Силует

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Силует

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Силует

Property Description
Active ingredients Dienogest, Ethinyl Estradiol
Form Oral Tablet
Pharmacological class Hormonal Contraceptives for Systemic Use (Estrogens and Progestogens)
Common purpose Contraception (Prevention of Pregnancy)
Origin Synthetic/Semisynthetic Derivatives

Classification and Identity of the Medication

Силует is a systemic hormonal preparation classified as a Fixed Combination Hormonal Contraceptive, meaning it contains two distinct active ingredients combined in a single Oral Tablet. It belongs to the pharmacological group of Hormonal Contraceptives for Systemic Use. This classification reflects its therapeutic role as a prescription-only method intended for planned pregnancy prevention in women of child-bearing age, delivered through an oral route of administration. The fixed combination structure provides the consistent, simultaneous presence of both hormonal components for the intended contraceptive efficacy.

Composition and Origin: Dienogest and Ethinyl Estradiol

The active core is formed by two synthetically derived steroid hormones: the estrogen Ethinyl Estradiol (EE) and the progestogen Dienogest (DNG). Ethinyl Estradiol is a synthetic estrogenic steroid, while Dienogest is a semisynthetic progestogen with selectivity for the progesterone receptor. Dienogest possesses specific Androgen Receptor Antagonist properties, differentiating its profile from older progestogens. This means the progestogen component may provide supplementary benefits related to hormonal balance beyond contraception.

General Therapeutic Purpose of Силует

The overarching general purpose of the medication is contraception, achieved by preventing the occurrence of pregnancy. For adult women who elect to use an oral contraceptive, the combination is a reliable form of scheduled contraception, which establishes its role as a method for preventing fertilization and implantation. The stable hormonal delivery provided by Dienogest and Ethinyl Estradiol also yields the therapeutic benefit of regulating the menstrual cycle, often leading to a more predictable pattern, and contributing to the management of hormonal balance.

What side effects are possible with Силует?

The official safety profile for the Dienogest/Ethinyl Estradiol combination is established by government regulatory bodies and specifies possible side effects by the systems affected and their expected frequency.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized based on incidence rates documented in clinical trials, using the following regulatory frequency framework:

  • Common (Affects 1 to 10 users in 100): Includes systemic effects such as headache (migraine), nausea, abdominal pain, breast pain or tenderness, irregular uterine bleeding, and weight increase.
  • Uncommon (Affects 1 to 10 users in 1,000): Encompasses reactions such as depressed mood, dizziness, diarrhea, fluid retention (edema), and nervousness.
  • Rare (Affects 1 to 10 users in 10,000): In this category are the most critical risks, including Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE).

Serious Safety Considerations

The most clinically significant risks documented in regulatory labels for this medicine are the potential for Thromboembolic Events (VTE/ATE, which may lead to stroke or myocardial infarction) and the rare occurrence of Hepatic Neoplasia (liver tumors). The risk of VTE is documented to be highest during the first year of treatment or upon re-initiation after a break of four or more weeks.

Population-Specific Restrictions

Use is contraindicated based on specific patient risk factors, including a history of thromboembolic diseases, severe hepatic impairment or liver tumors, known or suspected breast cancer, and in women over 35 who smoke. These regulatory restrictions define the mandatory limitations for its use.

Overdose and Emergency Response

The official regulatory profile for an overdose of Dienogest and Ethinyl Estradiol documents specific clinical manifestations. Overdosage is generally associated with low reported toxicity, with symptoms typically limited to those that are not life-threatening. The most common manifestations cited in the official labeling include gastrointestinal effects such as nausea and vomiting. Females may also experience withdrawal bleeding, which is a documented change in menstrual patterns that occurs following the overdosage event.

The regulatory assessment on severity emphasizes that an overdose is considered not likely to be life-threatening. Official data reflects that no reports of serious ill effects have been documented, a finding that extends even to cases of accidental ingestion by children. Nevertheless, regulatory guidance mandates that immediate medical attention must be sought immediately following any suspected overdose.

Management is restricted to supportive and symptomatic care, as the prescribing information states that no specific pharmacological antidote is known for this combination. Clinical monitoring, including the observation of vital signs, is the required procedure upon presentation.

