Certificate of conformity (COC) Siluette, pills, 21pcs

Siluette, pills, 21pcs

$69.00

Active ingredient:	Dienogest, Ethinylestradiol
Dosage form:	Pills
Indications for use:	Acne, Contraception

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Categories: Contraceptive, Medication, Obstetrics, gynecology

Description
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Composition

1 tablet contains:

active ingredients:

ethinyl estradiol 0.03 mg,

dienogest 2 mg,

excipients:

lactose monohydrate-47.66 mg;

corn starch-10.46 mg;

hypromellose 2910-0.65 mg;

talc-1.6 mg;

potassium polacrylin-1.3 mg;

magnesium stearate-1.3 mg

film shell:

Opadry II white 85F18422 (polyvinyl alcohol-1.2 mg, titanium dioxide-0.750 mg, macrogol 3350-0.606 mg, talc-0.444 mg) — 3 mg

Pharmacological action

Pharmaceutical group:

contraceptive (estrogen+progestogen).

Pharmaceutical action:

Siluet® is an oral combination drug with an antiandrogenic effect, containing ethinyl estradiol as an estrogen and dienogest as a progestogen. The contraceptive effect of Siluet® is determined by various factors, the most important of which are: inhibition of ovulation, increased viscosity of cervical mucus, changes in the peristalsis of the fallopian tubes and the structure of the endometrium. The antiandrogenic effect of the combination of ethinyl estradiol and dienogest is based on a decrease in the concentration of androgens in plasma.

Repeated studies have shown that taking a combination of ethinyl estradiol and dienogest resulted in the elimination of mild to moderate acne symptoms and had a positive result in patients with seborrhea.

Dienogest is a norethisterone derivative that has a 10-30-fold lower affinity for progesterone receptors in vitro compared to other synthetic progesterones. Dienogest has no significant androgenic, mineralocorticoid, or glucocorticoid effects in vivo.

When administered in isolation at a dose of 1 mg / day, dienogest inhibits ovulation.

Pharmacokinetics:

Ethinyl Estradiol:

Absorption Ethinyl estradiol is rapidly and completely absorbed in the small intestine after oral use. Cmax in plasma (67 pg / ml) is reached in 1.5-4 hours. During the initial passage through the liver, a significant part of ethinyl estradiol is metabolized. Absolute bioavailability is approximately 44%.

Distribution of ethinyl estradiol is almost completely (about 98%) bound to albumins, although not specifically. Ethinyl estradiol increases the plasma concentration of sex hormone binding globulin (SHBG). The apparent Vd is 2.8-8.6 l / kg. Css is achieved during the second half of the treatment cycle, and the concentration of ethinyl estradiol in the serum increases by 2 times.

Metabolismethinylestradiol undergoes conjugation in the intestinal mucosa and in the liver. The main route of ethinyl estradiol metabolism is aromatic hydroxylation, but its metabolism also leads to the formation of a large number of hydroxylated and methylated derivatives in free, glucuronated and sulfated forms. The clearance is approximately 2.3-7 ml / min / kg.

Elimination The decrease in the concentration of ethinyl estradiol in plasma occurs in two stages: the first stage of half – life is 1 h, the second – 10-20 h. Ethinyl estradiol is not excreted unchanged. Metabolites of ethinyl estradiol are excreted by the kidneys and liver in a ratio of 4: 6. T1 / 2 of metabolites is about 24 hours.

Dienogest:

Absorption After oral use, it is rapidly and completely absorbed in the intestine. Cmax in plasma (51 pg/ml) is reached in 2.5 hours. Absolute bioavailability when co-administered with ethinyl estradiol is 96%.

Distribution Dienogest binds to plasma albumins and does not bind to SHBG and corticosteroid hormone binding globulin. The fraction of free dienogest in plasma is 10%, while 90% is non-specifically associated with albumin. The apparent Vd is 37-45 l. The concentration of SHBG in plasma does not affect the pharmacokinetics of dienogest. The concentration of dienogest in plasma increases by 1.5 times, and Css is reached within 4 days.

