Drospyrenon, ethinyl estradiol | Dimia tablets 3 mg + 0.02 mg, 84 pcs.
Special Price
$51.94
Regular Price
$60.00
In stock
SKU
BID470295
Release form
film-coated tablets (set)
film-coated tablets (set)
Release form
film-coated tablets (set)
Packing
72 tablets drospirenone + ethinyl estradiol and 12 tablets placebo
Pharmacological action of
Dimia is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol.
According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogen, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid effect.
The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and a change in the endometrium.
Perl index, an indicator that reflects the pregnancy rate in 100 women of reproductive age during the year of contraceptive use, is less than 1.
Indications
Oral contraception.
Contraindications
The drug Dimia, like other COCs, is contraindicated in any of the following conditions:
hypersensitivity to the drug or any of the components of the drug
thrombosis (arterial and venous) and a history of thromboembolism or history (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders). Conditions preceding thrombosis (including transient ischemic attacks angina pectoris) currently or in the history of
, multiple or severe risk factors for venous or arterial thrombosis, including complicated valvular heart disease, atrial fibrillation, cerebrovascular or coronary artery disease, uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking over the age of 35 years, obesity with a body mass index> 30
hereditary or acquired predisposition to venous or arterial thrombosis, e.g. resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocy teinemiya and antibodies against phospholipids (antiphospholipid antibodies - antibodies to cardiolipin, lupus anticoagulant)
pregnancy and suspicion of it
lactation period
pancreatitis with severe hypertriglyceridemia currently or in the history of
severe (or history) severe liver disease, provided that liver function and currently severe or normal renal failure
liver tumor (benign or malignant) is currently or in the history of
hormone-dependent malignant neoplasms of the genitals or mammary gland currently or in the history of
vaginal bleeding of unknown origin
migraine with focal neurological symptoms in the history of
lactase deficiency, lactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency.
Caution: risk factors for thrombosis and thromboembolism - smoking under the age of 35 years, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or impaired myocardial infarction any of the next of kin) diseases in which peripheral circulatory disorders may occur (diabetes without vascular complications second, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins), hereditary angioedema, severe liver disease, hypertriglyceridemia (up to normalization of liver function tests), the disease, first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and / or pruritus associated with cholestasis, cholelithiasis, otosclerosis with hearing loss, porphyria, herpes during pregnancy, history, small chorea (disease Sydenham) postpartum chloasma
Use during pregnancy and lactation
The drug Dimia is contraindicated during pregnancy.
If pregnancy has occurred during the use of the drug Dimia, its administration should be stopped immediately. Extensive epidemiological studies did not reveal an increase in the risk of birth defects in children born to women who took CPC before pregnancy, nor the teratogenic effect of CPC when they were inadvertently taken 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 while taking CPC. These amounts may affect the baby. The use of the drug Dimia during breastfeeding is contraindicated.
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 the event of an exacerbation of an adverse event or in the event of any of these conditions or risk factors, a woman should contact her doctor. The physician must decide whether to interrupt COC.
Circulatory disorders
Taking any COC increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year a woman uses COCs.
Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (<0.05 mg ethinyl estradiol) as part of COCs, approximately 20 cases per 100,000 women-years (for second-generation levonorgestrel-containing COCs) or 40 cases per 100,000 women-years (for third-generation desogestrel / gestode-containing COCs). Women who do not use COCs experience 5–10 VTE and 60 pregnancies per 100,000 women-years. VTE is fatal in 1–2% of cases.
Data from a large, prospective, with 3 research directions showed that the frequency of VTE in women with or without other VTE risk factors using a combination of ethinyl estradiol and drospirenone, 0.03 + 3 mg, coincides with the frequency of VTE in women using levonorgestrel-containing oral contraceptives and other COCs. The degree of risk of VTE when taking DimiaВ® is currently not established.
Epidemiological studies have also revealed a correlation between COC intake and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).
Very rarely, women taking oral contraceptives have experienced thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidney, brain, or retina. There is no consensus on the connection of these phenomena with the use of hormonal contraceptives.
Symptoms of venous or arterial thrombotic / thromboembolic events or acute cerebrovascular accident:
- unusual unilateral pain and / or swelling of the lower extremities
- sudden severe chest pain, regardless of whether she gives
to her left hand or not - sudden shortness of breath
- sudden onset of cough
- any unusual severe long-term headache
- sudden partial or complete loss of vision
- diplopia
- speech or aphasia
- vertigo collpslrd with or without epileptic seizures
- weakness or very noticeable numbness that suddenly affects one side or one part of the body
- motor disorders
- acute abdomen.
A woman should consult a specialist before taking COCs. The risk of venous thromboembolic disorders when taking COC increases:
- with an increase in the age of
- a hereditary predisposition (VTE has ever occurred in siblings or parents at a relatively young 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 surgical intervention for at least 4 weeks) and not to resume until two weeks after the full restoration of mobility. If the drug was not stopped in advance, you should consider the possibility of anticoagulant treatment of
- obesity (body mass index more than 30)
- the lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.
