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Instructions for use of the drug for medical use Yasmin
The international non-proprietary name or grouping
Drospirenone + ethinylestradiol
Dosage form
Tablets film-coated
Composition
Each tablet film coating contains:
The tablet core:
Active substances
Ethinyl estradiol – 30 micrograms
Drospirenone – 3 mg
Excipients: lactose monohydrate – 48.170 mg, corn starch – 14,400 mg, corn starch pregelatinized – 9,600 mg, povidone K25 – 4,000 mg, magnesium stearate – 800 mcg.
Tablet Coating: Hypromellose (hydroxypropyl) – 1.0112 mg macrogol 6000 – 202.4 g talc (magnesium silicate) – 202.4 mg, titanium dioxide (E 171) – 556.5 g, iron (II) oxide ( E 172) – 27.5 mcg.
Description
Film-coated tablets, light yellow color, with one side etched hexagon within which «DO» letters.
Pharmacotherapeutic group
Contraceptives (estrogen + progestogen)
ATC code
G03AA12
Pharmacological properties
Pharmacodynamics
The drug Yasmin – low-dose monophasic oral combined estrogen-progestin contraceptive drug.
Yasmin contraceptive effect of the drug is mainly carried out by means of complementary mechanisms, the most important of which include inhibition of ovulation and increased the viscosity of cervical secretions, whereby it becomes impenetrable to sperm.
With the proper use of the drug Yasmin Pearl Index (an indicator of the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. When skipping pills or incorrect use Pearl Index may increase.
The increased risk of venous thromboembolism (VTE), which is associated with the use of combined oral contraceptives (COCs), refers primarily to the estrogen component. Currently ongoing scientific debate about the modulating effect of progestin, a member of the COC, in relation to the risk of VTE. Comparative epidemiological studies of the risk of VTE when using COCs containing ethinylestradiol / drospirenone and risks when using levonorgestrel-containing COCs have shown different results – from the lack of differences in the degree of risk, the risk increases to three times. In most studies, the drug was studied Yasmin.
To evaluate the risk of VTE in applying Yasmin drug (ethinylestradiol / drospirenone at doses of 0.03 mg / mg 3), two studies were conducted post-registration. The first prospective observational study showed that the incidence of VTE in women using the drug Yasmin, in the presence or absence of other risk factors for VTE was in the same range as that for women who use levonorgestrel-containing COCs and others. The second prospective controlled trial database in which conducted a comparative assessment of women using the drug Yasmin, with women using other COCs also confirmed a similar incidence of VTE among all cohorts of women.
Women using COCs, the cycle becomes more regular, less frequently observed bleeding menstrualnopodobnye painful, reduce the intensity and duration of bleeding, thereby reducing the risk of iron deficiency anemia. Also, there is evidence of reducing the risk of endometrial and ovarian cancer while taking COCs.
Drospirenone, which is part of the preparation Yasmin, has anti-mineralocorticoid activity and can prevent weight gain and other symptoms (eg, edema) associated with estrogen-dependent fluid retention. Drospirenone also has antiandrogenic activity and helps to reduce acne (acne), oily skin and hair (seborrhea). These features of drospirenone to consider when choosing a contraceptive for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. According to its characteristics drospirenone similar to natural progesterone, produced by the female body.
Pharmacokinetics
Drospirenone
Absorption
When administered drospirenone is rapidly and almost completely absorbed. After receiving a single maximal concentration (Cmax) in plasma drospirenone is equal to 38 ng / ml, achieved after 1-2 hours. Food does not affect the bioavailability of which ranges from 76 to 85%.
Distribution
Drospirenone is bound to albumin in blood plasma and does not bind to globulin, sex hormone binding (SHBG) or corticosteroid-binding globulin (CBG). Only 3.5% of the total concentration of substances present in blood plasma in the form of free hormone, 95-97% of the material non-specifically bind to albumin. SHBG ethinylestradiol induced increase does not affect the binding of plasma proteins drospirenone. Average apparent volume of distribution is 3,7 ± 1,2 l / kg.
