Content

The use of hormonal pills is considered the most effective method of contraception. Today, various pharmaceutical companies produce a huge number of products that help women avoid unwanted pregnancy. One of the most popular is the drug Dimia. Many experts recommend it to their patients due to the good tolerability of the main components and the rare occurrence of side effects.

Pharmacological action

The combination drug Dimia is a monophasic oral drug. This medicine contains ethinyl estradiol and drospirenone (a naturally occurring progesterone analogue). The active substances that make up the drug do not have estrogenic, antiglucocorticoid, or glucocorticoid properties. The medicine achieves its effectiveness due to changes in the endometrium, inhibition of ovulation and an increase in the viscosity of the cervical secretion, which prevents sperm from penetrating into its cavity.

After taking the drug orally, the active substances are completely absorbed into the bloodstream from the small intestine. They are distributed evenly throughout all tissues of the body. The maximum concentration of the drug is achieved two hours after administration. The breakdown products of ethinyl estradiol and drospirenone are excreted from the body primarily in the urine.

Release form and composition

The drug Dimia is produced in the form of round, biconvex white film-coated tablets, specially marked G73 on one side. The medicine also contains green placebo tablets that do not contain active ingredients. One package of the drug includes 28 tablets, packaged in one or three blisters. The composition of the product is presented in the table:

How to take Dimia

Dimia hormonal tablets should be taken daily, at the same time, with water, in the order indicated on the blister pack. The medicine should be taken continuously for 28 days, one piece per day. Taking tablets from the next package should begin after the product from the previous box runs out. Only a doctor can tell you how to take Dimia correctly, without health consequences. As a rule, the start of using the product varies:

• When switching from other OCs (oral contraceptives), you should start drinking Dimia the day after taking the last tablet of another drug (28 pieces) or a week after using a drug containing 21 capsules. If you are using a transdermal patch or vaginal ring, you can take dimia only after they have been removed.
• Before starting to take the pills, if the woman has not used other OCs for a month, she must start taking dimia from the first day of the menstrual cycle. You can take the product from the 3rd day of your period, but you should use condoms for a week.
• After removal of the intrauterine device, the use of tablets begins on the day of the procedure.
• If a woman has taken non-combined progesterone-based drugs, then the contraceptive can be started on any day.
• If a pregnancy is terminated in the first trimester, a woman, as prescribed by a doctor, can take pills on the same day.
• After an abortion or childbirth, experts advise starting to take the pills on day 28.

If a woman misses taking another pill, the following recommendations must be followed regarding resuming their use:

• skipping a placebo pill can be ignored and you must continue taking it the next day according to the regimen indicated in the instructions;
• if less than 12 hours have passed since the missed dose, the patient should take the pill as quickly as possible;
• if more than 12 hours have passed since the last use of the drug, then the woman should take a pill as soon as she remembers it, even if this coincides with taking the next one (you can take 2 tablets at once).

Indications and contraindications for taking pills

Dimia contraceptives are indicated for women of reproductive age to prevent unwanted pregnancy. In addition, the use of the drug is possible in the treatment of such diseases:

• fibroids;
• endometriosis;
• dysfunction of the menstrual cycle;
• iron deficiency anemia;
• polycystic ovary syndrome;
• premenstrual syndrome.

The use of tablets is contraindicated in the following situations:

• thrombophlebitis, thromboembolism (movement of blood clots through arterial vessels) or thrombosis (appearance of blood clots in the lumen of venous or arterial vessels);
• malignant hormone-dependent neoplasms of the mammary glands or reproductive organs;
• hereditary or acquired predisposition to thrombosis (protein deficiency, hyperhomocysteinemia);
• individual intolerance to the main or auxiliary components of the drug;
• pancreatitis (inflammation of the pancreas);
• pathological processes that preceded the appearance of severe thrombosis (transient ischemic attack, myocardial infarction, angina);
• undergone surgery with further immobilization of the body;
• acute or chronic severe renal failure;
• the presence in the female body of processes that can lead to cardiovascular diseases (damage to the heart valves, irregular contractions, pathology of the coronary vessels);
• smoking over the age of 35;
• lactation period;
• hypertension;
• liver diseases;
• acquired or congenital lactase deficiency;
• the presence of pathological bleeding from the vagina;
• confirmed pregnancy.

