Silhouette instructions for use. Hormonal contraceptive "Silhouette": reviews, instructions for use. Basic physical and chemical properties

In the modern world, a large number of different drugs are being developed on an ongoing basis to help maintain a normal lifestyle for any person. Of course, drugs are divided into several categories.

One of the popular categories of drugs is contraceptive drugs.

To be more precise, it may not necessarily be tablets, but also a drug produced in any other form. Undoubtedly, contraceptive drugs should be carefully selected taking into account all the characteristics of the patient.

It often happens that contraceptives cause quite a lot of damage to women's health during use.

Under no circumstances should this be allowed. Preparations of this purpose should not only preserve the health of a woman, but at the same time perform their intended function with high quality. For this, it is necessary to select the drug together with the doctor.

Oral contraceptive "Silhouette" is one of the well-known contraceptives.

What is Silhouette?

The drug is a contraceptive drug in tablet form, produced in a special white shell.

The basis of the composition are components such as:

• magnesium Ingredient,
• dienogest
• ethinylestradiol.

As part of these tablets, added as complementary and auxiliary components: magnesium stearate, corn starch, talc, and others.

As a rule, these components form an addition to the basis of any drugs that have a direct effect on women's health.

Pill Action Silhouette

Before you start taking pills, probably, anyone will be interested in the purpose and effect of the drug. These are the kinds of questions you need to ask before you start taking medications.

This is especially true of hormonal drugs, the use of which must be adjusted by a highly qualified specialist doctor.

The components that form the basis of the composition of the tablets "Silhouette" contribute to the stimulation of inhibited ovulation, as well as a change in the structuring of the endometrium and fallopian tubes.

In addition, this drug has such an effect as increasing the viscosity of cervical-type mucus, which, by the way, is important.

Indications for use

Undoubtedly, speaking about a particular drug, it is necessary first of all to familiarize yourself with what indications for use are established directly by the manufacturer.

This drug is used as an oral contraceptive.

In addition, quite a few patients choose this drug to get rid of acne, and in rare situations, a contraceptive is prescribed for endometriosis.

Application scheme

As you know, the Silhouette tablets are among the hormonal drugs and the use of these tablets is recommended to be observed in accordance with the instructions and recommendations of the doctor.

Probably, many are aware of the release of hormonal tablets in non-standard packages, which are divided into several parts, for the convenience of the patient.

Of course, it is extremely important to keep the schedule for taking these pills, as with many other hormonal drugs.

After all, the slightest overdose can have a strong impact on the health of any woman, which, of course, must be avoided.

Apply the drug according to the following scheme:

• Reception of a tablet is carried out 1 time at the same time. That is, the drug must be used daily at the set time, while drinking a tablet with a large volume of drinking water.
• Taking these pills is carried out for twenty-one days, and subsequently it is necessary to take a break for a week (for seven days). Then it is allowed to use the next package after the break.
• If the patient has not previously used or used such drugs, then it is necessary to start using "Silhouette" from the first day of the menstrual cycle.
• If the patient has replaced this drug with any other, then the use of "Silhouette" is recommended to start on the first day, after a break, or, it is permissible to start using the next day, after taking the final dose of another contraceptive.

The use of this drug is allowed after an abortion at any time, and after the postponed childbirth, it is allowed to take this drug only after 3-4 weeks and only with the consent of the doctor.

Missing a pill

It often happens that patients forget to take the next pill of a particular drug.

Unfortunately, it is very easy to forget to take a pill. In the daily bustle, many forget that the regime is above all, especially when it comes to hormonal-type drugs.

How to be in that case? It is very important to note that the omission of hormonal drugs, such as "Silhouette", which are among the hormonal drugs, can have a negative impact on health.

It is worth saying that the entire schedule for taking pills can go astray and be disrupted.

In fact, the price of skipping such a pill can be quite high, and first of all, unfortunately, for women's health.

Situations of skipping pills:

It is impossible to predict further development during the period of treatment with these tablets. If we talk about the primary week, then you can immediately drink a pill that is counted as a missed one.

Despite the fact that you have to take two tablets at the same time, you should take the missed tablet without fail.

1. If the patient missed a pill, then within a week after the missed pill, it is necessary to protect yourself with condoms. This is primarily due to the fact that the drug may lose its effectiveness for some time and it is better not to hope for the full effect of this drug.
2. If we talk about the second week of taking this drug, then you need to drink the pill that was missed as soon as possible. In this case, it is not recommended to apply and use any other barrier methods of contraception.
3. If we are talking about the third week, then it is worth noting that the drug is not so effective, provided that the woman has not previously missed taking pills during the treatment process.

Can children take Silhouette?

Speaking of drugs like "Silhouette", it should be noted that the drug, first of all, should be prescribed by a highly qualified medical specialist.

No doctor will prescribe such a drug to a child who has not reached a period of transitional age.