Metabolism
After oral administration drospirenone is completely metabolized. Most of metabolites in blood plasma are presented acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by isoenzyme CYP 3A4. The metabolic clearance rate of drospirenone from plasma is 1.5 ± 0.2 ml / min / kg.
breeding
The concentration in the blood plasma decreases dwuhfazno drospirenone. Second, the final phase has a half-life (T1 / 2) of about 31 hours. In unmodified form drospirenone excreted in trace amounts. Its metabolites are excreted through the gastrointestinal tract and kidneys in a ratio of about 1.2: 1.4. The half-life of metabolites of drospirenone is about 40 hours.
equilibrium concentration
SHBG concentration does not affect the pharmacokinetics of drospirenone. With daily use of the drug inside the drospirenone plasma concentration increases by 2-3 times, the equilibrium concentration is reached after 8 days of treatment.
If the kidney function
Studies have shown that concentrations of drospirenone in serum of women with mild renal impairment (creatinine clearance (CC) – 50-80 ml / min) when it reaches an equilibrium state, and in women with preserved renal function (creatinine clearance – 80 ml / min) are comparable . However, in women with moderate renal impairment (creatinine clearance – 30-50 ml / min), the average concentration in the blood plasma of drospirenone was 37% higher than that in patients with intact renal function. There was no change in the potassium concentration in blood plasma when applied drospirenone.
If abnormal liver function
In women with moderate hepatic impairment (class B on a scale Child-Pugh) area under the curve “concentration-time» (AUC) is comparable with the corresponding index in healthy women with similar values of Cmax in the absorption phase and distribution. T1 / 2 drospirenone in patients with moderate hepatic impairment appeared to 1.8 times higher than in healthy volunteers.
In patients with moderate hepatic impairment drospirenone clearance decreased by approximately 50% as compared with healthy women, while there was no difference in the potassium concentration in blood plasma in the studied groups. In identifying diabetes and concomitant use of spironolactone (both states are regarded as factors predisposing to hyperkalemia), increasing the concentration of potassium in the blood plasma is not established. Thus, it can be concluded that drospirenone tolerated in women with mild to moderate hepatic impairment good (class B on a scale Child-Pugh).
Ethnicity
Do not set the influence of ethnicity (research conducted on cohorts of Caucasian women and Japanese women) on the pharmacokinetic parameters of drospirenone and ethinylestradiol.
Ethinylestradiol
Absorption
After oral administration, ethinylestradiol is rapidly and completely absorbed. Cmax – 100 pg / ml is reached within 1-2 hours. During the suction and the “first pass” through the liver is metabolized ethinylestradiol, whereby its oral bioavailability averages about 45% of interindividual variability at high – from 20 to 65%. Simultaneous food intake, in some cases accompanied by a decrease ethinylestradiol bioavailability of 25%.
Distribution
Ethinylestradiol nonspecifically but closely associated with albumin in blood plasma (approximately 98%) and induces an increase in the plasma concentration of SHBG. The estimated volume of distribution of 5 l / kg.
Metabolism
Ethinylestradiol undergoes significant primary metabolism in the intestine and liver. Ethinyl estradiol and its oxidative metabolites initially conjugated to glucuronides or sulfate. The metabolic clearance rate of ethinyl estradiol is about 5 ml / min / kg.
breeding
Reducing the ethinyl estradiol concentration in blood plasma is biphasic; the first phase is characterized by a half-life of about 1 hour, the second – 20 hours. Ethinylestradiol hardly excreted unchanged. ethinyl estradiol metabolites are excreted via the kidneys and intestines in a ratio of 4: 6. The half-life of metabolites is about 24 hours.
equilibrium concentration
The equilibrium state is reached in the second half cycle of dosing, when the concentration of ethinyl estradiol in the blood plasma is increased by 40-110% as compared with a single dose.
Indications
Contraception.
Contraindications
The drug is contraindicated Yasmin if any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time in patients receiving the drug should be immediately repealed.
• Thrombosis (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), cerebrovascular disorders – now or in history.
• Conditions prior thrombosis (including transient ischemic attack, angina pectoris) now or in history.
• Identification of acquired or hereditary predisposition for venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein deficiency of the S, hyperhomocysteinemia, antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant).
• The presence of high-risk venous or arterial thrombosis (see section “Special Instructions”).
• Migraine with focal neurological symptoms in the present or in history.
• Diabetes mellitus with vascular complications.
