Content

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

Pharmacological action

The combined drug Dimia is a monophasic oral drug. This medicine contains ethinyl estradiol and drospirenone (an analogue of progesterone of natural origin). The active substances that are part of the drug do not have estrogenic, antiglucocorticoid, glucocorticoid abilities. The drug achieves its effectiveness due to changes in the endometrium, inhibition of ovulation and an increase in the viscosity of the cervical secretion, which prevents the penetration of sperm into its cavity.

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

Release form and composition

The drug Dimia is produced in the form of round, biconvex white film-coated tablets with a special G73 marking on one side. Also, the composition of the drug additionally includes placebo tablets of green color, which do not contain active 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 hormone 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 pills from the subsequent package should be started 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 beginning of using the product is different:

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

If a woman missed taking another pill, you must adhere to the following recommendations in relation to resuming their use:

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

Indications and contraindications for taking pills

Contraceptives Dimia 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 organs of the reproductive system;
• hereditary or acquired predisposition to thrombosis (lack of protein, hyperhomocysteinemia);
• individual intolerance to the main or auxiliary components of the drug;
• pancreatitis (inflammation of the pancreas);
• pathological processes preceding the appearance of severe thrombosis (transient ischemic attack, myocardial infarction, angina pectoris);
• undergone surgery with further immobilization of the body;
• acute or chronic severe kidney failure;
• the presence in the female body of processes that can lead to cardiovascular diseases (damage to the heart valves, violation of the rhythm of contractions, pathology of the coronary vessels);
• smoking over the age of 35;
• lactation period;
• hypertension;
• liver disease;
• acquired or congenital lactase deficiency;
• the presence of pathological bleeding from the vagina;
• confirmed pregnancy.

The drug should be taken 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 blood triglyceride levels).

Side effects

Before using a contraceptive medication, a woman should consult a doctor, because there is a risk of thromboembolic complications. In addition, the use of the drug can lead to the development of such side effects:

• emotional instability;
• nausea, vomiting;
• dizziness;
• migraine;
• stomach ache;
• inflammation of the gallbladder (cholecystitis);
• headache;
• depression;
• drowsiness;
• tremor (trembling) of the 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;
• increase in body weight;
• back pain;
• dyspareunia (painful intercourse);
• enlargement of the mammary glands;
• acne (acne);
• dryness of the vaginal mucosa;
• alopecia (hair loss);
• allergic reactions.

If you develop side effects or complications (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, over 40 years of age. The use of the drug does not exclude the possibility of contracting sexually transmitted infections.

Interaction of Dimia with other drugs

The effectiveness of the contraceptive can be weakened by joint administration of the drug with barbiturates (a group of drugs, derivatives of barbituric acid) and drugs that affect liver enzymes: Griseofulvin, Oxcarbazepine, Topiramate, Phenytoin, Primidon, Felbamat, 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 estrogens and, at the same time, the effectiveness of the contraceptive occurs with simultaneous use with antibiotics Ampicillin and Tetracycline. HIV protease inhibitors and their combinations have a negative effect on the hepatic metabolism of the drug. Women with short-term treatment with any of the above means should temporarily use barrier methods of contraception (condom).

Analogs

The manufacturer of the drug Dimia is the Hungarian firm Gedeon Richter. The absolute structural analogs of the agent, similar in the mechanism of action and chemical composition, are:

• Midiana;
• Angelique;
• Yarina;
• Jess;
• Vidora;
• Dailla;
• Belara;
• Simicia;
• Yarina plus;
• Anabella;
• Delsia;
• Modell trend.

Dimia tablets price

You can buy dimia at any pharmacy, but you need to get a prescription from your doctor. You cannot start taking pills on your own or on the recommendation of friends, you should definitely visit a specialist before using. 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 a contraceptive in Moscow is presented in the table.

pharmachologic effect

Dimia ® is a combined monophasic oral contraceptive drug 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 a pronounced antiandrogenic and moderate antimineralocorticoid effect. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. The Pearl index, an indicator reflecting the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive, 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 reached approximately 1-2 hours after a single dose.

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

Distribution

After oral administration, the concentration of drospirenone in blood plasma decreased with a final T 1/2 of 31 hours. Drospirenone binds to serum albumin and does not bind to sex hormone binding globulin (SHBG) or to corticosteroid-binding globulin (transcortin). Only 3-5% of the total serum concentration of drospirenone exists as free steroids. An increase in SHBG induced by ethinylestradiol 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 the final T 1/2 and the dosing interval.

Metabolism

Drospirenone is extensively metabolized after oral administration. The main metabolites in blood plasma are 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 metabolized to a small extent by CYP3A4 and is able to inhibit this enzyme, as well as CYP1A1, CYP2C9 and CYP2C19 in vitro.

Withdrawal

The renal clearance of the metabolites of drospirenone in the 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. T 1/2 of metabolites by the kidneys and through the intestines is about 40 hours.

