Sibilla Plus

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Sibilla Plus

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 Plus

Quick Facts

Property Description
Active Ingredients Ethinylestradiol & Dienogest
Form Film-coated tablets (Oral)
Pharmacological Class Combined Oral Contraceptive (COC); Steroid Hormones
Common Use Effective and reversible pregnancy prevention
Rx/OTC Status Prescription Only (Rx)

What Type of Medicine is Sibilla Plus?

Sibilla Plus is formally categorized as a Combined Oral Contraceptive (COC), a prescription-only oral medication containing two types of synthetic female hormones. This class of medication is clinically recognized for providing highly effective and reversible family planning when taken correctly.

This specific combination is a monophasic pill, meaning every active tablet contains the same consistent concentration of its ingredients. It is a synthetic steroid hormone product, typically supplied by its manufacturer, Gedeon Richter, in a daily tablet form.


Key Components: A Combined Hormonal Formula

The medication contains the active ingredients Ethinylestradiol (the estrogen component) and Dienogest (the progestogen component). Ethinylestradiol is one of the most widely used synthetic estrogens in oral contraceptives.

Dienogest is a defining feature of the formulation, as it is a progestogen with significant anti-androgenic properties. Pharmacological studies support the beneficial effect of this component, indicating it can counteract some effects of male hormones in the body.


The Main Therapeutic Purpose

The essential therapeutic purpose of Sibilla Plus is to achieve reliable and reversible contraception. This primary function is the basis for its classification.

Beyond contraception, the anti-androgenic activity of the Dienogest component is beneficial for women who also need assistance with hormone-sensitive conditions. This feature makes it a common choice for managing symptoms related to certain skin conditions, such as moderate acne, when an oral contraceptive is desired.

What side effects are possible with Sibilla Plus?

Possible Side Effects and Safety Information

The safety profile for the Ethinylestradiol/Dienogest combination, a Combined Oral Contraceptive, is structured by government regulatory bodies based on the frequency and nature of adverse events reported. This information details the spectrum of possible reactions and associated safety characteristics, without providing clinical advice.

Officially Classified Adverse Reactions

The adverse reactions are typically classified according to how often they occur in clinical studies:

  • Common (reported in 1% to 10% of users): Includes headache, nausea, breast pain or tenderness, weight gain, and irregular uterine bleeding (spotting), which is often more frequent during the first few months of use.
  • Uncommon (reported in 0.1% to 1% of users): Involves adverse reactions such as migraine, dizziness, changes in mood or libido, hypertension (high blood pressure), and certain skin disorders like rash or acne.

Serious Safety Considerations

Official regulatory documents emphasize the risk of Serious Thromboembolic Events—rare but life-threatening conditions—a known class effect of Combined Oral Contraceptives. These include Venous Thromboembolism (VTE), such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), such as Stroke or Myocardial Infarction. The risk of these events is documented as highest during the first year of use or upon re-initiation after a break of four weeks or longer.

Safety records also note contraindications for specific populations, strictly prohibiting use in individuals who smoke and are over the age of 35 and those with a history of or current severe hepatic disease, due to substantially elevated cardiovascular and liver risks.

Overdose and Emergency Response

The official regulatory documentation for combined oral contraceptives containing Ethinylestradiol and Dienogest provides specific guidance on overdose manifestations and required emergency actions.

Documented Clinical Manifestations

The clinical signs most frequently documented in regulatory information following an acute overdose include nausea, vomiting, and specific vaginal bleeding, which is often classified as withdrawal bleeding. Regulatory sources note that these hormonal overdose manifestations, such as withdrawal bleeding, may occur in females of all ages, including prepubertal girls.

Severity and Management Directives

Official prescribing information generally classifies acute overdose with this type of medicine as unlikely to result in serious or life-threatening outcomes. Despite the low risk of severe acute effects, the regulatory guidance strictly mandates that immediate medical attention must be sought. No specific antidote is known for this formulation. Management is thus restricted to symptomatic and supportive treatment. Healthcare providers may administer activated charcoal or monitor vital signs, including blood pressure and pulse, as part of the observation requirements listed in regulatory information.

