Dimia pills 3 mg + 0.02 mg №28
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Packaging
28 pcs.
Mechanism of action
Dimia is a combination monophasic oral contraceptive containing drospirenone and ethinyl estradiol. In terms of its pharmacological profile, drospirenone is close to natural Progesterone : it does not possess estrogenic, glucocorticoid and antiglucocorticoid activity and is characterized by pronounced antiandrogenic and moderate anti-mineralocorticoid action. 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 cervix and the change in the endometrium. The Pearl Index, an indicator reflecting the frequency of pregnancy in 100 women of reproductive age during a year of using a contraceptive, is less than 1.
Indications and usage
Oral contraception.
Contraindications
Hypersensitivity
thrombosis (venous and arterial) at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders), conditions preceding thrombosis (includingtransient ischemic attacks, angina) now and in history,
diabetes with vascular complications,
the presence of severe or multiple risk factors for venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of cerebral vessels or coronary arteries;
uncontrolled arterial hypertension, serious surgical intervention with prolonged immobilization, smoking after the age of 35;
liver failure, severe liver disease (before normalization of liver tests) currently or in history, liver tumors (benign or malignant), incl. in the anamnesis;
severe or acute renal failure, hormone-dependent malignant diseases of the genital organs or mammary glands, or suspicion of them, vaginal bleeding of unknown origin, pregnancy or suspicion of it, lactation.
Carefully.
Risk factors for thrombosis and thromboembolism:
smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, prolonged immobilization, serious surgical interventions, extensive trauma, a hereditary predisposition to thrombosis (thrombosis, myocardial infarction or impaired cerebral circulation in a young age, or with myocardial infarction or impaired cerebral circulation in a young man, or a myocardial infarction or a violation of the cerebral circulation in a young age, or with myocardial infarction or a violation of the cerebral circulation in a young man, or a myocardial infarction
diseases in which there may be violations of peripheral blood circulation: diabetes, SLE,hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; hereditary angioedema, hypertriglyceridemia, liver disease;
diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with impairment of hearing, porphyria, herpes of pregnancy, minor chorea (Sydengam disease), Chorea Sydenham, chloasma), the postpartum period.
Dosage and Administration
The drug should be taken orally, on 1 tablet, in the order specified on packing, every day approximately at the same time with a small amount of water, continuously within 21 days. Reception of each next package begins after a 7-day break, during which menstrual-like bleeding is observed. It usually starts 2-3 days from taking the last pill and may not end before taking a new pack.
In the absence of taking any hormonal contraceptives in the previous month, taking the drug begins on the first day of the menstrual cycle (the first day of menstrual bleeding). It is allowed to start taking on the 2-5 day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pills from the first package.
When switching from taking other combined oral contraceptives, it is preferable to start taking the drug the next day after taking the last active pill from the previous package,but no later than the next day after the usual 7-day break in the intake (for drugs containing 21 tablets) or after taking the last inactive pill (for drugs containing 28 pills per pack).
When switching from contraceptives containing only gestagens (mini-pili, injectable forms, implant): you can go from mini-pili on any day (without a break), from the implant on the day of its removal, from the injection form The following injection was given. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.
After an abortion in the first trimester of pregnancy, you can start taking immediately. Subject to this condition, there is no need for additional contraceptive protection.
After childbirth or abortion in the II trimester of pregnancy, it is recommended to start taking the drug on days 21-28. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. In the case of sexual contact, pregnancy should be excluded or the first menstruation should be avoided before taking the drug.
Acceptance of missed pills: if the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. It is necessary to take a pill as soon as possible, the next one is taken at the usual time.
If the delay in taking the pills is more than 12 hours (the interval from the moment of taking the last pill is more than 36 hours), contraceptive protection can be reduced.If you miss 1-2 weeks of taking the drug, you must take the last missed pill as soon as possible (even if it means taking 2 pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception should be used over the next 7 days. If sexual intercourse took place within 1 week before skipping the pill, it is necessary to take into account the probability of pregnancy. The more pills missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.
If you miss a drug for 3 weeks, you need to take the last missed pill as soon as possible (even if it means taking 2 pills at the same time). The next pill is taken at the usual time. Additionally, a barrier method of contraception should be used over the next 7 days. In addition, the intake of pills from the new packaging should be started as soon as the current packaging is finished, i.e. nonstop. Most likely, the "cancellation" bleeding will not be until the end of the second package, but there may be "spotting" bleeding or uterine "cancellation" bleeding on the days of taking the drug from the second package.
