Sibilla

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Sibilla

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 Sibilla

What is Sibilla?

Sibilla is a combined oral contraceptive pill, often referred to as 'the pill.' It contains two types of female hormones in low doses: an estrogen called ethinylestradiol and a progestogen called dienogest.

How it works

Combined oral contraceptives work in several ways to prevent pregnancy:

  • Inhibiting Ovulation: The primary action is the suppression of the monthly release of an egg from the ovaries.
  • Altering Cervical Mucus: It increases the thickness of the mucus at the neck of the womb, making it more difficult for sperm to reach an egg.
  • Modifying the Uterine Lining: It changes the properties of the lining of the womb (endometrium), making it less likely for a fertilized egg to implant.

Use in Acne Treatment

In addition to its role as a contraceptive, Sibilla is used for the treatment of moderate acne in women who have not seen improvement with topical treatments or oral antibiotics. Because it contains dienogest, which has anti-androgenic properties, it can help reduce the influence of hormones that trigger excess oil production in the skin. When used for acne, it is specifically intended for women who also choose to use an oral contraceptive as their method of birth control.

Physical Characteristics

Sibilla is typically presented as a film-coated tablet. Each tablet in the pack contains the same fixed dose of both hormones, making it a monophasic combined oral contraceptive.

Regulatory References

  1. European Medicines Agency - EMA
  2. NIH StatPearls

What side effects are possible with Sibilla?

Possible Side Effects and Safety Information for Sibilla

Sibilla, a combined hormonal contraceptive containing ethinylestradiol and dienogest, has a documented safety profile derived from regulatory assessments. The most significant safety concern is the risk of thromboembolic disorders (blood clots), which are serious, though rare, events. The use of any combined hormonal contraceptive is associated with an increased risk of both venous thromboembolism (VTE), such as deep vein thrombosis and pulmonary embolism, and arterial thromboembolism (ATE), such as heart attack and stroke, compared to non-use.


Adverse Reactions Summary

Classification Common Adverse Reactions (Affecting 1 to 10 users in 100)
Systemic Headache, nausea, abdominal pain, mood changes, increased or decreased sexual desire (libido).
Reproductive Breast pain, breast tenderness, metrorrhagia (bleeding between periods), vaginal moniliasis.
Dermatologic Acne.

Serious Safety Considerations and Contraindications

  • Serious Adverse Reactions: In rare cases, the product is associated with VTE, ATE, and liver tumors (benign or malignant). Discontinuation is required if jaundice, significantly increased blood pressure, or symptoms suggestive of a blood clot occur.
  • Absolute Contraindications: The medication is strictly contraindicated for females who smoke and are over 35 years of age due to the significantly increased risk of serious cardiovascular events. It is also contraindicated in individuals with a high risk of blood clots (e.g., current or history of DVT, pulmonary embolism, stroke), severe liver disease, uncontrolled hypertension, or known estrogen- or progestin-sensitive cancers.
  • Special Monitoring: Females with well-controlled hypertension, diabetes, or hyperlipidemia require careful medical monitoring while using this medication.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory descriptions for overdosage of this Combined Hormonal Contraceptive (CHC) primarily detail transient acute manifestations and mandated emergency procedures.

Documented Overdose Manifestations

The signs of acute overexposure documented in regulatory sources are generally limited to effects on the gastrointestinal and reproductive systems:

  • Nausea and Vomiting are commonly reported manifestations of acute overdosage.
  • Withdrawal bleeding (vaginal bleeding) is a documented hormonal sign expected in female patients following ingestion of multiple tablets.

Emergency Response and Management

In the event of a known or suspected overdosage, government labeling mandates that immediate medical attention must be sought. Contacting a poison control center is an officially required action. The regulatory profile emphasizes that no specific antidote is known for this combination preparation. Consequently, the officially described intervention is limited to symptomatic and supportive treatment to manage the manifestations.

Population-Specific Note

Regulatory data for similar hormonal preparations indicate that acute ingestion of large doses by young children has not been reported to cause serious toxic effects, but seeking medical assessment remains the required action.

Therapeutic Uses of Sibilla

The therapeutic application of Sibilla (Dienogest/Ethinyl Estradiol) is applied in clinical settings that involve symptomatic discomfort, and is also used to help manage specific symptom patterns. The combination is primarily used for effective control for the prevention of pregnancy, but also plays a role in managing symptoms related to the menstrual cycle and hormonal skin issues. Its role in managing moderate acne in women who choose oral contraception is a recognized application.


Menstrual Cycle and Skin Symptom Support

The medication is relevant in conditions where patients experience menstrual cycle variability and discomfort. It helps address symptom clusters like heavy menstrual bleeding (menorrhagia), painful menstrual cramps (dysmenorrhea), and dermatological concerns such as oily skin (seborrhoea) and moderate acne lesions. By managing these manifestations, the medication assists with easing the overall symptom load related to cyclical distress and may assist with maintaining a sense of stability regarding cycle predictability.