• Pancreatitis with severe hypertriglyceridemia now or in history.
• Liver failure and severe liver disease (liver function tests before normalization).
• liver tumors (benign or malignant) now or in history.
• Severe or acute renal failure.
• Identified hormone malignancies (including genital or mammary glands) or are suspected.
• Bleeding from the vagina of unknown origin.
• Pregnancy or suspicion of it.
• The period of breastfeeding.
• Hypersensitivity to any component of the drug Yasmin.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug includes lactose monohydrate).
Carefully
You should carefully weigh the potential risks and expected benefits of the use of COCs in each individual case in the presence of the following diseases / conditions and risk factors:
• Risk factors for thrombosis and thromboembolism: smoking; obesity; dislipoproteinemia controlled hypertension; migraine without focal neurological symptoms; valvular disease; a genetic predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in any of the next of kin);
• Other medical conditions, which may occur when peripheral circulatory disorders: diabetes; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn’s disease and ulcerative colitis; sickle cell anemia; phlebitis of superficial veins;
• Hereditary angioedema;
• Hypertriglyceridemia;
• Liver disease not related to the contraindications (see section “Contraindications”.);
• Diseases caused or aggravated first time during pregnancy, or on the background of the previous use of sex hormones (eg, jaundice and / or pruritus related to cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham’s chorea);
• Postpartum.
Application of pregnancy and during breastfeeding
Yasmin drug is contraindicated during pregnancy and lactation.
If pregnancy is detected during the reception Yasmin drug, the drug should be immediately abolished. Extensive epidemiological studies have revealed no increased risk of defects in children born to women treated with hormones prior to pregnancy or teratogenic effects in cases of use of sex hormones for negligence in the early stages of pregnancy. At the same time, the available data on the use of the drug during pregnancy Yasmin limited, which does not allow any conclusions about the negative effects of the drug on pregnancy, health of the fetus and newborn child. At present any significant epidemiological data available.
The drug can reduce the amount of breast milk and change its composition, so the use of the drug is contraindicated until weaning. A small amount of sex hormones and / or metabolites thereof can penetrate into breast milk and influence the health of the baby.
Dosing and Administration
How and when to take the tablets
Calendar pack Yasmin product contains 21 pill. Each tablet in the package is marked with the day of the week that it should be adopted. The tablets should be taken orally every day for 21 days in the order specified on the package, about the same time, with a little water. Receiving the next pack of tablets is started after a 7-day interval, during which usually develops menstrualnopodobnoe bleeding (bleeding “cancel”). Usually, it starts on day 2-3 after the last tablet and may not end before you start taking tablets from a new package. After a 7-day interval start pills from a new package is required even if the bleeding is not yet menstrualnopodobnoe stopped. This means that start taking tablets from a new package must be in the same day of the week, and every month the bleeding “cancel” will advance approximately one and the same day of the week.
Receiving tablets of the first package of the drug Yasmin
• When no hormonal contraceptive has not been applied in the previous month
Admission Yasmin preparation should begin on the first day of the menstrual cycle (ie the first day of menstrual bleeding). It is necessary to take the pill, which is marked with the corresponding day of the week. This is followed by taking pills in order. Allowed to start taking the drug on day 2-5 of the menstrual cycle, but in this case within the first 7 days of the first package of tablets is recommended to use an additional barrier method of contraception.
• When switching from other drugs combined contraceptive (COC, vaginal ring or transdermal patch)
Preferably Yasmin start taking the drug the next day after taking the last active tablet of the previous package, but in any case not later than the day after the usual 7-day break (for products containing 21 tablets), or after the last inactive tablet (for products containing 28 tablets per pack). Admission Yasmin drug should be started on the day of removal of the vaginal ring or patch, but not later than the day when it should be inserted a new ring or pasted a new patch.
• When switching from contraceptives containing only progestin ( “mini-pill”, an injectable form, implant) or intrauterine therapeutic system with the release of progestogen
Go to the “mini-pill” for the drug Yasmin possible any day (without a break), with an implant or intrauterine device with progestin – the date of their removal from the injection mold – the day when the next injection should be done. In all these cases during the first 7 days of tablet Yasmin drug must also use a barrier method of contraception (eg, condoms).