Mandated Emergency Action

The required emergency action, as explicitly written in the regulatory documents, is to seek emergency medical attention or contact a Poison Help line immediately upon any suspicion of an overdose.

Therapeutic Uses of Sibilla Plus

What Sibilla Plus Treats: Main Uses and Benefits

The medication is commonly used to provide effective and reversible prevention of pregnancy, and supports the patient's objective of consistent family planning. The medication is also considered relevant in contexts where additional symptomatic support is needed.

Sibilla Plus is applied across domains where symptomatic support is needed for androgen-related skin manifestations, menstrual cycle irregularity, and symptoms related to physical discomfort. It is used for managing symptom clusters such as moderate acne lesions, excessive seborrhea, painful cramps (dysmenorrhea), and heavy bleeding (menorrhagia). This may offer supportive relief that assists with maintaining functional stability and helps patients cope more steadily with difficult episodes.


Quick Fact: Relief for Key Symptom Clusters

Symptom Domain Practical Benefit
Fertility Management Effective, reversible pregnancy prevention.
Androgen-Sensitive Skin Contributes to easing the overall symptom load associated with moderate acne and oiliness.
Menstrual Discomfort Supports patients during difficult episodes by easing distress related to painful cramps and heavy flow.

Regulatory References

  1. European Medicines Agency guidance on Dienogest/Ethinylestradiol

Eligibility and Restrictions for Use

Who Can and Cannot Use Sibilla Plus?

Sibilla Plus is officially indicated for use by women of reproductive age, including postpubertal adolescents. Eligibility is strictly defined by government regulatory documents, which establish several absolute contraindications that prohibit its use.


Contraindicated Populations

The medicine must not be used by individuals with a current or history of thromboembolic risk, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or heart attack. Women over 35 who smoke are strictly contraindicated due to significantly increased cardiovascular risk. Additional absolute exclusions include known sex-steroid influenced malignancies (e.g., breast cancer), severe liver disease or tumors, and certain types of migraine with focal neurological symptoms.


Age and Use Restrictions

The medicine is not indicated for use before menarche (the start of menstruation) or after menopause. It is contraindicated during pregnancy and not recommended for women who are breastfeeding. Use is restricted around surgical procedures; it must be stopped at least four weeks before major surgery or prolonged immobilization due to elevated risk of blood clots. Furthermore, the efficacy of Sibilla Plus has not been evaluated in women with a Body Mass Index (BMI) greater than 30 kg/m².

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Sibilla Plus (Ethinylestradiol/Dienogest) is defined by pharmacokinetic changes that alter the concentration of its hormonal components, as documented in regulatory sources.


Exposure-Reducing Interactions

Co-administration with substances documented as strong CYP3A4 enzyme inducers can significantly decrease the plasma concentrations and, therefore, the contraceptive efficacy of Sibilla Plus. This class includes medicines such as Rifampicin, Carbamazepine, and Phenytoin. The herbal product St. John’s wort is also documented as a strong enzyme inducer that may compromise the effectiveness of the medication. Additionally, drugs that alter gastrointestinal motility, such as Tirzepatide, may reduce the absorption of the active components, officially resulting in a decreased maximum plasma concentration.


Exposure-Increasing Interactions

Conversely, the co-administration of potent CYP3A4 enzyme inhibitors may officially increase the plasma concentrations of the hormonal components. Grapefruit juice is documented as a substance that can lead to this type of metabolic inhibition.


Administration Constraints and Specific Cautions

Regulatory documents detail administration-timing constraints related to absorption: if severe vomiting or diarrhea occurs within three to four hours of taking the tablet, absorption may be incomplete. Furthermore, specific cautions are noted for patients with hepatic impairment, as the steroid hormones may be poorly metabolized, leading to altered clearance.