Quick Fact: Support for Androgen-Related Acne Symptoms

This medication's use in managing skin concerns is relevant in situations where symptoms are driven by hormonal activity, providing supportive relief when dermatological manifestations interfere with daily comfort.

Regulatory References

  1. European Medicines Agency

Eligibility and Restrictions for Use

Who is Eligible to Use Sibilla?

Sibilla (Dienogest/Ethinyl Estradiol) is officially indicated for women of reproductive age who have reached menarche (the start of menstruation). Use for conditions like moderate acne is permitted only when a woman also chooses to use an oral contraceptive for pregnancy prevention, and typically after other treatments have failed (second-line use). The regulatory label notes that women with renal impairment are generally eligible, as official data do not suggest a need for treatment change in this population.

Who Must Not Use Sibilla (Contraindications)

Official regulatory documents define strict exclusions. The medicine is contraindicated if a woman has a current or past history of:

  • Thromboembolic Events: Venous or Arterial Thromboembolism (VTE/ATE), such as deep vein thrombosis, pulmonary embolism, stroke, or heart attack, or any known predisposition to these events.
  • Severe Comorbidities: Severe hepatic disease (liver disease), liver tumors, severe uncontrolled hypertension, or severe diabetes mellitus with associated vascular damage.
  • Malignancy and Pregnancy: Known or suspected hormone-dependent malignancies (e.g., breast cancer) and established pregnancy.
  • Age and Status: The product is not indicated after menopause and is generally not recommended during lactation.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Sibilla’s official interaction profile is defined primarily by the hepatic enzyme CYP3A4, which metabolizes the active hormonal components. This establishes several regulatory constraints.


Contraindicated Combinations and Restrictions

Co-administration with Strong CYP3A4 Inducers is formally contraindicated because these substances significantly decrease the plasma concentrations of the hormones, leading to a high risk of contraceptive failure. This category includes certain anticonvulsants, antibiotics (e.g., Rifampicin), and the herbal product St. John's Wort ( extitHypericum perforatum).

Additionally, co-administration with specific Hepatitis C Virus (HCV) combination regimens (containing Ombitasvir/Paritaprevir/Ritonavir) is strictly prohibited due to the documented risk of causing major increases in liver enzyme levels ( ALT).


Exposure Alteration and Timing Rules

  • CYP Inducers: The interaction with strong CYP3A4 inducers establishes a mandatory separation rule: an alternative, non-hormonal contraceptive method must be used for a period of at least 28 days following the discontinuation of the inducer.
  • CYP Inhibitors: Conversely, co-administration with CYP3A4 inhibitors (such as Ketoconazole or Erythromycin) may result in an unwanted increase in the systemic exposure of the active hormonal ingredients.
  • Pharmacodynamic Interference: A documented pharmacodynamic interaction exists with Antidiabetic Agents (e.g., Insulin), as the hormonal components may diminish the therapeutic effect on glucose control.

Mechanism of Action

Central Suppression of Ovulation

Sibilla operates through the combined actions of Ethinylestradiol (estrogen) and Dienogest (progestin), which primarily establish a negative feedback loop on the Hypothalamic-Pituitary-Ovarian (HPO) axis. This sustained feedback suppresses the release of FSH and the crucial LH surge from the pituitary gland. This cascade prevents ovarian follicular maturation and inhibits the release of an oocyte, resulting in the physiological change of anovulation.


Peripheral and Anti-Androgenic Actions

Dienogest further modulates activity by binding to Progesterone Receptors (PR) in the reproductive tract, inducing structural changes in the endometrium and increasing the viscosity of the cervical mucus to create a local barrier. Separately, Dienogest acts as a competitive antagonist at Androgen Receptors (AR) in peripheral tissues. Ethinylestradiol contributes by increasing SHBG (Sex Hormone-Binding Globulin), which binds to circulating androgens. This combined action influences androgen-related physiological responses.

Dosage and Administration Information

Sibilla is administered as a fixed-dose oral preparation, taken systemically by mouth. The standard labeled dosing regimen requires the ingestion of one tablet daily, with the active tablets containing 2 mg of Dienogest and 0.03 mg of Ethinyl Estradiol. The route of administration is oral.


Administration Schedule and Timing

The medicine’s use is governed by a standardized 28-day cyclic pattern, which defines the continuous intake over time. This cycle involves taking active tablets for 21 consecutive days, followed by a 7-day hormone-free interval, during which placebo tablets may be taken. The instruction for use is that each tablet must be taken at approximately the same time each day to ensure consistent drug levels. Tablets must be swallowed whole, optionally with a small amount of liquid, and the order shown on the blister packaging must be followed. This medicine is not indicated for administration before the onset of menarche.


