Gynoflor

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Gynoflor

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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 Gynoflor

Quick Facts

Property Description
Active ingredient Clotrimazole, Metronidazole
Form Vaginal Tablet (Pessary)
Pharmacological class Broad-Spectrum Antimicrobial and Antiprotozoal Combination
Common use Addressing mixed fungal and bacterial/protozoal infections
Origin Synthetic Compound

What is the Identity and Type of Gynoflor?

Gynoflor is a synthetic, prescription-only, fixed-dose combination (FDC) product classified as a Broad-Spectrum Antimicrobial and Antiprotozoal Combination. This medicine is formulated as a vaginal tablet (pessary), a solid preparation designed for direct, local vaginal route administration. The FDC structure is clinically recognized for simplifying complex therapeutic needs through a unified approach to drug delivery, specifically designed to maximize therapeutic convenience and ensure concurrent administration of the two distinct agents.

What is the Composition of Gynoflor?

The core composition utilizes two distinct synthetic compounds as active ingredients: Clotrimazole and Metronidazole. Clotrimazole is an azole antifungal (imidazole derivative) used to manage fungal infections. Metronidazole, belonging to the nitroimidazole class of antimicrobials, is effective against certain bacteria and protozoa. This dual-agent formulation is a key differentiating feature, allowing for the simultaneous counteraction of multiple types of pathogenic organisms frequently identified in cases of mixed vaginal infections.

What is the General Purpose of This Dual-Action Combination?

The primary therapeutic purpose of Gynoflor is to provide comprehensive local action against infections caused by the concurrent presence of fungi, bacteria, and protozoa. The combination provides a synergistic benefit by integrating the unique actions of Clotrimazole and Metronidazole for broad coverage. The formulation is engineered to counter the mixed etiology that often complicates microbial imbalances, intending to relieve associated discomfort, irritation, and inflammation by targeting the broad spectrum of pathogens responsible for these complex local conditions.

What side effects are possible with Gynoflor?

Possible Side Effects and Safety Information

The safety profile for Gynoflor is established by regulatory documents, primarily focusing on localized reactions due to the low-dose, topical administration.

Adverse Reactions and Frequency

Adverse reactions are predominantly localized and occur at a low frequency. The most commonly reported events include:

System-Organ Class Adverse Reaction Frequency Classification
Reproductive system disorders Vulvovaginal burning sensation Low Incidence (Rare)
General disorders Vulvovaginal pruritus (itching) Low Incidence (Rare)

Local irritation, burning, or itching are most commonly experienced shortly after administration and especially at the start of treatment; these effects usually resolve. The finding of undissolved tablet residue on underwear is considered a normal observation.

Safety Restrictions and Contraindications

Regulatory agencies specify that Gynoflor should not be used in patients with the following conditions:

  • Existing or suspected estrogen-dependent malignant tumors, including breast cancer or endometrial cancer, or a history of these conditions.
  • Untreated endometrial hyperplasia.
  • Unexplained bleeding in the genital area.
  • Acute liver disease or severe vaginitis with inflammation.
  • Use in girls before puberty (pre-menarche).

Population-Specific and Monitoring Notes

Gynoflor is generally considered for use during pregnancy and breastfeeding. However, if long-term treatment is necessary, regulatory documents advise regular examinations with attention to symptoms suggestive of endometrial changes.

Due to the ultra-low dose of estriol, the systemic risks typically associated with oral estrogen use (e.g., Venous Thromboembolism, stroke) are not expected to be clinically relevant but remain a theoretical consideration within the regulatory framework.

Overdose and Emergency Response

Overdose Manifestations and Risk Profile

The official regulatory documents specify the course of action and expected manifestations in the event of an overdose of the Clotrimazole and Metronidazole vaginal tablet. The primary risk scenario addressed in the regulatory labeling for this local formulation is accidental oral ingestion of the tablet. Due to the product's design for local administration and the resulting low systemic absorption, the possibility of acute intoxication is considered unlikely.

However, if the tablet is swallowed, documented clinical manifestations may occur, including feelings of dizziness, nausea, and vomiting. These are the specific symptoms cited in official regulatory information concerning overdose.

When to Seek Immediate Medical Help

The official guidance mandates that individuals seek immediate medical attention following the accidental swallowing or ingestion of the vaginal tablet. This action is the required emergency response as stipulated in prescribing information.

In the management of an overdose, regulatory documents confirm that there is no specific antidote known for the components of the vaginal tablet. Therefore, management is focused on providing routine symptomatic measures to address the observed clinical manifestations. Certain official protocols also describe that gastric lavage may be considered, but only under the condition that clinical symptoms are apparent and that adequate measures are in place to protect the airway. No specific monitoring requirements are stated in the acute overdose section of the official labeling.