• After an abortion (including spontaneous) in the first trimester of pregnancy.
Start taking the drug can be immediately. Subject to this condition, additional contraceptive measures are required.
• After childbirth (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy.
Start taking the drug at the recommended 21-28 days after birth (no breastfeeding) or abortion in the second trimester of pregnancy. If the drug started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. If intercourse took place before you start taking the drug Yasmin, pregnancy must be excluded.
Admission missed tablets
If the delay in receiving the drug was less than 12 hours, contraceptive protection is not reduced. It is necessary to take the missed pill as the next tablet is taken at the usual time as soon as possible.
If the delay in the pill was more than 12 hours, contraceptive protection is reduced. The more missed tablets and the closer to the pass 7-day tablet-free interval, the higher the chance of pregnancy.
It should be remembered:
• The drug should never be interrupted for more than 7 days.
• 7 days continuous administration of pills required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.
Accordingly, if the delay in the pill exceeding 12 hours (from the time interval of receiving the last tablet – 36 hours), depending on the week, when a tablet is missed, it is necessary:
• The first week of taking the drug
It should take the last missed tablet as soon as possible, as soon as she remembers about it (even if it is necessary to take two tablets at the same time). The next tablet should be taken at the usual time. Over the next 7 days should additionally be used a barrier method of contraception (such as a condom). If intercourse took place during the 7 days before skipping pills, you need to consider the possibility of pregnancy.
• The second week of taking the drug
It should take the last missed tablet as soon as possible, as soon as she remembers about it (even if it is necessary to take two tablets at the same time). The next tablet should be taken at the usual time. Provided that if a woman is on the pill correctly within the preceding 7 days, there is no need to use additional contraceptive measures. Otherwise, as well as skipping of two or more tablets must also use barrier contraception (such as a condom) for the next 7 days.
• The third week of taking the drug
Risk reduction of contraceptive reliability is imminent because of the forthcoming tablet-free interval. In this case, you must adhere to the following algorithms:
– If during the 7 days preceding the first missed tablet, taken all the tablets correctly, there is no need to use additional methods of contraception. When you receive a missed tablets refer to paragraphs 1 and 2.
– If during the 7 days preceding the first missed tablet, tablets are taken properly, for the next 7 days is necessary to additionally use a barrier method of contraception (eg, condoms), and in this case should be guided by paragraph 1 for receiving the missed tablets.
1. It is necessary to take the missed pill as soon as possible, as soon as she remembers about it (even if this means taking two tablets at the same time). The next tablet at the usual time taken until the end tablets from the current package. Taking the pills from the next pack should be started immediately without the usual 7-day break. Bleeding “cancel” is unlikely until the end of the second tablet package, but can be marked “smearing” of isolation and / or “breakthrough” bleeding during treatment.
2. It is also possible to interrupt taking the tablets from the current package, make a break for 7 days or less (including the days pass pills), and then begin taking pills from a new package.
If a woman misses pills, and during a break in the reception she has no bleeding, “cancellation”, it is necessary to exclude pregnancy.
Are allowed to take no more than two tablets in one day.
Recommendations in the gastro-intestinal disorders
In severe gastrointestinal disorders, drug absorption may not be complete, so you should use additional methods of contraception.
If within 3-4 hours after taking the tablet marked vomiting or diarrhea, you should be guided by the recommendations by skipping pills mentioned above, depending on the week of dosing. If a woman does not want to change their usual dosage regimen and move the start of menstruation to another day of the week, an extra tablet to be taken from another package.
Stopping the drug Yasmin
Admission Yasmin drug can be discontinued at any time. If a woman is not planning a pregnancy, you should take care of other contraceptive methods. If you are planning a pregnancy, you should simply stop taking the drug and wait Yasmin natural menstrual bleeding.
Delaying the start of bleeding menstrualnopodobnoe
In order to delay the onset of menstrualnopodobnoe bleeding, you need to continue further pills from a new package of the drug Yasmin without 7-day break. Tablets of the new package may be made as long as necessary, including up until tablets are completed package. Against the background of the drug from the second package may be marked “smearing” bloody discharge from the vagina and / or “breakthrough” uterine bleeding. Reactivate the drug Yasmin of a pack should be after the usual 7-day break.