The risk of arterial thromboembolic complications or acute cerebrovascular accident when taking COC increases:
- with increasing age
- smoking (women over 35 years old are strongly recommended to quit smoking if they want to take COC)
- dyslipoproteinemia
- non-arterial hypertension focal neurological symptoms
- obesity (body mass index over 30)
- hereditary predisposition (arterial thromboembolism ever in siblings or parents no early age). If a hereditary predisposition is possible, a woman should consult a specialist before starting COC
- damage to the heart valves
- atrial fibrillation.
The presence of one serious risk factor for venous disease or several risk factors for arterial disease may also be a contraindication. The possibility of anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their healthcare provider if they suspect symptoms of thrombosis. In case thrombosis is suspected or confirmed, COC administration should be discontinued. It is necessary to begin adequate alternative contraception due to the teratogenicity of anticoagulant therapy with indirect anticoagulants - coumarin derivatives.
The increased risk of postpartum thromboembolism should be considered.
Other medical conditions associated with adverse vascular events include diabetes mellitus, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency or severity of migraine while taking COCs may be an indication for their immediate cancellation.
Tumors
The most significant risk factor for cervical cancer is human papillomavirus infection. Some epidemiological studies have reported an increased risk of developing cervical cancer with prolonged use of COCs, but there are conflicting opinions about the extent to which these findings are related factors, such as testing for cervical cancer or using barrier methods of contraception.
A meta-analysis of 54 epidemiological studies revealed a slight increase in relative risk (relative risk - RR = 1, 24) the development of breast cancer in women who are currently taking COCs. The risk gradually decreases within 10 years after stopping COC. Since breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in patients using COCs has little effect on the overall likelihood of breast cancer. In these studies, sufficient evidence of a causal relationship has not been identified. The 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. The diagnosed breast cancer in women who had ever taken COCs was clinically less severe due to early diagnosis of the disease.
Rarely in women taking COCs, benign tumors of the liver occurred and even more rarely, malignant tumors of the liver. In some cases, these tumors were life-threatening (due to intra-abdominal bleeding). This should be considered when making a differential diagnosis in the event of severe pain in the abdomen, enlarged liver, or signs of intra-abdominal bleeding.
Other
The progestogen component of DimiaВ® is an aldosterone antagonist that holds potassium in the body. In most cases, an increase in potassium content is not expected. However, in a clinical study in some patients with mild or moderate kidney diseases who were taking potassium-sparing drugs, the serum potassium content increased slightly while taking drospirenone. Consequently, it is recommended to control the serum potassium content during the first treatment cycle in patients with renal failure, in which the serum potassium concentration was at the level of VGN before treatment, and especially while taking potassium-sparing drugs. In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis when taking COCs may be increased. 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 reasonable to immediately stop taking COCs. If when taking COC in patients with concomitant arterial hypertension, blood pressure constantly increases or significantly increased pressure cannot be adjusted with antihypertensive drugs, COC should be discontinued. After the normalization of blood pressure with antihypertensive drugs, COC administration can be resumed.
The following diseases appeared or worsened during pregnancy and when taking COCs: jaundice and / or itching associated with cholestasis, gall bladder porphyria SLE hemolytic uremic syndrome rheumatic chorea (Sydenham chorea) herpes during pregnancy otosclerosis with hearing loss. However, evidence of their relationship with COC use is inconclusive.
In women with hereditary angioedema, exogenous estrogens can induce or exacerbate symptoms of edema.
Acute or chronic liver disease may be an indication for stopping COC before normalization of liver function. Relapse of cholestatic jaundice and / or pruritus associated with cholestasis, which developed during a previous pregnancy or with the earlier use of sex hormones, serve as an indication for stopping COC.
Although COCs may affect peripheral insulin resistance and glucose tolerance, a change in the treatment regimen for patients with diabetes mellitus while taking COCs with a low hormone content (containing <0.05 mg ethinyl estradiol) has not been shown. However, women with diabetes should be closely monitored, especially in the early stages of taking COCs.
While taking COCs, aggravation of endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis was observed.
Chloasma can occur from time to time, especially in women who have already had a history of pregnant chloasma. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet when taking COCs.
Drospirenone + ethinyl estradiol coated tablets contain 48.53 mg of lactose monohydrate, placebo tablets contain 37.26 mg of anhydrous lactose per tablet. Patients with rare inherited diseases (such as galactose intolerance, lactase deficiency or malabsorption of glucose-galactose) who follow a lactose-free diet should not take this medication.
Women who are allergic to soya lecithin may experience allergic reactions.
The efficacy and safety of DimiaВ® as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-puberty period up to 18 years, the effectiveness and safety of the drug are similar to those in women after 18 years. The use of the drug until the establishment of menarche is not shown.
Medical Examination
Before you start or re-use DimiaВ®, you should collect a complete medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure, to 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 practical guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least 1 time in 6 months.
A woman needs to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Decreased efficacy of
The effectiveness of COCs may be reduced, for example, by skipping drospirenone + ethinyl estradiol tablets, gastrointestinal upset while taking drospirenone + ethinyl estradiol tablets, or taking other medications at the same time.
Inadequate control of the
cycle As with other COCs, a woman may experience acyclic bleeding (spotting or withdrawal bleeding), especially in the first months of administration. Therefore, any irregular bleeding should be evaluated after a three-month adaptation period.