In case of missing a pill and the absence of a withdrawal bleeding interval in the first drug-free interval, it is necessary to exclude pregnancy.
In case of missing a drug, you can follow the following two main rules:the drug should never be interrupted for more than 7 days; 7 days of continuous pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.
In case of vomiting and diarrhea within 3-4 hours after taking the pill, absorption may not be complete. In this case, you must follow the rules of taking the drug in case of missing pills. If the patient does not want to change the normal mode of taking the drug, she should take an additional pill (or several pills) from another package if necessary.
To postpone the start of menstruation, it is necessary to continue taking the pills from the new package immediately after taking all the pills from the previous one, without interruption in the intake. pills from the new packaging can be taken as long as possible until the packaging is over. While taking the drug from the second package, "spotting" bleeding from the vagina or uterine bleeding "breakthrough" may occur. Resume taking the drug from the new pack should be after the usual 7-day break.
To transfer the day of the beginning of menstruation to another day of the week, the nearest break in taking pills should be shortened to as many days as necessary to postpone the onset of menstruation. The shorter the interval, the higher the risk of bleeding "cancellation" and further "spotting" discharge and "breakthrough" bleeding while taking the second package (as in the case of delaying the onset of menstruation).
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).
On the part of the urogenital system: acyclic vaginal bleeding (spotting or breakthrough bleeding); often - engorgement, breast tenderness, infrequently - breast hypertrophy, decreased libido, rarely - changes in the nature of vaginal secretion, discharge from the mammary glands, increased libido.
From the nervous system: often - headache, decrease in mood, emotional lability, infrequently - migraine.
On the part of the cardiovascular system: rarely - thrombosis (venous and arterial), thromboembolism.
On the part of the digestive system: often - nausea, abdominal pain, infrequently - vomiting, diarrhea.
On the part of the skin: infrequently - skin rash.
Allergic reactions: infrequently - urticaria, rarely - erythema nodosum, erythema multiforme.
Others: often - weight gain, infrequently - fluid retention, rarely - poor tolerance to contact lenses, weight loss; chloasma, especially with a history of pregnant chloasma.
Drugs that induce microsomal liver enzymes: phenytoin, barbiturates, primidone, carbamazepry and rifampicin, rifabutin, oxcarbazepine, topiramate, felbamate, Griseofulvin, and drugs that contain St. John’s wort, give rise to the cessation of sex hormones, griseofulvin, and drugs containing heart, increase the curability of sex hormones, griseofulvin, and drugs that contain wreathed hoofed skin, increase the cessation rate of women, increase crafting, increase crafts, increase the ccgl;
HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors and their combinations also have the potential to affect hepatic metabolism. Maximum induction of microsomal liver enzymes usually does not manifest itself within 2–3 weeks, but may then persist for at least 4 weeks after discontinuation of drug therapy.
Ampicillins and tetracyclines reduce the reliability of contraception (reduce the enterohepatic circulation of estrogens).
With the simultaneous use of drugs that affect the induction of liver enzymes and within 28 days after their cancellation, it is necessary to temporarily use a barrier method of contraception. During the reception of antibiotics (ampicillin, tetracycline) and within 7 days after their cancellation, it is necessary to temporarily use a barrier method of contraception. If the concomitant prescription of a drug is started at the end of the oral contraceptive package, the next package should be started without the usual interruption in administration.
In women who receive drugs for a long time, affecting liver enzymes, it is necessary to consider the possibility of using other methods of contraception.
Oral combined contraceptives can affect the metabolism of other drugs, which leads to an increase (cyclosporine) or a decrease (lamotrigine), their concentration in plasma and tissues.
There is a theoretical possibility of increasing the concentration of serum K + in women who receive oral contraceptives simultaneously with others.Drugs that increase the concentration of K + in the serum: ACE inhibitors, angiotensin II receptor blockers, some NSAIDs (for example, indomethacin), potassium-saving diuretics and aldosterone antagonists. However, in a study evaluating the interaction of an ACE inhibitor with the combination of drospirenone-estradiol in women with moderate arterial hypertension, there was no significant difference between serum K + concentrations in women who received Enalapril and placebo.
Symptoms: nausea, vomiting and slightly pronounced vaginal bleeding.
Treatment is symptomatic. There is no specific antidote.
The drug should be stored out of the reach of children, protected from light at a temperature not higher than 25 ° C.