Metabolism Dienogest is mainly metabolized by hydroxylation, with an alternative route being glucuronidation. Its metabolites are inactive and quickly eliminated from the plasma, so it is not possible to detect metabolites in significant quantities in the blood plasma, this does not apply to unchanged dienogest. The total clearance after a single dose is 3.6 l/h.

Excretion1 / 2 of dienogest is about 9 hours. A small amount in unchanged form is excreted by the kidneys. After oral use of 0.1 mg / kg, intestinal and renal excretion has a ratio of about 3.2. When taken orally,86% is excreted within 6 days, of which 42% is excreted within the first 24 hours, mainly by the kidneys.

Indications

oral contraception;
treatment of mild to moderate acne (acne) when local treatment is ineffective in women who need contraception.

Use during pregnancy and lactation

Siluet® is contraindicated during pregnancy.

If pregnancy occurs while taking Siluet®, the use of the drug should be stopped immediately. Available information regarding the use of Siluet® during pregnancy, it is too limited to draw conclusions about the negative effects of Siluet® on pregnancy, fetal and newborn health.

Extensive epidemiological studies have not shown an increased risk of developmental defects in children born to women who took sex hormones for the purpose of contraception before pregnancy or, inadvertently, in the early stages of pregnancy.

Siluet® is contraindicated in breast-feeding women.

Contraindications

Combined oral contraceptives (COCs) should not be used if any of the conditions/diseases listed below are currently present in the woman. At the first occurrence of any of these conditions while taking COCs, the drug should be stopped immediately:

hypersensitivity to the drug Siluette® or any of its components;
the arterial and venous thromboembolic diseases in the present or in history (e. g. deep vein thrombosis, pulmonary embolism);
thrombosis (venous and arterial) and thromboembolism in the present or in history, including thrombosis, deep vein thrombosis; pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders;
status, previous thrombosis (including transient ischemic attack, angina complicated by lesions of valvular apparatus of the heart, atrial fibrillation, subacute bacterial endocarditis, extended surgery with prolonged immobilization, extensive trauma);
pancreatitis with severe hypertriglyceridemia now or in history;
porphyria;
jaundice, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor);
sickle cell anemia;
severe or multiple risk factors for venous or arterial thrombosis; a history of risk factors for arterial thrombosis:
– diabetes mellitus with vascular complications (angiopathy, retinopathy);
– uncontrolled arterial hypertension (AH);
– severe dyslipoproteinemia.
congenital or acquired predisposition to arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, deficiency of protein C, S, hyperhomocysteinemia and the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
Smoking at the age of 35 years;
severe forms of liver disease (including in history) to the normalization in liver function tests;
liver tumors (benign or malignant), including in the anamnesis;
hormone-dependent cancers of the genitals or mammary gland, including history, or suspicion of them;
vaginal bleeding of unknown origin;
migraine with local neurological symptoms, including in the anamnesis;
epilepsy;
lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
pregnancy;
lactation.

With caution: the presence of risk factors (varicose veins, heart disease, overweight, blood clotting disorders) requires more careful research before starting COCs; smoking under the age of 35 (if a woman cannot stop smoking, another method of contraception should be used, especially if there are other risk factors); the potential risk and expected benefit of using oral contraceptives should be carefully weighed in each individual case if the following diseases, conditions or risk factors exist: dyslipoproteinemia, diabetes mellitus without vascular complications, controlled arterial hypertension, fibrocystic mastopathy, uterine fibroids, endometriosis, multiple sclerosis, a history of severe depression, impaired renal function, contact lens intolerance, Crohn’s disease, ulcerative colitis, superficial venous phlebitis, thromboembolism, acute cerebrovascular accident, myocardial infarction at a young age, chronic heart failure, breast cancer in relatives of the 1st degree of kinship; visual impairment (risk of retinal thrombosis), tetany, hypercalcemia, hypokalemia, bronchial asthma, hereditary angioedema, liver disease, idiopathic jaundice during previous pregnancy, herpes during pregnancy.

Side effects

From the blood and lymphatic system: rarely-anemia.

From the heart: rarely-tachycardia; very rarely-myocardial infarction.

From the nervous system: often-headache; infrequently-migraine, increased excitability, dizziness; rarely-violation of cerebral circulation.

From the side of the organ of vision: rarely-visual impairment, conjunctivitis, dryness of the mucous membrane, intolerance to contact lenses.