You should take the drug with caution in the postpartum period and with concomitant pathologies leading to impaired peripheral circulation:

• Crohn's disease;
• diabetes mellitus;
• sickle cell anemia;
• systemic lupus erythematosus;
• hereditary angioedema,
• phlebitis of superficial veins;
• hypertriglyceridemia (increased levels of triglycerides in the blood).

Side effects

Before starting to use a medicinal contraceptive, a woman should consult a doctor, because there is a risk of thromboembolic complications. In addition, the use of the medicine can lead to the development of the following side effects:

• emotional instability;
• nausea, vomiting;
• dizziness;
• migraine;
• stomach ache;
• inflammation of the gallbladder (cholecystitis);
• headache;
• depression;
• drowsiness;
• tremor (shaking) of hands;
• muscle cramps;
• increased blood pressure;
• tachycardia (increased heart rate);
• thrombocytopenia (decreased platelet count);
• phlebitis (inflammation of the veins);
• anemia (anemia);
• development of vaginal candidiasis;
• weight gain;
• back pain;
• dyspareunia (painful sexual intercourse);
• enlargement of the mammary glands;
• acne (acne);
• dryness of the vaginal mucosa;
• alopecia (hair loss);
• allergic reactions.

If side effects or complications develop (coughing up blood, double vision, sudden or partial loss of vision), you should immediately seek medical help. The risk of negative symptoms and vascular thrombosis increases with arterial hypertension, alcohol abuse, increased body weight, and age over 40 years. The use of the drug does not exclude the possibility of infection with sexually transmitted diseases.

Interaction of Dimia with other drugs

The effectiveness of the contraceptive can be weakened by combined use of the drug with barbiturates (a group of drugs derived from barbituric acid) and drugs that affect liver enzymes: Griseofulvin, Oxcarbazepine, Topiramate, Phenytoin, Primidone, Felbamate, Rifampicin. In addition, the instructions indicate that drugs that contain St. John's wort in their chemical composition, when used simultaneously with dimia, induce (stimulate) microsomal liver enzymes, which also negatively affects the female body.

A decrease in the circulation of estrogen and at the same time the effectiveness of the contraceptive occurs when Ampicillin and Tetracycline are used simultaneously with antibiotics. HIV protease inhibitors and their combinations have a negative effect on the hepatic metabolism of the drug. Women undergoing short-term treatment with any of the above drugs should temporarily use barrier methods of contraception (condom).

Analogs

The manufacturer of the drug Dimia is the Hungarian company Gedeon Richter. Absolute structural analogues of the product, similar in the mechanism of action and chemical composition, are:

• Midiana;
• Angelique;
• Yarina;
• Jess;
• Vidor;
• Dailla;
• Belara;
• Simicia;
• Yarina plus;
• Anabella;
• Delcia;
• Modell trend.

Price for Dimia tablets

You can purchase the drug dimia at any pharmacy, but you will need to get a prescription from your doctor. You cannot start taking pills on your own or on the recommendation of friends; before starting use, you should definitely visit a specialist. The cost of the drug depends on the region of distribution and the number of tablets in the package; on average, the price for 28 pieces is 700 rubles. The approximate cost of contraception in Moscow is presented in the table.

Dimia is one of the latest contraceptive drugs intended for women with signs of hyperandrogenemia. This is an analogue of Yarina with a reduced concentration of estrogen in each tablet. Dimia is a monophasic oral contraceptive, which means that the hormone content in each portion is the same, with the exception of pacifiers (placebo).

But the functioning of the female reproductive system occurs in cyclical modes. This is why cycle disorders often occur when using pills. What should I do if I don’t have my period while taking Dimia? When should I consult a doctor?

Read in this article

Reasons for lack of menstruation

Ideally, a girl should not have any problems or questions when taking birth control pills. But in practice, we have to deal with the opposite: various cycle disruptions are often observed, ranging from spotting to the absence of menstruation for several months.

In the first month of admission

Dimia, like most popular birth control pills, is a monophasic contraceptive. This has its pros and cons.

The advantages include the fact that due to the low concentration of hormones in each tablet, the incidence of side effects is lower. But a woman’s body functions cyclically from the moment of puberty, and it is thanks to these processes that the follicles grow and mature and the egg is released. Every minute, hormone levels fluctuate in one direction or another. That is why it is so difficult to treat any disorders of their production.