If acyclic bleeding recurs or begins after several regular cycles, you should consider the possibility of developing disorders of a non-hormonal nature and take measures to exclude pregnancy or cancer, including treatment and diagnostic curettage of the uterine cavity. In some women, withdrawal bleeding does not occur during the placebo phase. If COCs were taken in accordance with the instructions for use, it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like withdrawal bleeding or two bleeds were missed, pregnancy should be excluded before continuing COC.
Impact on the ability to drive vehicles and mechanisms. Not found.
Composition
Tablets ethinyl estradiol + drospirenone
1 tablet contains:
active ingredients:
ethinyl estradiol 0.02 mg,
rospirenone 3 mg,
excipients pregelatinized corn starch - 9.6 mg
macrogol and polyvinyl alcohol copolymer - 1.45 mg
magnesium stearate - 0.8 mg,
film coat:
Opadry II white 85G18490 (polyvinyl alcohol - 0.88 mg, 0.4 titanium dioxide mg, macrogol 3350 - 0.247 mg, talc - 0.4 mg, soy lecithin - 0.07 mg) - 2 g
placebo tablets 1 tablet contains:
MCC - 42.39 mg lactose
- 37, 26 mg
pregelatinized corn starch - 9 mg
magnesium stearate - 0.9 mg
silicon colloidal dioxide - 0.45 mg,
film coat:
Opadry II green 85F21389 (polyvinyl alcohol - 1.2 mg, titanium dioxide - 0 7086 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, indigo carmine - 0.0177 mg, dye quinoline yellow - 0.0177 mg, dye iron oxide black - 0.003 mg, dye "Sunny Sunset" yellow - 0.003 mg) - 3 mg
Dosage and administration
Inside, daily, at about the same time, with a little water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet each. per day. Reception of tablets from the next package begins after taking the last tablet from the previous package. Withdrawal bleeding usually begins on the 2nd – 3rd day after the start of taking a placebo pill (last row) and does not necessarily end by the beginning of the next pack.
Dima®
hormonal contraceptives have not been used in the last month. Reception of the drug Dimia® begins on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). The start of administration is possible on the 2nd – 5th day of the menstrual cycle, in which case additional application of the barrier method of contraception during the first 7 days of taking the tablets from the first package is necessary.
Transition from other combined contraceptives (COCs in pill form, vaginal ring or transdermal patch). It is necessary to start taking Dimia® the day after taking the last inactive tablet (for drugs containing 28 tablets. ) or the day after taking the last active pill from the previous package (possibly the day after the usual 7-day break) - for preparations containing 21 tablets. packaged. If a woman uses a vaginal ring or transdermal patch, it is preferable to start taking Dimia® on the day they are removed or, at the latest, on the day when it is planned to introduce a new ring or replace the patch.
Transition from contraceptives containing only progestogens (mini-pills, injections, implants), or from the intrauterine system (IUD) that releases progestogens. A woman can switch from taking mini-drinks to taking Dimia® on any day (from the implant or from the IUD - on the day of their removal, from the injection forms of drugs - on the day when the next injection was to be made), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
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 the birth (provided that she does not breast-feed) or abortion in the second trimester of pregnancy. If the intake is started later, the woman should use the additional barrier method of contraception during the first 7 days after the start of taking the drug Dimia®. With the resumption of sexual activity (before taking Dimia®), pregnancy should be excluded.
Taking missed tablets
Missing placebo tablets from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The directions below apply only to missed tablets containing active ingredients.
If the delay in taking the pill was less than 12 hours, contraceptive protection does not decrease. 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 is longer than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:
1. The intake of tablets should never be interrupted for more than 7 days.
2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
According to these women, you can give the following recommendations:
Days 1–7. A woman should take a missed pill as soon as she remembers it, even if it means taking two tablets at the same time. Then she should take the pill at the usual time. In addition, over the next 7 days, you should use a barrier method, such as a condom. If sexual intercourse occurred in the previous 7 days, the possibility of pregnancy should be considered. The more tablets missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.
Days 8-14. A woman should take a missed pill as soon as she remembers this, even if it means taking two tablets at the same time. Then she should take the pill at the usual time. If during the 7 days preceding the first missed pill, a woman took the pill as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier, such as a condom) is needed for 7 days.
Days 15-24. Reliability of the method inevitably decreases as the phase of placebo tablets 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 passing the pill a woman observed the regimen of taking the drug, the need for additional contraceptive measures will not arise. If this is not so,take extra precautions over the next 7 days.
1. A woman should take the last missed pill as soon as she remembers it, even if it means taking two tablets at the same time. Then she should take the pills at the usual time until the active pills run out. 4 placebo tablets from the last row should not be taken, you should immediately start taking tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second package, but spotting or spotting bleeding may occur on the days of taking the drug from the second package.
2. A woman may also stop taking active pills from her package. Instead, she should take the last placebo placebo pill for 4 days, including the days the pill was missed, and then start taking pills from the next pack. If a woman missed taking the pills and subsequently did not experience withdrawal bleeding in the placebo pill phase, pregnancy should be considered.
Use of the drug for gastrointestinal upset
In case of severe gastrointestinal upsets (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 from the usual time of taking the tablets. If more than 12 hours have passed, it is recommended that you follow the directions when skipping tablets. If a woman does not want to change the usual pill regimen, she should take an extra pill from another pack.