Only if there is excessive acne formation, a teenage child may be prescribed therapy with the "Silhouette", but this is allowed at the age of 16 years and older.

Children under 16 years of age are prohibited from such a drug and it can only be prescribed according to individual doctor's prescriptions.

Admission during pregnancy and lactation

The process of pregnancy is quite an important period in the life of any woman.

If you look at the composition of the "Silhouette" tablets, it is immediately worth noting that during pregnancy it is forbidden to take this drug.

What to do in this case, if you managed to get pregnant during the period of using this drug?

In such cases, you should not only consult a doctor, but also immediately cancel the drug.

This is primarily due to the fact that there is not enough evidence to suggest that it is safe during childbearing and lactation.

Not only during pregnancy, but also during lactation, the drug "Silhouette" must be stopped.

Admission for impaired renal function

Kidney dysfunction- a very common occurrence. Of course, this problem is still important today. After all, quite a lot of patients have problems with the kidneys and liver.

In such cases, not only food and consumption of certain types of products are limited, but there are also restrictions on medicines.

Tablets directly contribute to a significant effect on the body, including the kidneys and liver.

In case of impaired renal function, you need to see a doctor, as well as clarify information about whether it is possible to take a drug such as "Silhouette", if necessary.

Contraindications

Of course, any drug has a number of contraindications that you need to familiarize yourself with. You need to know that contraindications in the instructions are explained to the patient for a reason.

Due to the fact that the hormonal drug has a strong effect, it is necessary to inquire about what contraindications the manufacturer has established.

If the drug is prescribed by a doctor, it is also necessary to notify the presence of any diseases so that the doctor takes into account all the features and contraindications. In some cases, Silhouette should not be used.

Among the contraindications are diseases such as:

• deep vein thrombosis;
• vein thrombosis;
• thromboembolism of an organ such as arteries (pulmonary type);
• arterial thrombosis;
• thrombophlebitis;

Contraindications for patients with cardiac problems:

• angina;
• heart attack;
• cardiac ischemia;
• violations of the work and function of the valve apparatus;

For patients with other diseases:

• pancreatitis;
• jaundice;
• diabetes;
• liver disease

And also with individual intolerance to the components of the drug.

Side effects

Of course, in the process of taking any hormonal drug, depending on what purpose it has, side effects may occur.

According to reviews, any oral contraceptive in the complex begins to affect the woman's body.

Of all the most famous side effects, there are such as:

Overdose

The most important thing is to be interested in how much dosage is the norm. After all, the dosage must be observed throughout the entire time while taking such a drug as "Silhouette".

In case of non-observance of the required dose, the formation of negative consequences affecting the health of the woman is possible.

The drug is not classified as acutely toxic.

Subsequently, after an overdose, there may be such consequences as:

• vomit;
• nausea;
• open in the vagina;
• from the vagina.

There is no specific therapy to combat an overdose that has already occurred. It is only necessary to observe the dosage and not violate the schedule for taking the pills.

special instructions

It is worth noting that before any patient begins to take this contraceptive, it is necessary to prepare:

Analogues

Of course, any medicine has an analogue, and "Silhouette" is no exception.

Analogues are the following drugs:

• Janine
• Belara;
• Evra;
• Lindinet 30.

Storage conditions

Surely many people know that the instructions prescribe separately information on how to store the drug. In fact, many patients cannot provide decent storage of drugs, as it is written in the instructions.

It is for this reason that the drug begins to lose all available active properties and functions. Why, often, people do not see the effect and the result?

Firstly, this is due to the fact that the drug is stored in the wrong place. Secondly, the drug must be stored at the required temperature. This is pretty important.

In case of non-compliance with elementary storage rules, the drug loses its properties and, of course, its effectiveness, for the reason that the drug is bought.

In accordance with the instructions, such contraceptives must be stored first of all, of course, out of the reach of children.

In this medical article you can get acquainted with the drug Silhouette. The instructions for use will explain in which cases these tablets can be taken, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the form of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Silhouette, from which you can find out if the medicine for contraception in healthy women helped in therapy in adults and children, for which it is also prescribed. The instructions list the analogues of the Silhouette, the price of the drug in pharmacies, as well as its use during pregnancy.

The oral contraceptive medicine is Silhouette. Instructions for use reports that the tablets have antiandrogenic properties.

Release form and composition

Siluet is available in the form of white or off-white film-coated tablets, round, biconvex, debossed with "G53" on one side. Packed in blisters of 21 pieces.

Each tablet contains dienogest 2 mg and ethinyl estradiol 0.03 mg.

Excipients:

• talc;
• magnesium stearate;
• lactose;
• corn starch;
• hypromellose;
• potassium polacrilin.

pharmachologic effect

Siluet is an oral combination drug with antiandrogenic effects. The composition of the drug includes - ethinylestradiol and dienogest. The contraceptive effect is due to several factors. The most important is the inhibition of ovulation. It promises to increase the viscosity of cervical mucus, change the peristalsis of the fallopian tubes and the structure of the endometrium.