Therapeutic Uses of Gynoflor

What Gynoflor Treats: Main Uses and Benefits

The Clotrimazole and Metronidazole combination is commonly used for the treatment of mixed vaginal infections. This dual-agent medicine is generally applied when patients experience conditions involving the concurrent presence of both fungi and bacteria/protozoa. It helps in situations where the infection's etiology is complex, and supports the management of common conditions like bacterial vaginosis and vaginal candidiasis when they present together.


The core benefit is the relief provided from disruptive local symptoms. The formulation plays a role in managing intense symptoms related to physical discomfort, such as vaginal itching, burning, and irritation, and is also used for managing symptoms that interfere with daily functioning, specifically addressing abnormal discharge patterns. This support contributes to improved comfort during periods of heightened symptoms.


The combination is applied in addressing symptom clusters that may become intense or disruptive, especially in contexts involving recurrent or episodic manifestations. This approach may assist with maintaining functional stability during phases when symptoms become more noticeable, helping to ease the overall symptom burden.

Quick Fact Relief for Symptom Type
Dual Coverage Addresses concurrent fungal and bacterial/protozoal infections
Symptom Easing Eases symptoms related to inflammatory or irritative states
Context of Use Supports management during recurrent or episodic manifestations

Regulatory References

  1. NIH Clinical Trials Registry

Eligibility and Restrictions for Use

Who Can and Cannot Use Gynoflor?

This section outlines the official population eligibility and mandatory restrictions for Gynoflor (Clotrimazole/Metronidazole Vaginal Tablet) as documented by regulatory authorities.

Permitted and Restricted Populations

Gynoflor is generally permitted for adult women and adolescents aged 16 years and above. Use is also considered acceptable for women who are breastfeeding. Use becomes conditional, requiring prior medical consultation, for women aged over 60 years and for patients with a history of sexually transmitted disease or those experiencing recurrent infections (more than two in six months).

Absolute Contraindications

Use of this medicine is contraindicated if a patient has a known hypersensitivity to Clotrimazole, Metronidazole, or any excipient. The medicine is also strictly contraindicated when there is active presence of vulval or vaginal ulcers, blisters, or open sores. Furthermore, it must not be used in the presence of abnormal, blood-stained vaginal discharge or if discharge is accompanied by systemic signs such as fever, chills, or lower abdominal pain.

Use in Pregnancy

Use during pregnancy is permitted only under the supervision of a physician or midwife. The regulatory label mandates that the vaginal tablet must be inserted without the use of an applicator during this time.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Gynoflor is structured around the systemic effects documented for its active components, Metronidazole and Clotrimazole. Although systemic absorption from the vaginal route is low, regulatory agencies mandate the reporting of established systemic interactions and related precautions.

Interaction-Related Prohibitions and Restrictions

Substance Interaction Classification Required Timing/Restriction
Disulfiram Formal Contraindication Must not be used if taken within the last two weeks.
Alcohol (Ethanol) Disulfiram-like Reaction Risk Must be avoided during therapy and for at least 24 to 72 hours after the final dose.
Latex Contraceptives Physical Damage Risk Alternative precautions are advised for at least five days after treatment, due to potential material damage.
Intravaginal Products Administration Restriction Co-administration with other vaginal products, such as progesterone gel, is restricted.

Exposure and Pharmacodynamic Modification

  • Warfarin and Coumarin Anticoagulants: Official labeling states that Metronidazole may potentiate the anticoagulant effect, resulting in a prolongation of prothrombin time (INR).
  • Lithium: Co-administration has been associated with elevation of serum Lithium concentrations and potential toxicity.
  • Cimetidine: This drug is documented to decrease the plasma clearance and prolong the half-life of the Metronidazole component.
  • Oral Immunosuppressants: The Clotrimazole component may increase the plasma levels of drugs like oral Tacrolimus or Sirolimus.

Population-Specific Interaction Caution

Patients with severe hepatic impairment may experience reduced clearance of the Metronidazole component, which can lead to accumulation and potentially heighten the severity of systemic interactions.

Mechanism of Action

The mechanism involves the co-action of Lactobacillus acidophilus and Estriol.

The product introduces viable Lactobacillus acidophilus into the vaginal environment. The bacterial strain adheres to and colonizes the vaginal epithelium. Proliferation of Lactobacillus acidophilus results in the production of lactic acid. This process of lactic acid generation reduces the vaginal pH, which inhibits the proliferation of pH-sensitive microorganisms.

Estriol, a component of the product, binds to estrogen receptors ( ERs) on the epithelial cells. Receptor binding promotes epithelial cell proliferation and glycogen accumulation. Glycogen serves as a metabolic substrate for lactic acid production by Lactobacillus species, supporting the acidic environment. Estriol exerts a trophic effect on the vaginal epithelium, contributing to its structural integrity.