Ethinylestradiol

Suction

When taken orally, ethinyl estradiol is absorbed quickly and completely. C max in serum is about 33 pkg / ml and is achieved within 1-2 hours after a single oral administration. The absolute bioavailability as a result of presystemic conjugation and first-pass metabolism is approximately 60%. Concomitant food intake reduced the bioavailability of ethinyl estradiol in about 25% of the patients examined; the others did not.

Distribution

Serum concentrations of ethinyl estradiol decreased in two phases, in the final distribution phase T 1/2 is approximately 24 hours. Ethinylestradiol binds well, but nonspecifically to serum albumin (approximately 98.5%) and induces an increase in serum SHBG concentrations. Apparent V d - about 5 l / kg.

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

Metabolism

Ethinylestradiol is a substrate for presystemic conjugation in the mucous membrane of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, with the formation of 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 ethinyl estradiol metabolites is approximately 5 ml / min / kg.

Withdrawal

Unchanged ethinyl estradiol is practically not excreted from the body. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestines in a ratio of 4: 6. T 1/2 of metabolites is about 24 hours.

Pharmacokinetics in special clinical situations

With impaired renal function

C ss drospirenone in blood plasma in women with mild renal insufficiency (CC 50-80 ml / min) was comparable to the corresponding indicators in women with normal renal function (CC\u003e 80 ml / min). In women with moderate renal insufficiency (CC from 30 ml / min to 50 ml / min), the concentration of drospirenone in blood plasma was on average 37% higher than in women with normal renal function. Drospirenone was well tolerated in all groups. Drospirenone intake did not have a clinically significant effect on the serum potassium content. Pharmacokinetics in severe renal failure have not been studied.

If liver function is impaired

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

Indications

- oral contraception.

Dosage regimen

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

How to start taking Dimia ®

If a hormonal contraceptives have not been used in the last month,taking Dimia ® is started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is possible to start taking the pills on days 2-5 of the menstrual cycle, in this case, additional use of the barrier method of contraception is required during the first 7 days of taking the pills from the first package.

Switching from other combination contraceptives (combination oral contraceptives in pill form, 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 preparations containing 21 tablets per pack. If a woman uses a vaginal ring or a 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 replacement is planned.

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

A woman can switch from taking mini-pills to taking Dimia ® on any day (from an implant or from an IUD on the day of their removal, 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 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 directed 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 on days 21-28 after childbirth (provided that she is not breastfeeding) or an abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception within the first 7 days after starting the drug Dimia ®. With the resumption of sexual activity (before taking 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 unintentionally prolonging the placebo phase. The instructions below only apply to the missed tablets containing the active ingredients.

If the delay in taking the pill is 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 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 system requires 7 days of continuous pill intake.

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 it, even if that means taking two pills at the same time. Then she should take the tablets at the usual time. In addition, 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 tablets are 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

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 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 diminishes as the placebo pill phase approaches. However, adjusting the pill regimen can still help prevent pregnancy. When performing one of the two schemes described below, and if in the previous 7 days before skipping the pill, the woman followed the regimen of taking the drug, there will be no need to use additional contraceptive measures. If not, she should follow the first of the two regimens and take additional precautions for the next 7 days.

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

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

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

Use of the drug for gastrointestinal upset

In the case of severe gastrointestinal disorders (for example, 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 must take a new (replacement) tablet 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 act as directed when skipping tablets. If a woman does not want to change her usual pill regimen, she must take an additional pill from a different package.

Delaying "withdrawal" menstrual bleeding

To delay bleeding, a woman should skip taking placebo pills from the started package and start taking drospirenone + ethinyl estradiol tablets from a new package. 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 Dimia ® is resumed after the placebo phase.

To shift the bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking the placebo tablets by the desired number of days. With a shortening of the cycle, it is more likely that the woman will not have menstrual "withdrawal" bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (just as when lengthening the cycle).

Side effect

While taking Dimia ®, the following adverse events have been reported:

The following serious adverse events have been reported in women using combined oral contraceptives (COCs):

- venous thromboembolic diseases;

- arterial thromboembolic diseases;

- liver tumors;

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

- chloasma;

- Acute or chronic liver diseases may necessitate discontinuation of COC intake until the normalization of liver function tests;

- in women with hereditary angioedema, exogenous estrogens can induce or intensify the symptoms of angioedema.

Contraindications for use

The drug Dimia ®, like other combined oral contraceptives, is contraindicated in any of the conditions listed below:

- thrombosis (arterial and venous) and thromboembolism at the present time 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 the present time or in history;

- multiple or severe risk factors for venous or arterial thrombosis, incl. complicated lesions of the valve apparatus of the heart, atrial fibrillation, diseases of the vessels of the brain or coronary arteries; uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking over the age of 35, obesity with a BMI\u003e 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 (the presence of antibodies to phospholipids - antibodies to cardiolipin, lupus); anticoagulant

- pancreatitis with severe hypertriglyceridemia at the present time 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 the mammary gland at the present time 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 (lactase deficiency in some peoples of the North);

- pregnancy and suspicion of it;

- lactation period;

- hypersensitivity to the drug or any component of the drug.