Taking Dimia, a woman’s body finds itself in new conditions when the same dose of the hormone is received daily. This inhibits the ovaries' own function. And for some time, one gets used to the new regime. For some, it proceeds without a trace, while others note that when taking Dimia there are no periods.

• A similar picture can develop in two cases:
• It happens that while taking hormonal contraceptives, a woman experiences periodic symptoms throughout the entire cycle. Sometimes they are quite abundant and bring a lot of anxiety and discomfort. In this case, after taking Dimia, scanty periods occur at the appointed time, or they do not exist at all. The fact is that the endometrium does not have time to grow due to constant smearing. In most cases, everything returns to normal in the second month of treatment. If it continues, you should definitely consult a doctor.

Dummy pills not accepted

Often girls want to change the length of their menstrual cycle. This can be done if you do not take all the placebo pills or skip them altogether.

In this case, there will also be no menstruation until the placebo is taken.

The cycle has gone astray

You should know that menstrual-like bleeding occurs only when the drug is stopped. But some girls noticed that while using Dimia, all the active pills were finished. This is allowed.

It also happens that women, for some reason, do not finish part of the package, after which they begin to experience spotting. The beginning of such discharge should be considered the first day of a new cycle. Without knowing this, girls wait for their next period according to the “old” schedule, and worry when they don’t.

After complete withdrawal of the drug

When finishing the pack and deciding not to take hormonal pills anymore, many people think that their cycle will remain regular. However, this is not always the case. Your own hormonal levels are restored within 2 - 4 months, sometimes up to six months. During this time, various failures may occur.

• Often after stopping Dimia there is no period for several months. This happens in the following cases:
• If before the prescription of hormonal drugs the woman had irregular menstruation. After all, when taking pills, the effect is fixed only for the period of treatment, a maximum of a month or two after stopping the drug. Then your own hormonal levels are restored with the same disturbances as before.

No periods while taking placebo

Some girls believe that as soon as the active pills in the package are finished and the placebo is started, menstruation should begin. And when they are gone for a day or two or even three, they begin to worry. It is assumed that menstruation will begin within a week after the last active pill. In this case, there is no need to worry, and after taking a placebo, you should immediately switch to a new package. Every girl should know the main situations when taking Dimia, when menstruation should begin normally. This way you can avoid unnecessary worries.

Ovarian exhaustion

Sometimes, while taking hormonal drugs, the intrinsic function of the ovaries is completely suppressed, and their depletion is noted.

• The risk of this increases under the following conditions:
• with long-term continuous use of hormonal pills;
• if the woman is over 35 years old;
• in cases where ovarian surgery has previously been performed;

if this is a multiparous woman.

Given these risk factors, special attention should be paid to restoring menstruation. And if this does not happen within two months after stopping the drug, you should consult a doctor as soon as possible.

Pregnancy

Hormonal contraceptives are one of the most effective methods of preventing pregnancy. However, to achieve this effect, you must strictly follow the rules for taking pills.

If you miss even one, the likelihood of an unplanned conception increases. Therefore, in all situations where there are no periods on time while taking oral contraceptives, pregnancy should be excluded. This can be done using a regular urine test. But it is better and more reliable - which shows a 100% valid result already from the 10th day after fertilization, if it has occurred.

In the case when menstruation does not stop while using Dimia, it is also first necessary to exclude pregnancy, especially if the schedule for taking the pills is violated.

Watch the video about hormonal contraception: Why might bleeding start?

• Menstruation with Dimia tablets is in most cases regular, light, and practically painless.
• If a girl skips pacifier pills for several cycles in a row to eliminate her period, then she may experience breakthrough bleeding at any time. This is due to the fact that the endometrium constantly grows under the influence of estrogens and gestagens, but is not rejected - for this it is necessary to sharply reduce their level, for example, stop drinking or replace it with a placebo. In the end, it is so wide that it can be removed on its own, which results in heavy bleeding. Moreover, even skipping placebo once increases the risk of spotting and even heavy discharge outside of critical days.
• In the case where Dimia is not prescribed according to indications, and the woman may not have enough dose of the hormone. In this case, bleeding will not be critical.
• If a girl misses more than two tablets, then the risk of developing heavy discharge over the next five days increases sharply. This is menstrual-like bleeding. In such a situation, it is better to stop taking the old pack and start the next one after a four-day break.
• In the first month of use, if the use of tablets is started after childbirth or termination of pregnancy at any stage, breakthrough bleeding also occurs. As a rule, all violations disappear in the second or third month of treatment.