The combination of ethinylestradiol and dienogest has an antiandrogenic effect, which is based on a decrease in the concentration of androgens in plasma. The combination of ethinyl estradiol and dienogest can lead to the leveling of symptoms of mild to moderate acne and has a positive result in seborrhea.

Indications for use

What helps Silhouette? According to the instructions, the drug is prescribed as a means for oral contraception, as well as for the treatment of mild to moderate acne (acne) with insufficient effectiveness of local treatment in patients requiring contraception.

Instructions for use

Silhouette tablets are taken orally, one daily, as prescribed for 21 days. Tablets from a new package are taken after a week break. During this time, withdrawal bleeding occurs.

• When switching from other combined drugs, they begin taking after the usual break.
• If the drug is taken for the first time, then you need to start taking it on the 1st day of menstruation.
• If a pill is missed and the missed time is less than 12 hours, there is no need to worry about a decrease in contraceptive protection. However, you need to quickly take the pill. Reception cannot be interrupted for more than 7 days.
• After an abortion in the first trimester, they begin to take it immediately. After childbirth - on the 21st day.

The instruction contains complete information on how to drink the drug in other situations, how to delay withdrawal bleeding and in which cases additional contraceptive measures are needed.

Contraindications

Contraindications to Silhouette are:

• pancreatitis with hypertriglyceridemia;
• vaginal bleeding;
• jaundice and congenital hyperbilirubinemia;
• malignant diseases of the mammary glands or genital organs;
• migraine;
• severe dyslipoproteinemia, arterial hypertension, retinopathy, angiopathy;
• venous and arterial thromboembolic diseases;
• thromboembolism and thrombosis;
• severe violations of the liver;
• porphyria;
• smoking in women over the age of 35;
• sickle cell anemia;
• period of pregnancy and lactation;
• lactose deficiency, lactase intolerance, glucose-galactose malabsorption;
• intolerance to the components of the agent;
• liver tumors;
• epilepsy.

Side effects

Common side effects that Siluet may cause:

• increased appetite;
• weight gain;
• headache;
• decreased mood;
• menstrual bleeding;
• nausea, vomiting;
• backache;
• pain in the mammary glands, their increase;
• cramps of the calf muscles;
• venous thromboembolism.

Less common may be:

• abdominal pain;
• tinnitus, hearing impairment;
• phlebeurysm;
• vaginitis and fungal infections;
• allergic reactions;
• flu-like symptoms;
• anemia;
• diarrhea, gastritis;
• insomnia;
• acne
• tachycardia;
• increased excitability;
• blurred vision, dry eyes;
• arthralgia, muscle pain;
• dizziness;
• sinusitis, bronchitis;
• weakness.

Children, during pregnancy and lactation

Siluet is not prescribed during pregnancy and during breastfeeding. If pregnancy is detected during administration, the drug should be immediately discontinued. However, extensive epidemiological studies have not found an increased risk of malformations in children born to women who received sex hormones before pregnancy, or teratogenic effects when sex hormones were inadvertently taken early in pregnancy.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, their use is contraindicated during lactation. Small amounts of sex steroids and/or their metabolites may be excreted in milk.

special instructions

Before you start using the contraceptive in question, it is important to make certain preparations. For example, it is required to collect an anamnesis (personal and family), be sure to exclude pregnancy. It is important that the blood pressure indicators are normal, and the results of the general examination are satisfactory.

The potential patient should have a good understanding of the risks associated with the use of the drug, how exactly it should be used and why it is so important. The frequency of regular gynecological examinations should be determined. In any case, they should be held at least once every six months.

A woman should be clearly aware that the oral contraceptives in question will not be able to protect her from any sexually transmitted infections, including HIV infection (AIDS). It is important to know that very often the use of this kind of contraceptives leads to the fact that the picture of the results of a number of laboratory tests changes.

Among them: biochemical indicators of the function of the kidneys, thyroid gland, adrenal glands and liver. Also, hormone therapy can affect the level of transport proteins in plasma, the parameters of carbohydrate metabolism. Substantial changes are naturally a cause for concern.

Does the use of Silhouette (tablets) cause side effects in the form of impaired reaction and inability to drive vehicles? No. However, severe dizziness and significant temporary visual disturbances may occur. This is important to consider when planning your activities, so as not to endanger your life.

drug interaction

A decrease in the effectiveness of contraception is observed when administered simultaneously with ampicillin, rifampicin and tetracycline, so barrier methods of contraception should be used at this time. After taking rifampicin, it is necessary to use additional contraception for a longer time (28 days).

Breakthrough bleeding may occur while taking hydantoin, carbamazepine, phenobarbital, rifampicin, efavirenz, rifabutin, ritonavir, nevirapine, felbamate, griseofulvin, St. John's wort.

