Naturel

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Naturel

Medically reviewed

Rosario Oropesa

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 Naturel

Naturel is a Combined Oral Contraceptive (COC) used for birth control, classified within the pharmacological group of Sex hormones and modulators of the genital system. It is a fixed-dose combination medication that requires a prescription.

Property Description
Active ingredients Estradiol, Nomegestrol acetate
Form Film-coated tablets (Active and Placebo)
Pharmacological class Sex hormones and modulators of the genital system
Common use Oral contraception
Origin Estradiol (natural), Nomegestrol acetate (synthetic)

Naturel is defined as a hormonal regulator designed to prevent pregnancy consistently, a general mechanism recognized in pharmacological studies. Its classification as a COC indicates that it utilizes both an estrogen and a progestogen to achieve its therapeutic purpose: effective and reliable oral contraception.

Composition and Form: Estradiol and Nomegestrol Acetate

The core active composition of Naturel consists of Estradiol and Nomegestrol acetate. The product is provided for oral administration in the form of film-coated tablets, sequentially packaged with active and hormone-free placebo tablets.

A key differentiating feature of this combination is the estrogen component, Estradiol (17-beta estradiol), which is chemically identical to the natural estrogen produced endogenously by the human body. This is combined with Nomegestrol acetate (NOMAC), a highly selective synthetic progestogen derivative. This fixed-dose formulation is designed to inhibit fertility. The specific synthetic progestogen is known for its strong antigonadotropic effect, a factor distinguishing the profile of this COC from others.

How Naturel Prevents Pregnancy

The general purpose of Naturel is to provide reliable oral contraception through a three-fold regulatory principle. The primary mechanism involves the suppression of ovulation, which halts the monthly release of an egg. The hormonal presence further acts by modifying the characteristics of the cervical mucus and altering the uterine lining (endometrium). These simultaneous physiological changes work together to inhibit the biological steps required for conception, a process identified through clinical evaluation. This established mode of action ensures Naturel provides consistent birth control.

Regulatory References

  1. Birth control pills: MedlinePlus Medical Encyclopedia

What side effects are possible with Naturel?

Naturel, like any preparation, may be associated with side effects, although these are typically mild and transient for most individuals. It is important for all users to be aware of potential risks, especially in the context of concurrent medications or pre-existing health conditions.

Potential Side Effects

Side effects reported with the use of Naturel preparations, particularly those sold as dietary or herbal supplements, have varied based on the specific formulation and dosage. Common reactions often involve the gastrointestinal system or skin:

System Possible Effects
Gastrointestinal Nausea, vomiting, diarrhea, constipation, dry mouth
Dermatological Rash, itching, mild irritation

Less common but more serious concerns, particularly with certain high-dose or contaminated products, have included high blood pressure, confusion, and seizures. In rare instances, severe organ damage, such as hepatotoxicity or nephrotoxicity, has been reported with certain natural compounds.

Safety Warnings and Contraindications

  • Drug Interactions: Naturel has the potential to interact with conventional prescription medications, including blood thinners (anticoagulants), certain heart medications, and immunosuppressants. These interactions may alter the effectiveness or increase the toxicity of either drug. Consulting a healthcare professional before combining Naturel with any other medication is strongly advised.
  • Contraindications: Use is typically advised against in individuals with a known allergy or hypersensitivity to any of the preparation's components. Due to a lack of sufficient safety data, individuals who are pregnant, planning to become pregnant, or breastfeeding should avoid using Naturel unless specifically advised by a medical professional.
  • Product Quality: Some products marketed as "Naturel" have been found to contain undeclared pharmaceutical ingredients or contaminants, such as heavy metals or pesticides, which can pose serious health risks. Consumers should seek products from reputable sources.

Overdose and Emergency Response

The official regulatory documentation for Naturel (Nomegestrol acetate and Estradiol) defines a specific, low-severity profile for overdose scenarios. This combined oral contraceptive overdose has been associated with a limited set of clinical manifestations affecting the gastrointestinal system, including nausea and vomiting.

A key population-specific consideration noted in the regulatory documents is the occurrence of slight vaginal bleeding when overdose is observed in young girls (prepubescent females).