Mechanism of Action

Sibilla Plus exerts its physiological effects via the actions of its steroidal components: ethinylestradiol and dienogest. Ethinylestradiol, a synthetic estrogen, primarily functions by binding with high affinity to estrogen receptors ( ERalpha and ERbeta) located in target tissues, notably the hypothalamus and pituitary gland. This agonism suppresses the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus.

Dienogest, a progestin, acts as a progesterone receptor agonist and exhibits a 19-nortestosterone derivative structure, conferring antiandrogenic properties. The collective agonistic action on pituitary receptors, coupled with negative feedback on the hypothalamus, attenuates the pulsatile release of pituitary gonadotropins—specifically, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression of LH and FSH downstream prevents the final maturation of the dominant ovarian follicle and inhibits the ensuing ovulation event. Furthermore, the compounds modulate the endometrium by altering its proliferative and secretory phases, and modify the consistency of cervical mucus, increasing its viscosity.

Dosage and Administration Information

How to Use Sibilla Plus

Sibilla Plus is administered through oral use as a film-coated tablet, following a continuous, standardized cyclic schedule. The consistent application of the official regimen is the central principle for its proper use.


Administration Protocol

Usage Component Official Labeled Instruction
Route and Form One film-coated tablet is swallowed whole, designated for oral use.
Active Dose Each active tablet delivers 2 mg of Dienogest and 0.03 mg of Ethinylestradiol.
Frequency and Timing Intake is strictly once daily, and must occur at approximately the same time each day to maintain the required concentration profile.
Food and Liquid The tablet may be taken regardless of meals (with or without food) and can be consumed with water to facilitate swallowing.
Age Group The standard regimen is defined for use in postpubertal girls and women.

The Cyclic Dosing Schedule

The established administration protocol for this formulation involves a 28-day cycle, which must be followed sequentially. This cycle consists of taking 21 consecutive days of the active tablets, followed immediately by 7 consecutive days of inactive (placebo) tablets. The tablets must be consumed in the order indicated on the packaging. The regimen is designed for continuous, long-term repetition for as long as the need for administration persists.

Procedural Constraints

If the daily timing of an active tablet is missed by a specified duration, the official prescribing information outlines specific steps required, often necessitating the use of additional non-hormonal contraceptive measures to prevent reduced efficacy. Furthermore, severe gastrointestinal issues, such as vomiting or diarrhea occurring within 3 to 4 hours of taking an active tablet, are treated as a procedural constraint potentially leading to incomplete absorption.

Recent Clinical Evidence

Recent Clinical Evidence

The combined oral contraceptive Sibilla Plus contains 2 mg of the progestogen dienogest (DNG) and 0.03 mg of the estrogen ethinylestradiol (EE). Clinical research has primarily focused on the combination's high contraceptive efficacy and its non-contraceptive benefit in managing skin conditions, specifically moderate acne vulgaris.

Efficacy in Contraception and Cycle Control

Studies consistently report that the combination of dienogest/ethinylestradiol provides reliable ovulation inhibition. Trials examining its use over 12 cycles in healthy women have reported a high degree of contraceptive effectiveness, with the Pearl Index often reported to be near zero when used correctly. Furthermore, the combination has been associated with good cycle control, including a measured reduction in the incidence of unscheduled or intermenstrual bleeding and a decreased intensity of menstrual bleeding over time.

Studies on Acne Vulgaris

The anti-androgenic activity associated with dienogest is the basis for its use in treating androgen-related skin conditions. Large, multi-center, double-blind, randomized trials involving women with mild to moderate facial acne were conducted.

Outcome Measured Study Findings (Six Cycles)
Inflammatory Lesions Measured reduction compared to placebo.
Total Lesion Count Measured reduction compared to placebo.
Skin Appearance A higher percentage of participants achieved a classification of “clear” or “almost clear” skin compared to the placebo group.