FROM caution

- risk factors for the development of thrombosis and thromboembolism: smoking under the age of 35, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident) from one of the next of kin);

- diseases in which peripheral circulation 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 superficial veins;

- hereditary angioedema;

- hypertriglyceridemia;

- severe liver disease (before 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, herpes during pregnancy in history, small chorea (Sydenham's disease), chloasma;

- the postpartum period.

Application during pregnancy and lactation

Dimia ® is contraindicated during pregnancy.

If pregnancy occurs while using Dimia ®, it should be stopped immediately. Expanded epidemiological studies have not revealed an increase in the risk of birth defects in children born to women who have taken COCs before pregnancy, or teratogenic effects of COCs when unintentionally taken during pregnancy.

According to the data of 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.

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

Application in children

The use of the drug before setting menarche is not indicated.

Overdose

There have been no cases of overdose of Dimia ® yet. Based on general experience with combined oral contraceptives, potential symptoms overdose can be: nausea, vomiting, mild vaginal bleeding.

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

Drug interactions

The effect of other drugs on Dimia ®

Interactions between oral contraceptives and other drugs can lead to acyclic bleeding and / or contraceptive ineffectiveness. 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 liver microsomal enzymes. The maximum induction of liver microsomal enzymes is not achieved within 2-3 weeks, but after that it persists for at least 4 weeks after discontinuation of drug therapy.

Contraceptive ineffectiveness 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 monopreparations should temporarily use (during the period of concurrent administration of other drugs and for another 7 days after its termination), in addition to CPC, barrier methods of contraception.

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 taking concomitant medications lasts longer than the expiration date of the active tablets in the package, the inactive tablets should be discontinued and immediately started taking drospirenone + ethinyl estradiol tablets from the next package.

If a woman constantly takes medications - inducers of liver microsomal 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 interfere with the metabolism of drospirenone.

Influence of the drug Dimia ® on other drugs

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

Based on in vitro inhibition studies 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 administration of drospirenone and ACE inhibitors or NSAIDs does not significantly affect serum potassium levels. However, the simultaneous use of Dimia ® with aldosterone antagonists or potassium-sparing diuretics has not been studied. In this case, the concentration of serum potassium should be monitored during the first cycle of treatment.

Laboratory tests

Contraceptive steroid use can affect the results of some laboratory tests, including the determination of biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (transporter) concentrations such as corticosteroid-binding proteins and lipid / lipoprotein fractions, carbohydrate metabolism parameters and blood coagulation parameters and fibrinolysis. In general, changes remain within the normal range. Drospirenone causes an increase in renin activity in blood plasma and - due to a small anti-mineralocorticoid activity - reduces the concentration of aldosterone in plasma.

Terms of dispensing from pharmacies

The drug is available by prescription.

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 is 2 years.

Application for violations of liver function

Contraindicated:

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

- liver tumor (benign or malignant), currently or in history.

Application for impaired renal function

Contraindicated:

- severe chronic or acute renal failure

special instructions

If there are 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. In case of an exacerbation of an undesirable phenomenon or in the event of the appearance of any of these conditions or risk factors, a woman should contact her doctor. The doctor must decide whether to interrupt the use of the PDA.

Circulatory disorders

Taking any combined oral contraceptive pill 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 100 000 женщин-лет (для левоноргестрелсодержащих КПК "второго поколения") или 40 случаев на 100 000 женщин-лет (для дезогестрел/гестоденсодержащих КПК "третьего поколения"). У женщин, не пользующихся КПК, случается 5-10 ВТЭ и 60 беременностей на 100 000 женщин-лет. ВТЭ фатальна в 1-2% случаев.

Data from a large, prospective, 3-pronged study showed that the incidence of VTE in women with or without other risk factors for venous thromboembolism, who used a combination of ethinylestradiol and drospirenone, 0.03 mg + 3 mg, coincides with the incidence of VTE in women who used levonorgestrel-containing oral contraceptives and other PDAs. The degree of risk of venous thromboembolism while taking Dimia® is not currently established.

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

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

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

- unusual one-sided pain and / or swelling of the lower limbs;

- sudden severe pain in the chest, regardless of whether it radiates to the left arm or not;

- sudden shortness of breath;

- sudden onset of cough;

- any unusual severe long-term 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 one part of the body;

- movement disorders;

- "sharp" stomach.

Before taking the PDA, a woman should consult with a specialist.

Risk venous thromboembolic disorders

- increasing age;

- hereditary predisposition (venous thromboembolism has ever happened in siblings or parents at a relatively early age);

- prolonged immobilization, extended surgical intervention, 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 planned surgery, at least four weeks) and not resume until two weeks after full recovery of mobility. If the drug was not discontinued in advance, anticoagulant treatment should be considered;

- obesity (body mass index over 30 kg / m 2);

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

Risk arterial thromboembolic complications or acute cerebrovascular accident when taking a PDA, it increases with:

- increasing age;

- smoking (women over 35 are strongly advised to quit smoking if they want to take PDA);

- dyslipoproteinemia;

- arterial hypertension;

- migraines without focal neurological symptoms;

- obesity (BMI over 30 kg / m 2);

- hereditary predisposition (arterial thromboembolism ever in siblings or parents at a relatively early age). If a hereditary predisposition is possible, a woman should consult with a specialist before starting to take a PDA;

- damage to the heart valves;

- atrial fibrillation.