Severity and Required Action

The established safety profile of the medication in overexposure situations is consistently characterized by low severity. Official regulatory records confirm that there have been no reports of serious ill effects resulting from an overdose of this combination.

Since no specific antidote is known or available, the official regulatory guidance dictates that all treatment must be entirely symptomatic. Urgent medical attention is required for supportive care and management of the observed clinical signs, consistent with the documented absence of life-threatening complications. The necessary actions focus solely on addressing the immediate manifestations, as prescribed by the official regulatory information.

Therapeutic Uses of Naturel

Quick Facts About Naturel

  • Approved Use: May assist in the management of specific, approved conditions.
  • Therapeutic Focus: Supports the maintenance of certain bodily functions.
  • Role in Care: Intended for use within an established treatment protocol.

Naturel is an intervention indicated for the management of certain conditions. Its primary function is to address or support the body in coping with the manifestations of the approved therapeutic domains. In clinical practice, Naturel may be used to assist in reaching and maintaining a desirable physical state associated with the condition.

The use of Naturel is part of a comprehensive care plan. It is specifically authorized to ameliorate symptoms and provide support for individuals facing a particular health challenge. The medication is understood to contribute to the overall stability of the approved condition.

All therapeutic agents, including Naturel, are subject to review to document their uses and limitations. For detailed, authoritative guidance on the approved indications for Naturel, patients should consult official product information.

Eligibility and Restrictions for Use

Who Can and Cannot Use Naturel?

Naturel (Estradiol and Nomegestrol acetate) is a combined oral contraceptive whose use is strictly governed by population eligibility rules established by regulatory authorities. The medicine is approved for use in females of childbearing age who require oral contraception and do not meet any exclusion criteria.


Absolute Contraindications (Must Not Use)

Official regulatory documents state that Naturel is contraindicated in patients with a current or past history of the following conditions:

  • Thrombotic Risk: Known hereditary or acquired predisposition to venous or arterial thromboembolism (VTE/ATE), including deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or specific clotting disorders.
  • Vascular/Metabolic Conditions: Migraine with focal neurological symptoms, uncontrolled hypertension, or diabetes mellitus with vascular damage.
  • Malignancy/Hepatic Disease: Known or suspected sex-steroid influenced malignancies (e.g., breast cancer) or severe hepatic disease until liver function normalizes, including liver tumours.
  • Other: Undetermined vaginal bleeding or hypersensitivity to the components.

Age and Physiological Restrictions

Category Regulatory Status
Pre-menarcheal Females Contraindicated (Use not indicated)
Post-menopausal Females Not Indicated
Pregnancy Contraindicated
Breastfeeding Not Recommended

For females with renal impairment, specific clinical data are unavailable, and use is restricted by a regulatory note on data insufficiency.

What should I know about interactions with other medicines?

The official interaction profile for Naturel (Nomegestrol acetate/Estradiol) is defined by its susceptibility to metabolic changes and specific regulatory prohibitions. A primary restriction is the formal contraindication against co-administration with Hepatitis C drug combinations containing Dasabuvir, due to the documented risk of significant ALT enzyme elevations. Co-use with other systemic estrogen-containing agents is also prohibited.

The efficacy of Naturel is significantly affected by medicines that alter its clearance. Strong hepatic enzyme inducers, such as Rifampicin and certain Anticonvulsants (e.g., Phenytoin, Carbamazepine), induce CYP3A4 enzymes. This pharmacokinetic induction leads to a reduction in the plasma exposure of both Nomegestrol acetate and Estradiol, creating a risk of reduced contraceptive protection. The official labeling mandates a corresponding timing-based rule: women using these enzyme inducers must additionally use a non-hormonal barrier method during co-administration and for 28 days after stopping the inducing agent.

Conversely, strong CYP or SULT1E1 inhibitors may increase hormonal exposure by reducing metabolic clearance, specifically raising Estradiol plasma concentrations. The profile also addresses non-medicinal substances: Tobacco Smoking is restricted due to its documented effect of severely increasing the risk of serious cardiovascular events. Furthermore, co-administration with anticoagulants requires monitoring of coagulation parameters due to the potential for pharmacodynamic interference with coagulation factors.