Protocol for Missed Doses

There is a time-sensitive procedure for managing missed active tablets. If the lapse is less than 12 hours, the missed tablet must be ingested immediately, and the standard schedule maintained. However, if the lapse exceeds 12 hours, there are distinct, cycle-week-dependent management steps to mitigate the administration inconsistency, ensuring adherence to the labeled usage pattern.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sibilla

Evidence for Use in Contraception

Sibilla (dienogest/ethinylestradiol) was studied for its use in studying outcomes related to pregnancy prevention. Research included Randomized Controlled Trials (RCTs) and observational studies on women of reproductive age. The main outcomes measured included the rate of unintended pregnancy (Pearl Index) and measurements of bleeding patterns, such as cycle regularity. Research describes patterns related to cycle regulation and pregnancy rates observed over short-term and intermediate-term periods. Follow-up durations were limited in many primary studies, and evidence is limited for certain groups, such as women with a Body Mass Index (BMI) greater than 30 kg/m^2.

Evidence for Use in Moderate Acne Vulgaris

The combination was studied for its use in moderate acne vulgaris through double-blind, randomized trials. These studies examined women with mild to moderate facial acne. Researchers monitored outcomes linked to inflammatory or irritative states by counting lesion counts and using standardized scales for severity. Trials reported measurements of average lesion counts and patterns assessed using global investigator rating scales. This research provides insight into short-term changes in outcomes related to physical discomfort.

What is Still Uncertain about Sibilla Research

Evidence is limited for continuous use beyond twelve months, meaning long-term effects are not fully established regarding the persistence of measured outcomes. Data for certain groups remain insufficient, including specific adolescent populations and women nearing 40 years old, meaning subgroup findings are uncertain. Comparative evidence is lacking against all similar oral contraceptives and standard non-hormonal acne treatments. Research provides context but not individual predictions, and the evidence highlights what is known — and what is still uncertain.

Key Studies & References

  1. Ethinylestradiol/dienogest in oral contraception (Systematic Review)

Frequently Asked Questions (FAQ)

Common questions about Sibilla (FAQ)

Q: Is Sibilla a 'low-dose' birth control pill?

According to official documents, Sibilla contains 0.03 mg of Ethinyl Estradiol. This amount is consistent with what is commonly referred to as a low dose combined oral contraceptive preparation.

Q: How quickly does Sibilla start working for its intended use?

Official administration instructions indicate that when the tablet is started correctly according to the administration schedule, contraceptive protection is typically achieved after 7 consecutive days of taking the active tablets. Additional, non-hormonal methods are often used during this initial period.

Q: Do side effects from Sibilla usually go away after a few months?

Regulatory information indicates that many common reactions, such as irregular bleeding (spotting or breakthrough bleeding), are often experienced during the first few months of use. These effects may decrease as the body adjusts to the medication with continued use.

Q: Does Sibilla cause weight gain, according to patient reports?

Regulatory safety information for this combination lists weight changes (which can be either an increase or a decrease) as a possible undesirable effect. It is categorized as a common reaction that may be experienced by users.

Q: Is it common to have breakthrough bleeding or spotting on Sibilla?

Official documentation notes that metrorrhagia (bleeding between periods) and spotting are common adverse reactions, particularly during the first few cycles of use. This is a recognized pattern as the body adapts to the hormone levels.

Q: Does Sibilla protect against sexually transmitted infections (STIs)?

Regulatory warnings clearly state that combined oral contraceptive pills, including Sibilla, do not protect users against sexually-transmitted diseases (STIs). A barrier method is often utilized for STI protection.

Q: Is Sibilla a monophasic or multiphasic pill?

Sibilla is described as a monophasic oral contraceptive. This means that the dose of the two active hormones—Dienogest and Ethinyl Estradiol—is fixed and remains the same in every active tablet throughout the 21 -day cycle.

Q: What should I do if I have forgotten to take Sibilla for two or more days?

The procedure for two or more missed tablets is detailed in the official product information, as the necessary steps depend on the specific week of the cycle they were missed. The management steps typically involve specific actions based on the timing of the missed tablets and may include the use of additional non-hormonal contraception.

Q: Does alcohol interact with Sibilla?

Official drug interaction sections focus on the pharmacological effects of co-administered medicines that can alter Sibilla's concentration or effectiveness. These sections do not typically list a direct pharmacological interaction between the active components of Sibilla and alcohol.

Q: What specific warnings are listed for Sibilla in regulatory guidelines?