Analogues

A complete analogue of the drug Siluet is.

According to the structure, analogues are determined:

1. Logest.
2. Qlaira.
3. Jess.
4. Lindinet 20.
5. Novinet.
6. Mercilon.
7. Dimia.

Holiday conditions and price

The average cost of Siluet (tablets, 21 pcs.) in Moscow is 645 rubles. From pharmacies, the drug is dispensed by prescription.

Shelf life - 2 years. The instructions for Siluet indicate that the tablets should be stored in a dark place out of the reach of children.

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Catad_pgroup Combined oral contraceptives

The most physiological contraceptive that preserves the quality of sexual life. For the treatment of heavy and / or prolonged menstrual bleeding without organic pathology.
INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

Silhouette - official instructions for use

Registration number:

Tradename:

International non-proprietary name:

Dosage form:

Composition per 1 tablet:

*code: 85F18422

Description

Pharmacotherapeutic group:

ATC code:

pharmachologic effect

Indications for use

Contraindications

Carefully

Smoking under the age of 35. If a woman cannot quit smoking, another method of contraception should be used, especially if other risk factors are present.

The potential risk and expected benefit of using oral contraceptives should be carefully weighed in each individual case if the following diseases or conditions or risk factors exist: dyslipoproteinemia, diabetes mellitus without vascular complications, controlled arterial hypertension, fibrocystic mastopathy, uterine fibroids, endometriosis, multiple sclerosis history of severe depression, impaired renal function, contact lens intolerance, Crohn's disease, ulcerative colitis, superficial vein phlebitis, thromboembolism, acute cerebrovascular accident, myocardial infarction at a young age, chronic heart failure, breast cancer in relatives of the 1st degree of relationship; visual impairment (risk of retinal thrombosis), tetany, hypercalcemia, hypokalemia, bronchial asthma, hereditary angioedema, liver disease, idiopathic jaundice during a previous pregnancy, herpes during pregnancy.

Pregnancy and lactation

Dosage and administration

If hormonal contraception has not been used earlier (one month before), Siluette ® should be started on day 1 of the menstrual cycle (i.e., on the first day of menstruation).

If switching from a combined oral contraceptive:
It is preferable to start taking Siluette ® the day after the usual break in taking, or the day after the last dose of the last pill from the current package of oral contraceptives.

Injection form, implants:
Switching from taking progesterone-only pills can be done any day; the transition from the use of implants is carried out on the day of removal of the implant; when switching from an injectable form - from the day when the next injection should have been made.

After an abortion in the first trimester of pregnancy:

You can start taking 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 21-28th day after childbirth or abortion in the second trimester of pregnancy. If the drug is started later, the woman should be warned about the need to use additional barrier methods (condom) during the first 7 days. However, if sexual intercourse has already occurred, before taking combined oral contraceptives, it is necessary to exclude pregnancy or wait for the first menstruation.

Taking missed pills:
If the delay in taking the drug was less than 12 hours, 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 was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

The drug should never be interrupted for more than 7 days;
- 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given if the delay in taking the tablets was more than 12 hours:

First week of taking the drug
The woman should take the last missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If there was sexual intercourse within a week before skipping the pill, the likelihood of pregnancy must be considered. The more pills missed, and the closer this gap is to the 7-day break in taking the pill, the higher the risk of pregnancy.

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

Third week
The risk of reduced reliability is inevitable due to the upcoming 7-day break in reception. However, by adjusting the pill schedule, weakening of contraceptive protection can be prevented.

If one of the two proposed methods is followed, there is no need to use additional methods of contraception, if the woman has taken the pills correctly within 7 days before the miss. Otherwise, she must follow the first of these two methods, and also use additional methods of contraception for the next 7 days.

The woman should take the last missed tablet as soon as possible, even if it means taking two 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 not be a normal break between doses. The woman is most likely not to have withdrawal bleeding until the end of the second pack, but she may experience spotting or breakthrough bleeding on the days of taking the pills.

In addition, it is possible to stop taking the tablets from the current blister pack. Then there should be a 7-day break in taking the pills, including the days of the missed pills, and then you need to start taking the pills from the new package.

If a woman misses a pill and then does not have withdrawal bleeding in the first normal interval between doses, pregnancy should be ruled out. If a woman vomits within 4 hours of taking the tablet, absorption may not be complete and additional contraceptive measures should be taken. In these cases, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time, if possible. If more than 12 hours have passed, you should follow the recommendations for missing pills in the "Taking missed pills" section. If a woman does not want to change her normal pill regimen, she should use an additional pill from another blister pack.

How to Delay "Withdrawal" Bleeding
In order to delay the onset of menstrual-like bleeding, a woman should continue taking the Siluette ® drug from a new package immediately after taking all the tablets from the previous one, without interrupting the intake. While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume Siluette ® film-coated tablets from a new pack after the usual 7-day break.

