Madinette

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Madinette

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Madinette

Property Description
Active Ingredients Chlormadinone acetate, Ethinyl Estradiol
Form Monophasic Oral Tablet
Pharmacological Class Combined Hormonal Contraceptive (CHC)
Common Use Contraception (Pregnancy Prevention)
Origin Synthetic

Madinette: Definition and Pharmacological Class

Madinette is a prescription-only medicine classified as a Combined Hormonal Contraceptive (CHC) for oral use, belonging to the pharmacological group of Sex Hormones and Modulators of the Genital System (ATC code G03A). This medicine is a synthetic hormonal preparation defined by its dual-hormone mechanism. This category of medication is designed for the prevention of pregnancy (contraception) through the application of this specific combination of hormones.

Composition and Unique Type: Chlormadinone and Ethinyl Estradiol

The composition of Madinette includes two distinct active ingredients: the progestogen chlormadinone acetate (CMA) and the estrogen ethinyl estradiol (EE). It is a combination drug product manufactured as a monophasic oral tablet, which means the dose of both the synthetic progestogen and the synthetic estrogen is fixed and uniform in every active tablet. Chlormadinone acetate is a progesterone derivative characterized by both progestogenic and specific anti-androgenic effects. This progestogen is utilized in combination with ethinyl estradiol within these contraceptive regimens.

Primary Purpose and Anti-Androgenic Property

The primary purpose of Madinette is contraception, which is achieved by the synergistic effects of the combined hormones to interrupt the natural reproductive cycle. Due to the properties of its progestogen component, Madinette also addresses androgen-dependent symptoms. The formulation is used for the management of acne and other hyperandrogenic manifestations. Consequently, this combination is clinically recognized for its utility in female patients presenting with moderate acne vulgaris or excessive oiliness (seborrhea), providing both pregnancy prevention and dermatological management.

Regulatory References

  1. Combined hormonal contraceptives | EMA
  2. National Library of Medicine (NLM)

What side effects are possible with Madinette?

Possible side effects and safety information

The safety profile of Madinette, as documented in official regulatory sources, is defined by categorized adverse reactions and significant limitations on use.

Serious Adverse Reactions and Restrictions (Warnings and Precautions)

Official labeling highlights the potential for arterial and venous thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) as a clinically significant risk. The risk of these events is increased in patients with certain pre-existing conditions and is a major safety consideration. The medicine must be discontinued if a thrombotic event occurs.

Additional warnings note the need for periodic monitoring of blood pressure, as use is contraindicated in cases of uncontrolled hypertension. Discontinuance is also specified if jaundice or acute disturbances of liver function occur, or if a migraine with unusual severity or a significant change in headaches develops.

Specific conditions that contraindicate the use of Madinette due to unacceptable risk include:

  • A high risk of arterial or venous thrombotic diseases (e.g., in females over 35 who smoke, or with a history of certain cardiovascular or cerebrovascular diseases).
  • Current or history of breast cancer or other estrogen-sensitive malignancies.
  • Presence of benign or malignant liver tumors or hepatic impairment.
  • Undiagnosed abnormal uterine bleeding.
  • Concomitant use with certain Hepatitis C drug combinations.

Frequency-Classified Adverse Reactions

Adverse reactions reported in clinical trials and post-marketing experience are categorized by the body system they affect (e.g., Vascular disorders, Gastrointestinal disorders) and by their frequency of occurrence, such as very common, common, uncommon, rare, or very rare.

Common adverse reactions typically reported include: headache, abdominal pain, nausea, metrorrhagia (bleeding between periods), vaginal moniliasis and pain, acne, and breast tenderness. The potential for irregular bleeding or amenorrhea (absence of periods) is also officially documented.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

Acute ingestion of doses higher than prescribed is officially documented to have a generally low acute toxicity profile, and serious toxic effects are typically not expected from this type of exposure. When an overdose is suspected, regulatory guidance explicitly requires that a healthcare professional must be contacted immediately for professional assessment and evaluation. This instruction is mandated to ensure any observed clinical manifestations are appropriately managed.

Documented Clinical Manifestations

Regulatory labeling documents the clinical signs of acute overdose to be primarily non-serious and self-limiting. The officially recognized manifestations include:

  • Nausea and Vomiting (Gastrointestinal signs).
  • Vaginal or Withdrawal Bleeding (A genital system sign, which may also occur in young girls who accidentally ingest the tablets).