What to do

What should you do if your period does not come on time after taking Dimia? The algorithm of actions is as follows:

• For reliability and reliability, you should first do a urine pregnancy test. But it’s even better to take a blood test for hCG; it shows a reliable result already from the 10th day after fertilization, if it has occurred. If all signs indicate pregnancy, you should immediately make an appointment with a doctor.
• If you don’t have your period for just a couple of days after taking the active pills, you don’t need to worry, they will most likely go in a few days. Up to a week is allowed.
• If menstruation does not come in a certain month, especially at the beginning of use, and there are no signs of pregnancy, this is most likely the body’s adaptation to synthetic sex hormones. You must continue taking it strictly according to the instructions. The absence of bleeding for more than 2-3 cycles is a significant reason to consult a doctor. Most likely, hormonal medications will have to be stopped for a while to restore ovarian function.
• If menstruation does not come when you skip placebo pills, that’s how it should be. But when, after complete withdrawal of Dimia, menstruation is delayed for more than three months, especially in women after 35 years of age, you should immediately consult a doctor. There is a possibility that the ovarian reserve has been depleted. In such situations, it is sometimes necessary to take hormone replacement therapy until the age of menopause.

Dimia is one of the popular and modern contraceptive drugs, an analogue of Yarina. With its help, you can not only prevent pregnancy, but also treat it - it has an antiandrogenic and mineralocorticoid effect.

While taking the drug, various menstrual irregularities may occur, especially if there were errors in use.

It happens that after Dimia there is no menstruation for more than one cycle, or spotting of various types and sometimes heavy bleeding occurs. If any disorder occurs, only a specialist can determine the true cause and prescribe treatment that is effective and safe for the woman.

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I prescribed hormonal “dimia” and started drinking it from the first day of my period! And the brown discharge still remains!?

white or off-white, round, biconvex, embossed with "G73" on one side of the tablet; on a cross section, the core is white or almost white (24 pieces in a blister).

Excipients: lactose monohydrate - 48.53 mg, corn starch - 16.6 mg, pregelatinized corn starch - 9.6 mg, copolymer of macrogol and polyvinyl alcohol - 1.45 mg, magnesium stearate - 0.8 mg. Film shell composition:

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

Placebo tablets Film-coated tablets

green, round, biconvex; on a cross section, the core is white or almost white (4 pieces in a blister).

Excipients: lactose monohydrate - 48.53 mg, corn starch - 16.6 mg, pregelatinized corn starch - 9.6 mg, copolymer of macrogol and polyvinyl alcohol - 1.45 mg, magnesium stearate - 0.8 mg. Excipients: microcrystalline cellulose - 42.39 mg, lactose - 37.26 mg, pregelatinized corn starch - 9 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0.45 mg.

Opadrai II Green 85F21389 - 3 mg (polyvinyl alcohol - 1.2 mg, titanium dioxide - 0.7086 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, indigocarmine - 0.0177 mg, dye chinolnine yellow - 0.0177 mg, dye of iron oxide black , sunset yellow dye - 0.003 mg).
28 pcs. - blisters (3) - cardboard packs.

pharmachologic effect

Dimia ® is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol. In terms of its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by pronounced antiandrogenic and moderate antimineralocorticoid effects. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation, increased viscosity of cervical secretions and changes in the endometrium. The Pearl index, an indicator reflecting the pregnancy rate in 100 women of reproductive age during a year of contraceptive use, is less than 1.

Pharmacokinetics

Drospirenone

Suction

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

Bioavailability - 76-85%. Concomitant use with food does not affect the bioavailability of drospirenone.

Distribution

After oral administration, plasma concentrations of drospirenone decreased with a final 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 total serum concentrations of drospirenone exist as free steroids. The ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to serum proteins. The average apparent Vd of drospirenone is 3.7±1.2 l/kg.

During the treatment cycle, C ss max of drospirenone in blood plasma is about 70 ng/ml, it is achieved after 8 days of treatment. Serum concentrations of drospirenone increase approximately 3-fold due to the ratio of final half-life and dosing interval.

