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Silhouette (Dienogest/Ethinylestradiol) 2 mg/0.03 mg, 63 film-coated tablets

$54.00

b145c71fb796

Description

The instruction for medical use

of Siluet® medicine

the Trade name
of Siluet®

the International unlicensed name
Is not present

the Dosage form
of the Tablet, film coated, 2 mg / 0.03 mg

Structure
One tablet contains
active agents: diyenogest micronized 100% 2 mg, the ethinylestradiol micronized 100% 0.03 mg,
excipients: lactoses monohydrate, starch corn, talc, potassium polakrilin, magnesium stearate, gipromelloza type 2910
structure of a film cover of Opadray II. white 85F18422: polyvinyl alcohol, the titan dioxide (E 171), a macrogoal 3350, talc

the Description
of the Tablet, round shape, with a biconvex surface, film coated white or almost white color, with an engraving on one party of G53

Pharmacotherapeutic group
Sex hormones and modulators of a reproductive system. Hormonal contraceptives for system use. Progestogens and estrogen (the fixed combinations).
The ATX G03AA code

the Pharmacological

Pharmacokinetics Ethinylestradiol properties (30 mkg)
Absorption
Ethinylestradiol is quickly and completely soaked up after intake. After intake the maximum concentration in plasma (67 pg/ml) is reached in 1.5-4 hours. At the first passing through a liver a considerable part of ethinylestradiol is metabolized. The absolute bioavailability is about 44%.
Distribution
Etinilestraldiol in a large number, but is not specific contacts albumine (about 98%). It increases level in plasma of the globulin, connecting sex hormones (G,CSH). The seeming volume of distribution is 2.8 – 8.6 l/kg.
Metabolism
Ethinylestradiol is conjugated in mucous intestines and in a liver. The main metabolic way of ethinylestradiol is provided by aromatic hydroxylation, but his metabolism also leads to formation of a large number of hydroxylated and metilirovanny metabolites in the free, glyukuronirovanny and sulphated form. The clearance is about 2.3-7 ml/min.
Removal
ethinylestradiol Content in blood plasma decreases in two stages with elimination half-life at 1 and 10-20 hours. Ethinylestradiol in any quantity it is not removed in not changed form. Metabolites of ethinylestradiol are removed by kidneys and a liver in the ratio 4:6. Elimination half-life of metabolites makes about 1 day.
Equilibrium concentration
Equilibrium concentration is reached throughout the second half of a medical cycle, and concentration of ethinylestradiol in serum increases twice.
Diyenogest
Vsasyvaniye
Diyenogest is quickly and completely soaked up after intake. The maximum concentration in plasma (51 pg/ml) is reached in 2.5 hours. The absolute bioavailability at a concomitant use with ethinylestradiol is 96%.
Distribution
of Diyenogest contacts seralbumin and does not contact GSPG or globulin connecting corticosteroid hormones. The fraction of the free diyenogest in plasma makes 10% while 90% are nonspecific connected with albumine. The seeming volume of distribution of the diyenogest is 37-45 l.
Metabolism
of Diyenogest is generally metabolized by hydroxylation, an alternative way is the glyukuronization. Its metabolites are not active and eliminirutsya quickly from plasma therefore in significant quantities it is not possible to find metabolites in blood plasma, it concerns the changed diyenogest. The general clearance after single dose (Cl/F) is 3.6 l/h.
Removal
Elimination half-life of the diyenogest makes about 9 hours. The fraction of not changed diyenogest removed by kidneys is insignificant. After intake of 0.1 mg/kg the removal with a stake and urine has a ratio about 3.2. At intake of 86% it is removed within 6 days, 42% are brought out of them within the first 24 hours mainly with urine.
Equilibrium concentration
Concentration of GSPG in plasma does not influence diyenogest pharmacokinetics. Concentration of the diyenogest in plasma increases by 1.5 times, and equilibrium concentration is reached within 4 days.
The pharmacodynamics
of Siluet® is the combined oral contraceptive (COC) with anti-androgenic effect, contains etinilestradit as estrogen and diyenogest as progesterone. The contraceptive effect of the drug Siluet® is caused by various factors, the most important among them is the inhibition of an ovulation and change in endometrium.
The anti-androgenic effect of a combination of ethinylestradiol and the diyenogest is based generally on decrease in level of androgens in blood plasma. In one multicenter research it was shown that reception of a combination of ethinylestradiol and the diyenogest led to leveling of symptoms of an acne easy and moderately severe and had positive take at patients with seborrhea.
Diyenogest is derivative Norethisteronum which has at 10-30 times lower affinity to in vitro progesterone receptors in comparison with other synthetic progesterona. Diyenogest has no essential androgenic, mineralokortikoidny or glucocorticoid effects of in Vivo.
At the isolated use diyenogest inhibits an ovulation in a dose of 1 mg/day.
At use high-dose COC (ethinylestradiol content – 50 mkg) risk of developing endometrial cancer and ovarian cancer decreases. Presence of this effect at low – dose COC needs additional confirmation.