Postponement of menstrual bleeding withdrawal
To postpone bleeding, a woman should skip taking placebo tablets from the package she has started and start taking drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second package are over. During the delay, a woman may experience acyclic abundant or spotting spotting from the vagina. Regular use of Dimia® resumes after the placebo phase. To shift bleeding on another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When shortening the cycle, it is more likely that the woman will not have menstrual bleeding withdrawal, and there will be acyclic profuse or spotting spotting from the vagina when taking the next package (the same as when lengthening the cycle).
Side effects
Frequency: often (more than 1/100, less than 1/10) infrequently (more than 1/1000, less than 1/100) rarely (more than 1/10000, less than 1/1000).
From the genitourinary system: acyclic vaginal bleeding (spotting spotting or breakthrough bleeding) often - engorgement, tenderness of the mammary glands, infrequently - hypertrophy of the mammary glands, decreased libido, rarely - changes in the nature of vaginal secretion, discharge from the mammary glands, increased libido.
From the nervous system: often - headache, decreased mood, emotional lability, infrequently - migraine.
From the CCC side: rarely - thrombosis (venous and arterial), thromboembolism.
From the digestive system: often - nausea, abdominal pain, infrequently - vomiting, diarrhea.
From the skin: infrequently - a skin rash.
Allergic reactions: infrequently - urticaria, rarely - erythema nodosum, erythema multiforme.
Other: often - increase in body weight, infrequently - fluid retention, rarely - poor tolerance of contact lenses, decrease in body weight of chloasma, especially if there is a history of pregnant chloasma.
Drug Interactions
Note: Before taking concomitant drugs, you should read the instructions for use of the drug to identify potential interactions.
The effect of other drugs on the drug Dimia®. The interaction between oral contraceptives and other drugs can lead to acyclic bleeding and / or contraceptive failure. The interactions described below are reflected in the scientific literature.
The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and Hypericum perforatum preparations (Hypericum perforatum) is based on the ability of these active substances to induce liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, however, after that it persists for at least 4 weeks after the cessation of drug therapy.
Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is unclear. Women with short-term treatment (up to one week) with any of the above groups of drugs or monopreparations should temporarily use (during the period of simultaneous administration of other drugs and for another 7 days after its end), in addition to COCs, barrier methods of contraception.
Women receiving rifampicin therapy, in addition to taking COCs, should use the barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medication lasts longer than the active pill in the pack, the inactive pill should be discontinued and the drospirenone + ethinyl estradiol pill from the next pack should be taken 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, therefore, are unlikely to affect the metabolism of drospirenone.
Effect of Dimia® on other drugs. Oral contraceptives may affect the metabolism of certain other active substances. Accordingly, the concentration of these substances in blood plasma or tissues can either increase (for example, cyclosporine) or decrease (for example lamotrigine). Based on studies of in vitro inhibition and in vivo interactions in female volunteers taking omeprazole, simvastatin and midazolam as a substrate, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.
Other interactions. In patients without renal failure, the simultaneous administration of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the serum potassium content. But still, the simultaneous use of Dimia® with aldosterone antagonists or potassium-sparing diuretics has not been investigated. In this case, during the first cycle of treatment, it is necessary to monitor the concentration of serum potassium.
Laboratory tests. Taking contraceptive steroids can affect the results of some laboratory tests, including determining biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (carrier) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, carbohydrate metabolism parameters and blood coagulation and fibrinolysis parameters . Generally, changes remain within the normal range. Drospirenone is the cause of increased plasma renin activity and, due to its small antimineralocorticoid activity, reduces the concentration of aldosterone in plasma.
Overdose
There have been no cases of overdose with Dimia®.
Based on the common experience of COC use, the potential symptoms of overdose may be: nausea, vomiting, mild vaginal bleeding.
Treatment: No antidotes. Further treatment should be symptomatic.
Storage Conditions
The product should be stored out of the reach of children, protected from light at a temperature not exceeding 25 РC.
Shelf life
2 years.
Deystvuyushtee substance
Drospirenone, Эtinilэstradiol
Terms and conditions
prescription
dosage form
tablets
Prescribing
Prescribing
Prescribing
Adults as prescribed by a doctor, For women de orodnogo age
Gedeon Richter Vengriya
film-coated tablets (set)
Packing
72 tablets drospirenone + ethinyl estradiol and 12 tablets placebo
Pharmacological action of
Dimia is a combined monophasic oral contraceptive containing drospirenone and ethinyl estradiol.
According to its pharmacological profile, drospirenone is close to natural progesterone: it does not have estrogen, glucocorticoid and antiglucocorticoid activity and is characterized by a pronounced antiandrogenic and moderate antimineralocorticoid effect.
The contraceptive effect is based on the interaction of various factors, the most important of which are the inhibition of ovulation, an increase in the viscosity of the cervical secretion and a change in the endometrium.
Perl index, an indicator that reflects the pregnancy rate in 100 women of reproductive age during the year of contraceptive use, is less than 1.
Indications
Oral contraception.