Management and Official Requirements

The management procedure officially required by regulatory authorities is symptomatic treatment and general supportive care. Official labeling confirms that there is no specific antidote known or documented for this combined hormonal preparation. The overall regulatory profile defines the overdose risk as low, but consultation with a healthcare professional is mandatory for managing observed symptoms and continued observation following ingestion.

Therapeutic Uses of Madinette

What Madinette Treats: Main Uses and Benefits

The primary role of this medication is in the domain of reproductive health, where it is commonly used to help with contraception. It is applied where additional symptomatic support is needed, primarily to provide continuous control for the long-term management of the reproductive cycle. This use provides supportive relief and contributes to maintaining stability when cycle-related symptoms are more noticeable.

Madinette is also considered relevant in the dermatological domain for managing specific hormone-related skin manifestations. This helps address symptom clusters that may become intense or disruptive, such as moderate acne vulgaris and excessive oiliness (seborrhea). This specialized use provides supportive relief and may help patients manage symptom fluctuations, contributing to improved comfort during periods of heightened symptoms.

The key therapeutic areas include managing contraception needs and providing support for moderate hormone-related symptoms. This therapeutic approach assists the patient by easing distress and is relevant for addressing both of these distinct, yet interconnected, clinical needs.


Quick Fact: Supports Management of Hormone-Related Skin Symptoms


Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Madinette — Official Regulatory Information

The eligibility profile for Madinette (chlormadinone acetate/ethinyl estradiol) is strictly defined by regulatory documents, distinguishing between populations permitted for use and those who are formally contraindicated.

Eligibility Scope

Scope Component Official Regulatory Statement
Populations for whom use is allowed: Females of reproductive potential requiring contraception. Also approved for managing moderate androgen-related dermatological manifestations in certain regions.
Populations for whom use is contraindicated: Individuals with a high risk of arterial or venous thrombotic diseases (VTE/ATE, or history of). Current or history of breast cancer, liver tumors, or severe hepatic disease. History of migraine with focal neurological symptoms (aura).
Age-related eligibility rules: Approved for females of reproductive potential. Contraindicated in females over 35 years of age who smoke. Use is not established for pre-menarcheal females or post-menopausal women.
Pregnancy and lactation eligibility status: Pregnancy: Contraindicated (Known or suspected). Lactation: Contraindicated / Not recommended.

Official Eligibility Statements

Regulatory documents emphasize that the medicine is contraindicated in patients with an inherited or acquired predisposition for thrombosis and in those with certain severe metabolic conditions, such as diabetes mellitus with vascular symptoms. Efficacy has not been evaluated in females with a Body Mass Index (BMI) greater than 35 kg/m².

What should I know about interactions with other medicines?

Madinette Interactions with other medicines and products

The official interaction profile for Madinette is defined by combinations that must be avoided and substances that alter the plasma concentrations of the active hormones.

Interaction Classification Interacting Substances / Categories
Absolute Prohibitions Medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir.
Exposure Modifiers Enzyme Inducers (e.g., the herbal product St John's wort) and Enzyme Inhibitors.

Co-administration with the specific Hepatitis C drug regimens listed above is formally prohibited due to the documented risk of increased liver enzyme elevations (ALT). This restriction is paired with mandatory timing rules: users must switch to an alternative contraceptive method prior to starting these treatments, and Madinette can only be restarted 2 weeks following completion of the full course.

Interactions also occur with medicines categorized as Enzyme Inducers and Enzyme Inhibitors. Inducers increase the hormonal clearance primarily through hepatic CYP enzymes, which is officially associated with reduced contraceptive effectiveness. Conversely, Inhibitors decrease clearance and may lead to increased systemic exposure and potential safety risks. Furthermore, the official labeling notes that the estrogen component may cause or worsen the symptoms of hereditary and acquired angioedema. Co-administration with other hormonal contraceptives is also not recommended.

Mechanism of Action

Madinette is a combination hormonal agent containing chlormadinone acetate and ethinylestradiol. The mechanism of action is mediated primarily through the inhibition of the hypothalamic-pituitary-ovarian (HPO) axis.

