Active substanceEthinylestradiolEthinylestradiol
Similar drugsTo uncover
  • Diane-35®
    pills inwards 
    Bayer Pharma AG     Germany
  • Dosage form: & nbsp

    Dragee

    Composition:

    Each pellet contains:

    Active substances: 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.

    Excipients: lactose monohydrate - 31,115 mg, starch corn - 18,000 mg, povidone - 2,100 mg, talc - 1,650 mg, magnesium stearate - 0.100 mg.

    The composition of the shell: sucrose - 19.371 mg, povidone 700,000 - 0.189 mg, polyethylene glycol (macrogol 6000) - 2.148 mg, calcium carbonate - 8.606 mg, talcum - 4.198 mg, glycerol - 0.137 mg, titanium dioxide 0.274 mg, iron (II) oxide yellow - 0.027 mg, mountain glycolic wax 0.050 mg.

    Description:

    Round biconvex dragees of light yellow color.


    Pharmacotherapeutic group:Contraceptive agent (estrogen + antiandrogen)
    ATX: & nbsp

    G.03.C.A.01   Ethinylestradiol

    Pharmacodynamics:

    Diane-35 ® - Low-dose monophasic oral combined estrogen-antiandrogenic contraceptive.

    Contraceptive effect of Diane-35 ® is carried out by means of complementary mechanisms, the most important of which are suppression of ovulation and a change in the properties of the cervical secret, as a result of which it becomes impenetrable for spermatozoa.

    In women taking combined oral contraceptives,
    the menstrual cycle becomes more regular, less frequent
    painful menstruation, the intensity of bleeding decreases, in
    resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence that the risk of developing endometrial cancer and ovarian cancer is reduced.

    Against the background of Diana-35 ® decreases the increased activity of the sebaceous glands, which plays an important role in the occurrence of acne and seborrhea. After 3-4 months of therapy, this usually leads to the disappearance of the existing rash. Excessive fatness of hair and skin disappears even earlier. Also decreases hair loss, often accompanying seborrhea. Therapy Diane-35 ® in women of reproductive age reduces clinical manifestations of mild forms of hirsutism (in particular, increased hair growth on the face); However, the effect of treatment should be expected only after several months of use.

    Along with the anti-androgenic action described above, cyproterone acetate also has a pronounced gestagenic effect.

    Pharmacokinetics:

    - Cyproterone acetate

    Absorption. When ingestion of cyproterone, acetate is completely absorbed in a wide range of doses. After taking Diana-35 dragee inside ® the maximum concentration (Stach) of cyproterone acetate in serum, equal to 15 ng / ml,is achieved in 1.6 hours. Absolute bioavailability of cyproterone acetate is almost complete (88% of the dose).

    Distribution.

    Ciproterone acetate binds exclusively to serum albumin. In a free form, only about 3.5-4% of the total serum concentration is found. Ethinyl estradiol-induced increase in HES does not affect the binding of cyproterone acetate with serum proteins. The average apparent volume of distribution is 986 ± 437 l

    Metabolism. Cyproterone acetate is metabolized in two ways, including hydroxylation and conjugation. The main metabolite in human plasma is the 15β-hydroxyl derivative.

    Excretion. Some of the dose is excreted unchanged with bile. Most of the dose is excreted in the form of metabolites with urine or bile in a ratio of 1: 2. Metabolites from the plasma are eliminated with a half-life of 1.8 days.

    Equilibrium concentration. Since binding to proteins is not specific, changes in the level of globulin binding sex steroids (HESC) do not affect the pharmacokinetics of cyproterone acetate. During the cyclic treatment, the maximum equilibrium concentration of cyproterone acetate in the serum is reached in the secondhalf cycle.

    - Ethinylestradiol

    Absorption. After ingestion ethinyl estradiol quickly and completely absorbed. The maximum concentration (C max) in the serum, equal to about 71 pg / ml, is achieved in 1.6 hours. During the intake and the first passage through the liver ethinyl estradiol is metabolized, as a result of which its bioavailability when ingested is an average of about 45%.

    Distribution. Ethinylestradiol almost completely (approximately 98%), although non-specific, binds with albumin. Ethinylestradiol induces the synthesis of GSPC. The apparent volume of distribution of ethinyl estradiol is 2.8-8.6 l / kg.

    Metabolism. Ethinylestradiol is subjected to pre-systemic conjugation, both in the mucosa of the small intestine and in the liver. The main pathway of metabolism is aromatic hydroxylation. The clearance rate from plasma is 2.3-7 ml / min / kg.