Contraindications
The drug Dimia, like other COCs, is contraindicated in any of the following conditions:
hypersensitivity to the drug or any of the components of the drug
thrombosis (arterial and venous) and a history of thromboembolism or history (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders). Conditions preceding thrombosis (including transient ischemic attacks angina pectoris) currently or in the history of
, multiple or severe risk factors for venous or arterial thrombosis, including complicated valvular heart disease, atrial fibrillation, cerebrovascular or coronary artery disease, uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking over the age of 35 years, obesity with a body mass index> 30
hereditary or acquired predisposition to venous or arterial thrombosis, e.g. resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocy teinemiya and antibodies against phospholipids (antiphospholipid antibodies - antibodies to cardiolipin, lupus anticoagulant)
pregnancy and suspicion of it
lactation period
pancreatitis with severe hypertriglyceridemia currently or in the history of
severe (or history) severe liver disease, provided that liver function and currently severe or normal renal failure
liver tumor (benign or malignant) is currently or in the history of
hormone-dependent malignant neoplasms of the genitals or mammary gland currently or in the history of
vaginal bleeding of unknown origin
migraine with focal neurological symptoms in the history of
lactase deficiency, lactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency.
Caution: risk factors for thrombosis and thromboembolism - smoking under the age of 35 years, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or impaired myocardial infarction any of the next of kin) diseases in which peripheral circulatory disorders may occur (diabetes without vascular complications second, systemic lupus erythematosus (SLE), hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins), hereditary angioedema, severe liver disease, hypertriglyceridemia (up to normalization of liver function tests), the disease, first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including jaundice and / or pruritus associated with cholestasis, cholelithiasis, otosclerosis with hearing loss, porphyria, herpes during pregnancy, history, small chorea (disease Sydenham) postpartum chloasma
Use during pregnancy and lactation
The drug Dimia is contraindicated during pregnancy.
If pregnancy has occurred during the use of the drug Dimia, its administration should be stopped immediately. Extensive epidemiological studies did not reveal an increase in the risk of birth defects in children born to women who took CPC before pregnancy, nor the teratogenic effect of CPC when they were inadvertently taken 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 while taking CPC. These amounts may affect the baby. The use of the drug Dimia during breastfeeding is contraindicated.
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 the event of an exacerbation of an adverse event or in the event of any of these conditions or risk factors, a woman should contact her doctor. The physician must decide whether to interrupt COC.
Circulatory disorders
Taking any COC increases the risk of venous thromboembolism (VTE). The increased risk of VTE is most pronounced in the first year a woman uses COCs.
Epidemiological studies have shown that the incidence of VTE in women with no risk factors who took low doses of estrogen (<0.05 mg ethinyl estradiol) as part of COCs, approximately 20 cases per 100,000 women-years (for second-generation levonorgestrel-containing COCs) or 40 cases per 100,000 women-years (for third-generation desogestrel / gestode-containing COCs). Women who do not use COCs experience 5–10 VTE and 60 pregnancies per 100,000 women-years. VTE is fatal in 1–2% of cases.
Data from a large, prospective, with 3 research directions showed that the frequency of VTE in women with or without other VTE risk factors using a combination of ethinyl estradiol and drospirenone, 0.03 + 3 mg, coincides with the frequency of VTE in women using levonorgestrel-containing oral contraceptives and other COCs. The degree of risk of VTE when taking DimiaВ® is currently not established.
Epidemiological studies have also revealed a correlation between COC intake and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic disorders).
Very rarely, women taking oral contraceptives have experienced thrombosis of other blood vessels, such as veins and arteries of the liver, mesentery, kidney, brain, or retina. There is no consensus on the connection of these phenomena with the use of hormonal contraceptives.
Symptoms of venous or arterial thrombotic / thromboembolic events or acute cerebrovascular accident:
- unusual unilateral pain and / or swelling of the lower extremities
- sudden severe chest pain, regardless of whether she gives
to her left hand or not - sudden shortness of breath
- sudden onset of cough
- any unusual severe long-term headache
- sudden partial or complete loss of vision
- diplopia
- speech or aphasia
- vertigo collpslrd with or without epileptic seizures
- weakness or very noticeable numbness that suddenly affects one side or one part of the body
- motor disorders
- acute abdomen.
A woman should consult a specialist before taking COCs. The risk of venous thromboembolic disorders when taking COC increases:
- with an increase in the age of
- a hereditary predisposition (VTE has ever occurred in siblings or parents at a relatively young 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 surgical intervention for at least 4 weeks) and not to resume until two weeks after the full restoration of mobility. If the drug was not stopped in advance, you should consider the possibility of anticoagulant treatment of
- obesity (body mass index more than 30)
- the lack of consensus on the possible role of varicose veins and superficial thrombophlebitis in the appearance or exacerbation of venous thrombosis.
The risk of arterial thromboembolic complications or acute cerebrovascular accident when taking COC increases:
- with increasing age
- smoking (women over 35 years old are strongly recommended to quit smoking if they want to take COC)
- dyslipoproteinemia
- non-arterial hypertension focal neurological symptoms
- obesity (body mass index over 30)
- hereditary predisposition (arterial thromboembolism ever in siblings or parents no early age). If a hereditary predisposition is possible, a woman should consult a specialist before starting COC
- damage to the heart valves
- atrial fibrillation.
The presence of one serious risk factor for venous disease or several risk factors for arterial disease may also be a contraindication. The possibility of anticoagulant therapy should also be considered. Women taking COCs should be properly instructed to inform their healthcare provider if they suspect symptoms of thrombosis. In case thrombosis is suspected or confirmed, COC administration should be discontinued. It is necessary to begin adequate alternative contraception due to the teratogenicity of anticoagulant therapy with indirect anticoagulants - coumarin derivatives.