Therapeutic Uses of Силует

What Силует treats: Main Uses and Benefits

The combination of Dienogest and Ethinyl Estradiol is used in therapeutic situations involving certain symptoms that interfere with daily functioning. The combination is applied across multiple therapeutic areas, which include scheduled contraception and the management of symptoms associated with moderate acne vulgaris. This preparation is generally utilized where additional symptomatic support is needed, primarily addressing symptom clusters related to reproductive health and hormonal skin manifestations.

The medication is primarily used for scheduled pregnancy prevention in women of reproductive age, supporting ongoing use in family planning. Beyond this role, it is relevant for managing conditions characterized by periods of heightened symptoms, such as painful menstruation (dysmenorrhea) and heavy menstrual bleeding. This use provides symptomatic relief intended to help patients manage these episodes.


Quick Fact: Relief for Hormonal Symptoms

The combination is used to help with symptoms related to systemic imbalance, including the relief of moderate acne and assistance with managing menstrual cycle irregularities. This supportive relief is intended to improve day-to-day comfort during symptomatic periods.

Regulatory References

  1. European Union regulatory documents

Eligibility and Restrictions for Use

Who can and cannot use Силует?

The eligibility for Силует is strictly defined by regulatory authorities and is intended for women of child-bearing age who have already reached menarche. Its use is subject to formal restrictions based on age, specific health conditions, and life stage.

Population Status Regulatory Status
Eligible Population Women of child-bearing age who have reached menarche.
Restricted Use Smokers aged 35 years or older (due to increased vascular risk). Not recommended for women who are breastfeeding.
Not Indicated Postmenopausal women (use is not established or indicated after menopause).

Absolute Contraindications

Use of this medicine is strictly contraindicated in populations with an elevated risk of serious adverse events, as stated in regulatory labels:

  • Vascular and Thrombotic Conditions: A current or history of venous or arterial thromboembolism (such as DVT, pulmonary embolism, stroke, or myocardial infarction), or a known hereditary or acquired thrombogenic predisposition.
  • High Vascular Risk Factors: Individuals with severe uncontrolled hypertension, diabetes mellitus with vascular symptoms, or migraine with focal neurological symptoms.
  • Hormone-Sensitive Status: Current or past severe active liver disease, liver tumors, or known/suspected sex-hormone-dependent malignancies.
  • Pregnancy: Use is strictly contraindicated during pregnancy and must be excluded prior to initiation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interactions with Силует (dienogest/ethinyl estradiol) primarily affect the plasma concentration of the hormonal components, which can alter efficacy and safety. The official regulatory documents emphasize pharmacokinetic interactions, chiefly those involving hepatic enzyme metabolism.


Key Interacting Agents and Their Effects

Category Examples (explicitly listed) Primary Interaction Concern
Enzyme Inducers Phenytoin, carbamazepine, rifampicin, St. John's Wort, ritonavir Decreased plasma concentrations of hormonal components; potential for reduced efficacy.
Enzyme Inhibitors Azole antifungals, macrolide antibiotics Increased plasma concentrations of hormonal components; potential for increased adverse effects.
Victim Drugs Lamotrigine, Cyclosporine, Theophylline Altered clearance of the co-administered drug, potentially leading to reduced lamotrigine or increased cyclosporine concentration.

Official Regulatory Requirements

Risk of Reduced Efficacy: The regulatory labeling mandates specific action when initiating strong hepatic enzyme inducers. Concomitant use with drugs such as rifampicin or St. John's Wort requires the patient to use a reliable non-hormonal contraceptive method during the course of co-administration and for an additional period of 28 days after the inducer is discontinued. This requirement addresses the residual effect of enzyme induction.

Need for Monitoring: For other interactions, particularly those involving enzyme inhibitors or co-administered drugs whose plasma concentration is altered by Силует, official documentation emphasizes the need for close clinical monitoring and dose adjustment of the co-medication where appropriate.

Mechanism of Action

Central Suppression of the HPO Axis

This primary mechanism involves Ethinylestradiol and Dienogest binding to their respective receptors to exert a strong negative feedback on the hypothalamus and pituitary gland. This action fundamentally prevents the hormonal signals (FSH/LH) required for the maturation and release of an egg, resulting in the inhibition of ovulation.


