Marilow

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Marilow

Medically reviewed

Laura Arias

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 Marilow

Quick Facts

Property Description
Active Ingredients Nomegestrol acetate, Estradiol
Form Film-coated tablets
Pharmacological Class Sex hormones and modulators of the genital system
Common Use Oral Contraception
Origin Synthetic progestogen / Natural oestrogen combination

What Type of Contraceptive is Marilow?

Marilow is a combined oral contraceptive (COC), a prescription-only medication whose primary, singular function is the reliable prevention of pregnancy in women of reproductive age. It belongs to the high-level pharmacological class of sex hormones and modulators of the genital system, categorized as a fixed combination of progestogens and oestrogens. This positioning confirms its defined role as a recognized hormonal regulatory agent. The drug is structured as a monophasic pill because its active film-coated tablets deliver a consistent, fixed dose of both hormones daily. Marilow's singular general purpose is to provide effective oral contraception through systematic hormonal interference, a use that is clinically recognized and confirmed through pharmacological studies.

Composition and Origin: Estradiol and Nomegestrol Acetate

Marilow is a fixed-dose combination product containing the synthetic progestogen nomegestrol acetate (NOMAC) and the natural oestrogen 17-beta estradiol (as estradiol hemihydrate). This combination is a distinctive feature, as the estradiol component is chemically identical to the primary endogenous estrogen produced naturally by the body, setting it apart from formulations using synthetic estrogens. Nomegestrol acetate, a highly selective progestogen, works in synergy with the estradiol to achieve contraceptive efficacy via oral use. This nomegestrol acetate formulation provides an effective level of anti-gonadotropic activity essential for contraception. The product is supplied as a sequence of active tablets, which deliver the hormone combination, followed by a set of hormone-free placebo tablets in a defined regimen to facilitate adherence to the daily oral administration routine.

What side effects are possible with Marilow?

The official safety profile for nomegestrol acetate/estradiol is structured by frequency and System-Organ-Class (SOC) groupings, as defined in regulatory documents.

Adverse Reaction Classifications

Adverse effects are categorized based on their documented frequency in regulatory texts:

Frequency Examples of Adverse Reactions (by SOC)
Very Common (≥ 1/10) Acne
Common (≥ 1/100 to < 1/10) Headache, Migraine, Nausea, Mood altered, Menstruation irregular, Breast tenderness, Weight increased
Uncommon (≥ 1/1,000 to < 1/100) Hypersensitivity, Oedema (fluid retention), Hot flush, Vaginal dryness

Time-related patterns in regulatory data note that irregular bleeding (Metrorrhagia) is common, particularly during the initial months of treatment. The risk of serious events is also generally documented as highest during the first year of use.


Serious Adverse Reactions and Safety Restrictions

All combined hormonal contraceptives, including nomegestrol acetate/estradiol, are associated with a documented small increased risk of Venous Thromboembolism (VTE) (e.g., Deep Vein Thrombosis and Pulmonary Embolism) and Arterial Thromboembolism (ATE) (e.g., Stroke and Myocardial Infarction). These events are classified as rare, but represent the most critical safety concerns in the labeling. Rare associations with Hepatic Tumours (e.g., adenomas) and certain Malignancies are also noted.

Official prescribing information defines strict limitations for use. The medication is contraindicated in individuals with a current or history of VTE or ATE, severe hepatic impairment (liver function values not returned to normal), known or suspected hormone-dependent malignancies, and certain inherited or acquired thrombophilic disorders. These safety restrictions define the conditions that must be absent for use.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The information in this section is based strictly on the official regulatory documentation for the combination of nomegestrol acetate and estradiol, which defines the official profile for overdose situations.

Documented Overdose Manifestations

Clinical trials and post-marketing data reported in regulatory sources indicate that an overdose with combined oral contraceptives, including Marilow, is generally associated with a low risk of serious acute adverse effects.

The specific manifestations formally documented following an overdose are typically limited to:

  • Nausea
  • Vomiting
  • Vaginal bleeding (often referred to as withdrawal bleeding)
Overdose Effect Specific Population Note
Nausea / Vomiting General manifestation listed in official documentation.
Vaginal Bleeding May occur as slight vaginal bleeding if the product is inadvertently taken by young girls.

Required Emergency Actions

The official regulatory documentation provides clear guidance on the management approach:

  • Treatment: No specific antidote is described as available. Management is required to be symptomatic; care should focus on treating the manifestations that occur.
  • Urgent Medical Help: While the documented symptoms are typically mild, medical attention should be sought promptly for any severe or concerning symptoms, or if a large quantity of tablets was taken. However, the regulatory text does not explicitly mandate immediate emergency services for the mild, listed manifestations.

Therapeutic Uses of Marilow

The primary purpose of Marilow (nomegestrol acetate/estradiol) is to provide effective oral contraception for women of reproductive potential. Beyond this essential functional role, the medication may be part of symptomatic management by addressing common conditions associated with the menstrual cycle.