The increased risk of postpartum thromboembolism should be considered.
Other medical conditions associated with adverse vascular events include diabetes mellitus, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency or severity of migraine while taking COCs may be an indication for their immediate cancellation.
Tumors
The most significant risk factor for cervical cancer is human papillomavirus infection. Some epidemiological studies have reported an increased risk of developing cervical cancer with prolonged use of COCs, but there are conflicting opinions about the extent to which these findings are related factors, such as testing for cervical cancer or using barrier methods of contraception.
A meta-analysis of 54 epidemiological studies revealed a slight increase in relative risk (relative risk - RR = 1, 24) the development of breast cancer in women who are currently taking COCs. The risk gradually decreases within 10 years after stopping COC. Since breast cancer rarely develops in women under 40 years of age, an increase in the number of diagnosed cases of breast cancer in patients using COCs has little effect on the overall likelihood of breast cancer. In these studies, sufficient evidence of a causal relationship has not been identified. The 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. The diagnosed breast cancer in women who had ever taken COCs was clinically less severe due to early diagnosis of the disease.
Rarely in women taking COCs, benign tumors of the liver occurred and even more rarely, malignant tumors of the liver. In some cases, these tumors were life-threatening (due to intra-abdominal bleeding). This should be considered when making a differential diagnosis in the event of severe pain in the abdomen, enlarged liver, or signs of intra-abdominal bleeding.
Other
The progestogen component of DimiaВ® is an aldosterone antagonist that holds potassium in the body. In most cases, an increase in potassium content is not expected. However, in a clinical study in some patients with mild or moderate kidney diseases who were taking potassium-sparing drugs, the serum potassium content increased slightly while taking drospirenone. Consequently, it is recommended to control the serum potassium content during the first treatment cycle in patients with renal failure, in which the serum potassium concentration was at the level of VGN before treatment, and especially while taking potassium-sparing drugs. In women with hypertriglyceridemia or a hereditary predisposition to it, the risk of pancreatitis when taking COCs may be increased. 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 reasonable to immediately stop taking COCs. If when taking COC in patients with concomitant arterial hypertension, blood pressure constantly increases or significantly increased pressure cannot be adjusted with antihypertensive drugs, COC should be discontinued. After the normalization of blood pressure with antihypertensive drugs, COC administration can be resumed.
The following diseases appeared or worsened during pregnancy and when taking COCs: jaundice and / or itching associated with cholestasis, gall bladder porphyria SLE hemolytic uremic syndrome rheumatic chorea (Sydenham chorea) herpes during pregnancy otosclerosis with hearing loss. However, evidence of their relationship with COC use is inconclusive.
In women with hereditary angioedema, exogenous estrogens can induce or exacerbate symptoms of edema.
Acute or chronic liver disease may be an indication for stopping COC before normalization of liver function. Relapse of cholestatic jaundice and / or pruritus associated with cholestasis, which developed during a previous pregnancy or with the earlier use of sex hormones, serve as an indication for stopping COC.
Although COCs may affect peripheral insulin resistance and glucose tolerance, a change in the treatment regimen for patients with diabetes mellitus while taking COCs with a low hormone content (containing <0.05 mg ethinyl estradiol) has not been shown. However, women with diabetes should be closely monitored, especially in the early stages of taking COCs.
While taking COCs, aggravation of endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis was observed.
Chloasma can occur from time to time, especially in women who have already had a history of pregnant chloasma. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet when taking COCs.
Drospirenone + ethinyl estradiol coated tablets contain 48.53 mg of lactose monohydrate, placebo tablets contain 37.26 mg of anhydrous lactose per tablet. Patients with rare inherited diseases (such as galactose intolerance, lactase deficiency or malabsorption of glucose-galactose) who follow a lactose-free diet should not take this medication.
Women who are allergic to soya lecithin may experience allergic reactions.
The efficacy and safety of DimiaВ® as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-puberty period up to 18 years, the effectiveness and safety of the drug are similar to those in women after 18 years. The use of the drug until the establishment of menarche is not shown.
Medical Examination
Before you start or re-use DimiaВ®, you should collect a complete medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure, to 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 practical guidelines. The frequency of medical examinations is individual for each woman, but should be carried out at least 1 time in 6 months.
A woman needs to be reminded that oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Decreased efficacy of
The effectiveness of COCs may be reduced, for example, by skipping drospirenone + ethinyl estradiol tablets, gastrointestinal upset while taking drospirenone + ethinyl estradiol tablets, or taking other medications at the same time.
Inadequate control of the
cycle As with other COCs, a woman may experience acyclic bleeding (spotting or withdrawal bleeding), especially in the first months of administration. Therefore, any irregular bleeding should be evaluated after a three-month adaptation period.
If acyclic bleeding recurs or begins after several regular cycles, you should consider the possibility of developing disorders of a non-hormonal nature and take measures to exclude pregnancy or cancer, including treatment and diagnostic curettage of the uterine cavity. In some women, withdrawal bleeding does not occur during the placebo phase. If COCs were taken in accordance with the instructions for use, it is unlikely that the woman is pregnant. However, if the rules of admission were violated before the first missed menstrual-like withdrawal bleeding or two bleeds were missed, pregnancy should be excluded before continuing COC.