Having one major risk factor for vein 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 on the need to inform the attending physician in case of suspicion of symptoms of thrombosis. If thrombosis is suspected or confirmed, the COC should be discontinued. It is necessary to start an adequate alternative contraception due to the teratogenicity of anticoagulant therapy (indirect anticoagulants - coumarin derivatives).

Consideration should be given to the increased risk of thromboembolism in the postpartum period.

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 immediate withdrawal of combined oral contraceptives.

Tumors

The most significant risk factor for cervical cancer is human papillomavirus infection. Some epidemiological studies have reported an increased risk of cervical cancer with long-term use of combined oral contraceptives, but there are conflicting opinions as to the extent to which these findings relate to co-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 revealed a slight increase in the relative risk (RR \u003d 1.24) of breast cancer in women who are currently taking COCs. The risk gradually decreases within 10 years after stopping the use of the PDA. Since breast cancer rarely develops in women under 40 years of age, 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 find sufficient evidence of a causal relationship. An increased risk may be due to an earlier diagnosis of breast cancer in those using COCs, the biological effects of COCs, or a combination of both factors. The diagnosed breast cancer in women who have ever taken COCs was clinically less severe due to the early diagnosis of the disease.

Rarely, women taking 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 pain in the abdomen, enlarged liver or signs of intra-abdominal bleeding.

Other conditions

The progestogenic 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 took potassium-sparing drugs, the serum potassium content slightly increases while taking drospirenone. Therefore, it is recommended to monitor serum potassium during the first cycle of treatment in patients with renal insufficiency, in whom the serum potassium concentration was at the upper normal limit 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 slight increase in blood pressure was observed in many women taking COCs, a clinically significant increase was rare. Only in these rare cases is it justified to immediately stop taking the PDA. If, when taking a PDA in patients with concomitant arterial hypertension, blood pressure constantly increases or significantly increased blood pressure cannot be corrected with antihypertensive drugs, the PDA should be discontinued. After normalization of blood pressure with the help of antihypertensive drugs, the use of PDAs can be resumed.

The following diseases appeared or exacerbated during pregnancy and when taking PDAs, however, evidence of their relationship with taking PDAs is inconclusive: jaundice and / or pruritus 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 can induce or increase symptoms of edema.

Acute or chronic liver diseases may be an indication for stopping the use of PDAs until the liver function indicators return to normal. Recurrence of cholestatic jaundice and / or itching associated with cholestasis, which developed during a previous pregnancy or with earlier use of sex hormones, serve as an indication for discontinuation of COC use.

Although COCs can affect peripheral insulin resistance and glucose tolerance, changes in the treatment regimen in patients with diabetes mellitus while taking COCs with a low content of hormones (containing< 0.05 мг этинилэстрадиола) не показано. Однако следует внимательно наблюдать женщин с сахарным диабетом, особенно на ранних стадиях приема КПК.

During the use of COCs, an aggravation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis was observed.

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

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 diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should not take this drug.

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 starting or re-using 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.

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

Decreased efficiency

The effectiveness of the PDA may decrease, for example, if you skip taking drospirenone + ethinylestradiol tablets, gastrointestinal disorders while taking drospirenone + ethinylestradiol tablets or while taking other medications.

Insufficient cycle control

As with other PDAs, a woman may experience acyclic bleeding (spotting or “withdrawal” bleeding), especially in the first months of taking it. Therefore, any irregular bleeding should be assessed after a three-month adaptation period.

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

In some women, withdrawal bleeding does not occur during the placebo phase. If the PDA was taken in accordance with the instructions for use, then it is unlikely that the woman is pregnant. However, if the admission rules were violated before the first missed "withdrawal" menstrual bleeding, or if two bleedings were missed, pregnancy should be excluded before continuing to take the PDA.

Influence on the ability to drive vehicles and use mechanisms

A drug Dimiais a combined contraceptive, a 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 a pronounced antiandrogenic and moderate antimineralocorticoid effect. The contraceptive effect is based on the interaction of various factors, the most important of which are inhibition of ovulation, an increase in the viscosity of the cervical secretion and changes in the endometrium. The Pearl index, an indicator reflecting the frequency of pregnancy in 100 women of reproductive age during the year of using a contraceptive, is less than 1.