Indications
– oral contraception
– moderate acne rash at the women needing hormonal contraception

the Route of administration and doses
of the Tablet need to be accepted daily approximately at the same time, if necessary washing down with a small amount of liquid, in the order designated on the blister packing. On one tablet a day accept daily within 21 days. Each following packing begins to be accepted in 7 days after previous, during these 7 days usually there is cancellation bleeding. It, as a rule, begins for 2-3 day after reception of the last tablet and can not come to an end by the beginning of reception of the following packing.
How to begin administration of drug of Siluet®:
If hormonal contraception earlier (in 1 month) was not applied: administration of drug of Siluet® needs to be begun in 1 day of a menstrual cycle (i.e. in the first day of periods).
In case of transition from other combined hormonal contraceptive (the combined oral contraceptive (COC), a contraceptive vaginal ring or a transdermalny plaster):
It is preferable to begin administration of drug of Siluet® next day after a usual break in reception, or next day after the last day of reception of an active tablet of the previous COC, however, no later than the next day after a usual break in reception of tablets or after the period of reception of tablets placebos from packing of the previous COC. Upon transition from a contraceptive vaginal ring or a transdermalny plaster the woman should begin to use the drug Siluet® preferably in day of their removal, but no later than day when it would be necessary to use these means again.
In case of transition from a progesteronovy method (the tablets containing only progesterone, an injection form, implants, injection implants, progesterone – the allocating intrauterine system):
Transition from reception of the tablets containing only progesterone can be carried out in any day, transition from use of implants or progesterone – the allocating intrauterine system carry out in day of removal of an implant, upon transition from an injection form – from day when the following injection has to be made, but in these cases additional use of a barrier method of contraception during the first 7 days of use of drug is recommended.
After abortion in the first trimester of pregnancy:
It is possible to begin reception immediately, in this case there is no need of use of additional resources of contraception.
After the delivery or abortion in the second trimester of pregnancy:
Reception of Siluet® has to be begun for 21 – 28 days after the delivery or abortion in the second trimester of pregnancy. If administration of drug is begun later, it is necessary to warn the woman about need of use of additional barrier methods during the first 7 days. However if the sexual contact already happened, before reception the COOK it is necessary to exclude pregnancy or to expect approach of periods.
Reception of the passed tablets:
If delay in administration of drug made less than 12 hours, contraceptive protection does not decrease. The woman has to take a pill as soon as possible, the following pill is taken in usual time.
If delay in reception of a tablet made more than 12 h, contraceptive protection can be reduced. At the same time it is possible to be guided by the following two basic rules:
– administration of drug never has to be interrupted more than for 7 days,
– 7 days of continuous administration of drug are necessary for achievement of adequate suppression gipotalamo – hypophysial and ovarian regulation.
According to it it is possible to give the following advice:
The first week
the Woman has to take the last passed pill as soon as possible even if it means reception of two tablets at the same time. The following pill is taken in usual time. The barrier method of contraception (for example, condom) during the next 7 days has to be in addition used. If the sexual contact took place within a week before the admission of a tablet, it is necessary to consider pregnancy approach probability. Than more tablets are passed, and the this admission is closer to a 7-day break in administration of drug, the risk of approach of pregnancy is higher.
The second week
the Woman has to take the passed pill as soon as possible even if it means reception of two tablets at the same time. The following pill is taken in usual time. In case within 7 days to the admission of drug the woman correctly took a pill, there is no need for additional resources of contraception. However if it missed reception more than one tablet, she should use additional methods of contraception within 7 days.
The third week
the Risk of decrease in reliability is inevitable because of the forthcoming 7-day break in reception. However at correction of reception of tablets it is possible to prevent weakening of contraceptive protection.
At observance of one of two offered ways there is no need for use of additional methods of contraception if within 7 days to the admission of drug the woman correctly took a pill. Otherwise it has to follow the first of these two ways and also use additional methods of contraception during the next 7 days.
The woman has to take the last passed pill as soon as possible even if it means reception of two tablets at the same time. The following pill is taken in usual time. Administration of drug from the following blister packing has to be begun right after administration of drug from previous is complete, i.e. the usual break between receptions should not be. Most likely, that the woman will have no cancellation bleeding before the termination of tablets from the second packing, but the smearing bloody discharges or breakthrough uterine bleeding in days of reception of tablets can be observed.
Besides it is possible to stop reception of tablets from the current blister packing. Then there has to be a 7-day break in reception of tablets, including days of the passed tablets, and then it is necessary to begin reception of tablets from new packing.
If the woman missed reception of a tablet, and then in the first normal interval between administrations of drug it has no cancellation bleeding, it is necessary to exclude pregnancy.
In gastrointestinal disorders
If the woman had a vomiting or heavy diarrhea within 3-4 h after reception of a tablet, absorption can be incomplete, and additional measures of contraception have to be taken. In these cases it is necessary to take as soon as possible following (instead of accepted earlier) a pill. This pill has to be whenever possible taken within 12 hours after usual time of reception. If there passed more than 12 hours, it is necessary to be guided by recommendations at the admission of tablets. If the woman does not want to change the normal mode of reception of tablets, she has to use an additional tablet (i) from other blister packing.
How to delay cancellation bleeding
to delay the beginning of periods, the woman has to continue administration of drug of Siluet® from new packing right after all pill from previous, without interruption in reception is taken. Against the background of administration of drug from the second packing at the woman the smearing discharges or breakthrough uterine bleedings can be noted. It is necessary to resume administration of drug of Siluet® from a new pack after a usual 7-day break.
To transfer day began periods the next day of week, the woman can recommend to truncate the next break in reception of tablets for so many days on how many she wants. The interval is shorter, the risk is higher that there will be no cancellation bleeding, and further, during reception of tablets from the following packing, there will be smearing discharges and breakthrough bleedings (as well as in case the woman like to delay the beginning of periods).