From the side of the organ of hearing and labyrinth: rarely-hypoacusia, tinnitus, sudden hearing loss, hearing disorders.

Respiratory, thoracic and mediastinal disorders: rarely-sinusitis, bronchial asthma, bronchitis.

From the gastrointestinal tract: often-nausea, vomiting; infrequently-abdominal pain; rarely-diarrhea, dyspepsia, gastritis, enteritis; very rarely-cholecystitis, gallstone disease.

From the side of the kidneys and urinary tract: infrequently-infection of the urinary system.

Skin and subcutaneous tissue disorders: infrequently — acne, dermatitis acneforme, exanthema, allergic skin reactions, chloasma, alopecia, erythema multiforme, pruritus, including generalized pruritus, erythema nodosum, vascular purpura; rarely — hypertrichosis, virilism, hyperhidrosis, seborrhea, hyperpigmentation, eczema, dandruff, angioedema, telangiectasia (vascular diseases). asterisks).

From the side of metabolism and nutrition: often-increased body weight; infrequently-increased appetite, weight loss; rarely-decreased appetite.

Infectious and parasitic diseases: infrequently-vaginitis, vaginal candidiasis; rarely-fungal infections, herpetic lesions of the oral cavity.

From the vascular system: infrequently-hypertension, hypotension, varicose veins, superficial vein thrombophlebitis; rarely-deep vein thrombophlebitis, thrombosis, pulmonary embolism, hematoma, cerebrovascular accident, hot flashes, pain along the veins.

General disorders and disorders at the injection site: infrequently-feeling tired/unwell, edema; rarely-flu-like symptoms.

Immune system disorders: rarely-allergic reactions.

From the genital organs: often — pain and soreness of the mammary glands, enlargement of the mammary glands; infrequently — acyclic spotting or bleeding, painful menstrual — like bleeding, ovarian cysts, dyspareunia, increased vaginal discharge, endometrial hyperplasia, vaginitis/vulvovaginitis, salpingitis, endometritis; rarely-scanty menstrual — like bleeding, mastitis, fibrocystic dysplasia of the mammary glands, appearance of breast secretions, leiomyoma, endometritis, salpingitis, cervicitis, vulvovaginal pruritus, breast lipoma; very rarely-endometrial cancer.

From the side of the psyche: often-a decrease in mood; rarely-insomnia, sleep disorders, depression, anorexia, changes in libido, aggressiveness, apathy.

Musculoskeletal and connective tissue disorders: often-back pain, calf cramps; rarely-arthralgia, myalgia.

The following serious adverse events have been reported in women using Siluet®::

– venous thromboembolic disorders;

arterial thromboembolic disorders;

– hypertension;

– liver tumors;

the emergence or worsening of conditions for which the connection with the reception of the CCP is not proven Crohn’s disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes pregnant, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice;

– chloasma.

The incidence of breast cancer in women taking COCs increases very slightly. Because breast cancer rarely occurs in women younger than 40, this excess is very small relative to the overall risk of developing breast cancer. Breast cancer is a hormone-dependent tumor. Known risk factors for breast cancer, such as early menarche, late menopause (later than 52 years), absence of labor, presence of anovulatory cycles, etc., indicate the role of hormones in the development of this disease. Hormone receptors play a key role in the cell biology of breast cancer, and estrogens can enhance the effects of growth factors (eg, TGF-alpha).

Epidemiological studies have shown a possible causal relationship between long-term use of COCs initiated at a young age and the development of breast cancer in middle age. However, the use of PDAs is only one of many risk factors.

Interaction

Interactions involving the activation of microsomal enzymes between oral contraceptives and other medications can lead to breakthrough bleeding and / or reduce the effectiveness of contraception. These effects have been shown for hydantoin, phenobarbital, primidone, carbamazepine, and rifampicin.

Such effects are also possible for rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and herbal drugs-preparations of St. John’s wort (Hypericum perforatum). The mechanism of these interactions is based on the ability of these drugs to activate microsomal liver enzymes.

According to clinical observations, concomitant use with certain antibiotics (such as ampicillin and tetracycline) can lead to a decrease in the effectiveness of contraception, the cause of this phenomenon is unknown.