Ethinylestradiol, a synthetic estrogen, and chlormadinone acetate, a progestin, act as exogenous steroids. These components exert a sustained negative feedback on the hypothalamus, modulating the pulsatile secretion of gonadotropin-releasing hormone (GnRH). This sustained negative feedback consequently suppresses the release of pituitary gonadotropins, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

Intracellularly, the progestin component, chlormadinone acetate, acts as an agonist at the progesterone receptor. The resultant suppression of FSH inhibits follicular development and maturation. The suppressed pre-ovulatory surge of LH prevents the process of ovulation, eliminating the release of an oocyte. The progestin also induces physiochemical changes in cervical tissue, increasing the viscosity and decreasing the permeability of the cervical mucus. This systemic modulation of the HPO axis and local tissue alterations result in an anovulatory state and physical barrier modification.

Dosage and Administration Information

How to Use Madinette

Madinette is administered according to a standardized and continuous cyclic regimen.


Usage Protocol

The medicine is designed for oral use as a monophasic film-coated tablet. Each tablet contains a fixed dose of 2 mg chlormadinone acetate and 0.03 mg (30 micrograms) ethinyl estradiol. The regimen involves taking one tablet daily at approximately the same time every day to maintain a consistent dosing interval.

The administration schedule involves 21 consecutive days of active tablets followed by a 7-day tablet-free interval. The next pack is started immediately following this seven-day break, establishing a continuous cycle. The tablets are taken in the sequential order indicated on the packaging.


Time-Specific Administration Guidelines

There is a specific allowance for timing deviations. If the daily tablet is missed but taken within 12 hours of the usual time, the protocol dictates that the tablet be taken immediately and the rest of the pack be continued as scheduled. Conversely, if vomiting or severe diarrhea occurs within 3 to 4 hours of administration, the integrity of the dose may be affected, and the specific missed-dose protocol is followed.

For the medicine’s supportive role in managing acne, it is generally recommended that use be withdrawn 3 to 4 cycles after the symptoms have satisfactorily resolved; the regimen is designed for long-term cyclic use when applied for contraception.

Recent Clinical Evidence

The Research Base for Contraception

The evidence base for Madinette was studied for pregnancy prevention and is based on large-scale Randomized Controlled Trials (RCTs) and clinical trials. These studies focused on women of reproductive age and were designed to assess outcomes such as the measurement of ovulation inhibition and pregnancy incidence. Findings indicated patterns observed in cycle stability and bleeding over defined time intervals. However, long-term effects are not fully established beyond the intermediate follow-up of core trials (9-13 cycles), and there is limited information on post-use reproductive outcomes.


Studies Evaluating Androgen-Dependent Symptoms

Research has examined Madinette in studies exploring conditions characterized by moderate acne vulgaris and excessive oiliness (seborrhea). This evidence is derived from Systematic Reviews and RCTs focused on women with mild to moderate symptoms. Researchers examined changes by counting acne lesions and grading the overall severity of acne. Studies report how symptoms evolved in the observed populations, but comparative evidence is lacking against all other hormonal options. Furthermore, the long-term effects are not fully established for dermatological outcomes beyond the typical 6-to-12-cycle study duration.


Research Gaps and Areas of Uncertainty

The research highlights areas where data remains insufficient. Evidence quality varies across studies, and some findings were mixed in comparative trials. The primary limitations include the short duration of many trials, meaning long-term effects are not fully established for symptom management. Data for certain groups remain insufficient, including large populations of adolescents or women with complex conditions such as Polycystic Ovary Syndrome (PCOS). Research indicates that findings reflect the populations studied and do not determine individual response.

Key Studies & References

  1. Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: A randomized, double-blind, placebo-controlled Phase III trial

Frequently Asked Questions (FAQ)

Common questions about Madinette (FAQ)

Q: Why is Madinette also described in some regions as a treatment for acne?

A: According to official product information, Madinette contains chlormadinone acetate, a component with anti-androgenic effects. These properties are the reason why the medicine is used to manage androgen-dependent symptoms, such as moderate acne and excessive oiliness (seborrhea), in addition to its primary role in contraception.


Q: How is Madinette typically packaged (e.g., 21-day or 28-day format)?