Indications for use

Mode of application

The procedure for taking the drug Dimia:
Hormonal contraceptives have not been used in the last month. Taking Dimia® begins on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). It is possible to start taking the pills on the 2-5th day of the menstrual cycle, in this case, additional use of the barrier method of contraception is required during the first 7 days of taking the pills from the first package.
Switching from other combined contraceptives (COC pills, vaginal ring or transdermal patch). It is necessary to 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 preparations containing 21 tablets. packaged. If a woman uses a vaginal ring or a 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 contraceptives containing only progestogens (mini-pills, injections, implants), or from an intrauterine system (IUD) that secretes progestogens. A woman can switch from taking mini-pills to taking Dimia® on any day (from an implant or from an IUD - on the day of their removal, from injectable forms of drugs - on the day when the next injection was to be made), but in all cases it is necessary 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. Taking Dimia® can be started as directed 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 on the 21-28th day after childbirth (provided that she is not breastfeeding) or an abortion in the second trimester of pregnancy. If the reception is started later, the woman should use an additional barrier method of contraception within the first 7 days after starting the drug Dimia®. With the resumption of sexual activity (before taking Dimia®), pregnancy should be excluded.

Taking missed pills
Skipping placebo pills from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid unintentionally prolonging the placebo phase. The instructions below only apply to the missed tablets containing the active ingredients.
If the delay in taking the pill is 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. Tablet-taking should never be interrupted for more than 7 days.
2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous pill intake.
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 it, even if that means taking two pills at the same time. Then she should take the tablets at the usual time. In addition, 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 tablets are 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. 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 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 table, an additional method of contraception (barrier, for example, a condom) is required for 7 days.
Days 15-24. The method's reliability is inevitably diminished as the placebo pill phase approaches. However, adjusting the pill regimen can still help prevent pregnancy. When performing one of the two schemes described below, and if in the previous 7 days before skipping the pill, the woman followed the regimen of taking the drug, there will be no need to use additional contraceptive measures. If not, she should follow the first of the two regimens and take additional precautions for the next 7 days.
1. A woman should take the last missed pill as soon as she remembers it, even if that means taking two pills at the same time. She should then 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 the tablets from the next blister pack. Most likely, withdrawal bleeding will not occur until the end of the second pack, but spotting spotting or withdrawal bleeding may occur on the days of taking the drug from the second pack.
2. The woman can also stop taking active tablets from the started package. Instead, she should take the last row of placebo pills for 4 days, including skipped days, and then start the next pack of pills. 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.

Use of the drug for gastrointestinal upset
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 must take a new (replacement) tablet as soon as possible. If possible, the next tablet should be taken within 12 hours of the usual tablet-taking time.

Delaying menstrual bleeding with withdrawal
To delay bleeding, a woman should skip taking placebo tablets from the started package and start taking drospirenone + ethinyl estradiol tablets from a new package. 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 Dimia® is resumed after the placebo phase. To shift the bleeding to another day of the week, it is recommended to shorten the upcoming phase of taking the placebo tablets by the desired number of days. With a shortening of the cycle, it is more likely that the woman will not have menstrual withdrawal bleeding, but will have acyclic profuse or spotting bleeding from the vagina when taking the next pack (just as when lengthening the cycle).

Side effects

Contraindications

Pregnancy

Interaction with other medicinal products

Overdose

Storage conditions

Release form

Composition

main parameters

In addition, as auxiliary compounds in the composition of the drug there are such substances as: corn starch (16.6 mg.), Including pregelatinized (9.6 mg.), magnesium stearate (0.8 mg.) And copolymer of polyvinyl alcohol (1.45 mg.).

The drug shell contains a complex of compounds Opadry II 85G18490, which, in turn, includes substances such as talc, titanium dioxide, and soy and macrogol.

As part of the second tablet (the so-called placebo ), covered with a green shell contains 37.26 mg. lactose , 42.39 mg. MCC, 0.9 mg. magnesium stearate , 0.45 mg. colloidal silicon dioxide as well as 9 mg. pregelatinized corn starch .

Film casing placebo pills contains a complex of compounds under the name Opadry II 85F21389 , the chemical composition of which includes macrogol , polyvinyl alcohol , talc, quinoline yellow dye , indigo carmine and also dye "Sunset Sun".

Release form

Dimia tablets containing active substances drospirenone and ethinylestradion have a rounded biconvex shape. On one of the sides of the tabletted medicinal product, the “G73” mark is stamped.

The same rounded and biconvex in shape placebo pills are distinguished by a green shell. One package of the drug contains 28 tablets, which can be packaged in 1 or 3 blisters.

pharmachologic effect

Dimia is a combined drug that is monophasic contraceptive .

Pharmacodynamics and pharmacokinetics

This medicinal product contains ethinyl estradiol , and drospirenone (a substance close to natural origin). The active substances that make up this contraceptive do not have antiglucocorticoid, estrogenic, glucocorticoid abilities , as well as a pronounced moderate anti-mineralocorticoid and antiandrogenic action .

Its effectiveness contraceptive Dimia achieves thanks to several factors, for example, due inhibition of ovulation , changes endometrium and raising secretion viscosity located in cervix .

When taken orally drospirenone almost completely and rather quickly absorbed in the stomach. The maximum concentration of the substance in the blood (Cmax) is reached within a maximum of two hours after ingestion contraceptive ... After the stage of distribution and metabolism drospirenone excreted from the body kidneys , a small part of the drug comes out with intestines .

Actively active substance ethinyl estradiol, included in a contraceptive just like drospirenone is rapidly absorbed and reaches its maximum concentration in the blood after two hours. The compound is excreted from the body intestines and kidneys .