Women who take the above medications for a short period of time (up to a week) should temporarily use barrier methods of contraception in addition to the CPC, for example, during the period of taking one of the listed medications and 7 days after.

Women taking rifampicin should use barrier methods during the time of taking rifampicin and 28 days after the end. If the concomitant drug is taken at the end of taking tablets from the package, the next package should be started immediately, without the usual interval.

If a concomitant medication with the ability to activate liver enzymes is prescribed for a long time, the doctor may consider increasing the dose of hormonal contraceptives. If this approach results in adverse events (such as irregular bleeding) or reduced effectiveness, a different method of contraception should be used.

Based on in vitro studies, it was shown that DNG does not inhibit cytochrome P 450 at normal concentrations, so no interaction of this nature is expected.

Drug interactions that increase the clearance of sex hormones can lead to breakthrough uterine bleeding and reduce the contraceptive effectiveness of the drug.

How to take, course of use and dosage

Inside,1 tablet/day, daily, at approximately the same time, if necessary, with a small amount of liquid, in the order indicated on the blister pack, for the 21st day. Taking tablets from the next package begins 7 days after taking the last tablet from the previous package, during which withdrawal bleeding usually occurs. It usually begins on the 2-3 th day after taking the last tablet and may not end by the beginning of taking tablets from the next package.

You can switch from taking progesterone-only pills on any given day.

If hormonal contraception was not used earlier (for a month)

Siluet® should be started on the 1st day of the menstrual cycle (i. e., on the 1st day of menstruation).

In case of switching from the PDA

It is preferable to start taking Siluet® the day after the usual break in taking or the day after the last time you took the last pill from the current package of an oral contraceptive.

Injectable form, implants

The transition from the use of implants is carried out on the day of removal of the implant; when switching from the injection form — on the next day after the last injection.

After an abortion in the first trimester of pregnancy

You can start taking it immediately; in this case, there is no need to use additional contraceptives.

After childbirth or abortion in the second trimester

It is recommended to start taking the drug on the 21st-28th day after delivery or abortion in the second trimester of pregnancy. If you start taking the drug later, you should warn the woman about the need to use additional barrier methods (a condom) during the first 7 days. However, if sexual contact has already occurred, it is necessary to exclude pregnancy or wait for the 1st menstruation before taking the PDA.

Taking missed pills

If the delay in taking the drug is less than 12 hours, the contraceptive protection is not reduced. The woman should take the drug as soon as possible, taking the next pill at the usual time. If the delay in taking the pill is more than 12 hours, the contraceptive protection may be reduced. In this case, you can follow the following two basic rules::

– the drug should never be interrupted for more than 7 days;

– 7 days of continuous tablet use are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following tips can be given if the delay in taking pills was more than 12 hours

of the 1st week. A woman should take the last missed pill as soon as possible, even if it means taking 2 tablets at the same time. The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) should be used for the next 7 days. If you had sexual intercourse during the week before skipping the pill, you should consider the likelihood of pregnancy. The more pills you skip and the closer that skip is to the 7-day pill break, the higher the risk of pregnancy.

2nd week.A woman should take the last missed pill as soon as possible, even if it means taking 2 tablets at the same time. The next tablet is taken at the usual time. In the event that the woman correctly took pills within 7 days before the admission, there is no need for additional contraceptives. However, if she missed more than Table 1, she should use additional methods of contraception (a condom) for 7 days.

3rd week. The risk of reduced reliability is unavoidable due to the upcoming 7-day reception break. However, by adjusting the schedule of taking pills, you can prevent the weakening of contraceptive protection. If one of the 2 suggested methods is followed, there is no need to use additional methods of contraception if the woman correctly took pills within 7 days before the pass. Otherwise, she should follow the first of these 2 methods, as well as use additional methods of contraception for the next 7 days.

1. A woman should take the last missed pill as soon as possible, even if it means taking 2 tablets at the same time. The next tablet is taken at the usual time. Taking tablets from the next blister pack should be started immediately after the previous one is completed, i. e. there should be no usual break between doses. Most likely, the woman will not have withdrawal bleeding until the end of the 2nd pack, but she may have spotting spotting or breakthrough uterine bleeding on the days of taking the pills.