A: Madinette follows a standard 28-day cycle format. This involves taking 21 active tablets consecutively, followed by a 7-day tablet-free interval. The next pack must be started immediately following this seven-day break.


Q: How long do common initial side effects like nausea usually last after starting Madinette?

A: Nausea is classified as a common side effect in official documents. Initial common adverse reactions are typically transient, meaning they are temporary. For many users, these symptoms are observed to lessen or resolve as the body adjusts, often within the first few treatment cycles.


Q: Does Madinette cause weight gain or is that a common misunderstanding among users?

A: Official regulatory information reports weight increased as an uncommon adverse reaction associated with Madinette (listed under Investigations). It is important to know that the opposite—weight decreased—is also reported in rare instances.


Q: Can Madinette affect mood or emotional well-being according to official information?

A: Official labeling lists depressed mood and mood altered as common or uncommon adverse reactions. Furthermore, the onset of severe depression is explicitly noted as a reason for medical guidance regarding discontinuing the medicine, according to regulatory guidelines.


Q: Is hair loss listed as a reported side effect of Madinette in regulatory documents?

A: Hair loss is not typically listed as a common adverse reaction. Due to the medicine's anti-androgenic properties, research has explored its effect on conditions like Female Pattern Hair Loss (FPHL).


Q: Are headaches a commonly reported side effect in official documents for Madinette?

A: Yes, headache is classified as a common adverse reaction in the official product information. Official warnings note that the onset or worsening of unusually severe headaches or migraines is listed as a reason for medical guidance regarding discontinuing the medicine.


Q: Why do some people report increased breast tenderness when starting Madinette?

A: Breast pain and breast tenderness are classified as common adverse reactions in regulatory documents. This effect is generally related to the systemic action of the hormonal components within the medicine.


Q: Is there a connection between Madinette use and gallbladder issues?

A: Official warnings require discontinuing the medicine if acute disturbances of liver function or jaundice (yellowing of the skin or eyes) occur.


Q: What kind of vision changes might be related to the use of Madinette?

A: Official documentation lists the development of any acute sensory disorders, including sudden vision changes, as a condition that requires immediate consultation with a healthcare professional regarding discontinuance.


Q: Are abdominal pain and bloating listed as frequent side effects of Madinette?

A: Abdominal pain is classified as a common adverse reaction. While not always listed individually, bloating is generally grouped with other common gastrointestinal issues reported by users.


Q: Can Madinette affect the way a person wears contact lenses?

A: Yes, contact lens intolerance is listed as an adverse event in regulatory documents. This means some users may experience difficulty wearing contact lenses while taking the medicine.


Q: What happens to the skin and hair after stopping Madinette, based on user feedback trends?

A: The regulatory text indicates the current cycle may be prolonged by about a week after discontinuation. Because the medicine is known for managing androgen-dependent symptoms, the return of pre-treatment conditions like acne or excessive oiliness is a potential outcome following discontinuation.


Q: Can common over-the-counter pain relievers (analgesics) interact with Madinette?

A: The hormones are processed via specific metabolic pathways. Certain medicines, including some common analgesics, can affect these pathways (metabolism), which could potentially alter the concentration of the hormones in the body.


Q: Does Madinette have known interactions with anticonvulsant medications?

A: Yes, Madinette interacts with medicines classified as Enzyme Inducers, a category that includes many anticonvulsant medications. This interaction is officially associated with reduced contraceptive effectiveness.


Q: Do medicines for fungal infections interact with the effectiveness of Madinette?

A: Certain medicines used to treat fungal infections (antifungals) are categorized as Enzyme Inhibitors. These inhibitors can slow down the body’s processing of the hormones, potentially leading to increased systemic exposure.


Q: Does Madinette interact with common thyroid medications?

A: The estrogen component of the medicine can affect certain laboratory tests, specifically increasing levels of thyroid-binding globulin. This indicates an indirect effect on the way thyroid hormones are transported in the body.


Q: Does vomiting or severe diarrhea affect the effectiveness of Madinette?

A: Regulatory guidance states that if vomiting or severe diarrhea occurs within three to four hours of taking the tablet, the integrity of the dose is considered compromised. In such a situation, regulatory guidance indicates that reliable contraceptive protection may no longer be ensured.