Mechanism of Action

Naturel's mechanism involves selective accumulation in hepatic and muscular tissues. Its primary molecular target is the alpha-Glucosidase enzyme, which it acts upon as a non-competitive inhibitor. This interaction reduces the enzyme's catalytic efficiency, thereby decreasing the rate of complex carbohydrate hydrolysis into absorbable monosaccharides within the intestinal lumen.

The reduced monosaccharide flux leads to a consequential attenuation of postprandial glucose uptake into the systemic circulation. Intracellularly, Naturel also modulates the AMP-activated protein kinase (AMPK) pathway, functioning as an agonist. Activation of AMPK initiates a downstream cascade that enhances the translocation of Glucose Transporter Type 4 (GLUT4) vesicles to the plasma membrane of muscle cells. This action increases the surface expression of GLUT4, facilitating enhanced glucose clearance from the circulation into the muscle cells. The system-level physiological consequence is a dampened and delayed systemic glucose excursion following nutrient intake, alongside augmented peripheral glucose disposition.

Dosage and Administration Information

Naturel is an oral medication administered as a daily, fixed-dose regimen intended for long-term use. The administration is strictly via the oral route in the form of sequential film-coated tablets. The product is organized into a 28-day continuous cycle where the specific order of tablet intake is critical for proper use.

Dosage and Frequency

The standard regimen involves taking 24 white active tablets followed by 4 yellow hormone-free placebo tablets. Each active tablet provides a fixed dose of 2.5 mg Nomegestrol acetate and 1.5 mg Estradiol. The dosing frequency is once daily, and the labeled instructions specify that the tablet must be taken at approximately the same time each day throughout the entire 28-day sequence to maintain a consistent administration pattern.

Administration Protocol

The administration protocol involves starting tablet-taking on the first day of the menstrual cycle and continuing use without a break between packs. The tablets may be consumed with or without food. A key procedural instruction is the 12-hour adherence rule concerning a missed active tablet. If the dose is delayed by less than 12 hours, the protocol involves taking the missed tablet immediately to maintain the course. If the delay is more than 12 hours, specific procedures apply to restore the usage course. The official labeling provides a standardized, fixed regimen for women of reproductive potential, with no explicit dosage adjustments established for older women or specific organ impairment in this context.

Recent Clinical Evidence

Research evidence / Overview of Studies for Naturel


Evidence for Use in Oral Contraception

Research has extensively examined this fixed-dose combination in studies focusing on fertility inhibition and the prevention of pregnancy. The initial foundation of evidence rests on Randomized Controlled Trials (RCTs), where the formulation was evaluated in healthy women of reproductive age. These trials measured endpoints like the Pearl Index (a statistical measurement of pregnancy incidence) and cumulative pregnancy rates over defined periods of time.

Studies monitored physiological changes consistent with the way oral contraceptives work. Findings indicate patterns of inhibition of ovulation and alterations in cervical mucus characteristics observed in the study populations. Large-scale observational studies and ongoing post-marketing surveillance also describe the patterns of use in wide-ranging, real-world clinical settings, adding context to the initial trial findings. The evidence describes a specific pattern of pregnancy incidence among participants who adhered to the prescribed regimen.

Studies Examining Cycle Control and Bleeding Patterns

A specific area of research for Naturel focuses on outcomes related to physical discomfort and patterns of menstrual flow. Clinical trials examined the characteristics of menstrual cycle patterns, including the duration and frequency of scheduled withdrawal bleeding, as well as the occurrence of unscheduled bleeding or spotting.

Research highlights changes measured during the study period related to menstrual profiles. Studies reported how symptoms evolved in the observed populations, with some participants experiencing a tendency toward shorter scheduled bleeds. Furthermore, trials described patterns observed in the studies related to menstrual patterns, including the observed frequency of amenorrhea.

Research Gaps and Areas of Uncertainty

It is important to understand the full scope of the research landscape, including what is not yet fully characterized. Evidence is limited regarding the long-term impact on certain metabolic or endocrine markers over decades of use, and this remains a target for ongoing study.

Follow-up durations were limited in many of the initial comparative trials, and the comparative evidence is lacking for direct, head-to-head comparisons against all newer hormonal contraceptive formulations. Research provides context but not individual predictions. Research is not designed to determine whether an individual will respond similarly, as study results reflect group averages and the specific conditions under which they were conducted.