Peripheral Changes via Receptor Modulation

The progestin component, Dienogest, acts directly on the Progesterone Receptors in the reproductive tract, independently inducing two peripheral changes. This modulates the physical environment by inducing endometrial thinning and by significantly increasing the viscosity and reducing the permeability of the cervical mucus.


Combined Modulation of Androgen Signaling

This mechanism addresses androgen-driven processes through a dual approach. Ethinylestradiol boosts the production of SHBG (binding and inactivating circulating androgens), while Dienogest directly antagonizes the Androgen Receptor (AR) in target tissues. This combined action reduces the concentration of circulating free androgens and antagonizes receptor binding.

Dosage and Administration Information

How to Use Силует: Official Administration Guidelines

Силует is a fixed-combination hormonal medication intended for daily, continuous oral use, following strict cyclic patterns. The medication is designed for administration according to established cyclic sequences.


Administration Scope

Instruction Map: How to use Силует — official administration guidelines
Route of administration: Oral, requiring the tablet to be swallowed whole with a small amount of liquid.
Dosing schedule: One tablet is taken every day. Regimens follow a cyclic pattern of 21 or 24 consecutive days of active tablets (Dienogest/Ethinyl Estradiol), followed by a specified interval of placebo tablets or a tablet-free break.
Timing in relation to meals (if applicable): The tablet may be taken with or without food.
Age-group administration rules: Use in postpubertal adolescents follows adult schedules. For non-breastfeeding women postpartum, initiation should be no earlier than 4 weeks postpartum.
Missed-dose rules: If active tablet intake is delayed by more than 12 hours, the dose is considered missed. Non-hormonal barrier methods are generally required for the subsequent 7 days of continuous active tablet-taking.
Special procedural conditions: The daily tablet is taken at approximately the same time each day, following the numerical order indicated on the blister pack. If vomiting or severe diarrhea occurs within 3 to 4 hours of taking an active tablet, it is treated as a missed dose.

Connection to the Overall Use Protocol

The use protocol is defined by the daily oral administration requirement coupled with a cyclic sequence of active and placebo tablets. This structure ensures a continuous dosing pattern, where the order and timing for each tablet are maintained. For use in the management of moderate acne, a formal reassessment of the need for continuation is typically indicated after an initial period of 3 to 6 months.

Recent Clinical Evidence

Research evidence / Overview of Studies for Силует


Evidence for use in Contraception (Prevention of Pregnancy)

Research for this medication's intended use in pregnancy prevention has been conducted through large-scale clinical trials and long-term observational studies. The primary goal of these studies was to establish the medication's effectiveness, measured using the standardized Pearl Index, which reports the number of pregnancies that occur per 100 women using the method for one year. The trials reported the data used in the calculation of the medication's Pearl Index across diverse groups of users. Study findings also provided data related to the observation of menstrual pattern changes and the suppression of the ovulatory cycle in study participants. While these core studies provide a significant volume of research data for the primary outcome in healthy populations, long-term head-to-head trials comparing this specific combination against all other available hormonal contraceptives are limited.

Evidence for use in Moderate Acne Vulgaris

The research supporting the study of this medication for moderate acne involves multicenter, randomized controlled trials (RCTs), many of which were double-blind. Researchers examined outcomes related to dermatological measurements, such as the number of inflammatory lesions and the total number of lesions. The double-blind trials reported the measured percentage change in total lesion counts and inflammatory lesion counts over the 6-month period. Regulatory reviews note that studies often included women who had experienced limited results with other, non-hormonal, acne treatments. Extended follow-up data past 9 to 12 months in a controlled setting remains less extensive, and evidence is limited regarding its use for more severe forms of acne.

Associated Evidence for Symptom Management

The study of this medication's effect on painful periods, known as dysmenorrhea, and on menstrual cycle regularity often occurs as secondary findings within the larger contraception trials, or through specific observational studies. Research examined patient-reported outcomes related to physical discomfort by using standardized pain rating scales to monitor the intensity of menstrual pain over consecutive cycles. These studies reported changes measured in patients’ self-assessed pain scores and described the patterns observed in the stabilization of cycle length. The evidence contributes to the broader landscape of research exploring outcomes reflecting systemic or functional imbalance when using combined oral contraceptives.