    Excretion. The decrease in the concentration of ethinyl estradiol in serum is biphasic; the first phase is characterized by a half-life period of about 1 hour, the second- 10-20 hours. Unchanged from the body is not excreted. Metabolites of ethinyl estradiol are excreted in urine and bile in a ratio of 4: 6 with a half-life of about 24 hours.

    Equilibrium concentration. Equilibrium concentration is achieved during the second half of the treatment cycle.

    Indications:

    Contraception in women with androgenation phenomena.

    Treatment of androgen-dependent diseases in women, such as acne, especially common forms and forms, accompanied by seborrhea, inflammation or the formation of nodules (papular-pustular acne, nodular-cystic acne); androgenetic alopecia and mild forms of hirsutism.

    Contraindications:

    The drug Diane-35® is contraindicated in presence of any of the states, listed below.

    - Thrombosis (venous and arterial) and thromboembolism currently or history (including, thrombosis of deep veins, thromboembolism of the pulmonary artery, myocardial infarction, cerebrovascular such as a stroke).

    - Conditions preceding thrombosis (including, transient ischemic attacks, angina pectoris) currently or in the anamnesis.

    - A predisposed predisposition to venous or arterial thrombosis, including resistance to activated protein C, anthrombin III deficiency, protein C deficiency, protein deficiency S, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant).

    - Migraine from focal neurological symptoms in anamnesis.

    - Diabetes mellitus with vascular complications.

    - Multiple or expressed risk factors for venous or arterial thrombosis (see section "Special instructions").

    - Uncontrolled arterial hypertension.

    - Pancreatitis with severe hypertriglyceridemia now or in the anamnesis.

    - Severe liver disease (as long as the liver function is not normal).

    - Liver tumors (benign or malignant) are currently or in the anamnesis.

    - Revealed hormone-dependent malignant diseases (including number of genital organs or dairy glands) or suspicion of them.

    - Vaginal bleeding of unclear genesis.

    - Pregnancy or suspicion of it.

    - The period of breastfeeding.

    - Hypersensitivity to any of the components of the drug Diane-35®.

    - Intolerance to lactose, sucrose, deficiency of lactase, sucrose / isomaltase, glucose-galactose malabsorption.

    If any of these conditions appear for the first time against the background of preparation Diane-35®, immediately stop taking this medication and consult a doctor. Topics time, use non-hormonal contraceptives. See also "Special instructions".

    Carefully:

    If any of the conditions / risk factors indicated below are currently available, the potential risk and the expected benefit of using combined oral contraceptives in each individual case should be carefully weighed:

    - Risk factors for thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in someone of the next of kin; obesity; dyslipoproteinemia (eg, arterial hypertension, migraine, heart valve disease, heart rhythm disturbances, prolonged immobilization, serious surgical interventions, extensive trauma

    - Other diseases in which there may be violations of peripheral circulation: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and nonspecific ulcerative colitis; sickle-cell anemia; as well as phlebitis of superficial veins

    - Hypertriglyceridemia

    - Diseases of the liver

    - Diseases that first appeared or worsened during pregnancy or on the background of previous reception of sex hormones (eg, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, pregnancy herpes, Sydenham's chorea)

    Pregnancy and lactation:

    Diane-35 ® is not prescribed during pregnancy and during lactation. If the pregnancy is detected during the drug Diane-35 ® , the drug should be immediately canceled. Cyproterone acetate is excreted in milk, so the use of Diane-35 ® contraindicated during lactation.

    Dosing and Administration:

    When and how to take pills

    To achieve therapeutic effect and provide the necessary contraception should be taken drug Diane-35® on a regular basis. If before beginning of the drug Diane-35® used some other drug hormonal contraception, its reception should be discontinued. The dosing regimen of Diane-35® coincides with the dosing regimen of the majority oral contraceptive drugs (COCs). Thus, the administration of Diane-35® is subject to the rules for accepting other COCs.Irregular intake of Diane-35® can cause to acyclic bleeding, reduce therapeutic effect and contraceptive effectiveness. When used correctly, Perl's index (an indicator that reflects the frequency of pregnancy in 100 women during the year of contraceptive use) is approximately 1. The calendar pack of Diane 35® contains 21 tablets. In the package, each dragee is marked with the day of the week in which it should be taken. Take the pills at the same time each day, with a small amount of water. Follow the direction of the arrow until all the pills are taken. During the next 7 days you do not take the drug. Bleeding "cancellations" should begin within these 7 days. Usually it begins on day 2-3 after the last drug of Diane-35®. After a 7-day break, start taking the dragees from the next package, even if the bleeding is not yet has ceased. This means that you always start a new packaging in the same day of the week, and that each month bleeding "cancellation" will come approximately on the same day of the week.

