of drugs — on the day when the next injection should have been made), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking tablets.

After an abortion in the first trimester of pregnancy. Dimia® may be started as directed by your doctor on the day of termination of pregnancy. At the same time, a 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 21st-28th day after giving birth (provided that she is not breastfeeding) or having an abortion in the second trimester of pregnancy. If started later, the woman should additionally use a barrier method of contraception for the first 7 days after starting Dimia®. With the resumption of sexual activity (before taking Dimia®), pregnancy should be excluded.

Taking missed pills

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

If the delay in taking the pill is less than 12 hours, the 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, the contraceptive protection may be reduced. In this case, you can follow 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 use are required.

In accordance with this, women can be given the following recommendations::

Days 1-7. A woman should take a missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then she should take the pills at the usual time. In addition, for the next 7 days, you should use a barrier method, such as a condom. If sexual contact has occurred in the previous 7 days, the possibility of pregnancy should be considered. The more pills you skip and the closer that skip is to the 7-day break from taking the drug, the higher the risk of pregnancy.

Days 8-14. A woman should take the missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then she should take the pills 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 skipped more than 1 table, an additional method of contraception (barrier, such as a condom) is required for 7 days.

Days 15-24. The reliability of the method inevitably decreases as the placebo pill phase approaches. However, correcting the pill regimen can still help prevent pregnancy. If you perform one of the two schemes described below, and if in the previous 7 days before skipping the pill, the woman followed the medication regimen, there will be no need to use additional contraceptive measures. If this is not the case, she should follow the first of the two schemes and use additional precautions for the next 7 days.

1. A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then she should take the pills at the usual time until the active pills run out. 4 placebo tablets from the last row should not be taken, you should immediately start taking tablets from the next blister pack. Most likely, withdrawal bleeding will not occur until the end of the second package, but there may be spotting or withdrawal bleeding on the days of taking the drug from the second package.

2. A woman may also stop taking active pills from the original package. Instead, she should take placebo pills from the last row for 4 days, including the days of skipping pills, and then start taking pills from the next pack. If a woman missed taking the pill and subsequently did not experience withdrawal bleeding during the placebo pill phase, the possibility of pregnancy should be considered.

Use of the drug for gastrointestinal disorders

In the case of severe gastrointestinal disorders (such as 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, you should take a new (replacement) tablet as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual time of taking tablets. If more than 12 hours have passed, it is recommended to follow the instructions when skipping tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from a different package.

Delaying menstrual-like withdrawal bleeding

To delay bleeding, the woman should skip taking placebo tablets from the original package and start taking drospirenone+ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second package run out. During the delay, a woman may experience acyclic profuse or smearing spotting from the vagina. Regular use of Dimia® resumes after the placebo phase. To shift the 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 heavy or smearing spotting from the vagina when taking the next package (as well as when the cycle is extended).

Overdose

Cases of overdose of Dimia® have not yet been described.

Based on general experience with COCs, potential overdose symptoms may include:: nausea, vomiting, slight bleeding from the vagina.

Treatment: there are no antidotes. Further treatment should be symptomatic.

Special instructions

If there are any of the conditions / risk factors mentioned below, the benefits of taking COCs should be evaluated 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 occur, a woman should contact her doctor. The doctor must decide whether to stop taking COCs.

Circulatory disorders

Taking any COC increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year of using COCs by a woman.

Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low-dose estrogens ( Women who do not use COCs have 5-10 VTE and 60 pregnancies per 100,000 women-years. VTE is fatal in 1-2% of cases.

Data from a large, prospective,3-pronged study showed that the frequency of VTE in women with or without other VTE risk factors treated with a combination of ethinyl estradiol and drospirenone,0.03+3 mg, coincides with the frequency of VTE in women treated with levonorgestrel-containing oral contraceptives and other COCs. The risk of VTE with Dimia® is currently unknown.

Epidemiological studies have also shown an association of COCs with an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).

Very rarely, women taking oral contraceptives have experienced thrombosis of other blood vessels, such as the veins and arteries of the liver, mesentery, kidneys, brain, or retina. There is no consensus on the connection of these phenomena with the use of hormonal contraceptives.

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

– unusual unilateral pain and/or swelling of the lower extremities;

sudden severe pain in the chest, regardless of whether it is in the left hand or not;

sudden breathlessness;

sudden onset of coughing;

any unusual, severe prolonged headache;

sudden partial or complete loss of vision;

– diplopia;

– violated the speech or aphasia;

– vertigo;

collapse with partial epileptic seizures or without them;

– the weakness or very marked numbness, suddenly struck one side or one part of the body;

musculoskeletal disorders;

acute abdomen.

Before starting taking COCs, a woman should consult a specialist. The risk of venous thromboembolic disorders increases with COCs:

– with increasing age;

– hereditary predisposition (VTE has ever occurred in siblings or parents at a relatively early age);

– prolonged immobilization, extended surgery, any surgery on the lower extremities or a major injury. In such situations, it is recommended to stop taking the drug (in the case of elective surgery for at least 4 weeks) and not resume it until two weeks after full recovery of mobility. If the drug was not stopped in advance, the possibility of anticoagulant treatment should be considered;

– obesity (body mass index more than 30);

– lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the occurrence or exacerbation of venous thrombosis.