Indications for use

Dimia is used as a contraceptive.

Contraindications

This contraceptive is contraindicated in conditions such as:

• hypersensitivity to any of the active components of the drug;
• venous or arterial ;
• heart attack ;
• cerebrovascular disorders ;
• some diseases of cardio-vascular system e.g. damage heart valve or atrial fibrillation ;
• stroke ;
• cerebrovascular disease ;
• hypertension ;
• smoking, provided that the woman has reached the age of 35 years or more;
• , including suspicions about her;
• period lactation ;
• renal failure ;
• , including benign;
• unreasonable vaginal bleeding ;
• lactase deficiency ;
• lapp failure .

Dimia contraceptives should be used with caution when , otorosclerosis, porphyria, small chorea, thromboembolism, cholelithiasis, as well as for diseases that are accompanied by disorders circulation , eg, crohn's disease , phlebitis , other.

Side effects of Dimia

Side effects of Dimia can be expressed in the following ailments from the side genitourinary, nervous, digestive and cardiovascular systems :

• vaginal bleeding smearing or breakthrough acyclic ;
• engorgement of the mammary glands;
• rare, but may develop hypertrophy mammary glands, and the composition secretions vagina ;
• increase or decrease libido ;
• migraine ;
• mood swings;
• extremely rare, but may occur arterial , and ;
• nausea ;
• hyperkalymia ;
• vomiting .

In addition, while taking the drug, you may experience allergic reactions and expressed in , rashes on the skin, and ... It is worth remembering that when using contraceptive , including the drug Dimia, body weight may increase, and intolerance to contact lenses may appear, develops chloasm (hyperpigmentation) .

Dimia tablets, application instruction (Way and dosage)

You can read about how to take the drug correctly in the instructions for Dimia. These contraceptives should be taken every day without skipping. Doctors recommend doing this at the same time, without fail in the order that is usually indicated on the blister. TOontraceptives Dimia, as well as other similar drugs, must be used continuously for 28 days.

New packaging birth control pills Dimia should be opened only after the end of the previous one. From about the third day after the start of the last row of pills in the blister (placebo period), an abundant bleeding ... If packing contraceptive is not over by the end of the month, then the pills are taken again on the first day menses .

During sexual intercourse during the first seven days of using the drug, additional methods must be used contraception (barrier). When switching to the use of Dimia after other complex contraceptives , eg, transdermal patch , pills , vaginal rings and so on, you should start taking this drug immediately the next day after using the previous method contraception .

When switching to Dimia after use contraceptive that contain exclusively ( injections, implants, ) or after taking this drug on any convenient day. However, before using the tablets, you should apply barrier methods of contraception.

As directed by a doctor, a woman can start taking these pills on the day after interruption pregnancy (, vacuum) ... After childbirth it is recommended to wait 28 days and only then resume taking the drug. It is important to note that a missed appointment placebo pills (from the 4th row of the blister) is an insignificant factor.

However, this rule does not apply to tablets containing active ingredients. ethinyl estradiol and drospirenone ... If 12 hours have not passed since the last pill was taken, then the level of contraceptive protection does not decrease. The missed pill should be taken as soon as possible, and the next one should be taken at the usual time.

It is not necessary to take a break in taking pills for more than 7 days, since this is the amount of time needed to suppress hypothalamic-pituitary ovarian system ... For proper use contraceptive it is worth adhering to the following recommendations:

• if you skip taking a pill during the first week of using the drug, a woman should resume use as soon as possible contraceptive , as well as in order to avoid the risk of getting pregnant, be sure to resort to additional methods barrier contraception over the next seven days;
• if you skip taking the drug from 8 to 14 days of use, you should also resume using Dimia as soon as possible, and then return to the usual schedule, while there is no need for additional contraception if the woman did not forget to take contraceptive pills in the previous seven days;
• the effectiveness and reliability of this method contraception significantly reduced if the drug was missed for a period from 15 to 24 days of its use, since at this time the woman needs to switch to placebo pills .

To avoid unwanted pregnancy if the last of the described situations of missing the drug occurs, the woman should take the pill as soon as possible instead of the missed one. Next, you should stick to your usual medication schedule until you run out of active pills. As a result of mixing the reception schedule contraceptive , calculated for 28 days, will remain in the blister placebo pills that do not need to be accepted.

Most likely, with this variant of normal bleeding "withdrawal" there will be no contraceptive until the end of the next package, however, I may appear spotting ... If the drug is missed between 15 and 24 days of the start of its use, the woman may not return to the usual schedule contraceptives and take 4 days (including missed days) placebo pills and then proceed to new packaging.

If with this option did not come withdrawal bleeding then the possibility of pregnancy should be considered. In the presence of gastrointestinal upset the effectiveness of the drug decreases, since active compounds will not be completely absorbed by the stomach. If, after 4 hours after taking the contraceptive pill, a woman vomited, it is worth immediately taking the second, i.e. replacement pill.