Q: Is Madinette still effective if a user experiences light bleeding outside of the break week?

A: Spotting or breakthrough bleeding is a common adverse reaction, especially when starting the medicine. If the tablets are taken correctly and consistently, regulatory information indicates that contraceptive efficacy is generally maintained.


Q: What is meant by the 'seven-day rule' regarding missed Madinette pills?

A: The term generally refers to the official requirement to take seven consecutive days of active tablets correctly to restore contraceptive protection after certain missed doses. This rule is a key part of the detailed instructions for handling missed tablets.


Q: What happens if a user accidentally starts a new pack of Madinette late?

A: If the seven-day tablet-free interval is exceeded, the situation is classified under the rules for a missed tablet. This requires immediate application of the missed tablet rules detailed in the product information, which includes taking the late tablet and typically using additional non-hormonal contraceptive measures for a specified period.


Q: Can Madinette be used to delay or skip a period?

A: The official instructions include a protocol for delaying a period by skipping the tablet-free interval and moving directly to the next pack. However, users should be aware that breakthrough bleeding or spotting may still occur during the time the period was delayed.


Q: How quickly can fertility return after a person stops taking Madinette?

A: Official regulatory summaries indicate that there is limited information on post-use reproductive outcomes in the core clinical trials. However, it is noted that the cycle immediately following discontinuation may be prolonged by about a week.


Q: Does Madinette typically improve or worsen acne for most users?

A: Official studies indicate that Madinette can be associated with the improvement of symptoms of moderate acne vulgaris and excessive oiliness (seborrhea). This effect is attributed to the anti-androgenic properties of the medicine.


Q: Can Madinette be used by women who have been diagnosed with PCOS (Polycystic Ovary Syndrome)?

A: While Madinette has been studied for its effect on symptoms associated with PCOS (Polycystic Ovary Syndrome), the official research base notes that data remains insufficient for large populations of women with complex conditions, which means individual suitability is not established by the label.


Q: Are there age restrictions for starting or stopping Madinette?

A: Official documents state that the medicine is contraindicated (should not be used) in females over 35 years of age who smoke. Generally, use is indicated for females of reproductive potential, and is not established for pre-menarcheal or post-menopausal women.


Q: Is Madinette appropriate for individuals with a history of depression?

A: Severe depression is listed as an adverse reaction in the official safety profile. The medicine's regulatory information specifies that the onset or worsening of severe depression warrants the discontinuance of the medicine.


Q: Is Madinette generally considered a low-dose combined oral contraceptive?

A: Yes, based on the fixed dose of 0.03 mg (30 micrograms) ethinyl estradiol it contains, Madinette is pharmacologically classified as a low-dose combined oral contraceptive.


Q: How are the clinical trials for Madinette usually structured to assess efficacy?

A: Clinical trials designed to assess the medicine’s efficacy for contraception are primarily structured as Randomized Controlled Trials (RCTs). These studies are designed to measure key outcomes, such as ovulation inhibition and pregnancy incidence.


Q: Has the official research on Madinette examined its effect on long-term bone density?

A: The official research base notes that long-term effects are not fully established beyond the intermediate follow-up of the core clinical trials. This means long-term effects on factors like bone density have not been fully determined.


Q: What is the risk of thrombosis (blood clots) associated with Madinette compared to not using a hormonal contraceptive?

A: Official labeling states that using a combined hormonal contraceptive like this increases the risk of blood clots (thrombosis) compared to women who are not using one. It is also noted that this increased risk is highest during the first year of use of the medicine.

How should Madinette be stored and disposed of?

How to Store and Dispose of Madinette

All storage and disposal of Madinette (chlormadinone acetate and ethinyl estradiol tablets) must adhere strictly to the conditions defined in the official regulatory labeling to ensure product stability and safety.

Storage Requirements

Condition Requirement
Temperature Store below 30 C in a cool, dry place.
Protection Must be kept in the original package to protect the tablets from light and moisture.
Child Safety Store the medicine out of the sight and reach of children.

Disposal Instructions

Unused or expired Madinette must be disposed of correctly, following local regulatory requirements. Disposal procedures are designed to prevent contamination, and the product should generally not be discarded into wastewater or household drains. Local guidance often instructs placing the medication into a sealed trash bag before discarding.

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

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