Therapeutic Support and Benefits

Marilow is relevant across domains where additional symptomatic support is needed, primarily focusing on gynecological symptom management. Its core applications include providing effective contraception, supporting cycle predictability and managing heavy menstrual bleeding (Menorrhagia), and assisting with severe cyclic pain like menstrual cramps (Dysmenorrhea) and Premenstrual Dysphoric Disorder (PMDD) emotional symptoms. It is applied in scenarios where patients experience symptoms that interfere with daily comfort and require assistance in coping more steadily with difficult episodic manifestations.

“This approach supports the patient during difficult episodes by easing distress and contributes to improved comfort during symptomatic periods.”

Quick Fact: Relief for Cyclic Discomfort

Symptom Domain Key Benefit
Menstrual Irregularity Supports the management of cycle regularity and predictability.
Severe Pain (Dysmenorrhea) Helps ease the overall symptom burden of physical discomfort.
Mood Symptoms (PMDD) May assist with managing symptoms related to systemic imbalance.

Eligibility and Restrictions for Use

The eligibility for a medicine is strictly determined by official regulatory documents, which define populations for whom the drug is safe and effective, and those who must not use it due to prohibitive risk. The following criteria reflect the standard regulatory profile for Marilow.

Eligibility Scope

Category Status (Regulatory Standard)
Populations for whom use is contraindicated Patients with known hypersensitivity to the active substance or any non-active component listed in the formulation.
Age-related eligibility rules Pediatric Use (under 18 years) is not established and generally restricted due to insufficient safety or efficacy data.
Condition-specific eligibility rules Use requires special consideration or is restricted in patients with severe hepatic or renal impairment, as defined by official laboratory cutoffs.
Pregnancy and lactation eligibility Contraindicated or not recommended; status is based on documented or theoretical risk of harm to the fetus or infant.

These official statements establish definitive non-eligibility for high-risk populations. Any patient not meeting the strict contraindication criteria may be considered eligible for treatment under the guidance of a healthcare professional.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Marilow is defined by specific pharmacokinetic alterations and formal restrictions documented in regulatory labeling. The co-administration of certain anti-HCV drug combinations, namely Glecaprevir/Pibrentasvir and Dasabuvir, is formally contraindicated due to the documented potential for significant Alanine Aminotransferase (ALT) enzyme elevations.

Pharmacokinetic Alterations and Restrictions

The product's efficacy is sensitive to medicines that interfere with steroid hormone metabolism. CYP3A Enzyme Inducers, a class that includes antiepileptics (e.g., Carbamazepine, Phenytoin) and antituberculars (e.g., Rifampicin), are documented to reduce the plasma concentration of the active hormones. This reduction in exposure can result in a significant risk of contraceptive failure. The herbal product St John's Wort is also documented as an enzyme inducer that may reduce contraceptive efficacy. Conversely, potent CYP3A Enzyme Inhibitors (e.g., Ketoconazole, Atazanavir) may increase the serum concentration of nomegestrol acetate.

Administration and Population Constraints

An administration rule exists to maintain therapeutic exposure: if acute gastrointestinal events like vomiting or severe diarrhea occur within three to four hours after taking an active tablet, a replacement tablet is required. Furthermore, use is formally contraindicated in severe hepatic disease because the metabolism and subsequent clearance of the steroid hormones may be impaired, leading to potential accumulation.

Mechanism of Action

How Marilow Works

The mechanism of action of Marilow centers on the modulation of electrical conduction in nerve cells, primarily within the central nervous system. The drug functions as a use-dependent inhibitor of presynaptic voltage-gated sodium channels ( Na v).

Targeted Inhibition of Na^+ Channels

Marilow binds to the inner pore of the Na v channel when it is in its open or inactivated state, physically limiting the rapid influx of sodium ions ( Na^+). This action results in an altered excitability profile of the neuronal membrane and a prolonged refractory period.

Modulation of Excitatory Signal Transmission

The inhibition of Na v channels reduces the frequency of action potentials propagating along the nerve axon. This decrease in electrical activity leads to a proportional reduction in the release of excitatory neurotransmitters at the synapse, which modifies overall signal transmission in high-frequency firing neural circuits. Due to the use-dependence of its binding, this mechanism results in the core physiological consequence of decreasing elevated network excitability with a comparatively lower effect on basal nerve conduction.

Dosage and Administration Information

How to Use Marilow: Official Administration Guidelines

Marilow (nomegestrol acetate / estradiol) is administered according to a fixed 28-day sequential regimen designed for continuous oral intake. The use protocol establishes the standards for dosing, frequency, and timing.


Standard Dosing and Administration

The standard dosage is one tablet daily for 28 consecutive days. The regimen consists of 24 white active tablets (containing 2.5 mg nomegestrol acetate and 1.5 mg estradiol) followed by 4 yellow placebo tablets. Each tablet must be taken at about the same time each day, and the intake must strictly follow the order indicated on the blister pack to maintain the correct sequence of hormones and placebo. Tablets may be taken without regard to meals and with some liquid as needed.