Side effects
Often (≥1/100 to & lt, 1/10)
– a headache
– an abdominal pain
– mammary gland pain, morbidity of mammary glands
Infrequently (≥1/1000 to & lt, 1/100)
– increase in appetite
– change of mood (including a depression), migraine, hyperexcitability
– increase and a lowering of arterial pressure, a varicosity
– nausea, vomiting
– an acne, akneformny dermatitis, a dieback, skin allergic reactions, a hloazma, an alopecia
– a vaginitis, vaginal candidiasis
– infections of urinary tract
– irregular bleedings, a dysmenorrhea, increase in mammary glands, cysts of ovaries, a dispareuniya, changes of a vaginal secret
– raised fatigue / discomfort, increase in body weight, hypostases
is rare (≥1/10000 to & lt, 1/1000)
– allergic reactions
– a loss of appetite, anorexia
– changes of a libido, aggression, apathy, mental disturbances, insomnia, sleep disorders
– a disorder of vision, conjunctivitis, xerophthalmus, irritation of eyes, an ostsillopsiya, intolerance of contact lenses
– decrease in hearing, a sudden hearing loss, tinnita, vertigo
– tachycardia, cardiovascular disturbances
– thrombophlebitis, a fibrinferments / pulmonary embolism, a hematoma, disturbance of cerebral circulation, an ischemic stroke, dystonia, orthostatic circulator dysregulation, inflows of heat
– a varicosity, changes in veins, vein pains
– sinusitis, bronchial asthma, bronchitis
– diarrhea
– a hyperhidrosis, a multiformny erythema, a skin itching, a hypertrichosis, a virilism
– a hypomenorrhea, mastitis, fibrous and cystous mastopathy, emergence of a secret in mammary glands, a leiomyoma, an endometritis, a salpingitis, a cervical dysplasia
– herpes of a mucous membrane of a mouth
– grippopodobny symptoms
– anemia
– dorsodynias, musculoskeletal discomfort, myalgias, extremity pains
At the women applying the COOK were noted the following serious undesirable phenomena:
– venous thromboembolic disturbances
– arterial thromboembolic disturbances
– liver tumors
– a gipertriglitseridemiya
– disturbance of tolerance to glucose or effects of peripheral insulin resistance
– emergence or aggravation of states for which communication with reception the COOK is not proved: Crohn’s disease, ulcer colitis, a porphyria, a system lupus erythematosus, herpes of pregnant women, Sydenham’s trochee, a gemolitiko-uraemic syndrome, cholestatic jaundice
– a hloazma

of the Contraindication
– hypersensitivity to drug components
– venous fibrinferments now or in the anamnesis (deep vein thrombosis, a pulmonary embolism)
– arterial fibrinferments now or in the anamnesis (for example, a myocardial infarction) or the previous states (for example, stenocardia or the tranzitorny ischemic attacks)
– existence of heavy or multiple factors of risk of arterial thrombosis (diabetes with vascular complications, heavy arterial hypertension, a heavy dislipoproteinemiya)
– the congenital or acquired predisposition to venous or arterial fibrinferments, for example, resistance to the activated protein With, insufficiency of antithrombin III, insufficiency of a protein With, insufficiency of a protein of S, a gipergomotsisteinemiya and existence of antibodies to phospholipids (antibodies to cardiolipin, lupoid anticoagulant)
– serious or multiple factors of risk of developing venous or arterial thromboses
– existence at the moment or in the anamnesis of a serious illness of a liver provided that functional hepatic tests did not return to normal values, presence of tumors of a liver (benign or malignant)
– the known or suspected hormonedependent malignant diseases (for example, genitals or a mammary gland)
– bleeding from a vagina of not clear genesis
– pregnancy and the period of a lactation
– existence in the anamnesis of migraine with focal neurologic symptomatology
– hereditary intolerance of fructose, deficiency of Lapp-lactases enzyme, glucose malabsorption – galactoses