Changing the date of commencement menstrualnopodobnoe bleeding
In order to move the first day of bleeding menstrualnopodobnoe on another day of the week, the woman should be reduced (but not lengthen) the next 7-day tablet-free interval for as many days, on how much a woman wants. For example, if the cycle usually starts on a Friday and in future she wants it began on Tuesday (3 days earlier), tablet-taking from the next pack should start on 3 days earlier than usual. The shorter the tablet-free interval, the higher the probability that menstrualnopodobnoe bleeding does not occur, and while taking tablets from the second package will be observed “smearing” of isolation and / or “breakthrough” bleeding.
Use in specific patient groups
In children and adolescents
The drug Yasmin shown only after menarche. Available data do not require dose adjustment in this group of patients.
elderly
Not applicable. The drug is not shown Yasmin after menopause.
If abnormal liver function
Yasmin The drug is contraindicated for use in women with severe liver disease as long as liver function tests have not come back to normal. See. Also “Contraindications” and “Pharmacological properties”.
When violations of renal function
Yasmin drug is contraindicated for women with severe renal insufficiency or acute renal failure. See. Also “Contraindications” and “Pharmacological properties”.
Rated frequency according to epidemiological studies, covers a group of COCs.
Venous and arterial thromboembolic events were combined following nosologic forms: occlusion of peripheral deep vein thrombosis and thromboembolism / pulmonary vascular occlusion, thrombosis, embolism, and heart attack / myocardial infarction / cerebral infarction, and stroke is not classified as hemorrhagic.
For venous and arterial thromboembolism, migraine cm. Also “Contraindications” and “Cautions”.
The following are adverse reactions at very low frequency of occurrence or the development of delayed symptoms that are considered to be related to the COC group (see also “Contraindications”, “Cautions”.)
Tumors
• In women using COCs, very slightly increased incidence of breast cancer. Because breast cancer is rare in women younger than 40 years, increased cancer incidence in women using COCs, slightly relative to the total risk of breast cancer. A causal relationship with the use of COCs is not known.
• liver tumors (benign or malignant).
Other state
• Erythema nodosum.
• Women with hypertriglyceridemia (increased risk of pancreatitis when using COCs).
• Increased blood pressure.
• The onset or worsening of conditions in which the connection with the use of COCs is not uncontested: jaundice and / or pruritus related to cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis.
• In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
• Violations of the liver.
• Impaired glucose tolerance or effect on peripheral insulin resistance.
• Crohn’s disease, ulcerative colitis.
• Chloasma.
• Hypersensitivity (including symptoms such as rash, urticaria).
Interaction
Due to the interaction of other drugs (enzyme inducers) with oral contraceptives may experience “breakthrough” bleeding and / or reduction of the contraceptive effect (see. “Interaction with other medicinal products” section).
Overdose
Serious violations were reported in overdose. Based on the cumulative experience of the COC symptoms that may occur with overdose include nausea, vomiting, spotting from the vagina, metrorrhagia.
No specific antidote, symptomatic treatment should be conducted.
Interaction with other drugs
The influence of other drugs on the drug Yasmin
Possible interactions with drugs that induce hepatic microsomal enzymes which may result in increased clearance of sex hormones, which in turn can lead to “breakthrough” uterine bleeding and / or reducing the contraceptive effect.
Women who receive treatment such preparations, in addition to the drug Yasmin, it is recommended to use a barrier method of contraception or select a non-hormonal method of contraception. Barrier contraceptive method should be used during the reception period of concomitant medications as well as 28 days after their withdrawal. If the period of use of a barrier method of contraception ends later than tablets in a package of the drug Yasmin should start taking pills Yasmin preparation of the new packaging without interruption in the reception of tablets.
• Substances that increase clearance of the drug Yasmin (weaken the effectiveness of the enzymes by induction):
phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing St. John’s wort.
• Substances with a different effect on the clearance of the drug Yasmin
In a joint application with preparation Yasmin many HIV protease inhibitors or the hepatitis C virus and nenukliozidnye reverse transcriptase inhibitors may both increase and decrease the concentration of estrogen or progestin in the blood plasma. In some cases, this effect can be clinically significant.