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

Side effect

The side effects listed below are presented by system organ class according to the MedDRA classification and with the following frequency: very common (? 1/10); frequent (from? 1/100 to< 1/10); нечастые (от? 1/1 ООО до < 1/100); редкие (от? 1/10000 до < 1/1000); очень редкие (< 1/10000).

Venous thromboembolic disorders; The following serious adverse events have been reported in women using Siluet ® :

The incidence of breast cancer in women taking COCs increases very slightly. Since 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 (after 52 years), no delivery, anovulatory cycles, etc., point to 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 COC use started at a young age and the development of breast cancer in middle age. However, COC use is only one of many risk factors.

Overdose

Interaction with other drugs

special instructions

Influence on the ability to drive vehicles and work with mechanisms

Release form

Storage conditions

Best before date

Terms of dispensing from pharmacies

Manufacturer

Consumer claims should be sent to:

Oral contraceptives are used by many women to prevent unwanted pregnancies. There are several drugs with proven effectiveness. In addition to their main purpose, these products can improve skin condition, normalize weight and eliminate problems caused by hormonal imbalances. One of these medications is "Silhouette".

Action

This combination drug has a pronounced antiandrogenic effect. It contains two main and several auxiliary substances: ethinylestradiol - a hormonal agent of the estrogen series (acts as estrogen); dienogest - a hormonal drug (performs the functions of progestane); lactose monohydrate, corn starch, magnesium stearate.

Therapy with this drug leads to certain changes in the female body:

• Peristalsis in the fallopian tubes slows down (due to a decrease in the intensity of muscle fiber contractions, which prevents the egg from moving).
• The mucus in the cervical canal thickens (which creates obstacles for the advancement of spermatozoa in the genitals).
• Due to the decrease in androgens, ovulation is suppressed, and folliculogenesis is also disturbed.
• The structure of the endometrium in the uterus changes in such a way that the embryo cannot gain a foothold in it.

Taking dienogest in combination with ethinyl estradiol helps to reduce ovulation and the level of androgens in a woman's body.

Indications for use

• As an oral contraceptive to prevent unwanted pregnancy.
• In the treatment of acne in girls and women caused by an increased level of androgens.
• For the treatment of endometriosis (thickening of the layer lining the uterus).

Each of the hormones contained in the tablets is used in the treatment of infertility, while their combined action has a contraceptive effect.

"Silhouette" for the treatment of endometriosis

This combination medicine is used to treat the growth of the endometrium in young girls and women. In the case when surgical intervention is contraindicated, Silhouette therapy is performed for endometriosis:

1. Decreased estrogen synthesis.
2. There is a blockage of the growth of the endometrium outside the uterus.
3. Ovulation is suppressed.
4. Regular intake contributes to the atrophy of endometriosis foci (by reducing their blood circulation).

In addition to a complete cure for the disease, many women note that the remedy restores the menstrual cycle, removes pain during sexual contact and reduces pain during menstruation.

Contraindications

Since this is a fairly strong hormonal drug, there are a number of body conditions in which it is not recommended to use it:

• Cardiovascular diseases (angina pectoris, myocardial infarction, pulmonary embolism, thrombosis, severe arterial hypertension; hereditary tendency to form blood clots).
• Pancreatitis.
• Liver dysfunction (failure, hepatitis).
• Malignant tumors (especially of the uterus, appendages and mammary glands).
• Diabetes.
• Epilepsy.
• sickle anemia.
• Pregnancy and lactation. If pregnancy was detected while taking the drug, it is canceled. The conducted studies did not reveal the effect on the fetus of contraceptives, which were taken through negligence. The combination of the active ingredients of the drug can penetrate into the mother's milk and have a negative effect on the child, therefore, during lactation, the drug is prohibited.
• Severe migraines, especially with neurological symptoms.
• Lactose intolerance.
• Vaginal bleeding (of unknown cause).

In addition, the contraceptive is forbidden to be taken by those who smoke and after the age of 35. If the disease was detected during the course of treatment with the drug, it should be canceled and immediately consult a doctor.

Side effects

When using Silhouette birth control pills, women may experience certain body reactions:

• Emotional changes.
• Headaches or migraines.
• Increased heart rate.
• Abdominal pain, nausea, diarrhea.
• Eruptions on the skin.
• Increase (or decrease) in appetite.
• Pain in the mammary glands.
• Lack of libido.
• Insomnia.

Many women who have taken Siluet note that the most common symptoms are pulling pain in the lower abdomen (as with menstruation), nausea and headaches. As a rule, these symptoms disappear within a month after the start of the drug.

In addition, some of the side effects may occur due to smoking, so a woman is advised to quit this habit before starting to take a contraceptive. Silhouette can cause dry eyes and reduced visual acuity in women who wear contact lenses.