the Medicinal interactions
of Interaction connected with induction of microsomal enzymes between oral contraceptives and other medicines can lead to breakthrough bleedings and/or to decrease in efficiency of contraception. These effects were shown for hydantoin, phenobarbital, Primidonum, carbamazepine and rifampicin. Such effects are possible also for a rifabutin, an efavirenz, not Virapinum, oxycarboazepine, the topiramat, the felbamat, a ritonavir, griseofulvin, and herbal remedy of the St. John’s wort of made a hole (Hypericum perforatum). The mechanism of these interactions is based on ability of the listed drugs to induce microsomal enzymes of a liver.
According to clinical observations the co-administration with some antibiotics (such as ampicillin and tetracycline) can lead to decrease in efficiency of contraception, the reason of this phenomenon is unknown.
The women taking above-mentioned medicines during the short span (about one week), have to in addition with reception the COOK temporarily use barrier methods of contraception, for example, during the period of reception of one of the listed medicines and 7 days after their cancellation.
The women accepting rifampicin have to use barrier methods of contraception during the period of intake of rifampicin and 28 days after its cancellation. If intake of the accompanying drug is the share of the end of reception of tablets from this packing, reception of the following packing should be begun at once, without usual break.
At prolonged use of the accompanying drug having ability to induce liver enzymes, the doctor can consider need of increase in a dose of contraceptive steroids. If this approach leads to emergence of the undesirable phenomena (for example, irregular bleedings) or to decrease in efficiency, it is necessary to use other method of contraception.
Oral contraceptives can break metabolism of some medicines. Therefore, concentration of these drugs in plasma and fabrics can be as raised (for example, cyclosporine) and lowered (lamotrigin).
The laboratory
researches Use of Contraceptive Steroids the corticosteroid – the connecting globulin and fractions of lipids/lipoproteins, on parameters of carbohydrate metabolism and also coagulation and a fibrinolysis can affect results of some laboratory researches, including biochemical indicators of function of a liver, thyroid gland, adrenal glands and kidneys and also level in plasma of transport proteins, for example. Changes usually remain within normal values.