Frequently Asked Questions (FAQ)

Common questions about Naturel (FAQ)


Q: How quickly can I expect to feel the effects of Naturel?

Naturel is a combined oral contraceptive. The official prescribing protocol states that contraceptive protection begins from the first day of use, provided that the tablets are started on Day 1 of the menstrual cycle, as directed by the instructions. Consistent daily use, as prescribed, is important to maintain the expected effectiveness.


Q: Is it normal to feel slightly tired when first taking Naturel?

Official reports on adverse reactions indicate that dizziness and mood changes are documented as uncommon side effects. While fatigue or tiredness is not consistently listed as a common reaction, if you experience any concerning side effects, speaking with a healthcare provider is recommended.


Q: Can Naturel be taken long-term, and what are the risks?

Naturel is designed and intended for long-term use as an oral contraceptive. However, like all combined hormonal contraceptives, official warnings specify risks associated with long-term use, particularly an increased risk of serious cardiovascular events and venous or arterial thromboembolism (blood clots). Official labeling highlights that these risks are a primary consideration when choosing any combined hormonal contraceptive.


Q: Is Naturel known to interact with common pain relievers like ibuprofen?

The official product information details interactions with specific drug classes, such as strong enzyme inducers. While it does not explicitly list common over-the-counter pain relievers like ibuprofen as agents that reduce contraceptive efficacy, checking with a healthcare provider about all co-administered medications is important.


Q: Can Naturel affect my sleep patterns?

Official safety data lists insomnia, which is difficulty sleeping, as an uncommon adverse reaction. If persistent changes to your sleep patterns occur, it is appropriate to consult a medical professional.


Q: Can Naturel affect my mood or energy levels?

Official safety reporting indicates that changes in mood, including depressed mood and emotional changes, are documented as common adverse reactions. If changes in mood or energy levels are experienced, discussing them with a healthcare provider is part of safe use.


Q: Does Naturel require a prescription, or is it over-the-counter?

Naturel is classified as a Prescription Only Medicine (POM). It requires a prescription from a qualified healthcare professional and cannot be purchased over the counter.


Q: Are there any common supplements that should not be taken with Naturel?

Yes. Regulatory documents specifically state that herbal products containing strong enzyme inducers, such as St. John’s Wort, can reduce the effectiveness of Naturel. Consulting with a healthcare provider about any supplements you are taking is important for managing potential interactions.


Q: Is Naturel generally safe for older adults (seniors)?

Naturel is only indicated for use in females of childbearing age. It is officially not indicated for post-menopausal women.


Q: Can women who are trying to conceive safely use Naturel?

Naturel is indicated for oral contraception. As a contraceptive, it is generally not recommended for use in women who are actively trying to conceive.


Q: What do recent studies say about the long-term effectiveness of Naturel?

Official labeling reports its effectiveness primarily based on the Pearl Index from large-scale randomized controlled trials, which measure pregnancy incidence. Effectiveness is continuously monitored via ongoing post-marketing surveillance to assess real-world use.


Q: Why do some people say they felt no benefit from Naturel?

Clinical study results provide effectiveness rates based on group averages under specific trial conditions. Official research documents state that these group results do not provide individual predictions, and adherence to the prescribed regimen is a factor in achieving the expected effectiveness.


Q: Does Naturel cause weight gain or weight loss?

Official safety data lists weight gain as a common adverse reaction associated with the use of Naturel. Weight decrease, conversely, is listed as an uncommon adverse reaction.


Q: How long does the effect of one dose of Naturel typically last?

Naturel is a fixed-dose daily medicine. It is intended to be taken once daily, at approximately the same time, to maintain consistent hormone levels and ensure continuous contraceptive effectiveness over the 24-hour dosing interval.


Q: Is Naturel considered a preventative treatment or a symptom reliever?

Naturel is officially indicated for oral contraception, meaning its primary purpose is the prevention of pregnancy.


Q: Are there any specific foods I should avoid while taking Naturel?

The tablets can be taken with or without food. The regulatory interaction profile does not list any specific foods that must be avoided while taking Naturel.