Research Gaps and Areas of Uncertainty

A review of the research indicates several areas where certainty remains low. One key limitation is the lack of extensive, controlled long-term comparative data differentiating this combination from every other similar oral contraceptive on the market for non-contraceptive outcomes. Additionally, the evidence quality varies across studies, with the largest volume of evidence being for its primary use (contraception) and secondary benefits sometimes being supported by less controlled or smaller observational data.

Frequently Asked Questions (FAQ)

Common questions about Силует (FAQ)


Q: How long does it typically take to see any effect from Силует?

For the purpose of contraception, continuous, daily intake of the active tablets is required for the intended hormonal suppression. When the medication is used for the treatment of moderate acne, official documents suggest that a formal re-assessment of the need for continuation may be considered after an initial period of 3 to 6 months.


Q: How often are serious side effects reported in research for Силует?

Based on the frequency classification derived from clinical trial data, the most serious risks associated with this type of medicine, such as Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), are formally categorized as Rare in regulatory documents. This typically means they affect 1 to 10 users out of every 10,000 users.


Q: What kind of studies have been done on the long-term safety of Силует?

The safety and effectiveness of this medicine have been examined using a combination of research methods. These include large-scale, controlled clinical trials for initial confirmation and additional long-term observational studies that monitor outcomes across diverse user populations over extended periods.


Q: What research exists about using Силует in women over 35?

Official regulatory warnings highlight a key restriction regarding this age group. The use of this medicine is contraindicated in women over 35 who also smoke due to an increased risk of serious cardiovascular events.


Q: How does Силует affect future attempts to become pregnant?

The mechanism of action for this medicine involves the hormonal suppression of the ovulatory cycle. This effect is described as reversible in official documents, and the body's natural hormonal cycle typically returns to its usual pattern after the medication is discontinued.


Q: What are the typical non-serious side effects that usually go away after a few months?

Regulatory documents list common initial side effects such as headache, nausea, and irregular bleeding. While these sources categorize the frequency of these effects, they do not offer a guaranteed resolution timeline. Patient information often notes that some non-serious effects may lessen or resolve during the first few cycles of use.


Q: If I have a history of migraines, can I still use Силует?

Combination oral contraceptives are formally contraindicated (not recommended for use) in patients who have a history of migraines with aura, as this condition is associated with an increased risk of stroke. Migraine is also listed as a common adverse reaction for the medication itself.


Q: Why is Силует sometimes used for conditions other than its primary purpose?

Official regulatory documents indicate that the medicine is approved for more than one use. While primarily prescribed for contraception (pregnancy prevention), in certain formulations, it is also formally indicated for the treatment of moderate acne vulgaris and sometimes for heavy menstrual bleeding.


Q: If I miss a dose of Силует, what's the general information about what to do?

Official administration instructions specify that if the delay in taking an active tablet is more than 12 hours past the scheduled time, the dose is considered missed. In this event, a reliable non-hormonal barrier method is generally required for the subsequent 7 days of continuous active tablet-taking.


Q: Is weight gain or loss a possible side effect of taking Силует?

Based on clinical trial data published in regulatory documents, weight increase is listed as a common adverse reaction observed in clinical trials, but weight loss is not typically listed among the reported side effects for this medicine.


Q: Can Силует affect my mood or emotional state?

Regulatory documents list depressed mood and nervousness as uncommon adverse reactions observed in clinical trials. Official patient warnings note that severe or concerning mood changes should be communicated to a healthcare provider.


Q: Are there any common foods or drinks that interact with Силует?

The tablets can generally be taken with or without food, as noted in official patient instructions. However, regulatory or product-specific information often cautions against consuming grapefruit juice, which may potentially increase the concentration of one of the drug components in the body.


Q: Can I take pain relievers (like ibuprofen or acetaminophen) while using Силует?

Official regulatory interaction tables primarily focus on agents known to significantly alter drug metabolism, such as certain prescription drugs and strong enzyme inducers. Common over-the-counter pain relievers like ibuprofen or acetaminophen are generally not listed as agents that cause a major interaction that reduces the effectiveness of this contraceptive.


Q: Is it safe to use herbal supplements while taking Силует?