Special instructions
If any of the states/risk factors provided below are available now, it is necessary to weigh carefully potential risk and the expected advantage of treatment in each case and to discuss it with the woman before she decides to begin reception the COOK. In case of aggravation, aggravation or primary manifestation of any of these states or risk factors the woman has to consult with the doctor who can make the decision on need of cancellation the COOK.
Circulator disturbances
Due to the possible serious conditions connected with a thrombembolia, presence of risk factors (such as varicosity, thrombophlebitis in a late stage and thrombosis, heart diseases, the considerable excess weight, disturbance of blood clotting) the COOK demands more careful inspection before reception.
Use of the combined oral contraceptives leads to increase in risk of a venous thrombembolia (VTE) in comparison with the persons which are not accepting the COOK. Risk of VTE the highest on the first year of use of the combined oral contraceptive. The risk of VTE connected with the COOK is, less, than the risk connected with pregnancy, it makes 60 cases on 100000 pregnancies. VTE comes to an end with a lethal outcome in 1-2% of cases.
The risk of VTE connected with reception levonorgestrel – containing the COOK which part 30 mkg of an etinilestraliol are is about 20 cases on 100000 women a year.
Results of clinical trials, reviews and post-market researches did not show higher risk at use of a combination of the diyenogest and ethinylestradiol in comparison with levonorgestrel – containing the COOK.
It was reported that at the women applying contraceptives extremely rare development of thromboses of other blood vessels, for example, vessels of a liver, mezenterialny, renal vessels, veins and arteries of a brain or retina of an eye was recorded. There is no consensus concerning communication of these phenomena with reception of hormonal contraceptives.
Symptoms of arterial or venous trombotichesky or tromboembolic episodes can include:
– the unusual unilateral scelalgia and/or hypostasis
– sudden severe pain in a breast, with possible irradiation in the left hand
– a sudden asthma
– a sudden fit of coughing
– any unusual, severe and long headache
– sudden partial or total loss of sight
– a diplopia
– the muffled speech or aphasia
– dizziness
– the unconscious state which is followed by a partial epileptic seizure or without it
– sudden weakness or considerable numbness from one party or in one part of a body
– motive disturbances
– acute abdomen
Risk of venous tromboembolic episodes raises:
– with age
– in the presence of the family anamnesis (the venous thrombembolia ever taking place at close relatives or parents at rather young age) if there is genetic predisposition, the woman needs to be directed to the expert for making decision on use the COOK)
– at a long immobilization, after serious surgical intervention, any surgical intervention on the lower extremities, or after a serious injury. In these cases it is preferable to stop reception of tablets (at planned operations at least in four weeks) and not to resume their reception before the expiration of two weeks after complete recovery of physical activity. In case drug was not cancelled beforehand, it is necessary to appoint antitrombotichesky therapy
– in obesity (body mass index more than 30 kg/m ²)
there is no consensus concerning a role of a varicosity or thrombophlebitis of superficial veins in emergence and development of venous thrombosis.
The risk of arterial tromboembolic episodes or risk of developing a stroke at the women applying the COOK increases:
– with age
– in the presence of a dislipoproteinemiya
– in the presence of arterial hypertension
– in the presence of migraine
– in obesity (body mass index more than 30 kg/m ²)
– at the burdened family anamnesis (an arterial thrombembolia at brothers, sisters or parents at relatively young age). If genetic predisposition is allowed, the woman should consult with the expert concerning a possibility of use the COOK:
– at defect of valves of heart
– at fibrillation of auricles
– when smoking (at smokers the COOK increases risk of emergence of heavy cardiovascular complications, such as myocardial infarction, the stroke, risk raises with age and quantity of the smoked cigarettes).