Metabolism

Drospirenone is actively metabolized after oral administration. The main metabolites in the blood plasma are the acidic forms of drospirenone, formed during the opening of the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, both formed without the participation of the P450 system. Drospirenone is slightly metabolized by CYP3A4 and is capable of inhibiting this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.

Removal

Renal clearance of drospirenone metabolites 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 intestines with an excretion ratio of about 1.2:1.4. T1/2 of metabolites by the kidneys and through the intestines is about 40 hours.

Ethinyl estradiol

Suction

When taken orally, ethinyl estradiol is absorbed quickly and completely. Cmax in blood serum is about 33 pkg/ml and is achieved within 1-2 hours after a single oral dose. Absolute bioavailability as a result of first pass conjugation and first pass metabolism is approximately 60%. Concomitant food intake decreased the bioavailability of ethinyl estradiol in approximately 25% of the patients studied; others had no changes.

Distribution

Serum concentrations of ethinyl estradiol decreased biphasically, in the final distribution phase T1/2 is approximately 24 hours. Ethinyl estradiol binds well, but nonspecifically, to serum albumin (approximately 98.5%) and induces an increase in serum concentrations of SHBG. Apparent V d - about 5 l/kg.

C ss is achieved in the second half of the treatment cycle, and the serum concentration of ethinyl estradiol increases by 2-2.3 times.

Metabolism

Ethinyl estradiol is a substrate of presystemic conjugation in the mucous membrane of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, resulting in a wide range of hydroxylated and methylated metabolites, which are present both in free form and as conjugates with glucuronic acid. Renal clearance of ethinyl estradiol metabolites is approximately 5 ml/min/kg.

Removal

Unchanged ethinyl estradiol is practically not excreted from the body. Metabolites of ethinyl estradiol are excreted by the kidneys and through the intestines in a ratio of 4:6. T1/2 of metabolites is about 24 hours.

Pharmacokinetics in special clinical situations

If kidney function is impaired

Css of drospirenone in blood plasma in women with mild renal failure (creatinine clearance 50-80 ml/min) was comparable to the corresponding values ​​in women with normal renal function (creatinine clearance > 80 ml/min). In women with moderate renal failure (creatinine clearance 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. Taking drospirenone did not have a clinically significant effect on serum potassium levels. Pharmacokinetics in severe renal failure have not been studied.

In case of liver dysfunction

Drospirenone is well tolerated by patients with mild to moderate hepatic impairment (Child-Pugh class B). Pharmacokinetics in severe hepatic impairment have not been studied.

Indications

Oral contraception.

Dosage regimen

The tablets should be taken daily, at approximately the same time, with a small amount of water, in the order indicated on the blister pack. The tablets are taken continuously for 28 days, 1 tablet/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 start of the next pack.

How to start taking Dimia ®

If hormonal contraceptives have not been used in the last month, Taking Dimia ® begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is possible to start taking it on days 2-5 of the menstrual cycle; in this 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 contraceptives in the form of tablets, vaginal ring or transdermal patch)

You should start taking Dimia ® 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 drugs containing 21 tablets per package. If a woman uses 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 is planned to be inserted or the patch is replaced.

Switching from contraceptives containing only progestogens (mini-pills, injections, implants), or from an intrauterine system (IUD) that releases progestogens.

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

After an abortion in the first trimester of pregnancy

Taking Dimia ® can be started as prescribed by a doctor 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.

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

Taking missed pills

Skipping 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 instructions below only apply to missed tablets containing active ingredients.

If the delay in taking the pill is less than 12 hours, contraceptive protection is not reduced. A 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 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 axis, 7 days of continuous pill use are required.

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

Days 1-7

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

Days 8-14

A woman should take the missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the pills at the usual time. If during the 7 days preceding the first missed pill, a woman took her pills as prescribed, 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 required for 7 days.

Days 15-24

The reliability of the method inevitably decreases as the placebo pill phase approaches. However, adjusting your pill regimen can still help prevent pregnancy. When following one of the two regimens described below, and if in the previous 7 days before skipping the pill the woman complied with the drug regimen, there will be no need to use additional contraceptive measures. If this is not the case, she should follow the first of two regimens and use additional precautions for the next 7 days.