Impact on the ability to drive vehicles and mechanisms. Not found.
Composition
Tablets ethinyl estradiol + drospirenone
1 tablet contains:
active ingredients:
ethinyl estradiol 0.02 mg,
rospirenone 3 mg,
excipients pregelatinized corn starch - 9.6 mg
macrogol and polyvinyl alcohol copolymer - 1.45 mg
magnesium stearate - 0.8 mg,
film coat:
Opadry II white 85G18490 (polyvinyl alcohol - 0.88 mg, 0.4 titanium dioxide mg, macrogol 3350 - 0.247 mg, talc - 0.4 mg, soy lecithin - 0.07 mg) - 2 g
placebo tablets 1 tablet contains:
MCC - 42.39 mg lactose
- 37, 26 mg
pregelatinized corn starch - 9 mg
magnesium stearate - 0.9 mg
silicon colloidal dioxide - 0.45 mg,
film coat:
Opadry II green 85F21389 (polyvinyl alcohol - 1.2 mg, titanium dioxide - 0 7086 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, indigo carmine - 0.0177 mg, dye quinoline yellow - 0.0177 mg, dye iron oxide black - 0.003 mg, dye "Sunny Sunset" yellow - 0.003 mg) - 3 mg
Dosage and administration
Inside, daily, at about the same time, with a little water, in the order indicated on the blister pack. Tablets are taken continuously for 28 days, 1 tablet each. per day. Reception of tablets from the next package begins after taking the last tablet from the previous package. Withdrawal bleeding usually begins on the 2nd – 3rd day after the start of taking a placebo pill (last row) and does not necessarily end by the beginning of the next pack.
Dima®
hormonal contraceptives have not been used in the last month. Reception of the drug Dimia® begins on the 1st day of the menstrual cycle (i.e. on the 1st day of menstrual bleeding). The start of administration is possible on the 2nd – 5th day of the menstrual cycle, in which case additional application of the barrier method of contraception during the first 7 days of taking the tablets from the first package is necessary.
Transition from other combined contraceptives (COCs in pill form, vaginal ring or transdermal patch). It is necessary to start taking Dimia® the day after taking the last inactive tablet (for drugs containing 28 tablets. ) or the day after taking the last active pill from the previous package (possibly the day after the usual 7-day break) - for preparations containing 21 tablets. packaged. If a woman uses a vaginal ring or transdermal patch, it is preferable to start taking Dimia® on the day they are removed or, at the latest, on the day when it is planned to introduce a new ring or replace the patch.
Transition from contraceptives containing only progestogens (mini-pills, injections, implants), or from the intrauterine system (IUD) that releases progestogens. A woman can switch from taking mini-drinks to taking Dimia® on any day (from the implant or from the IUD - on the day of their removal, from the injection forms of drugs - on the day when the next injection was to be made), but in all cases it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
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 the birth (provided that she does not breast-feed) or abortion in the second trimester of pregnancy. If the intake is started later, the woman should use the additional barrier method of contraception during the first 7 days after the start of taking the drug Dimia®. With the resumption of sexual activity (before taking Dimia®), pregnancy should be excluded.
Taking missed tablets
Missing placebo tablets from the last (4th) row of the blister can be ignored. However, they should be discarded to avoid inadvertently prolonging the placebo phase. The directions below apply only to missed tablets containing active ingredients.
If the delay in taking the pill was less than 12 hours, contraceptive protection does not decrease. 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 is longer than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by two basic rules:
1. The intake of tablets should never be interrupted for more than 7 days.
2. To achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
According to these women, you can give the following recommendations:
Days 1–7. A woman should take a missed pill as soon as she remembers it, even if it means taking two tablets at the same time. Then she should take the pill at the usual time. In addition, over the next 7 days, you should use a barrier method, such as a condom. If sexual intercourse occurred in the previous 7 days, the possibility of pregnancy should be considered. The more tablets missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.
Days 8-14. A woman should take a missed pill as soon as she remembers this, even if it means taking two tablets at the same time. Then she should take the pill at the usual time. If during the 7 days preceding the first missed pill, a woman took the pill as expected, there is no need for additional contraceptive measures. However, if she missed more than 1 tablet, an additional method of contraception (barrier, such as a condom) is needed for 7 days.
Days 15-24. Reliability of the method inevitably decreases as the phase of placebo tablets 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 passing the pill a woman observed the regimen of taking the drug, the need for additional contraceptive measures will not arise. If this is not so,take extra precautions over the next 7 days.
1. A woman should take the last missed pill as soon as she remembers it, even if it means taking two tablets at the same time. Then she should take the pills at the usual time until the active pills run out. 4 placebo tablets from the last row should not be taken, you should immediately start taking tablets from the next blister pack. Most likely, there will be no withdrawal bleeding until the end of the second package, but spotting or spotting bleeding may occur on the days of taking the drug from the second package.
2. A woman may also stop taking active pills from her package. Instead, she should take the last placebo placebo pill for 4 days, including the days the pill was missed, and then start taking pills from the next pack. If a woman missed taking the pills and subsequently did not experience withdrawal bleeding in the placebo pill phase, pregnancy should be considered.
