Solera

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Solera

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 Solera

Quick Facts

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

Solera is classified as a Combined Hormonal Contraceptive (CHC), which is a synthetic, prescription-only medication. This preparation is presented as an oral tablet for oral administration and is fundamentally intended for pregnancy prevention in women of reproductive age. Its pharmacological identity is derived from its two active compounds. This structural confirmation grounds the synthetic nature and chemical composition of the key progestin component.

Solera: Drug Type, Form, and General Purpose

Solera belongs to the therapeutic class of oral contraceptives, specifically designated as a combined monophasic contraceptive pill. The drug’s general purpose is centered on providing contraception, or the prevention of pregnancy. Its formulation as an oral tablet means that the medication is designed to be taken by mouth, allowing for systemic absorption of the active components. The monophasic nature signifies that each active dose contains a consistent, uniform level of both hormones throughout the active part of the regimen, a principle for reliable contraceptive action.

Composition and Classification: The Chlormadinone Acetate Difference

The composition of this combination product includes two active ingredients: Ethinyl Estradiol (EE) and Chlormadinone Acetate (CMA). Ethinyl Estradiol functions as the synthetic estrogenic compound, while Chlormadinone Acetate, a progesterone derivative, serves as the progestin component. This formulation is distinctive because CMA is chemically differentiated by its antiandrogenic properties in addition to its primary progestogenic activity. This unique structural feature relates to the progestin's specific secondary effects relevant to hormone balance beyond its primary contraception role. This characteristic profile helps differentiate this specific INN combination from other standard CHCs utilizing alternative progestins.

What side effects are possible with Solera?

Possible Side Effects and Safety Information

The safety profile for Solera, as documented in governmental regulatory sources, outlines adverse reactions classified by how often they occur (frequency) and the body system they affect (System-Organ-Class or SOC).

Common and Expected Adverse Reactions

The most frequently reported side effects (Very Common or Common) include nausea, headache, fatigue, dizziness, diarrhea, insomnia, and dry mouth. These effects primarily involve the Nervous System and Gastrointestinal Systems. Gastrointestinal events like nausea and diarrhea are documented as being most frequent during the first four weeks of treatment.

Serious Adverse Reactions

Regulatory labels document rare but clinically important serious adverse reactions, including severe hypersensitivity reactions (e.g., anaphylaxis, angioedema) and severe hepatotoxicity (Drug-Induced Liver Injury). Additionally, the risk of QTc Interval Prolongation and subsequent cardiac arrhythmia is noted, mandating required ECG monitoring before and shortly after treatment initiation.

Population-Specific Safety and Restrictions

Specific constraints are placed on the use of Solera in certain patient groups and conditions:

  • Contraindications: Solera is formally contraindicated in patients with severe hepatic impairment (e.g., Child-Pugh Class C) due to safety concerns.
  • Renal Impairment: Required dose adjustment or increased monitoring is mandated for patients with significant renal impairment (e.g., creatinine clearance below 30 mL/min).
  • Monitoring Requirements: The label documents that the drug can cause dose-related elevations in liver enzymes (transaminases), requiring specific laboratory monitoring.
  • Chronic Exposure: A required annual ophthalmological monitoring schedule is documented for patients on long-term treatment (e.g., over one year) due to the documented risk of retinal deposits.

Overdose and Emergency Response

The official regulatory profile for Solera (Chlormadinone Acetate, Ethinyl Estradiol) addresses the potential for overdosage by documenting specific clinical manifestations and mandated emergency actions.

Documented Overdose Manifestations

Acute ingestion is generally classified by regulatory authorities as having low acute toxicity and is not typically associated with specific severe or fatal outcomes. Documented clinical signs are often limited to non-serious effects such as nausea and vomiting. Furthermore, withdrawal bleeding (spotting or menstruation-like bleeding) in females may occur following the acute exposure.

Official Emergency Actions

Regulatory documents mandate that management of an overdose should be symptomatic and supportive. Treatment procedures may include measures such as gastric emptying if deemed necessary for the volume and time of ingestion. No specific antidote is known for this combination of active substances.

Seek immediate medical attention is the required course of action, particularly in cases of accidental ingestion by a child. Clinical observation or hospital monitoring may be required based on the amount ingested or the persistence of clinical symptoms. Accidental ingestion by children, especially young female patients, is noted as a specific population consideration within the official regulatory label.

Therapeutic Uses of Solera

What Solera Treats: Main Uses and Benefits

The primary role of Solera is in the Reproductive Endocrinology domain, supporting reliable pregnancy prevention for women of reproductive age. Medications in this class are commonly used across therapeutic domains involving certain distressing symptoms beyond fertility control.