2. It is possible to stop taking tablets from the current blister pack. Then there should be a 7-day break in taking pills, including the days of missed pills, and then you need to start taking pills from a new package. If a woman missed taking the pill and then in the 1st normal interval between taking the drug she does not have withdrawal bleeding, pregnancy should be excluded.

If the woman has been vomiting for 4 hours after taking the pill

Absorption may be incomplete, and additional contraceptive measures should be taken. In these cases, you should take a new (replacement) tablet as soon as possible. If possible, a new tablet should be taken within 12 hours after the usual intake time. If more than 12 hours have passed, follow the recommendations when skipping pills in the section Taking missed pills.

If a woman does not want to change her normal pill regimen, she should use an additional pill from a different blister pack.

How to delay withdrawal bleeding

In order to delay the onset of menstrual-like bleeding, a woman should continue taking Siluet® from the new package immediately after taking all the tablets from the previous one, without interruption. Against the background of taking the drug from the 2nd package, a woman may have spotting discharge or breakthrough uterine bleeding. Resume taking Siluet® from the new pack after the usual 7-day break.

In order to move the day of the onset of menstrual-like bleeding to another day of the week, a woman can be recommended to shorten the next break in taking the pill for as many days as she wants. The shorter the interval, the higher the risk that there will be no withdrawal bleeding and further spotting and breakthrough bleeding will occur during the next pack (as well as in the case when she would like to delay the onset of menstrual-like bleeding).

Overdose

Acute toxicity with oral use of the combined drug EE and DNG in overdose is low.

Symptoms: Nausea, vomiting, and spotting/bleeding from the vagina may occur.

Treatment: symptomatic, there is no need for special therapy.

Special instructions

Before starting or resuming Siluet®, a medical history (including family history) should be collected, and pregnancy should be excluded. It is necessary to measure blood pressure and conduct a general examination, taking into account contraindications and warnings. It is necessary to explain to the woman the need to carefully read the instructions for use of Siluet® and follow the recommendations set out in it. The nature of medical examinations, including general medical and gynecological examination, is determined by the attending gynecologist on an individual basis for each woman and is carried out with different frequency, but at least once every 6 months. A woman should be warned that oral contraceptives do not prevent her from contracting HIV (AIDS) or any other sexually transmitted disease.

Reduced efficiency

A decrease in the effectiveness of the combination of EE and DNG occurs in the case of, for example, missed appointments, gastrointestinal disorders, or when taking concomitant therapy.

Changing the nature of bleeding

The use of Siluet®, especially in the first 3 cycles, may be accompanied by the appearance of acyclic spotting/bleeding from the vagina, which can be considered as a period of adaptation.

If irregular bleeding occurs consistently or occurs after previous normal regular cycles, non-hormonal causes of these phenomena should be considered and malignancies and pregnancy should be excluded. In this case, you should consult a gynecologist.

In some women, withdrawal bleeding may not occur during the break between taking the drug. If a woman has taken Siluet® as directed, pregnancy is unlikely. However, if a woman has experienced a violation of the drug intake prior to the 1st withdrawal bleeding skip or if there have been 2 skips, pregnancy should be excluded before continuing to take Siluet®. Herbal medicines containing St. John’s wort (Hypericum perforatum) should not be used in parallel with Siluet® (due to their ability to reduce the level of the drug in plasma and reduce the effectiveness of the combination of DNG with EE).

The use of combined oral contraceptives leads to an increased risk of venous thromboembolism (VTE). The risk of VTE is highest in the 1st year of using the CPC. The risk of VTE associated with taking a combination of DNG and EE is less than the risk associated with pregnancy, it is 60 cases per 100,000 pregnancies. VTE is fatal in 1-2% of cases.

Symptoms of arterial or venous thrombotic or thromboembolic complications may include the following conditions:

– unusual unilateral leg pain and/or swelling;

sudden severe pain in the chest with a possible radiating to the left arm;

sudden breathlessness;

sudden onset of coughing;

any unusual, severe prolonged headache;

sudden partial or complete loss of vision;

– diplopia;

– slurred speech or aphasia;

– dizziness;

– unconscious condition, accompanied by partial seizures with or without it;

– sudden weakness or significant numbness on one side or in one part of the body;

musculoskeletal disorders;

– syndrome of acute abdomen.