1. A woman should take the last missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the tablets at the usual time until the active tablets are gone. 4 placebo tablets from the last row should not be taken; you should immediately start taking tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second package, but spotting or withdrawal bleeding may occur on the days of taking the drug from the second package.

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

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

Use of the drug for gastrointestinal disorders

In case of severe gastrointestinal disorders (for example, vomiting or diarrhea), 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 must take a new (replacement) tablet as quickly 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 as directed when missing tablets. If a woman does not want to change her usual pill regimen, she should take an additional pill from a different pack.

Delay of menstrual-like withdrawal bleeding

To delay bleeding, a woman should skip taking placebo tablets from the started pack and start taking drospirenone + ethinyl estradiol tablets from a new pack. The delay can be extended until the active tablets in the second package run out. During the delay, a woman may experience acyclic heavy or spotting bleeding from the vagina. Regular use 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 the woman will not have menstrual-like “withdrawal” bleeding, but will have acyclic heavy or spotting bleeding from the vagina when taking the next package (the same as when the cycle is lengthened).

Side effect

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

Venous thromboembolic diseases;

Arterial thromboembolic diseases;

Liver tumors;

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

Chloasma;

Acute or chronic liver disease may require discontinuation of COCs until liver function tests return to normal;

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

Contraindications for use

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

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

Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history;

Multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking over the age of 35 years, obesity with a BMI >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);

Pancreatitis with severe hypertriglyceridemia currently or in history;

Severe chronic or acute renal failure;

Liver tumor (benign or malignant) currently or in history;

Hormone-dependent malignant neoplasms of the genital organs or breast, currently or in history;

Bleeding from the vagina of unknown origin;

History of migraine with focal neurological symptoms;

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, lapp lactase deficiency (lactase deficiency in some peoples of the North);

Pregnancy and suspicion of it;

Lactation period;

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

WITH caution

Risk factors for the development of thrombosis and thromboembolism: smoking under the age of 35 years, 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 any of the immediate relatives);

Diseases in which peripheral circulatory disorders may occur: diabetes mellitus without vascular complications, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of the superficial veins;

Hereditary angioedema;

Hypertriglyceridemia;

Severe liver disease (until normalization of liver function tests);

Diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and/or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, history of herpes during pregnancy, minor chorea (disease Sydenham), chloasma);

Postpartum period.

Use during pregnancy and breastfeeding

Dimia ® is contraindicated during pregnancy.

If pregnancy occurs while using the drug Dimia ®, its use should be stopped immediately. Extensive 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 if taken unintentionally during pregnancy.

According to preclinical studies, it is impossible to exclude undesirable effects that affect the course of pregnancy and fetal development due to the hormonal action of the active components.

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 during COC use. These amounts may affect the child. The use of Dimia ® during breastfeeding is contraindicated.

Use for liver dysfunction

Contraindicated:

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

Liver tumor (benign or malignant) currently or in history.

Use for renal impairment

Contraindicated:

Severe chronic or acute renal failure

Use in children

The use of the drug before menarche is not indicated.

special instructions

If you have any of the conditions/risk factors listed 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 occur, 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 increase in the 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 estrogens (
Data from a large, prospective, 3-arm study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism using a combination of ethinyl estradiol and drospirenone 0.03 mg + 3 mg was the same as the incidence of VTE in women using levonorgestrel-containing oral contraceptives and other PDAs. The degree of risk of venous thromboembolism when taking Dimia ® has not currently been established.

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

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

Symptoms of venous or arterial thrombotic/thromboembolic events or acute cerebrovascular accidents:

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, long-lasting 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 that suddenly affects one side or part of the body;

Movement disorders;

Symptom complex "acute" abdomen.

Before starting to take COCs, a woman should consult a specialist.

Risk venous thromboembolic disorders

Increasing age;

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

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

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the onset or exacerbation of venous thrombosis.

Risk arterial thromboembolic complications or acute cerebrovascular accident when taking COC increases with:

Increasing age;

Smoking (women over 35 years of age are strongly advised to quit smoking if they want to take COCs);

Dyslipoproteinemia;

Arterial hypertension;

Migraines without focal neurological symptoms;

Obesity (BMI more than 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 to take COCs;

Damage to heart valves;

Atrial fibrillation.

Having 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).