To women 35 years insistently are more senior advise not to smoke if they intend to apply the COOK. If the woman cannot leave off smoking, it is necessary to use other method of contraception, especially with other risk factors.
Presence of one heavy or several risk factors of developing venous or arterial diseases, respectively, can also be a contraindication.
It is also necessary to consider the possibility of use of anticoagulating therapy. It is necessary to draw the attention of the women applying the COOK to need to contact the doctor in case of suspicion on existence of symptoms of thrombosis. In case of suspicion or confirmation of thrombosis, reception the COOK has to be stopped, at the same time women need to use other suitable methods of contraception. It is necessary to take presence of the increased risk of developing of a thrombembolia in a puerperal period into account.
Other states connected with adverse side vascular reactions include diabetes, a system lupus erythematosus, a gemolitiko-uraemic syndrome and chronic inflammatory bowel disease (Crohn’s disease or ulcer colitis).
Increase in frequency of attacks and severity of migraine at reception the COOK (that can be a harbinger of disturbance of cerebral circulation) can be the basis for the immediate termination of reception the COOK.
Biochemical factors which can indicate the congenital or acquired predisposition to venous or arterial fibrinferments include: resistance to the activated protein With, a gipergomotsisteinemiya, insufficiency of antithrombin III, insufficiency of a protein With, insufficiency of a protein of S, existence of antibodies to phospholipids (antibodies to cardiolipin, lupoid anticoagulant).
To a tumor
In some pharmako-epidemiological researches it was reported about the increased risk of developing cervical cancer at prolonged use the COOK (more than 5 years). However contradictions concerning in what degree these cases are connected with features of sexual behavior and other factors, for example, the human papillomavirus (HP) remain.
Meta-analysis of 54 pharmako-epidemiological researches showed that there is slightly increased relative risk (RR=1.24) of development of the breast cancer diagnosed for women who at the time of the research used the COOK. The breast cancer is a hormonedependent tumor. The known risk factors of developing a breast cancer, such as early menarche, late menopause (after 52 years), indicate lack of childbirth, existence of anovulatory cycles, etc. a role of hormones in development of this disease. Frequency of developing of a breast cancer at the women accepting the COOK increases very slightly. As the breast cancer seldom arises at women more young than 40 years, this exceeding is not enough in relation to the general risk of developing a breast cancer. Receptors to hormones play a key role in cellular biology of a breast cancer, estrogen is capable to enhance effects of growth factors (for example, a TGF alpha). Estrogen and progestogens influence growth of cancer cells in a mammary gland. Among others these biological bonds are a pharmacological basis of treatment a receptor – a positive breast cancer during the postmenapauzalny period.
Epidemiological researches showed existence of a possible causal relationship between long reception the COOK, begun at young age, and development of a breast cancer in the middle age. However, use the COOK is only one of many risk factors. The increased risk gradually decreases within 10 years after cancellation the COOK.
In rare instances against the background of use the COOK development of benign tumors of a liver, in even more exceptional cases – malignant was observed. In some cases these tumors led to zhizneugrozhayushchy intra belly bleedings. At appearance of severe pains in an upper part of a stomach, increase in a liver and at symptoms of intra belly bleeding at the women accepting the COOK it is necessary to exclude liver tumors.
Other conditions
of the Woman with a gipertriglitseridemiya or the family anamnesis of a gipertriglitseridemiya have the increased risk of developing pancreatitis at use the COOK.