• Substances that reduce the clearance of COCs (enzyme inhibitors)
Moderate and strong inhibitors of CYP3A4, such as azole antifungals (e.g., itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem and grapefruit juice may increase the plasma concentrations of estrogen or progestin, or both.
It was shown that at doses etoricoxib 60 and 120 mg / day coadministered with a COC containing 0.035 mg of ethinyl estradiol, ethinyl estradiol increases the concentration in plasma of 1.4 and 1.6 times, respectively.
Effect of the drug on Yasmin other drugs
COC may affect the metabolism of other drugs, which leads to an increase (e.g., cyclosporin) or decrease (eg lamotrigine) in their blood plasma concentration and tissue.
In vitro, drospirenone is able to weakly or moderately inhibit the enzymes of the cytochrome P450 CYP1A1, CYP2C9, CYP2C19 and CYP3A4.
Based on the in vivo interaction studies in female volunteers taking omeprazole, simvastatin or midazolam as marker substrates it can be concluded that a clinically significant effect of 3 mg of drospirenone drug metabolism mediated by the enzyme cytochrome P450, it is unlikely.
In vitro ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1 and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8 and CYP2J2. In clinical studies assignment hormonal contraceptive containing ethinylestradiol, did not lead to any increase or resulted in only a slight increase in CYP3A4 substrate concentrations in plasma (e.g. midazolam), while plasma CYP1A2 substrate concentration may increase slightly (e.g., theophylline ) or moderately (e.g., tizanidine and melatonin).
Other forms of interaction
Patients with intact renal function and drospirenone combined use of ACE inhibitors or nonsteroidal antiinflammatory drugs has no significant effect on the potassium concentration in the blood plasma. However, the combined use of the drug Yasmin with aldosterone antagonists or potassium-sparing diuretics has not been studied. When co-administered with these drugs potassium concentration in the blood plasma is necessary to control for the first intake cycle (see. “Special Instructions” section).
Preclinical safety data
Preclinical data obtained in the course of standard tests to identify the toxicity after repeated doses of the drug taking, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate a particular risk to humans. Nevertheless, we should remember that sex hormones may promote the growth of certain hormone-dependent tissues and tumors.
Laboratory tests
Receiving Yasmin drug can affect the results of some laboratory tests including liver function tests, renal, thyroid, adrenals, concentration in plasma transport proteins, carbohydrate metabolism, blood clotting parameters and fibrinolysis. Changes do not usually go beyond the normal range. Drospirenone increases plasma renin activity and aldosterone concentration, due to its antimineralokortikoidnym effect.
decline in efficiency
Efficacy Yasmin drug may be reduced in the following cases: when skipping tablets, gastro-intestinal disorders or as a result of drug interactions.
The frequency and severity of bleeding menstrualnopodobnoe
While taking the drug could experience Yasmin irregular (acyclic) bleeding from the vagina ( “smearing” spotting and / or “breakthrough” uterine bleeding), especially during the first months of use. Therefore, the evaluation of any irregular bleeding menstrualnopodobnoe should be carried out after a period of adaptation of approximately three cycles. If irregular bleeding menstrualnopodobnye recur or occur after previous regular cycles, you should conduct a thorough examination to exclude malignancy or pregnancy.
Some women during the tablet-free interval may not develop bleeding “cancel.” If the drug Yasmin taken according to the recommendations, it is unlikely that the woman is pregnant. However, the irregular use of the drug and the absence of two consecutive menstrualnopodobnoe bleeding, the drug can not be extended to exclude pregnancy.
Medical examinations
Before the start or resumption of use of the drug Yasmin should be familiar with the history of life, a family history of the women, to conduct a thorough general medical and gynecological examination to exclude pregnancy. The volume of research and the frequency of control examinations should be based on existing standards of medical practice with the need to consider the individual characteristics of each patient. As a rule, measured blood pressure, heart rate, determined by the body mass index, checked the state of the mammary glands, abdomen and pelvic organs, including cytology cervical epithelium (Papanicolaou test). Typically, control examinations should be carried out at least 1 time in 6 months.
It should be borne in mind that Yasmin drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases through!
Effects on ability to drive vehicles and mechanisms
Not found.
Storage conditions
Store at temperatures not above 25 ° C.
Keep out of the reach of children.
Shelf life
3 years. Do not use after the expiration date!