Peculiarities

Instructions for use indicate the following regimens:

1. If the drug is used for the first time, it is necessary to start on the first day of menstrual bleeding.
2. If Silhouette replaces another contraceptive, it should be taken 24 hours after the end of the course of the previous drug.
3. It is necessary to use a contraceptive once a day, preferably at the same time, after meals, drinking plenty of water.
4. You need to drink the product in accordance with the order indicated on the blister pack.
5. If the contraceptive is taken after an abortion in the first trimester of pregnancy, it is prescribed on the day of the operation.
6. In case of abortion or childbirth in the second and third trimesters, the drug is taken 21-28 days after the intervention or natural childbirth.
7. Breaks during the course of taking are unacceptable, if a woman forgot to take a pill, it is necessary to resume taking it as soon as it became clear.
8. If you experience side effects from the gastrointestinal tract (vomiting 3-4 hours after ingestion), you must take the remedy again.

Before prescribing a course of oral contraceptives, a complete examination of the body should be carried out to identify possible diseases in which the use of the drug is prohibited. It is also necessary to exclude pregnancy.

The drug should be taken only as described in the instructions, since a deviation from the specified order can cause hormonal changes in the body.

Interaction with other drugs

Taking Silhouette at the same time as other medicines can cause vaginal bleeding or reduce the contraceptive effect. This can happen when interacting with certain substances:

• Carbamazepine.
• Phenobarbital.
• Ribafutin.
• Ritonavir.
• Hypericum extract.
• Tetracycline.
• Ampicillin.

In addition, a decrease in the protective effect and vaginal bleeding may occur while taking a contraceptive with drugs that increase the clearance of sex hormones.

Oral contraceptives are used by women to protect against unwanted pregnancies. These drugs allow you to normalize the condition of the skin and weight, problems with which were provoked by a violation of the hormonal balance. Silhouette is also used to treat endometriosis.

It should be remembered that by appointing yourself to take birth control pills on your own, you can harm the body. Therefore, before starting the Silhouette course, it is imperative to consult a gynecologist and undergo a complete medical examination.

Siluet is a monophasic combined oral contraceptive (CPC) with an antiandrogenic effect.

Release form and composition

Siluet is produced in the form of film-coated tablets: biconvex, round, white or almost white, engraved with "G53" on one side (21 pcs. in a PVC/PE/PVDC-aluminum foil blister, in a carton box 1 or 3 blisters together with a flat cardboard storage case).

Composition of 1 tablet:

• Active ingredients: dienogest - 2 mg, ethinylestradiol - 0.03 mg;
• Additional components: magnesium stearate, potassium polacrilin, talc, hypromellose 2910, corn starch, lactose monohydrate; shell: Opadry II white 85F18422 (talc, macrogol 3350, titanium dioxide, polyvinyl alcohol).

Indications for use

• Contraception;
• Therapy of moderate and mild acne (acne) in case of ineffective local treatment in women who need contraception.

Contraindications

Absolute:

• Venous and arterial thromboembolic diseases in history or at present: pulmonary embolism, deep vein thrombosis, etc.;
• Conditions preceding thrombosis: atrial fibrillation, valvular heart disease with complications, angina pectoris, transient ischemic attacks, extended surgery with prolonged immobilization, subacute bacterial endocarditis, extensive trauma;
• Thrombosis (venous and arterial) and thromboembolism, including history data, including hemorrhagic or ischemic cerebrovascular disorders, myocardial infarction, deep vein thrombophlebitis, thrombosis, pulmonary embolism;
• Congenital hyperbilirubinemia (Rotor, Dubin-Johnson, Gilbert syndromes), jaundice, porphyria;
• Pancreatitis with severe hypertriglyceridemia, present or in history;
• Severe or multiple risk factors for arterial or venous thrombosis (including risk factors for arterial thrombosis indicated in the anamnesis): uncontrolled arterial hypertension, diabetes mellitus with vascular damage (retinopathy, angiopathy), severe dyslipoproteinemia;
• Predisposition to arterial thrombosis (acquired or congenital), for example, protein C, S deficiency, hyperhomocysteinemia, antithrombin III deficiency, resistance to activated protein C, existing antibodies to phospholipids (including lupus anticoagulant, antibodies to cardiolipin);
• sickle cell anemia;
• Severe liver disease, incl. in history (before normalization of liver function tests);
• Benign or malignant neoplasms of the liver, including indications in history;
• Bleeding from the vagina of unknown nature;
• Epilepsy;
• Migraine with local neurological symptoms, incl. in history;
• Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
• Smoking over the age of 35;
• The period of breastfeeding and pregnancy;
• Hypersensitivity to the components of the drug.

At the first manifestations of any of the above diseases during the period of taking oral contraceptives, the use of the latter must be stopped immediately.