Procedural Rules and Cycle Continuity

Feature Official Labeled Instruction
Route of Administration Oral use (taken by mouth).
Cycle Transition A subsequent pack must be started immediately after finishing the previous one, ensuring no interruption in the daily intake schedule.
Missed Active Tablet If an active tablet is missed by less than 12 hours, protection is maintained, provided the tablet is taken immediately.
Gastrointestinal Event Vomiting or severe diarrhoea occurring within 3–4 hours of taking an active tablet requires management as a missed dose.

These instructions establish a continuous use model based on strict daily adherence to the 24/4 sequential structure, defining the required procedural approach for the duration of needed use.

Recent Clinical Evidence

Evidence for Primary Use: Oral Contraception

This section summarizes the official research evidence that was evaluated in the regulatory assessment of Marilow. The primary research consists of large-scale, controlled Randomized Controlled Trials (RCTs) that compared the nomegestrol acetate/estradiol combination to other active birth control pills already in use. Research examined the main outcome of Contraceptive Efficacy in thousands of healthy women of reproductive age.

The studies monitored outcomes such as the Pearl Index, which calculates the number of pregnancies that data show patterns related to during the study intervals. These trials contribute to the broader evidence landscape regarding how the combination was evaluated in research exploring the prevention of pregnancy. Findings describe patterns observed in the studies when comparing this combination against established active controls.


Research on Menstrual Cycle Patterns and Control

Research examined how the menstrual cycle was observed in participants during the main contraceptive trials. Studies explored two key areas: the characteristics of the expected, or scheduled, withdrawal bleeding, and the occurrence of unscheduled bleeding or spotting while taking the active tablets.

Studies monitored both the duration and the overall pattern of the expected withdrawal bleeding. Researchers also tracked the incidence of amenorrhea—a term for when no scheduled withdrawal bleeding was observed in a cycle. Research highlights changes measured during the study period related to the consistency of the cycle pattern. Evidence contributes to the broader evidence landscape regarding symptoms related to functional imbalance.


Studies on Symptomatic Management

The evidence base for how the medicine was studied for gynecological symptom outcomes is derived mainly from secondary analyses of the main contraceptive trials, and some smaller observational studies. Research examined outcomes related to physical discomfort, such as severe menstrual cramping (dysmenorrhea), and patient-reported outcomes describing perceived discomfort related to premenstrual symptoms.

However, the certainty for these symptomatic outcomes remains low because the evidence often comes from secondary analyses rather than from large trials specifically designed and powered for these conditions. Sample sizes were modest for some studies focusing on objective measures like blood loss. Comparative evidence is lacking for some of these outcomes.

Frequently Asked Questions (FAQ)

Common questions about Marilow (FAQ)

Q: Does Marilow help with inflammation?

Studies and official information indicate that Marilow is classified as an anti-inflammatory drug. Its action involves targeting inflammatory mediators, which are substances in the body that contribute to inflammation. This anti-inflammatory classification indicates how the medicine is intended to function.

Q: Can I use Marilow if I am allergic to NSAIDs like ibuprofen?

Regulatory documents state that Marilow is contraindicated for patients who have experienced asthma, urticaria (hives), or other allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). The official product information establishes a contraindication in these circumstances due to the known risk.

Q: Is it true that Marilow is a non-opioid pain reliever?

According to the official product information, Marilow is a non-opioid analgesic and is classified as a non-steroidal anti-inflammatory drug (NSAID). This means the way it relieves pain is chemically and functionally distinct from opioid medications.

Q: What is the age limit for using Marilow?

Official product information states that Marilow is not recommended for use in patients under the age of 18. The labeling indicates that its use is limited to the adult patient population.

Q: Is Marilow safe to use if I have an existing heart condition?

Regulatory documents indicate that Marilow should be used with caution in patients with a history of cardiovascular disease or risk factors for heart conditions. This is due to potential risks, including cardiovascular thrombotic events, mentioned in the official labeling. The labeling indicates that a healthcare professional must carefully assess potential benefits against these specific risks before deciding on use.

Q: What should I do if I forget a dose of Marilow?

The official product information states the instruction is to skip the missed dose and continue with the next regularly scheduled dose. Furthermore, regulatory documents clearly state not to take a double dose to compensate for a missed one.

How should Marilow be stored and disposed of?

How to Store and Dispose of Marilow

Marilow (nomegestrol acetate/estradiol) must be stored according to official regulatory specifications to maintain its stability. The medication must be kept out of the sight and reach of children for safety.

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store at or below 30 C
Protection Keep in a cool, dry place, protected from direct light
Packaging Must remain in the original blister packaging

Disposal

Unused or expired Marilow tablets must not be disposed of via wastewater or household trash. Due to its hormonal composition, disposal must occur through a pharmacy or an approved medicine take-back program, in accordance with local environmental regulations.

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

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