    The beginning of the drug Diane-35 ®

    - When no hormonal the contraceptive is not was applied in the previous month.

    Start taking the drug Diane-35 ® at the first day of the cycle, that is, the first day menstrual bleeding. Accept pills, which are marked the corresponding day of the week.

    For example, if your cycle started in Friday, then take the pills, which marked by a relevant day weeks (Fri). Then take the order. Action of the drug Diane-35 ® will begin immediately after the first dragees, while there is no need for use of additional contraceptive methods.

    You can also start reception at 2-5 day of menstrual bleeding, but in In this case it is necessary to use addition barrier method contraception within the first 7 days taking the pills from the first package.

    - When switching from other COCs, vaginal ring or contraceptive patch, you can start taking Diane-35® the day after you take the last dragee from the current COC package (ie, without interruption of admission). If the current package contains 28 pills, you can start taking Diane-35® the day after taking the last active pills. If you are not sure what kind of pills it is, ask the doctor.You can also start taking it later, but in no case later than the day after the usual break in the admission (for preparations containing 21 tablets) or after taking the last inactive dragee (for preparations containing 28 dragees in the package).

    Diane-35® should be taken on the day of removal of the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is stuck.

    - When switching from COC containing only gestagen ("mini-drank").

    You can stop taking minipillin any day and start taking Diane-35® the next day, at the same time. During the first 7 days of taking the pills, the barrier method of contraception must also be used.

    - When switching from an injection Contraceptive, implant or with a releasing gestagen intrauterine therapy system (Mirena).

    Start taking the drug Diane-35 ® on the day that the next injection is to be made or on the day of removal implant or intrauterine contraceptive. During the first 7 days of taking the pills, the barrier method of contraception must also be used.

    - After childbirth.

    After the birth of a child, the drug Diane-35® can be started no earlier than 21 days after the birth, provided that your child is not breast-feeding.

    - After a spontaneous miscarriage or abortion.

    Talk to your doctor.

    Acceptance of missed pills

    - If the delay in taking the next dragee is less than 12 hours, the contraceptive effect of the drug Diane-35 ® is retained. Take the pills as soon as you remember it. The next dragee is taken at the usual time.

    - If the delay in taking the dragees was more than 12 hours, contraceptive protection can be reduced. The more the dragee is missed and the closer this pass to the beginning of the reception or the end of the reception, the higher the risk of pregnancy. In doing so, you can follow the following rules:

    - Forgot more than one pills from packing

    Consult with your doctor.

    - One pills missed in the first week of taking the drug

    Take the missed pills as soon as possible, as soon as you remember (even if it means taking two pills at the same time). Next take the pills at usual time.

    Additionally, use the barrier method of contraception for the next 7 days.If the sexual intercourse took place during the week before skipping the dragees, it is necessary to take into account the probability of pregnancy. Immediately consult a physician.

    - One pills missed the second week of taking the drug

    Take the missed pills as soon as possible, as soon as you remember (even if it means taking two pills at the same time). Next take the pills at usual time.

    The contraceptive effect of Diane-35® is preserved, and you do not need at use of additional contraceptive measures.

    - One dragee missed the third week of taking the drug. You can follow any of the following two recommendations, without the need use additional contraceptive precautions.

    1. Take the missed pills as soon as possible, as soon as you remember (even if it means taking two pills at the same time). The next dragee is taken at the usual time. Begin taking the dragee from the next package immediately after the end of the dragee intake from the current packaging, so there will be no break between the packages. Bleeding "cancellation" is unlikely, until the dragee is finished from the second package, but there may be "smearing" discharge or "breakthrough" bleeding on the days of taking the pills.

    2. Stop taking the pills from the current package, take a break for 7 or less days (including the day the dragee passes), and then start taking the pills from the new package. Using this scheme, you can always start taking the pills from the next packing on the day of the week when you usually do it.

    If after a break in taking the dragee is absent the expected menstrual like bleeding, you can be are pregnant.

    Consult your doctor before you start taking the pills from the new package.

    Recommendations for gastrointestinal disorders If you had vomiting or diarrhea within 3 to 4 hours after taking the Diane-35® dragee, the active ingredients may not have completely absorbed. This situation is similar to skipping a drug. Therefore, follow the recommendations for skipping pills.