Relative (it is necessary in each individual case to carefully weigh the possible risk and the expected benefits of using the remedy):

• Controlled arterial hypertension;
• Diabetes mellitus without vascular complications;
• Dyslipoproteinemia;
• Fibrocystic mastopathy;
• Endometriosis, uterine fibroids;
• History of severe depression;
• Multiple sclerosis;
• Intolerance to contact lenses;
• Ulcerative colitis, Crohn's disease;
• Violations of the kidneys;
• Thromboembolism, phlebitis of superficial veins;
• Chronic heart failure;
• Myocardial infarction at a young age;
• Acute violation of cerebral circulation;
• Violation of the function of vision (threat of thrombosis of the retina);
• Breast cancer in close relatives;
• Hypokalemia, hypercalcemia;
• Tetany;
• Hereditary angioedema;
• Bronchial asthma;
• Idiopathic jaundice/herpes during a previous pregnancy;
• Liver diseases.

In the presence of risk factors (blood clotting disorders, overweight, heart disease, varicose veins), a thorough study is necessary before starting a COC course.

If a woman under the age of 35 cannot stop smoking, it is recommended to use another method of contraception (especially if there are other risk factors).

Method of application and dosage

Siluet is taken orally, 1 tablet daily at about the same time, with a small amount of liquid if necessary. Tablets are used in the sequence indicated on the blister pack for 21 days. Then, in the next 7 days after taking the last tablet from the blister, a break is made during which withdrawal bleeding occurs (usually on days 2-3). After the end of the break (on the eighth day), they start taking the tablets from the next package, regardless of whether the bleeding has stopped or not.

If you have previously used pills containing only progesterone, you can switch to taking the drug on any day.

In the case when hormonal contraception was not used a month before the start of the course, you should start taking the pills on the first day of the menstrual cycle.

After taking a COC, it is recommended to switch to the use of Siluette the next day after the usual interval in taking or after finishing taking the tablets from the current package of the previous drug.

If you have an implant, you should start using Siluette on the day of its removal, and when switching from an injectable form, on the day the next injection is scheduled.

After an abortion in the first trimester of pregnancy, the drug is recommended to be taken immediately after surgery, without the use of additional contraceptives.

After an abortion in the II trimester or childbirth, the drug is allowed to be taken after 21-28 days. In the case when the reception is started later, it is required to use barrier methods of contraception during the first 7 days. If there was sexual intercourse before using the product, you must wait for the first menstruation or exclude pregnancy.

If you are late in taking the next pill, which is less than 12 hours, the contraceptive effect of Siluet does not decrease. The missed tablet should be taken as soon as possible, and the next one should be taken as usual.

If you are late in taking the next pill, which is more than 12 hours, the contraceptive effect may be reduced, as a result, it is recommended to follow two basic rules:

1. The use of the tool cannot be interrupted for more than 7 days;
2. The drug should be taken for 7 days and be continuous (for adequate suppression of the hypothalamic-pituitary-ovarian regulation).

If the delay in taking the next dose of Siluet exceeds 12 hours, depending on the missed period, the following recommendations should be followed:

• I week. The last missed tablet should be taken as soon as possible (even if you need to take 2 tablets at the same time), the next dose at the usual time. Additionally, for the next 7 days, you must use a barrier method of contraception (for example, a condom). If sexual intercourse took place in the previous 7 days before the skip, the possibility of pregnancy should be taken into account, the probability of which is the higher, the more doses are missed and the closer the skip is to a week-long break in admission;
• II week. It is necessary to take the last missed tablet as soon as possible (even if you have to take 2 at once), then continue taking the remedy according to the usual method. If a woman missed 1 tablet, there is no need to use additional contraception, if the missed amount was more than 1 tablet, condoms should be used for 7 days;
• III week. Due to the upcoming interruption in reception, a decrease in the reliability of the PDA is inevitable. But if one of the two schemes proposed below is observed, the need to use barrier methods of protection can be avoided. According to the first scheme, the last missed tablet should be taken as soon as possible, even if the simultaneous use of 2 tablets is required. Further, continue the application according to the usual scheme, but without the usual weekly break (after the completion of the previous blister, they immediately begin taking the next one). The appearance of menstruation before the end of the second package is unlikely, but breakthrough uterine bleeding or spotting may occur. According to the second scheme, you can stop taking the pills from the current package, take a break for 7 days (which should include skip days), and then start taking the drug from the new blister. In the absence of withdrawal bleeding in the first subsequent interval between doses, it is necessary to exclude the possibility of pregnancy.

If a woman vomits within 4 hours after taking Siluet, this may lead to incomplete absorption of the drug. In such cases, it is necessary to take a new pill as soon as possible (within 12 hours after the usual time of admission). If the interval between doses was more than 12 hours, the same recommendations should be followed as for the missed tablets.

In order to delay the onset of menstruation after the completion of the use of the product from the previous blister pack, it is required to immediately start taking the tablets from the new blister without a break. In this case, breakthrough uterine bleeding or spotting may occur. You can resume taking the usual scheme after the next week break.