The 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 disease.

An increase in the frequency or severity of migraine while taking COCs may be an indication for immediate discontinuation 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 there remains controversy regarding the extent to which these findings are attributable to confounding factors such as testing for cervical cancer or use of barrier methods of contraception.

A meta-analysis of 54 epidemiological studies found a small increase in the relative risk (RR = 1.24) of breast cancer in women who were currently taking COCs. The risk gradually decreases over 10 years after stopping COC use. Because Breast cancer rarely develops in women under 40 years of age, and an increase in the number of diagnosed cases of breast cancer in COC users has little effect on the overall likelihood of breast cancer. These studies did not find sufficient evidence of causality. The increased risk may result from earlier diagnosis of breast cancer in COC users, the biological effects of COCs, or a combination of both factors. Diagnosed breast cancer in women who had ever taken COCs was clinically less severe, which was due to 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 the event of severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Other states

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

Women with hypertriglyceridemia or a hereditary predisposition to it may have an increased risk of pancreatitis when taking COCs.

Although slight increases in blood pressure were observed in many women taking COCs, clinically significant increases were rare. Only in these rare cases is it justified to immediately stop taking the COC. If, when taking COCs in patients with concomitant arterial hypertension, blood pressure constantly increases or

Overdose

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

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

Drug interactions

The influence of other drugs on the drug Dimia ®

Interactions between oral contraceptives and other drugs may result in acyclic bleeding and/or contraceptive failure. The interactions described below are reflected in the scientific literature.

Mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin; oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and St. John's wort (Hypericum perforatum) preparations is based on the ability of these active substances to induce microsomal liver enzymes. Maximum induction of liver microsomal enzymes is not achieved within 2-3 weeks, but then persists for at least 4 weeks after cessation 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 during short-term treatment (up to one week) with any of the above groups of drugs or single drugs should temporarily use (while taking other drugs simultaneously and for another 7 days after its end), in addition to COCs, barrier methods of contraception.

Women receiving rifampin therapy other than COCs should use a barrier method of contraception and continue to use it for 28 days after stopping rifampin treatment. If the use of concomitant medications lasts longer than the expiration date of the active tablets in the package, the inactive tablets should be stopped and the 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 the metabolism of drospirenone.

Effect of Dimia ® on other drugs

Oral contraceptives may affect the metabolism of some other active ingredients. Accordingly, the concentrations of these substances in blood plasma or tissues may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

Based on in vitro inhibition studies and in vivo interaction studies in female volunteers taking omeprazole, simvastatin and midazolam as substrates, the effect of drospirenone 3 mg on the metabolism of other active substances is unlikely.

Other interactions

In patients without renal failure, simultaneous use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on serum potassium levels. However, 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, the concentration of serum potassium should be monitored.

Laboratory tests

Taking contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, concentrations of plasma proteins (transporters), such as corticosteroid binding proteins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and blood coagulation parameters and fibrinolysis. In general, changes remain within the normal range. Drospirenone causes an increase in renin activity in the blood plasma and, due to its slight antimineralocorticoid activity, reduces the concentration of aldosterone in the plasma.

Storage conditions and periods

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.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Good afternoon, Maria!

While taking oral hormonal contraceptives, the menstrual cycle indeed returns to normal. Menstrual-like discharge begins a few days after taking the last active tablet in the blister. Women suffering from menstrual irregularities will certainly appreciate this effect of contraceptives, because it is very convenient to know exactly when your period will come, not to suffer from prolonged and/or heavy bleeding and severe pain, etc. All this is painfully familiar to a good half of the female population of the planet. Of course, the onset of menstruation “like clockwork” is very relaxing, and any disruption in the usual schedule can cause panic. And perhaps not in vain.

Pregnancy or failure?

As you know, there is not a single method of contraception in the world that would provide 100% protection against pregnancy, except, perhaps, complete sexual abstinence. Oral contraceptives, according to manufacturers, provide protection against unwanted pregnancy in 97 - 99% of cases. This is a high level of protection, and if you take the pills correctly and regularly, pregnancy is, indeed, practically excluded. Naturally, taking a pill late or skipping it, as well as a number of diseases, reduce the contraceptive effect of the drugs. A variety of food poisoning (vomiting, diarrhea) can also negatively affect the effect of the contraceptive.