    Postponement start menstrual like bleeding

    You can delay the onset of menstrual bleeding if you start taking the pills from the next pack of Diane-35® immediately after the end of the current package. You can continue to take the pills from this package for as long as you want, or until the packaging is finished.If you want to start menstrual bleeding, stop taking the pills. During the administration of Diane-35® from the second package, there may be "smearing" discharge or "breakthrough" bleeding on the days of taking the pills. Start the next packing after an ordinary 7-day break.

    Change the day start menstrual like bleeding

    If you take pills in accordance with the recommendations, you will have menstrual-like bleeding about the same day every 4 weeks. If you want to change it, shorten (but do not extend) the time interval, free from taking the pills. For example, if your menstrual cycle usually starts on Friday, and in the future you want it to start on Tuesday (3 days earlier), the next package should start 3 days earlier than usual. If the break from taking the pills is very short (for example, 3 days or less), menstrual bleeding during the break may not occur. In this case, there may be "breakthrough" bleeding or "spotting" spotting during the reception of the dragee from the following package.

    Duration of application

    The duration of the drug Diane-35® for treatment androgen-dependent diseases (such as acne, seborrhea, hirsutism, alopecia) depends on the severity of the symptoms of androgenation and response to treatment. Basically, the treatment is carried out for several months. Response to treatment acne and seborrhea usually occurs faster response to treatment hirsutism or alopecia.

    It is recommended to take the drug not less than 3-4 courses after the disappearance signs of the disease. When recurrence of the disease after a few weeks or months after discontinuation dragee intake, drug treatment Diane-35 ® can be renewed. AT if the drug is resumed (after a four-week break and more) should take into account increased risk of VTE (see also section "Special instructions "and" With care ").

    Additional information for some groups of patients

    Children and teens

    Preparation Dians-35 ®shown only after the establishment of menstrual cycle.

    Patients in postmenopausal women

    Not applicable. The drug Diane-35 ® not is shown after menopause.

    Patients with impairedliver

    Diane-35® is contraindicated women with serious illnesses liver, as well as with functional hepatic indicators, not returning to normal values. See also the section "Contraindications."

    Patients with impaired renal function The drug Diane-35® was not specifically studied in patients with impaired renal function. The available data do not give grounds for changing treatment in such patients.

    Side effects:

    When receiving a COC (which includes a drug Diane-35®) there may be irregular bleeding ("smearing" bleeding highlighting or "breakthrough" bleeding), especially during the first months of use.

    Against the background of the reception of COCs (which include a drug Diane-35®), women also had other undesirable effects.

    System

    bodies

    Often

    (>1/100)

    Nemax

    then

    (> 1/100 0 and

    <1/100)

    Rarely

    (<1/1000)

    Body of sight

    intolerant of contact lenses

    Gastro-

    intestinal

    tract

    nausea, abdominal pain

    vomiting,

    diarrhea

    Immune

    system

    reactions

    hypersensitivity

    the

    Are common

    symptoms

    increase in body weight

    Weight loss

    Metabolism and nutrition

    delay

    liquid

    and

    Nervous

    system

    head

    pain

    migraine

    decline

    Psychic

    there are three of us

    tion,

    swings

    moods

    decreased libido

    enlargement

    libido

    Pain / Disease

    Genital organs and mammary glands

    in

    dairy

    glands,

    loads

    the

    dairy

    glands

    hypertrophy

    fiya

    milk glands

    Discharge from the vagina, discharge from the mammary glands *

    Skin and

    subcutaneous

    fabrics

    rash,

    nettle

    egg

    erythema nodosum, erythema multiforme

    *AT the course post-marketing studies reported painful menstrual-like bleeding and the absence of menstrual bleeding, the frequency of which could not be assessed.

    The following serious undesirable phenomena in women, using COCs (to which drug Diane-35®):

    - Venous thromboembolic violations.

    - Arterial thromboembolic disorders.

    - Stroke.

    - Increased blood pressure.

    - Hypertriglyceridemia.

    - Impairment of glucose tolerance or influence on peripheral insulin resistance.

    - Liver tumors (benign and malignant). Violation of functional indicators of the liver.

    - Hloazm.

    - In women with hereditary angioedema exogenous estrogens can cause or enhance symptoms angioedema.