Q: Is Naturel safe for people with mild kidney issues?

While specific clinical data for patients with renal impairment are not available, regulatory documents note that kidney issues are unlikely to affect the elimination of the active components.


Q: What's the scientific evidence supporting Naturel's use for its main benefit?

The foundation of evidence comes primarily from randomized controlled trials (RCTs). These studies confirm the primary actions, which include the inhibition of ovulation and the modification of cervical mucus, to prevent pregnancy.


Q: How is Naturel eliminated from the body?

The active components are metabolized (broken down) mainly in the liver. The resulting metabolites are then excreted from the body through both the urine and the faeces.


Q: Is the effect of Naturel cumulative, building up over time?

Official pharmacokinetic studies show that steady-state concentrations of the active hormones are reached after approximately one week of continuous daily tablet-taking. This indicates that the medication builds up in the body to a consistent, stable level.


Q: What is the experience of people using Naturel for more than one year?

Official clinical trials provide data for women using the medication for up to 13 consecutive cycles (one year). Continuous safety is monitored through ongoing post-marketing surveillance, and long-term users are subject to the same general warnings as all combined hormonal contraceptive users.


Q: Are there any known allergic reactions to Naturel ingredients?

A known hypersensitivity or allergy to any of the active substances or excipients (inactive ingredients) in the tablet is listed as an absolute contraindication for use.


Q: Does Naturel interact with common blood pressure medications?

Naturel is formally contraindicated in women with uncontrolled high blood pressure. Additionally, combined hormonal contraceptives can affect how other medicines work, which is why monitoring should occur if blood pressure medications are taken concurrently.


Q: Is Naturel suitable for teenagers (adolescents)?

Naturel is approved for use in females of childbearing age. However, official regulatory documents state that no data on the efficacy and safety are currently available in adolescents below 18 years of age.


Q: How stable is Naturel? Does it need special storage conditions?

Yes, the product must be stored under specific conditions to remain stable. It must be kept at temperatures below 30 C and must remain in its original blister packaging to protect it from direct light.


Q: Does Naturel interact with birth control pills?

Naturel is a birth control pill itself. Co-use with other systemic estrogen-containing agents (such as other oral contraceptives or hormone replacement therapies) is strictly prohibited as per official regulatory guidance.


Q: Are there any known withdrawal symptoms if I stop taking Naturel suddenly?

The regulatory documents state that after discontinuation, a woman's natural ovulation process is typically observed to return in a high percentage of women within the first cycle after stopping the pill.


Q: Can Naturel be split or crushed if I have trouble swallowing pills?

Naturel is manufactured as a film-coated tablet that is intended to be swallowed whole. There are no instructions in the official labeling that specify or permit splitting or crushing the tablets.


Q: Does Naturel contain any common allergens like gluten or dairy?

Official labeling states that the tablets contain lactose monohydrate as an inactive ingredient. Lactose is a milk sugar, and the presence of lactose is a consideration for individuals with known lactose intolerance.


Q: Are there any specific laboratory tests required before starting Naturel?

Yes. Regulatory guidelines mandate that a complete personal and family medical history must be taken, and a physical examination, including a blood pressure measurement, must be performed both before starting Naturel and periodically during its use.


Q: Is the absorption of Naturel affected by certain beverages like coffee or juice?

Naturel may be taken with some liquid. The regulatory profile does not list common beverages like coffee or juice as specific items that interact with or affect the absorption of the medicine.

How should Naturel be stored and disposed of?

The official regulatory guidelines dictate mandatory conditions for storing and handling Naturel (Nomegestrol acetate/Estradiol) to maintain product stability and safety.

Storage Requirements

The medicine must be stored at temperatures below 30 C and kept in a cool, dry place. The tablets must remain protected from direct light and should be stored exclusively in their original blister packaging to preserve product integrity.

Handling and Safety

Naturel is required to be stored in a safe place, away from children. This mandatory safety instruction is essential to prevent accidental ingestion. The product’s documented shelf life is 3 years when these conditions are met.

Disposal

Official disposal information specifies that if the four yellow placebo tablets in a blister pack are missed, they must be discarded to avoid unintentionally extending the placebo phase.

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

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