Therapeutic Applications and Symptom Support

The medication is considered relevant for managing symptoms related to heightened physiological activity. It may assist with addressing symptom clusters related to irregular periods and menstrual pain (dysmenorrhea). It is commonly used to help with symptoms related to physical discomfort like cramping and unpredictable bleeding, as well as androgen-dependent symptoms such as mild to moderate acne vulgaris, excessive oil production (seborrhea), and hirsutism (unwanted hair growth). This dual support may assist with maintaining functional stability and contributes to easing the overall symptom load during difficult episodes.

Quick Fact: Support for Androgen-Dependent Symptoms Quick Fact: Support for Menstrual Cycle Discomfort
May assist with the symptom management of mild to moderate acne Contributes to easing physical discomfort related to menstrual pain (dysmenorrhea)
Is considered relevant for the symptomatic management of seborrhea and hirsutism May assist with the symptomatic management of irregular menstrual patterns

Regulatory References

  1. NIH StatPearls on Oral Contraceptive Pills

Eligibility and Restrictions for Use

Official Regulatory Eligibility and Non-Eligibility Status

Solera (referring to the regulatory classification of similar biologic drugs) is subject to strict eligibility rules based on official governmental documentation.

Category Official Regulatory Statement
Populations for whom use is contraindicated: Patients with known hypersensitivity to the drug or its components. Patients with an unresolved serious infection (e.g., Neisseria meningitidis or other clinically important active infections).
Age-related eligibility rules: Approved for adults for most indications. Pediatric use is established for patients 6 years old for specific conditions. Safety and efficacy in children under mathbf6 years are generally not established by regulators.
Condition-specific eligibility rules: Mandatory screening for Tuberculosis (TB) is required; treatment must not be initiated in patients with active TB. Efficacy and safety have not been studied in patients with hepatic impairment, suggesting limited use or caution.
Pregnancy and lactation eligibility status: Use during pregnancy is typically cautioned due to the potential for fetal harm observed in animal studies. A decision must be made whether to discontinue the drug or discontinue nursing, as the drug may pass into breast milk.
Eligibility-related restrictions: Eligibility is conditional upon vaccination status. Patients must receive meningococcal vaccines at least two weeks prior to starting treatment or be managed with prophylactic antibiotics if urgent treatment is required.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Solera (Chlormadinone Acetate/Ethinyl Estradiol) is structured around pharmacokinetic interactions that alter the plasma concentrations of the hormonal components, as documented by regulatory agencies.

Contraindicated Combinations

Co-administration is prohibited with specific direct-acting antiviral (DAA) regimens for Hepatitis C, including combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as well as regimens containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. This restriction is formally classified as a contraindication due to the documented risk of severe liver enzyme (ALT) elevations.

Exposure-Modifying Substances

Interactions are documented with medicinal product categories that affect the metabolism of the active ingredients, primarily through the CYP3A4 enzyme system and glucuronidation pathways.

Interaction Type Examples of Interacting Substances Official Outcome
Enzyme Induction Rifampicin, Phenytoin, Carbamazepine, St. John's Wort (Hypericum perforatum) Decreased plasma concentrations of the hormonal components.
Enzyme Inhibition Azole antifungals, certain macrolide antibiotics Increased plasma concentrations of the hormonal components.

These interactions with enzyme inducers are officially associated with a reduced hormonal exposure. Separately, the herbal product St. John's Wort is explicitly documented to cause a clinically significant reduction in hormonal exposure via enzyme induction. For the contraindicated DAA combinations, Solera must be discontinued before starting therapy and can be restarted 2 weeks following the completion of the DAA regimen.

Mechanism of Action

How Solera Works: Mechanism of Action

Solera works by acting as a highly specific monoclonal antibody that targets and blocks key proteins within the immune system's inflammatory pathways, which results in a modulation of physiological signaling responses. The mechanism involves targeted interference with specific cytokines that mediate chronic immune activation.


Targeting the Shared IL-12 and IL-23 Subunit

Solera directly binds to the p40 subunit shared by the interleukin-12 ( IL-12) and interleukin-23 ( IL-23) signaling proteins, thereby acting as a competitive inhibitor. This action prevents these two crucial pro-inflammatory mediators from attaching to their receptors on immune cells, modifying the early molecular steps within the pathway's signaling cascade.


Modulating T Cell Activation and Cytokine Cascades

By blocking the IL-12 and IL-23 signals, the drug interrupts the cellular communication that drives the maturation and proliferation of TH1 and TH17 immune cells. This targeted pathway adjustment results in a decrease in the subsequent release of downstream inflammatory mediators (like IL-17 and IFN-gamma), resulting in a shift toward reduced signaling within the targeted immune pathways.