Key regulatory warnings focus on the serious, though rare, risk of thromboembolic disorders (blood clots), which is increased in certain populations like women over 35 who smoke. Official guidance requires discontinuation if symptoms of a blood clot or severe hypertension (high blood pressure) occur.

Q: Is it normal to feel nauseous when first starting Sibilla?

Nausea is listed in regulatory documents as a common adverse reaction that affects a number of users. It is frequently reported during the initial period of starting the medication as the body adjusts to the hormonal changes.

Q: Can the effectiveness of Sibilla be reduced by herbal supplements?

The effectiveness of Sibilla can be significantly reduced by co-administration with certain herbal products. Specifically, St. John's Wort (Hypericum perforatum) is formally contraindicated because it is described in regulatory documents as decreasing the concentration of the hormones.

Q: Why does Sibilla have different colored pills in the pack?

The different colors are used to distinguish the active tablets (which contain the hormones) from the placebo or hormone-free tablets (which contain no active ingredients). This is a feature intended to help distinguish between the 21 active tablets and the 7 tablets with no active ingredient (placebo).

Q: Can women who have migraines use Sibilla?

Official contraindications typically state that combined hormonal contraceptives must not be used by women who currently have or have a history of migraine with focal neurological symptoms (aura). This is related to the established increased risk of certain vascular events.

Q: Can Sibilla be used during breastfeeding?

Use of combined oral contraceptives is not recommended during breastfeeding or lactation. This is because the hormonal components may affect the quantity and composition of breast milk, and small amounts of the hormones may pass into the milk.

Q: Is a follow-up visit required after starting Sibilla?

Regulatory guidance recommends that women have routine medical check-ups and monitoring while using this medication. This includes checking blood pressure before starting treatment and periodically during long-term use.

Q: Are there any specific lifestyle factors that can affect Sibilla's safety profile?

A major lifestyle factor that affects the safety profile is cigarette smoking. Official documents state that smoking significantly increases the risk of serious cardiovascular adverse effects, making the medication strictly contraindicated for women over 35 who smoke.

Q: What is the percentage of women who report mild side effects with Sibilla?

Regulatory documents categorize common adverse reactions as affecting 1 to 10 users in every 100. These common reactions include symptoms like headache, nausea, breast pain, and mood changes.

Q: Will Sibilla change my natural menstrual cycle when I stop taking it?

The contraceptive effect of Sibilla is reversible. After discontinuation, the body is expected to return to its previous natural menstrual cycle, which confirms that the drug does not cause permanent changes.

Q: How long after stopping Sibilla can I expect to become pregnant?

The contraceptive effect is reversible, and the return to the ability to become pregnant (fertility) is expected soon after the product is discontinued. However, the exact timing for the return of natural ovulation varies by individual user.

Q: Can Sibilla affect my cholesterol or blood pressure readings?

Regulatory documents state that blood pressure should be checked before starting treatment and regularly during use, as the product can cause a significant increase in blood pressure in some individuals. It may also affect other metabolic parameters, such as cholesterol, which may require monitoring.

Q: Does Sibilla have a generic equivalent, and is it the same?

Sibilla is a brand name. Other products containing the same two active ingredients—Dienogest 2 mg and Ethinyl Estradiol 0.03 mg—exist and are considered pharmaceutically equivalent to Sibilla based on regulatory standards.

Q: Can I skip my period by adjusting how I take Sibilla?

The standardized regimen includes a 7 -day hormone-free interval when withdrawal bleeding is expected. Adjusting the hormone-free interval is noted in official information to increase the possibility of experiencing breakthrough bleeding or spotting.

Q: What official information is available about Sibilla and liver function?

Official information lists both severe hepatic (liver) disease and liver tumors as contraindications. Furthermore, the product is strictly prohibited from use with certain Hepatitis C Virus combination regimens due to the documented risk of significantly increasing liver enzyme levels.

Q: Is it true that Sibilla may have non-contraceptive benefits?

Yes, in addition to its primary function of contraception, the product is officially indicated for the treatment of moderate acne vulgaris in women who also choose to use an oral contraceptive. This is generally considered a second-line treatment after other options have been tried.

How should Sibilla be stored and disposed of?

How to Store and Dispose of Sibilla?

This section summarizes the official requirements for storing and discarding Sibilla (Dienogest/Ethinyl Estradiol) tablets, as documented in regulatory information.


Storage Conditions

Sibilla tablets do not require any special temperature storage conditions according to official product labeling. It is a mandatory requirement that the medicine must be kept out of the sight and reach of children. The product must not be used after the expiry date printed on the blister and the outer carton.


Disposal Instructions

Disposal must follow the established procedure for pharmaceutical waste. Unused medicine and waste material must not be disposed of via wastewater or regular household waste to protect the environment. Disposal should be managed in accordance with local requirements for unused or expired medicines.

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

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