These studies indicate that treatment is typically required for at least three to six months before significant improvement in acne symptoms is observed, with further improvement noted after six months of continuous use. The combination has been compared to other hormonal contraceptives and has been demonstrated to be an effective option for women seeking oral contraception who also require treatment for moderate acne.

Frequently Asked Questions (FAQ)

Common questions about Sibilla Plus (FAQ)


Q: How quickly does Sibilla Plus start to be effective?

A: According to official prescribing information, contraceptive protection is typically considered established immediately if the first active tablet is taken on Day 1 of your menstrual cycle. If the start is between Days 2 and 5, regulatory guidance advises using a temporary non-hormonal barrier method for the first seven days of the cycle.

Q: What should I expect in the first month of taking Sibilla Plus?

A: Regulatory documents indicate that women may experience irregular bleeding, often called spotting or breakthrough bleeding, which is often observed to be more frequent during the initial months of use. Official safety information also notes that the risk of developing a blood clot (VTE/ATE), while rare, is highest during the first year of use, especially when first starting or re-initiating the pill.

Q: Are there specific foods or drinks that I should avoid while on Sibilla Plus?

A: The official product information mentions that grapefruit juice may increase the plasma concentration of the pill's hormonal components in the body. For this reason, official guidance suggests limiting or avoiding it.

Q: What types of antibiotics are known to reduce the effectiveness of Sibilla Plus?

A: Some powerful antibiotics, such as Rifampicin, are documented as substances that can increase the speed at which the body processes hormones, which may reduce the pill's effectiveness. For many other antibiotics, if an interaction is suspected, regulatory guidance describes using a temporary non-hormonal barrier method during treatment and for the following seven days.

Q: Is it okay to use herbal supplements while taking Sibilla Plus?

A: Regulatory documents specifically state that the herbal medicine St. John's wort can interfere with how the body metabolizes the hormones in the pill. Using it alongside Sibilla Plus can compromise the medication's effectiveness, and it is advised against its use.

Q: Is Sibilla Plus considered safe to use for women over 35?

A: The official contraindications strictly prohibit the use of this pill for women over the age of 35 who smoke. The restriction is associated with a significantly increased risk of serious cardiovascular events documented in safety records.

Q: Do I need to take a break from Sibilla Plus after a certain number of years?

A: The established regimen for this medicine is designed for continuous, long-term use as needed. However, official safety information indicates that the risk of serious blood clots (thromboembolic events) is highest upon re-initiation after a break of four weeks or longer.

Q: What is the purpose of the placebo pills in the Sibilla Plus pack?

A: The seven inactive (placebo) tablets are included primarily to maintain a daily routine of taking a pill. This structured approach helps ensure continuous adherence to the daily schedule of the active tablets when the next cycle begins.

Q: Why might a doctor prescribe Sibilla Plus instead of a progestogen-only pill?

A: Sibilla Plus is a combined pill containing both an estrogen and a progestogen with anti-androgenic properties. The official documentation describes its use for both contraception and treatment for moderate acne, a benefit not typically noted for progestogen-only pills.

Q: How long does it take for side effects from Sibilla Plus to typically go away?

A: For common side effects like irregular uterine bleeding (spotting), regulatory documentation notes that this is often more frequent during the first few months of use and often improves thereafter, according to safety reports. The duration for other common side effects can vary among individuals.

Q: What are the signs of a serious, but rare, side effect mentioned in official documents?

A: Serious, rare side effects include thromboembolic events (blood clots). Signs of a Deep Vein Thrombosis (DVT) may involve pain, swelling, or warmth in one leg. Signs of a Pulmonary Embolism (PE) may include sudden shortness of breath or sharp chest pain. Official safety documents indicate that these symptoms require immediate medical attention.

Q: What should I do if I miss a pill of Sibilla Plus?