Though small increase in the arterial blood pressure (ABP) was described at many women accepting the COOK, clinically significant increase in the ABP was noted seldom. Only in these exceptional cases the immediate termination of administration of drug is justified. Nevertheless, if during reception the COOK at women with the arterial hypertension which was already taking place (in the anamnesis) constantly raises the ABP, or the significant raising of the ABP which is not responding to hypotensive therapy, reception the COOK is observed it has to be stopped. Whenever possible, reception can be continued if by means of hypotensive therapy the AD normal values are reached.
The following states develop or aggravated both during pregnancy, and at reception the COOK, but their communication with reception the COOK is not proved: the jaundice and/or an itching connected with a cholestasia, forming of stones in a gall bladder, a porphyria, a system lupus erythematosus, a gemolitiko-uraemic syndrome, Sydenham’s chorea, herpes of pregnant women, a hearing loss connected with an otosclerosis.
Acute or chronic abnormal liver functions can demand the reception termination the COOK until indicators of function of a liver do not return to norm. Recurrent cholestatic jaundice which develops for the first time in time of pregnancy or previous intake of sexual steroids demands the reception termination the COOK.
Though the COOK can influence resistance of fabrics to insulin and the tolerance to glucose, usually is not present need to correct the scheme of treatment at the patients with diabetes applying the COOK. Nevertheless, women with diabetes have to be under careful observation of the doctor during reception the COOK.
At use the COOK aggravation of the course of the disease Krone and ulcer colitis was noted. There can
periodically be a hloazma, especially at women from hloazmy pregnant women in the anamnesis. Women with tendency to a hloazma during reception the COOK have to avoid long stay to the sun and influences of UF of radiation.
Medical examination / consultation
Before the beginning or resuming of administration of drug of Siluet®, tablet, film coated, it is necessary to collect the anamnesis (including the family anamnesis) and also it is necessary to exclude pregnancy. It is necessary to measure arterial blood pressure and to perform the general inspection taking into account contraindications and cautions. It is necessary to explain to the woman need of attentive study the instruction for use to implementation of its recommendation. Frequency and the nature of inspections have to be based on the established recommendations and be selected individually.
It is necessary to warn the woman that oral contraceptives do not protect from infection with HIV infection (AIDS) or any other disease, sexually transmitted.
Decrease in efficiency
Decrease in efficiency the COOK happens in a case, the missed reception of tablets, in gastrointestinal disorders or at reception of the accompanying therapy.
Decrease in control of a cycle
At use of any the COOK is possible developing of unusual bleedings (the smearing bloody discharges or breakthrough uterine bleedings), especially in the first months of use the COOK. Thus, the assessment of atypical bleedings is carried out only later the adaptation period equal to three cycles.
If irregular bleedings are observed constantly or develop after the previous normal regular cycles, it is necessary to consider the non-hormonal reasons of these phenomena and to hold diagnostic events to exclude malignant new growths and pregnancy. They can include diagnostic scraping.
At some women of bleeding of cancellation can not arise in a break between administrations of drugs. If the woman accepted the COOK according to Regulations of Admission, approach of pregnancy is improbable. However if the COOK were not accepted according to these rules to the first absent cancellation bleeding or if two missed cancellation bleedings took place, it is necessary to exclude pregnancy before reception continuation the COOK.
Can lead the interactions of drugs enhancing clearance of sexual steroids to breakthrough uterine bleeding and decrease in efficiency of contraception.
The medications on the basis of herbs containing a St. John’s wort (Hypericum perforatum) should not be applied along with the drug Siluet® because of their ability to reduce a koncentre
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