The risk of venous thromboembolic complications increases:

– age;

– in the presence of a family history (VTE ever occurred in close relatives and parents at a relatively young age); if possible congenital predisposition, women should be referred to the relevant specialist for a decision on the appointment of Siluette®;

– during prolonged immobilization, after major surgery, any surgery on the legs, or after a serious injury. In these cases, it is preferable to stop taking the tablets (for planned operations at least 4 weeks in advance) and not resume until 2 full weeks after remobilization. If the drug was not canceled in advance, antithrombotic therapy should be prescribed;

– for obesity (body mass index more than 30 kg / m2). There is no consensus on the role of varicose veins or superficial venous thrombophlebitis in the occurrence and development of venous thrombosis.

The risk of arterial thromboembolic complications or stroke increases in women who use a combination of DNG and EE:

– with age;

– in the presence of dyslipoproteinemia;

– hypertension;

– heart valve diseases;

– atrial fibrillation;

– smoking-smokers have an increased risk of severe cardiovascular complications (such as myocardial infarction, stroke); the risk increases with age and the number of cigarettes smoked.

The presence of one or more severe risk factors for the development of venous or arterial diseases, respectively, may also be a contraindication. The possibility of using anticoagulant therapy should also be considered. Women receiving Siluet® should be advised to contact their doctor if symptoms of thrombosis are suspected. In case of suspected or proven thrombosis, the drug should be discontinued. At the same time, women should use other suitable methods of contraception due to the teratogenic effect of anticoagulants (coumarins).

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

Diseases such as diabetes mellitus, SLE, hemolytic-uremic syndrome, Crohn’s disease, ulcerative colitis, sickle cell anemia, increase the risk of venous thromboembolic diseases.

An increase in the frequency and severity of migraines when taking a combination of DNG and EE (which may be a harbinger of cerebral circulation disorders) may be an indication for immediate discontinuation of the drug.

Tumors

Some epidemiological studies have reported an increased risk of developing cervical cancer with prolonged use of a combination of DNG and EE (more than 5 years). However, there is still controversy about the extent to which these cases are related to sexual behavior and other factors, such as the human papillomavirus.

Studies have shown a slight increase in the relative risk (RR — 1.24) of developing breast cancer in women who used COCs. The increased risk gradually decreases over 10 years after discontinuation of these medications.

In rare cases, against the background of the use of a combination of DNG and EE, the development of benign liver tumors was observed, in even rarer cases — malignant ones. In some cases, these tumors led to life-threatening intra-abdominal bleeding. If severe pain in the upper abdominal region, liver enlargement, and signs of intraperitoneal bleeding occur in women taking combinations of DNG and EE, liver tumors should be excluded.

Other conditions

Women with a current or previous history of hypertriglyceridemia have an increased risk of developing pancreatitis when using a combination of DNG and EE. Although a small increase in blood pressure has been reported in many women taking combinations of DNG and EE, clinically significant increases have rarely been observed.

However, if a stable increase in blood pressure is observed during the use of COCs in women with hypertension or sharp rises in blood pressure do not respond to antihypertensive therapy, the drug should be discontinued. If possible, the use can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

Acute or chronic liver diseases may require discontinuation of Siluet® until liver function indicators return to normal.

Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of the combination of DNG and EE.

Although the combination of DNG and EE may affect tissue insulin resistance and glucose tolerance, there is usually no need to adjust the treatment regimen in diabetic patients. However, women with diabetes should be under close medical supervision while taking Siluet®.

With the use of a combination of DNG and EE, the course of Crohn’s disease and ulcerative colitis may worsen.

Chloasma may occur periodically, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and UV radiation while taking Siluet®.

Laboratory tests

The use of contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, as well as plasma levels of transport proteins, such as corticosteroid hormone binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis. Changes usually remain within normal values.

Influence on the ability to drive vehicles and work with mechanisms. The drug Siluet® does not affect the ability to drive a car and use complex equipment. When using the drug, the possibility of visual impairment or dizziness should be taken into account.