Use of the drug for gastrointestinal upset
In case of severe gastrointestinal upsets (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 from the usual time of taking the tablets. If more than 12 hours have passed, it is recommended that you follow the directions when skipping tablets. If a woman does not want to change the usual pill regimen, she should take an extra pill from another pack.
Postponement of menstrual bleeding withdrawal
To postpone bleeding, a woman should skip taking placebo tablets from the package she has started and start taking drospirenone + ethinyl estradiol tablets from the new package. The delay can be extended until the active tablets in the second package are over. During the delay, a woman may experience acyclic abundant or spotting spotting from the vagina. Regular use of Dimia® resumes after the placebo phase. To shift bleeding on another day of the week, it is recommended to shorten the upcoming phase of taking placebo tablets by the desired number of days. When shortening the cycle, it is more likely that the woman will not have menstrual bleeding withdrawal, and there will be acyclic profuse or spotting spotting from the vagina when taking the next package (the same as when lengthening the cycle).
Side effects
Frequency: often (more than 1/100, less than 1/10) infrequently (more than 1/1000, less than 1/100) rarely (more than 1/10000, less than 1/1000).
From the genitourinary system: acyclic vaginal bleeding (spotting spotting or breakthrough bleeding) often - engorgement, tenderness of the mammary glands, infrequently - hypertrophy of the mammary glands, decreased libido, rarely - changes in the nature of vaginal secretion, discharge from the mammary glands, increased libido.
From the nervous system: often - headache, decreased mood, emotional lability, infrequently - migraine.
From the CCC side: rarely - thrombosis (venous and arterial), thromboembolism.
From the digestive system: often - nausea, abdominal pain, infrequently - vomiting, diarrhea.
From the skin: infrequently - a skin rash.
Allergic reactions: infrequently - urticaria, rarely - erythema nodosum, erythema multiforme.
Other: often - increase in body weight, infrequently - fluid retention, rarely - poor tolerance of contact lenses, decrease in body weight of chloasma, especially if there is a history of pregnant chloasma.
Drug Interactions
Note: Before taking concomitant drugs, you should read the instructions for use of the drug to identify potential interactions.
The effect of other drugs on the drug Dimia®. The interaction between oral contraceptives and other drugs can lead to acyclic bleeding and / or contraceptive failure. The interactions described below are reflected in the scientific literature.
The mechanism of interaction with hydantoin, barbiturates, primidone, carbamazepine and rifampicin oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and Hypericum perforatum preparations (Hypericum perforatum) is based on the ability of these active substances to induce liver enzymes. The maximum induction of microsomal liver enzymes is not achieved within 2-3 weeks, however, after that it persists for at least 4 weeks after the cessation of drug therapy.
Contraceptive failure has also been reported with antibiotics such as ampicillin and tetracycline. The mechanism of this phenomenon is unclear. Women with short-term treatment (up to one week) with any of the above groups of drugs or monopreparations should temporarily use (during the period of simultaneous administration of other drugs and for another 7 days after its end), in addition to COCs, barrier methods of contraception.
Women receiving rifampicin therapy, in addition to taking COCs, should use the barrier method of contraception and continue to use it for 28 days after stopping treatment with rifampicin. If concomitant medication lasts longer than the active pill in the pack, the inactive pill should be discontinued and the drospirenone + ethinyl estradiol pill from the next pack should be taken 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, therefore, are unlikely to affect the metabolism of drospirenone.
Effect of Dimia® on other drugs. Oral contraceptives may affect the metabolism of certain other active substances. Accordingly, the concentration of these substances in blood plasma or tissues can either increase (for example, cyclosporine) or decrease (for example lamotrigine). Based on studies of in vitro inhibition and in vivo interactions in female volunteers taking omeprazole, simvastatin and midazolam as a substrate, the effect of drospirenone at a dose of 3 mg on the metabolism of other active substances is unlikely.
Other interactions. In patients without renal failure, the simultaneous administration of drospirenone and ACE inhibitors or NSAIDs does not significantly affect the serum potassium content. But still, the simultaneous use of Dimia® with aldosterone antagonists or potassium-sparing diuretics has not been investigated. In this case, during the first cycle of treatment, it is necessary to monitor the concentration of serum potassium.
Laboratory tests. Taking contraceptive steroids can affect the results of some laboratory tests, including determining biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein (carrier) concentrations, such as corticosteroid-binding proteins and lipid / lipoprotein fractions, carbohydrate metabolism parameters and blood coagulation and fibrinolysis parameters . Generally, changes remain within the normal range. Drospirenone is the cause of increased plasma renin activity and, due to its small antimineralocorticoid activity, reduces the concentration of aldosterone in plasma.
Overdose
There have been no cases of overdose with Dimia®.
Based on the common experience of COC use, the potential symptoms of overdose may be: nausea, vomiting, mild vaginal bleeding.
Treatment: No antidotes. Further treatment should be symptomatic.
Storage Conditions
The product should be stored out of the reach of children, protected from light at a temperature not exceeding 25 РC.
Shelf life
2 years.
Deystvuyushtee substance
Drospirenone, Эtinilэstradiol
Terms and conditions
prescription
dosage form
tablets
Prescribing
Prescribing
Prescribing
Adults as prescribed by a doctor, For women de orodnogo age
Gedeon Richter Vengriya
Write Your Own Review