A: Official product information outlines steps for missed active tablets based on the delay. If the delay is less than 24 hours, taking the tablet immediately is advised, and protection is generally considered to maintain contraceptive protection. If the delay is more than 24 hours, official guidance advises taking the missed tablet, continuing the pack, and using additional barrier contraception for seven days.

Q: Is the active ingredient in Sibilla Plus the same as in other common pills?

A: Sibilla Plus contains Ethinylestradiol, which is a synthetic estrogen widely used in combined oral contraceptives. Its progestogen component, Dienogest, provides specific anti-androgenic properties that distinguish it from some other commonly prescribed hormonal pills.

Q: Does Sibilla Plus interact with common over-the-counter pain relievers?

A: The official product information does not specifically list interactions with common over-the-counter pain relievers. However, since all medication use can vary, it is necessary to consult with a healthcare professional regarding all concurrent medicines.

Q: Does Sibilla Plus affect cholesterol levels?

A: Regulatory documents note that severe dyslipoproteinaemia (a serious lipid metabolism disorder) is a contraindication. Hormone levels can affect lipid and glucose metabolism, and official documents indicate that monitoring may be required for certain patients.

Q: Does Sibilla Plus interact with common antifungal treatments?

A: Antifungal agents, particularly those known as Azole antifungals, may increase the concentration of the hormonal components in the body. Official regulatory guidance advises that any concurrent use of these medicines typically requires monitoring by a healthcare professional.

Q: What is the guidance on using Sibilla Plus if I have diabetes?

A: Official prescribing information states that Sibilla Plus is contraindicated in patients with diabetes that has developed vascular complications. For diabetic patients without vascular complications, regulatory guidance requires careful medical monitoring while using the pill.

Q: Is there a link between Sibilla Plus and changes in vision?

A: Regulatory adverse event listings include visual disturbances, such as blurred vision or sudden partial or complete loss of vision, as a rare and serious symptom. The occurrence of such a symptom requires immediate discontinuation of the pill and emergency medical attention.

Q: How is the use of Sibilla Plus monitored by doctors?

A: Official guidelines recommend a complete medical history and physical examination, including a blood pressure check, before beginning the pill. Regular check-ups are also generally recommended throughout the course of use, especially for individuals with existing risk factors.

Q: Is it safe to drink alcohol while taking Sibilla Plus?

A: The official product information does not list alcohol as a contraindication or an interaction that reduces contraceptive effectiveness. The document lists no specific constraints regarding alcohol use.

Q: Can women with a history of gallbladder problems use Sibilla Plus?

A: The estrogen component in the pill may increase the formation of gallstones. Conditions such as cholecystitis (gallbladder inflammation) or pre-existing gallstones are listed as conditions that typically require careful monitoring and medical review before the pill is used.

Q: Can I use Sibilla Plus if I am taking medicines for HIV?

A: Some medicines used to treat HIV, such as specific antiretrovirals, can significantly decrease the concentration of the pill's estrogen component. This may result in a reduction of contraceptive protection, and supplementary barrier contraception may be required according to medical guidance.

Q: Is it possible for Sibilla Plus to cause skin darkening (melasma)?

A: Official warnings note a risk of chloasma, which appears as patches of brown skin discoloration on the face, particularly in women with a history of the condition during pregnancy. Official guidance suggests avoiding prolonged exposure to the sun or ultraviolet radiation while taking the pill.

How should Sibilla Plus be stored and disposed of?

Sibilla Plus must be stored under specific environmental conditions to maintain the stability of the active ingredients, as directed by regulatory bodies.


Storage Conditions

  • Temperature: The product must be stored below 30 C (86°F).
  • Protection: The medicine must be kept in the original package to protect it from light and moisture.
  • Child Safety: It is mandatory to keep Sibilla Plus out of the sight and reach of children.

Disposal Instructions

To ensure proper pharmaceutical waste management, the medication must not be disposed of via wastewater or household waste. Unused or expired Sibilla Plus should be returned to the pharmacist so it can be discarded according to local environmental regulations.

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

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