In the case when it is necessary to transfer the day of the start of menstruation to another day of the week, it is recommended to reduce the next interval in taking the tablets by the desired number of days. The shorter the break, the more likely there will be no withdrawal bleeding during the break, and the greater the risk of spotting and breakthrough bleeding during the second pack.

The following serious undesirable effects have also been noted with the use of Siluet:

• Tumors of the liver;
• Hypertension;
• Venous/arterial thromboembolic disorders;
• Chloasma;
• Ulcerative colitis, Crohn's disease, systemic lupus erythematosus, porphyria, Sydenham's chorea, herpes in pregnancy, cholestatic jaundice, hemolytic uremic syndrome (the relationship between the occurrence and aggravation of these conditions with the use of PDA has not been proven).

The incidence of breast cancer when taking Siluet is slightly increased. Since the disease is rarely seen in women younger than 40, this increase is very small relative to the overall risk of developing breast cancer.

Epidemiological studies have identified a possible causal relationship between long-term use of oral contraceptives started at a young age and the development of breast cancer in middle age. However, it should be borne in mind that COC use is only one of many risk factors.

special instructions

Before starting or resuming the use of Siluette, and then at least once every six months during the period of its use, a complete medical examination (gynecological and general) should be carried out to identify possible contraindications to admission.

It must be remembered that oral contraceptives do not protect against contracting HIV (AIDS) and any other sexually transmitted infections.

Against the background of the use of the drug (especially in the first three cycles), the occurrence of irregular bleeding / bloody discharge from the vagina may be observed. Evaluation of such reactions should be carried out after an adaptation period (approximately 3 months later). If acyclic bleeding recurs or occurs after previous normal regular cycles, an examination is required to rule out possible pregnancy or malignant neoplasms.

In some cases, withdrawal bleeding may not occur in the interval between doses, if the woman strictly adhered to the recommended instructions, the presence of pregnancy is unlikely.

When using COCs, the risk of venous thromboembolism increases, especially in the first year of admission. Symptoms of arterial or venous thrombotic/thromboembolic events may include:

• Sudden severe chest pain (possibly radiating to the left arm);
• Unilateral unusual leg pain and/or swelling;
• Respiratory failure;
• A sudden attack of coughing;
• unusually long, severe headache;
• Complete or partial sudden loss of vision;
• Aphasia or slurred speech;
• Diplopia;
• Dizziness;
• Movement disorders;
• Loss of consciousness (with possible partial epileptic seizure);
• Sharp weakness or severe numbness of one side or one part of the body;
• Sharp belly.

If any of the above conditions occur, stop taking the remedy and consult a doctor.

Factors leading to an increased risk of venous thromboembolic complications and arterial thrombosis are: hereditary predisposition, age, prolonged immobilization (after major surgery), high obesity, hypertension, dyslipoproteinemia, heart valve disease, atrial fibrillation, smoking.

The aggravation of the severity and increase in the frequency of migraine attacks while taking Siluet may be a harbinger of cerebrovascular accident, which requires immediate discontinuation of the drug.

Very rarely, the development of liver tumors (benign or malignant) has been reported with the use of COCs. In some cases, these tumors have caused life-threatening intra-abdominal bleeding. When conducting differential diagnosis, it is required to take into account the appearance of severe pain in the abdomen, symptoms of intra-abdominal bleeding and liver enlargement.

drug interaction

With the combined use of Siluet with drugs that can activate microsomal liver enzymes, it is possible to reduce the effectiveness of contraception and / or develop breakthrough bleeding. These drugs include: rifampicin, carbamazepine, primidone, phenobarbital, hydantoin, oxcarbazepine, nevirapine, efavirenz, rifabutin, griseofulvin, ritonavir, felbamate, topiramate, and drugs containing St. John's wort (Hypericum perforatum).

According to clinical observations, the simultaneous use of Siluet with certain antibiotics (tetracycline, ampicillin) may also help reduce the contraceptive effect. As a result, during the period of use of any of the above drugs and for 7 days after the withdrawal of concomitant therapy, in addition to COC, it is required to use barrier methods of protection.

During the entire course of treatment with rifampicin, as well as 28 days after its completion, additional methods of contraception should be used. If the concomitant is used during the period of completion of taking the tablets from the blister, the next package is taken without a 7-day break.

In the case of long-term therapy with the drugs listed above, it may be necessary to increase the dose of COC. If against the background of this measure there are undesirable reactions (irregular bleeding, etc.), it is necessary to use another method of contraception.

When using drugs that increase the clearance of sex hormones, breakthrough uterine bleeding and a decrease in the contraceptive effect of Siluet may occur.

Terms and conditions of storage

Store in a place protected from light and out of the reach of children, at a temperature not exceeding 25 °C.

Shelf life - 2 years.