If not monthly when taking Dimia, it may signal the onset pregnancy ... It is worth noting that a woman can correct the “withdrawal” spotting, for example, to delay it on her own by changing the schedule of taking the drug.

For this you can skip placebo pills and immediately start taking tablets containing an active compound from a new package. It is noteworthy that when delaying or shifting bleeding "withdrawal" may appear acyclic smears or profuse bleeding .

Overdose

At the moment, there is no information about cases of overdose of Dimia. However, based on experience using complex contraceptive , similar to this drug, in case of an overdose, symptoms such as nausea, vaginal bleeding, and vomiting ... If you experience these symptoms, you should stop using the drug and consult a doctor for advice.

Interaction

In order to avoid weakening the effectiveness of contraceptives, you should not use Dimia together with drugs that affect liver enzymes , eg, , Primidone, Phenytoin, Oxcarbazepine, Felbamate, barbiturates and others, as well as medicines containing St. John's wort in their chemical composition.

On the hepatic metabolism the drug can have a negative effect hIV protease inhibitors and non-nucleoside as well as their combinations. Decrease circulation of estrogen , and consequently, the effectiveness of Dimia occurs while taking and .

Within 28 and 7 days (respectively) after taking medications that affect induction of liver enzymes, and antibiotics you should stop using this drug. Contraceptives can affect the action of some drugs, so before using Dimia, you should carefully read the instructions.

Terms of sale

Sold by prescription only.

Storage conditions

Contraceptives are stored out of the reach of children, at a temperature not exceeding 25 C.

Shelf life

special instructions

Continuous use contraceptives may increase the risk of developing. Moreover, this risk is highest in the first year of contraceptive use. If the following symptoms occur while taking Dimia, you should immediately stop using the drug:

• swelling of the lower extremities and strong pain ;
• sudden loss of sight ;
• cough ;
• unreasonable severe headache;
• diplopia ;
• vertigo ;
• speech disorder ;
• sharp stomach ;
• collapse ;
• numbness ;
• weakness ;
• movement disorders .

During the use of Dimia, the risk of dangerous thromboembolic disorders essentially occurs when:

• hereditary disposition;
• after the age of 30;
• immobilization and after emergency surgery;
• smoking;
• hypertension ;
• dyslipoproteinemia ;
• diseases heart valves.

When using a contraceptive, be sure to consider the risk of thromboembolism especially after childbirth , as well as the development of other adverse consequences when diabetes mellitus, Crohn's disease, colitis, anemia etc. Women should not start taking the drug without the advice of a doctor, as well as a preliminary medical examination.

It is important to be sure to exclude pregnancy ... Withdrawal bleeding may occur during contraceptive use, so the assessment of the secretions can be carried out after three months (adaptation period) from the moment you start using the contraceptive pill.

Combined oral contraceptives, when taken correctly, are the most reliable method of contraception. In addition, such drugs contain female sex hormones in a strictly verified, small dosage. And this allows you to solve many women's health problems, improve the condition of the skin, hair and nails.

Dimia is a modern, multi-phase contraceptive that has received a lot of positive reviews. What features does the drug have, according to what scheme to use the pills and who should refrain from using OC?

Composition

The contraceptive drug has the form of round, white and green tablets with a marker "G73", is available in a blister, in a pack of 28 pieces. Dispensed by doctor's prescription.

White tablets contain the following ingredients:

1. Active. This is microfollin, a progestogen, a derivative of spironolactone.
2. Auxiliary. This category includes lactoline, corn dextrin, polyethylene glycol copolymer, stearic acid, a polymer of a hypothetical vinyl alcohol with the structural formula of a repeating compound unit.

Green pills are placebo. Contain:

1. Milk sugar.
2. Dietary fiber of purified cotton cellulose.
3. Stearic acid.
4. Corn dextrin.
5. The adsorbent is pyrogenic silicon dioxide.

Self-medication, in particular, improper use of the medication, can cause side effects or reduce the contraceptive function of the drug.

Pharmacology

Dimia is, first of all, an effective contraceptive. By a doctor, he can be appointed as nulliparous, and artificially terminated pregnancy in the first and second trimesters. It is also recommended for women who have given birth who are not breastfeeding.

In addition to direct prescription (protection against unwanted pregnancy), the drug can be prescribed to girls of reproductive age to treat acne, seborrhea, severe dysmenorrhea. In addition, taking COCs reduces the likelihood of developing:

• Genital cancer.
• Pelvic inflammatory disease.
• Osteoporosis.

Tablets are prescribed for women who have undergone or have a predisposition to ectopic pregnancy. Also suffering from infertility (increase the likelihood of fertilization after stopping the use of COCs).

It should be borne in mind that the body of every woman has its own characteristic features. Therefore, before using a contraceptive, you should, without fail, pass all the necessary tests for the tolerability of the components of the medication. It would be a good idea to take a complete medical history and consult with your gynecologist.