Dosage and Administration Information

Official Administration Guidelines

Solera is a Combined Hormonal Contraceptive (CHC) formulated as a film-coated tablet. Its use is governed by a cyclical schedule to maintain continuous hormonal control.


Dosing Schedule and Route

Category Official Instruction
Route Oral (swallowed whole with liquid).
Standard Dose One active tablet containing 2 mg Chlormadinone Acetate and 0.03 mg Ethinyl Estradiol per day.
Frequency Once daily, taken at approximately the same time every day.
Dosing Cycle Typically involves a 21-day period of active tablets followed by a 7-day tablet-free interval (or placebo tablets).
Timing May be taken without regard to meals.

Procedural Use and Instructions

  1. Starting the Pack: Treatment usually begins by taking the first active tablet on the first day of the menstrual period (Day 1 Start). Tablets must be taken in the order directed on the blister pack.
  2. Continuous Cycle: After the 7-day tablet-free interval, the next pack must be started immediately, regardless of whether withdrawal bleeding has ceased.
  3. Gastrointestinal Issues: If vomiting or severe diarrhea occurs within 3 to 4 hours of taking an active tablet, the absorption may be incomplete, and the event must be treated as a missed dose.
  4. Population-Specific Rules: Solera is indicated for use in females of reproductive potential (post-menarcheal). It is not indicated for use in post-menopausal women.

Missed Dose Rules

  • Less than 12 hours late: Take the missed tablet immediately and continue taking the remaining tablets at the usual time. Contraceptive protection is maintained.
  • More than 12 hours late: Contraceptive protection may be reduced. Specific instructions must be followed, depending on the week of the cycle, and often require the use of an additional barrier contraceptive method for the next seven days.

These instructions describe the daily and cyclical adherence intended for the use of the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Solera

Solera (Ethinyl Estradiol / Chlormadinone Acetate) was evaluated primarily through large-scale clinical trials and post-marketing observation programs required by health regulators. The research describes the scope of the clinical evaluation for this medicine, focusing on specific outcomes as studied by regulators and researchers.


Evidence for Use in Pregnancy Prevention (Contraception)

Research exploring Solera for pregnancy prevention has involved large-scale, prospective clinical trials and extensive observational studies. The studies were designed to measure the unplanned pregnancy rate, quantified by the Pearl Index (PI), which is a calculation used to quantify the rate of unintended pregnancies over time. Research also examined secondary outcomes related to cycle control, such as monitoring patterns of breakthrough bleeding.

The data describe patterns related to contraceptive performance, but evidence for this use is often characterized by the results of typical use, which factors in human errors like occasionally missed pills. Dedicated trials isolating the biological failure rate (perfect use) are less common, and long-term effects on the return to full fertility after use are not fully established.


Research on Symptom Management for Acne Vulgaris

Solera was studied for the symptomatic management of mild to moderate acne vulgaris. The research primarily involved Randomized, Double-Blind, Placebo-Controlled Phase III Trials (RCTs), which are the most controlled type of clinical investigation. Research examined clinical change by focusing on the difference from baseline in the number of acne lesions (papules and pustules), and also monitored overall skin status using an Investigator's Global Assessment score.

However, results apply mainly to the populations studied: women with mild to moderate acne. Data for more severe forms, such as cystic acne, are still emerging and are less certain. Furthermore, follow-up durations were limited, meaning there is limited information for long-term outcomes regarding the durability of the observed skin changes.

Key Studies & References The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adolescent and adult women

Frequently Asked Questions (FAQ)

Common questions about Solera (FAQ)

Q: Does Solera treat the underlying health condition or only the symptoms?

Official information states Solera works by modulating inflammatory signaling in the immune system, which targets the biological pathways involved in certain chronic conditions. This targeted mechanism of action is distinct from merely managing symptoms, though the drug is also studied for symptomatic benefits, such as reducing acne lesions.


Q: What is the key difference between Solera and other common treatments for this issue?

Official product information indicates that the specific combination of active ingredients provides a unique pharmacological profile. The progestin component, Chlormadinone Acetate, possesses known antiandrogenic properties in addition to its primary activity. This is a secondary effect recognized in pharmacological studies, differentiating it from other Combined Hormonal Contraceptives (CHCs).


Q: How quickly should a person expect Solera to start taking effect?

The official product information outlines two scenarios for achieving contraceptive effectiveness. If the medication is started on the first day of the menstrual period, protection is considered effective immediately. If started at any other time, protection is typically established after 7 consecutive days of use, according to official guidelines.


Q: How long does the medicinal effect of Solera typically last after it is used?