    Offensive or aggravated states for which the relationship with application of COCs (to which Diane-35® preparation) is not is undeniable: jaundice and / or itching associated with cholestasis; formation of gallstones a bubble; porphyria; system red lupus; hemolytic-uremic syndrome; chorea; herpes in time of pregnancy; loss of hearing, associated with otosclerosis; disease

    Crown; ulcerative colitis; cervical cancer the uterus.

    Visual impairment.

    Dizziness.

    Pancreatitis.

    Cholecystitis.

    The frequency of diagnosing breast cancer glands in women using COCs ( which includes the drug Diane-35®), increased very slightly. Cancer mammary gland is rarely observed in women under 40 years, exceeding the frequency is insignificant in relation to the general risk of breast cancer. The causal relationship of the occurrence of breast cancer with the use of COC is not established. For more information, see "Contraindications" and "Special instructions".

    Overdose:

    No serious violations were reported in case of an overdose.Symptoms that may be noted in an overdose: nausea, vomiting, spotting spotting or metrorrhagia.

    There is no specific antidote, symptomatic treatment should be performed.

    Interaction:

    Some drugs can reduce the effectiveness of the drug Diane-35®. These include drugs used to treat epilepsy (for example. primidon, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin) and HIV infection (ritonavir, nevirapine); antibiotics for the treatment of certain other infectious diseases (eg, ampicillin, tetracyclines, griseofulvin), as well as preparations of St. John's wort (used, mainly, in the treatment of depressive conditions).

    The drug Diane-35 ® can affect the effectiveness of other drugs, such as: lamotrigine and ciclosporin.

    Always tell your doctor who is prescribing to you Diane-35®, what medicines you are already taking. Also tell any doctor or dentist who prescribes other drugs, and pharmacist selling you drugs in the pharmacy that You are taking Diane-35®.

    The doctor can recommend In addition, the use of barrier methods of contraception.

    Special instructions:

    If you suffer from hirsutism, and this disease has occurred recently or in Recently, significantly increased, It is necessary to inform about this doctor, because it is necessary to find out the cause of this phenomenon.

    Data on estrogen / progestogen combinations such as Diane-35®, are based, mainly, on experience with the use of COCs. Consequently, the following caveats, related to the use of COCs, are also applicable to the drug Diane-35®.

    - Thrombosis

    Thrombosis - the formation of a blood clot, which can clog blood vessel.

    The risk of developing venous and arterial thromboembolic complications maximum in the first year of admission of such preparations. Increased risk is present after the initial application of COC or renewal reception of the same or different COC (after a break between doses drug in 4 weeks or more). Data from a large prospective study with 3 groups of patients show that this increased risk is present, mainly,during the first 3 months.

    The general risk of venous and arterial thromboembolic complications in patients, host low-dose COCs (<50 μg ethinylestradiol) are two to three times higher than those in patients who do not take COC and it remains lower compared to the risk of VTE on pregnancy and childbirth.

    Very rarely, venous thromboembolism can lead to disability or death.

    Thromboembolic complications (deep vein thrombosis, thrombophlebitis of the subcutaneous veins, thromboembolism of the pulmonary artery) may occur with any COCs.

    Very rarely, when using COCs, thrombosis occurs in other blood vessels, for example, veins or arteries of the liver, mesenteric, renal, brain or retina.

    The risk of thrombosis (venous and / or arterial) and thromboembolism increases with multiple or significant risk factors for venous or arterial thrombosis:

    - diseases of the vessels of the brain or coronary arteries of the heart.

    - family history (ie, venous or arterial thromboembolism ever the close relatives or parents at a relatively young age); in the case of hereditary predisposition,a woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;

    - obesity (body mass index more than 30 kg / m2);

    - subacute bacterial endocarditis;

    - dyslipoproteinemia;

    - arterial hypertension;

    - migraine;

    - heart valve diseases;

    - atrial fibrillation;

    - prolonged immobilization in cases of: large surgical operations, any operation on the lower limbs or extensive trauma. In these situations, it is advisable to stop taking the drug Diane-35 * (in the case of a planned operation, at least four weeks before) and not to resume reception within two weeks after the end of immobilization.

    - Tumors

    The relationship between COC and cancer mammary gland is not proven, although women who take COC, he is detected somewhat more often than in women of the same age, they are not using. Perhaps this difference is caused by the fact that when taking the drug Women are more often breast cancer is detected in early stage. Increased risk gradually disappears after termination reception of these drugs.

    In rare cases, against the background of sexual hormones liver tumors that can lead to life-threatening intraabdominal hemorrhages. Communication with the use of drugs has not been proven.

    When suddenly a strong abdominal pain immediately consult a doctor.