Side effects

Taking Dimia contraceptive pills can have unpleasant consequences if the dosage is incorrectly selected, the patient regularly violates the drug intake regimen. The most common side effects of COC use are: dizziness, nausea, sleep disturbance, loss of consciousness, increased pressure, depression, depression, bleeding from the nasal cavity. The more severe are:

• Skin diseases and allergic responses of the body to the active or auxiliary components of the drug (itching, rashes, burning sensation).
• Inflammation of the gallbladder, vaginal mucosa, local proliferation of tissues of the cervical canal and breast.
• Sexual dysfunction and decreased desire for intercourse.
• Stopping menstruation.
• Pathology of the breast cavity with liquid-like contents, chest pain.
• Vaginal pain, vaginal dryness, thrush.
• Abdominal bloating or pain.
• Headaches, muscle pains (spasmodic), pain in the lumbosacral region, limbs.
• Disorder of motor function.

No cases of drug intoxication from taking Dimia have been reported. But potential syndromes of drug use in excess of the norm (based on other COCs) can be: nausea, vomiting, insignificant blood excretion of the vagina.

Contraindications

Like most OK, contraceptive Dimia is prohibited to use during pregnancy, breastfeeding. They attribute this to the fact that an increased concentration of hormones can adversely affect the natural development of the fetus. Also, the active substances in the composition of the product can not only reduce its amount, but also change the composition.

Contraindications to the use of contraceptive are the presence of a woman:

• Intolerance to one or more of the constituent components of the drug.
• Acute inflammation of the pancreas.
• Malignant tumors of generative organs, mammary glands, liver.


• Violations of one or more functions of the liver.
• High blood pressure, blockages of arterial vessels, veins.
• Quantitative and qualitative violations of the composition of blood lipoproteins.
• Diseases associated with an insufficient amount or activity of the C1-inhibitor, impaired blood circulation in the peripheral arteries.
• Migraine with pronounced focal neurological symptoms.
• Diseases associated with impaired absorption of glucose, lactose.
• Supraventricular tachyarrhythmias with chaotic atrial electrical activity.

Be sure to consult your doctor to prescribe the most effective dosage of Dimia birth control pills in the presence of work-related diseases:

• Liver.
• Heart muscle.
• Blood flow and in other acute or chronic conditions.

In addition, women in the postnatal period should be treated with special care and caution in the use of Dimia. Also, with caution, the agent is prescribed to those who have suffered diseases provoked by pregnancy or the use of hormone-containing drugs (herpes, jaundice, porphyrin disease, etc.).

Women suffering from obesity, tobacco intoxication, cardiac pathologies have an increased risk of side effects.

Admission rules

Taking Dimia is designed for 28 days, during which a woman should take one pill (alternating active and placebo) every day. Roughly necessary at the same time, drinking plenty of clean, still water. After the packaging has ended, you need to start taking a new one immediately, without interruption. The use of medicines from one blister should not be interrupted for more than one week (7 days).

1. If a woman has not taken oral contraceptives before or took a break in taking for 30-31 days, then the start of taking the drug should fall on the first day of menstruation. It is also permissible for 2–5 days of the cycle, but at the same time, during intercourse, you should additionally protect yourself with barrier contraceptives.
2. When switching to Dimia from other OCs, the intake should be started the next day after taking a placebo pill (medications for 28 days) or tablets with an active substance (for contraceptives designed for 21 days).
3. In case of refusal of implants, injections, hormonal minimal pills or intrauterine contraceptives in favor of COCs, the use of oral contraceptives is recommended to start on the day the injections stop or the contraceptive forms are withdrawn.
4. Taking the drug with a delay of no more than 12 hours will not affect the quality of the contraceptive protection of the medication. If, after the estimated time of taking, more than 12 hours have passed without taking the medication, then the pill should be taken as soon as the woman remembered this, even if this leads to the joint taking of several pills. Further, the reception of contraceptive should take place according to the usual scheme.

The adaptation period (for primary and secondary) but after a significant break in the use of a contraceptive is on average up to three months.

If, after this period, the use of contraceptives is accompanied by discomfort, then you should consult a female doctor to adjust the regimen or a new appointment.

Interaction with other medicines

Reacting with other medications, the effectiveness of Dimia can be either reduced or increased. So, a decrease in the main function of the contraceptive is observed with the simultaneous use of antibiotics (especially ampicillin, tetracycline).

OC can enhance the process of metabolism of active substances:

• Antiviral and sedative medications.
• Medicines prescribed for the treatment of diseases of the respiratory and urinary tract, liver and gastrointestinal tract of an infectious nature.
• The effect of oral contraceptives can be enhanced and increased by taking metronidazole and vitamin C.

At the same time, the rapid metabolism of active substances by OC is prevented by:

• Pomegranate juice.
• Third generation lipid-lowering drugs from the statin group.

In addition, COCs can also affect the level of drug concentration in the blood. So, the drug is capable of:

1. Reduce the plasma concentration of some medicines from the group: aldehydes (Paracetamol), IV generation fluoroquinolones (Trovafloxacin), salicylic acid.
2. To increase the degree of influence on the body of caffeine, some antidepressants (imipramine), immunosuppressants (for example, such as cyclosporine).

Dimia is an excellent contraceptive drug, but even it must be taken with the permission of a gynecologist.