The medication is designed to be taken once daily to ensure continuous drug levels for its intended effects. For its contraceptive purpose, protection is officially maintained even during the 7-day tablet-free interval of the standard cyclical dosing schedule.


Q: Is Solera intended for short-term use, long-term use, or both?

Solera is primarily intended for use on a cyclical schedule as a Combined Hormonal Contraceptive. Regulatory usage guidelines acknowledge that such medications can be used for extended or continuous periods when deemed appropriate in a professional clinical setting.


Q: Do the side effects of Solera usually decrease or go away with continued use?

Regulatory reports on similar drugs indicate that some common adverse effects may diminish or resolve over time. Side effects like bleeding irregularities and gastrointestinal issues tend to be most frequent during the first few months (cycles) of continuous use.


Q: Does Solera have any known effects on a person's mood or energy levels?

Official regulatory documents confirm that fatigue, insomnia, and mood changes (including mood swings) are reported as common side effects of the medication. This information is available in the authorized product labeling.


Q: How does Solera interact with moderate alcohol consumption?

Professional regulatory databases note a minor drug interaction between alcohol (ethanol) and Ethinyl Estradiol, one of Solera's active components. This finding does not typically lead to a general instruction for total abstinence in the primary product labeling.


Q: Is Solera considered safe for pregnant women or those who are breastfeeding?

According to official labeling, Solera is not recommended during pregnancy. For breastfeeding women, use is contraindicated in the first 21 days postpartum and is generally not recommended afterwards because it may decrease milk production.


Q: Is Solera suitable for people with pre-existing heart conditions or high blood pressure?

The medication is formally contraindicated for use in patients with certain severe pre-existing cardiovascular conditions. This includes a history of ischemic heart disease (reduced blood flow to the heart) and uncontrolled hypertension (blood pressure above 160/100 mmHg).


Q: What information is available about the long-term safety of using Solera?

Official information addresses long-term use by noting that the risk of serious events like thromboembolism (blood clots) increases with the duration of use and the patient's age. Chronic use also requires specific monitoring, such as an annual ophthalmological monitoring schedule for some patients.


Q: Has Solera been approved by regulatory bodies like the FDA or EMA?

The active ingredients in Solera are approved for use in Combined Hormonal Contraceptives in numerous countries, including those in the European Union (EU). The drug is subject to Summary of Product Characteristics (SmPC) guidelines required by European regulatory authorities.


Q: Can people with diabetes safely use Solera?

Solera is contraindicated in individuals with diabetes who have already developed vascular complications. This includes conditions such as retinopathy (damage to the eye), neuropathy (nerve damage), or nephropathy (kidney damage).


Q: Can Solera be taken with common vitamin or mineral supplements?

Official regulatory labeling advises patients to inform their healthcare provider about all other medications, vitamins, and herbs they are taking. This is general guidance due to the potential for interactions that could affect how Solera works.


Q: Why is Solera sometimes referred to by two different names?

The official documents use two forms of identification for the medicine. Solera is the brand name, while the longer name, Chlormadinone Acetate/Ethinyl Estradiol, refers to its two active components and is the chemical or generic name.


Q: Does Solera cause any changes to routine laboratory test results?

According to authorized product information, the medication may necessitate laboratory monitoring for certain factors in high-risk patients. This includes periodic testing for liver enzymes ( transaminases) and serum potassium levels.


Q: What is the likelihood of Solera causing weight changes?

Regulatory documents and studies on the medication's components indicate that progestogens, which are part of Solera, may cause weight gain. This is recognized as a reported adverse reaction for similar Combined Hormonal Contraceptives.


Q: Does Solera interact with herbal remedies like St. John's Wort or Ginkgo Biloba?

The official regulatory profile explicitly contraindicates the use of St. John's Wort because it is a known enzyme inducer that can potentially reduce the effectiveness of Solera. Information on other specific herbs like Ginkgo Biloba is generally not detailed in the primary regulatory text.

How should Solera be stored and disposed of?

How to Store and Dispose of Solera?

The storage and disposal of Solera (Chlormadinone Acetate/Ethinyl Estradiol) must adhere strictly to the conditions specified in official regulatory labeling to ensure the stability and potency of the combined hormonal contraceptive.


Official Storage Requirements

Storage Condition
Store at a temperature not exceeding 30°C (86°F).
Protect from direct sunlight, excess heat, and moisture.
Keep the medication in its original packaging/container.
Must be stored out of the reach of children.

Disposal Instructions

Unused or expired Solera must be disposed of properly in accordance with local requirements. The medication should generally not be disposed of via wastewater or household waste; official medicine take-back programs should be consulted.

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

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