    Cervical cancer was detected several times more often in women who use COCs in for a long period of time. The connection with the reception of the COC has not been proved. This may be due to more frequent gynecological examinations to detect cervical disease or with peculiarities of sexual behavior (a more rare use of barrier methods of contraception). The most significant risk factor for developing cervical cancer is persistent papillomavirus infection.

    Women with a tendency to chloasma while taking COC should avoid prolonged exposure to the sun and exposure ultraviolet radiation.

    You should consider the increased risk of thromboembolism in the postpartum period. Violations peripheral blood circulation can also occur in diabetes mellitus, systemic lupus erythematosus, haemolytic-uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.An increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of these medications.

    Acyclic bleeding

    As with the use of other COCs, when taking Diane-35® during the first few months, irregular vaginal bleeding may occur ("smearing" bleeding or "breakthrough" bleeding) in the intermenstrual period. Use hygiene products and continue to take the pills as usual. Irregular vaginal bleeding usually ceases as your body adapts to Diane-35® (usually after 3 cycles of taking the pills). If these disorders continue, become severe or resume after discontinuation, see a doctor.

    Absence of the next menstrual like bleeding

    If you took all the pills correctly, and you did not have vomiting in time of taking a pills or simultaneous reception of other medicinal drugs, the probability of pregnancy is small. Continue taking the drug Diane-35®, as usual.

    If no two menstrualnopodobnyh bleeding in a row, immediately consult a doctor. Do not start taking the pills from the next package until the doctor excludes the pregnancy.

    When necessary consult with a doctor

    Regular inspections

    If you are taking Diane-35 ®, The doctor will notify you regular inspections, which are usually a woman should go about 1 every 6 months.

    Consult your doctor as as soon as possible:

    - with any changes health, especially any states listed in this the leaflet (see also "Contraindications" and "Use with caution");

    - for local compaction in the mammary gland; If you you intend to use other medicinal products (see "Interaction with other medicinal products ");

    - if a prolonged immovability imposed gypsum), it is planned hospitalization or surgery (consult a doctor, at least 4-6 weeks before her);

    - when an unusual severe bleeding from the vagina;

    - if you forgot to take the pills in The first week of receiving the package and lived a sexual life in 7 days before;

    - you twice did not have a contract the next menstrual bleeding or you suspect that you are pregnant (not start taking the pills from The next package, until consult a doctor).

    Stop taking pills and consult a doctor immediately if you notice possible signs of thrombosis: symptoms of deep vein thrombosis (DVT): unilateral swelling of the lower limb or in the vein on the lower limb, pain or soreness in the lower limb only when standing or walking, feeling warm in the lower extremity, redness or change in the color of the skin on the lower limb.

    Symptoms of pulmonary embolism (ELA): sudden unexplained shortness of breath or rapid breathing; sudden cough, including with blood; acute pain in the chest, which can intensify with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, "shortness of breath", "cough") are nonspecific and can be misinterpreted as signs of more or less severe conditions / diseases (eg, respiratory tract infection).Arterial thromboembolism can lead to stroke, vascular occlusion or myocardial infarction. Symptoms of stroke: sudden weakness or loss of face sensitivity, in the limbs, especially on one side of the body, sudden confusion, problems with speech and understanding; dizziness, loss of balance, or coordination of movements; sudden, loss of vision of one or two eye; sudden violation of gait, dizziness, loss of balance, or coordination of movements; sudden, severe or prolonged headache pain for no apparent reason; a loss consciousness or fainting with epileptic a fit or without it. Other signs of vascular occlusion: sudden Pain, swelling and mild blueing extremities, "sharp" abdomen.

    Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, feeling compression or extension of the chest, arm or under the sternum; discomfort with irradiation in the back, cheekbone, throat, hand, stomach; cold perspiration, nausea, vomiting, or dizziness, severe weakness, anxiety or shortness of breath; rapid or irregular heartbeat.

    The drug Diane-35® does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

    The drug Diane-35® is recommended by your doctor to you personally, do not pass the drug to others!

    Effect on the ability to drive transp. cf. and fur:

    Not found.

    Form release / dosage:Dragee.
    Packaging:

    For 21 dragees in a blister of PVC and aluminum foil. Blister together with instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:5 years. Do not use after expiry date!
    Terms of leave from pharmacies:On prescription
    Registration number:П N012240 / 01
    Date of registration:02.06.2010
    The owner of the registration certificate:Bayer Pharma AGBayer Pharma AG Germany
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp01.10.2015
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