Regulatory documents specifically list the herbal product St. John's Wort as a strong hepatic enzyme inducer. Co-use with St. John’s Wort requires the use of a reliable non-hormonal barrier method because it can reduce the plasma concentration and potential effectiveness of the contraceptive.


Q: Is there an age limit for starting Силует?

The use of the medicine is not indicated prior to the onset of menstruation (menarche). Once menstruation has begun, use in postpubertal adolescents typically follows the adult dosing schedules.


Q: Does research show that Силует's effects continue after stopping the medicine?

The medication's primary mechanism involves the temporary hormonal suppression of the ovulatory cycle. These effects are generally expected to cease after discontinuation of the medicine, allowing the natural cycle and related bodily functions to resume.


Q: What should I do if I think I'm having an allergic reaction to Силует?

Official patient information notes that signs of a severe allergic reaction (hypersensitivity) or other serious adverse events listed in the warnings may require immediate medical attention.


Q: Why is liver function mentioned in the eligibility criteria for Силует?

The liver plays a critical role in metabolizing the drug components. Consequently, use is contraindicated in patients with conditions such as severe hepatic impairment (poor liver function) or the presence or history of liver tumors (hepatic neoplasia), as stated in official documents.


Q: Does Силует change the results of any routine lab tests?

Official labeling includes a section noting that the use of hormonal contraceptives can influence the results of certain laboratory tests. These may include tests for thyroid function, various binding proteins, and coagulation parameters.


Q: Is it possible to be allergic to one of the inactive ingredients in Силует?

The product is formally contraindicated (must not be used) in patients who have a known hypersensitivity to the active substances or to any of the listed excipients (inactive ingredients). The list of excipients is available in the official prescribing information.


Q: Why is high blood pressure listed as a condition related to Силует's eligibility?

Regulatory documents list untreated or uncontrolled hypertension (high blood pressure) as a contraindication. This restriction is in place due to the associated risk of increased cardiovascular events, such as stroke or heart attack, when combined with oral contraceptive use.


Q: Is Силует suitable for women who have had a history of depression?

Regulatory information notes that depressed mood is an uncommon adverse reaction. Official prescribing information may advise for clinical monitoring in patients who have a pre-existing history of depression while using this medicine.


Q: What is the general advice for taking Силует after a surgical procedure?

Due to the increased risk of blood clots (thromboembolism), official documents indicate that the medicine is generally discontinued before major surgery and during any period of prolonged immobilization following a medical procedure.


Q: Does the use of Силует affect bone density over time?

Clinical research has examined the potential effect of hormonal contraceptives on Bone Mineral Density (BMD). For this specific combination, the official labeling may contain specific precautionary statements or monitoring requirements based on the available research evidence.


Q: Does Силует interact with lamotrigine?

Yes, official documents indicate that combination oral contraceptives are known to reduce the plasma concentration of certain co-administered drugs, including lamotrigine. Clinical monitoring and potential dose adjustment of the co-medication may be emphasized when these medicines are used together.


Q: Does alcohol consumption interfere with the use of Силует?

While the product generally has no major drug-specific interaction with alcohol listed in its primary warnings, patient information often includes a general caution regarding the concurrent use of alcohol with any systemic medication.


Q: What are the signs of a serious side effect that would require immediate attention?

Official warnings list key signs of serious adverse events, particularly blood clots, which require immediate medical attention. These signs include sudden, severe pain or swelling in the leg, sudden chest pain, or sudden shortness of breath.

How should Силует be stored and disposed of?

The storage and disposal instructions for this combined oral contraceptive (Dienogest/Ethinyl Estradiol) are defined by regulatory authorities to maintain product integrity and ensure environmental safety.


Storage Requirements

  • Temperature: The product must be stored at a temperature not exceeding 30 C.
  • Protection: To maintain stability, the tablets must be kept in the original blister pack and outer carton to protect them from both light and moisture.
  • Handling: The medication must not be refrigerated or frozen.
  • Child Safety: As with all prescription medicines, the product must be kept out of the sight and reach of children.

Disposal Instructions

  • Procedure: Unused or expired tablets must be disposed of according to local pharmaceutical waste regulations.
  • Restriction: The product must not be discarded via wastewater (e.g., flushed down the toilet) or general household rubbish, as required by environmental protection guidelines for hormonal substances.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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