The risk of arterial thromboembolic complications or acute cerebrovascular accident increases with COCs:

– with increasing age;

– Smoking (women over 35 years old are strongly advised to quit Smoking if they want to take KOK);

– dyslipoproteinemia;

– arterial hypertension;

– migraine without focal neurologic symptoms;

– obesity (a body mass index over 30);

– hereditary predisposition (arterial thromboembolism ever have siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult a specialist before taking COCs;

– damage to the heart valves;

– atrial fibrillation.

The presence of one serious risk factor for venous disease or several 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 the attending physician if symptoms of thrombosis are suspected. If thrombosis is suspected or confirmed, COCs should be discontinued. It is necessary to start adequate alternative contraception due to the teratogenicity of anticoagulant therapy with indirect anticoagulants-coumarin derivatives.

An increased risk of developing thromboembolism in the postpartum period should be considered.

Other medical conditions associated with adverse vascular events include diabetes mellitus, SLE, 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 migraines while taking COCs may be an indication for their immediate withdrawal.

Tumors

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

A meta-analysis of the results of 54 epidemiological studies revealed a slight increase in the relative risk (RR=1.24) of developing breast cancer in women who are currently taking COCs. The risk gradually decreases within 10 years after stopping taking COCs. Since breast cancer rarely develops in women under the age of 40, an increase in the number of diagnosed cases of breast cancer among those using COCs has little effect on the overall likelihood of breast cancer. These studies did not provide sufficient evidence for a causal relationship. The increased risk may be due to an earlier diagnosis of breast cancer in those using COCs, the biological effect of COCs, or a combination of both factors. Diagnosed breast cancer in women who had ever taken COCs was clinically less severe, due to early diagnosis of the disease.

Rarely, women who took COCs developed benign liver tumors, and even more rarely, malignant liver tumors. 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, enlarged liver, or signs of intra-abdominal bleeding.

Other services

The progestogen component of Dimia® is an aldosterone antagonist that retains potassium in the body. In most cases, an increase in the potassium content is not expected. However, in a clinical study in some patients with mild or moderate kidney disease who were taking potassium-sparing medications, serum potassium levels increased slightly while taking drospirenone. Therefore, it is recommended to monitor the serum potassium content during the first treatment cycle in patients with renal insufficiency, whose serum potassium concentration was at the ULN level before treatment, and especially when taking potassium-sparing drugs at the same time. Women with hypertriglyceridemia or a hereditary predisposition to it may have an increased risk of pancreatitis when taking COCs. Although a small increase in blood pressure was observed in many women taking COCs, clinically significant increases were rare. Only in these rare cases is immediate discontinuation of COCs justified. If the use of COCs in patients with concomitant arterial hypertension constantly increases blood pressure or significantly elevated blood pressure cannot be corrected by antihypertensive drugs, COCs should be discontinued. After normalization of blood pressure with the help of antihypertensive drugs, the use of COCs can be resumed.

The following diseases appeared or worsened both during pregnancy and when taking COCs: jaundice and / or pruritus associated with cholestasis, gallstones; porphyria; SLE; hemolytic-uremic syndrome; rheumatic chorea (Sydenham’s chorea); herpes during pregnancy; otosclerosis with hearing loss. However, the evidence for their association with COCs is inconclusive.

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

Acute or chronic liver diseases may be an indication to stop taking COCs until liver function indicators normalize. Recurrent cholestatic jaundice and / or cholestasis-related pruritus, which developed during previous pregnancy or with earlier use of sex hormones, serve as an indication for discontinuing COCs.

Although COCs can affect peripheral insulin resistance and glucose tolerance, changing the treatment regimen in patients with diabetes mellitus while taking COCs with a low hormone content (containing However, women with diabetes should be closely monitored, especially in the early stages of taking COCs.

Endogenous depression, epilepsy, Crohn’s disease, and ulcerative colitis worsened during COCs administration.

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

Drospirenone + ethinyl estradiol coated tablets contain 48.53 mg of lactose monohydrate, placebo tablets contain 37.26 mg of anhydrous lactose per tablet.Patients with rare hereditary problems (such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption) who follow a lactose-free diet should not take this medication.

Women who are allergic to soy lecithin may experience allergic reactions.

The efficacy and safety of Dimia® as a contraceptive were studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years, the effectiveness 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

A complete medical history (including family history) should be collected and pregnancy excluded before starting or re-using Dimia®. It is necessary to measure blood pressure, conduct a medical examination, guided by contraindications and precautions. A woman should be reminded 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 should be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COC may decrease, for example, if you skip taking drospirenone+ethinyl estradiol tablets, have gastrointestinal disorders while taking drospirenone+ethinyl estradiol tablets, or take other medications at the same time.

Insufficient cycle control

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

If acyclic bleeding recurs or begins after several regular cycles, you should consider the possibility of developing disorders of a non-hormonal nature and take measures to exclude pregnancy or cancer, including therapeutic and diagnostic curettage of the uterine cavity. In some women, withdrawal bleeding does not occur during the placebo phase. If the COC was taken in accordance with the instructions for use, 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 bleeds were missed, pregnancy should be excluded before continuing to take COCs.

Influence on the ability to drive vehicles and mechanisms. Not detected.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Shelf life

2 years

Active ingredient

Drospirenone, Ethinyl Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, For women of childbearing age

Indications

Contraception