However, a delay in menstruation can be caused not only by pregnancy. A woman’s hormonal background is very sensitive to various kinds of internal and external influences. Thus, a delay in menstruation even while taking oral contraceptives can occur due to weight fluctuations when following a diet, severe stress, climate change, etc. These factors can delay the onset of menstrual bleeding by a day or two. You will be surprised, but some foods can also affect a woman's menstrual cycle. Thus, daily consumption of lemons can delay menstruation by 2-7 days, and a decoction of tansy or nettle can, on the contrary, speed up the onset of menstruation.

However, if you had unprotected sex this cycle, the likelihood of pregnancy still prevails over all other reasons for delayed menstruation. Naturally, if you have conceived a child, you should not start the next pack of pills. Therefore, you need to establish or deny the fact of pregnancy as soon as possible.

Methods for determining pregnancy

The simplest and most accessible method of determining pregnancy at home is special test strips. Purchase 2 - 3 test strips from different manufacturers at the pharmacy (they will be needed in case of a controversial result) and test. To do this, collect your morning urine sample (it is the most concentrated) and dip a test strip into it. In just a few minutes you will be able to evaluate the result. One line on the test will mean the absence of pregnancy, two lines - the presence of pregnancy.

An alternative to testing is a blood test to determine the level of human chorionic gonadotropin - the so-called "pregnancy hormone". The test can be taken now in any medical laboratory, and the result can be ready on the same day.

Best regards, Ksenia.

Mode of application: for oral administration.

How to take Dimia®

The tablets should be taken daily, at approximately the same time, with a small amount of water, in the order indicated on the blister pack. The tablets are taken continuously for 28 days, 1 tablet 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 start of the next pack.

How to start taking Dimia®

Have not used hormonal contraceptives in the last month

Taking Dimia® begins on the first day of the menstrual cycle (i.e., on the first day of menstrual bleeding). It is possible to start taking it on days 2-5 of the menstrual cycle; in this 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 contraceptives in the form of tablets, vaginal ring or transdermal patch)

You should start taking Dimia® 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 tablets per package. If a woman uses 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 it is planned to insert a new ring or replace the patch.

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 IUD on the day of their removal, from injectable forms of drugs - on the day when the next injection was due), but in all cases it is necessary to use additionally a barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

Taking Dimia® can be started as prescribed by a doctor 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

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

Taking missed pills

Skipping 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 instructions below only apply to missed tablets containing active ingredients.

If the delay in taking the pill is less than 12 hours, contraceptive protection is not reduced. A 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 axis, 7 days of continuous pill use are required.

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

- Days 1-7

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

- Days 8-14

A woman should take the missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the pills at the usual time. If during the 7 days preceding the first missed pill, a woman took her pills as prescribed, 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 required for 7 days.

- Days 15-24

The reliability of the method inevitably decreases as the placebo pill phase approaches. However, adjusting your pill regimen can still help prevent pregnancy. When following one of the two regimens described below, and if in the previous 7 days before skipping the pill the woman complied with the drug regimen, there will be no need to use additional contraceptive measures. If this is not the case, she should follow the first of two regimens and use additional precautions for the next 7 days.

1. A woman should take the last missed pill as soon as she remembers, even if this means taking two pills at the same time. She should then take the tablets at the usual time until the active tablets are gone. 4 placebo tablets from the last row should not be taken; you should immediately start taking tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second package, but spotting or withdrawal bleeding may be observed on the days of taking the drug from the second package.

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

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

Use of the drug for gastrointestinal disorders

In case of severe gastrointestinal disorders (for example, vomiting or diarrhea), 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 your usual tablet taking time. If more than 12 hours have passed, it is recommended to proceed as directed when skipping pills. If a woman does not want to change her usual pill regimen, she should take an additional pill from a different pack.

Delay of menstrual-like withdrawal bleeding

To delay bleeding, the woman should skip the placebo tablets from the started pack and start taking drospirenone + ethinyl estradiol tablets from the new pack. The delay can be extended until the active tablets in the second package run out. During the delay, a woman may experience acyclic heavy or spotting bleeding from the vagina. Regular use 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 the woman will not have menstrual-like “withdrawal” bleeding, but will have acyclic heavy or “spotting” bleeding from the vagina when taking the next package (the same as when the cycle is lengthened).