Dosage and Administration Information

Official Administration Guidelines

Gynoflor is formulated as a fixed-dose combination (FDC) vaginal tablet, which dictates its intravaginal route of administration only. This product typically contains Clotrimazole 100 mg and Metronidazole 500 mg per unit, a composition designed for local action. The usage instructions focus strictly on ensuring proper, consistent application over a defined course.

The standard regimen is one vaginal tablet daily. This dose is consistently scheduled for insertion at bedtime (before sleep). This specific timing is a procedural requirement intended to maximize retention and effectiveness by administering the tablet while the user is non-ambulatory, ensuring the unit dissolves high in the vagina.

Procedural and Course Structure

The medicine is administered as a short-term course of therapy. While duration may vary slightly by specific label, a common protocol specifies a seven-day course of consecutive use. It is a fundamental instruction that the entire course of therapy must be completed, even if symptomatic improvement is noted early in the process. The only preparation required involves ensuring hands are clean before handling and insertion.

No high-level dose adjustments are generally mandated for older adult patients or those with renal or hepatic impairment, as the drug’s administration is localized and not systemic. The official instructions define this standardized protocol for use, adhering to the principle of one unit, once daily, for the prescribed duration.

Recent Clinical Evidence

Research evidence / Overview of studies for Gynoflor

The research into the Clotrimazole and Metronidazole fixed-dose combination (FDC) was studied for complex, co-occurring vaginal infections. The evidence base primarily consists of randomized controlled trials (RCTs) and systematic reviews of those trials, which was observed in research exploring how symptoms change over time. These trials examined treatments for the same pathogens, and research explored short-term symptom changes in symptoms that may vary in intensity.


Evidence for Use in Mixed Infectious Vaginitis

This section summarizes the structure of the primary clinical research, detailing the types of studies that exist (such as randomized trials and meta-analyses) and the key endpoints that were measured in patients with simultaneous fungal and bacterial infections.

The main body of evidence comes from RCTs that was evaluated in adult women with mixed infectious vaginitis. Researchers monitored both patient-reported outcomes describing perceived discomfort and microbiological outcomes, including the clearance of pathogens and whether the vaginal microflora returned to a balanced state. The high-level evidence, derived from meta-analyses that reviewed several trials, was categorized as High and data show patterns related to clinical response and change in the microbiological environment.


Durability of Effect and Post-Treatment Follow-up

Research was studied for not only the immediate outcome following treatment but also the durability of the effect. Studies monitored the rate of infection recurrence, which refers to symptoms or pathogens returning shortly after treatment is finished. These follow-up durations were limited and typically extended for approximately 30 days post-treatment. Long-term effects are not fully established, and there is limited information for long-term outcomes regarding sustained stability of the vaginal environment beyond the immediate follow-up period.


Unanswered Questions and Research Gaps

The evidence highlights what is known, but also where uncertainty remains. A primary research limitation is that long-term effects are not fully established, particularly concerning the prevention of infection recurrence over several months. Additionally, the subgroup findings are uncertain, as comparative evidence is lacking for patients with complex or underlying health issues. The core research was evaluated in adult women in the premenopausal period, and data for certain groups remain insufficient because these populations (e.g., pregnant or older women) were usually excluded from the pivotal research.

Key Studies & References

  1. Metronidazole and Clotrimazole Combination Vaginal Suppository for Mixed Vaginitis (ClinicalTrials.gov entry)
  2. Metronidazole Vaginal (MedlinePlus Drug Information)

Frequently Asked Questions (FAQ)

Common questions about Gynoflor (FAQ)

Q: How quickly do most people notice a change after starting Gynoflor?

Studies describe the initiation of the beneficial effects of the Lactobacillus occurring within a few hours as the vaginal pH begins to lower. The initiation of the estriol effect on the vaginal lining is also noted quickly. Improvement may progress over the course of treatment, according to the official product information.

Q: Is Gynoflor meant for long-term use?

Gynoflor is typically used as a short-term course of treatment. Official information describes the use of repetitive courses in research for the prevention of recurrent issues. However, long-term effects regarding sustained prevention require further clinical investigation.

Q: Do studies support the use of Gynoflor for recurring vaginal issues?

Official studies investigate the use of repetitive courses of therapy for the prevention of recurrent bacterial vaginosis. While this research theme exists, official sources note that further long-term clinical study is needed to fully substantiate the benefit of this prolonged application.

Q: Can women who have gone through menopause still use Gynoflor?

Official product information states that this combination product has been used in both pre- and postmenopausal women. The product is indicated for the treatment of symptomatic vaginal atrophy, a condition often experienced after menopause. Regulatory data show that plasma estriol levels remained within the normal range for postmenopausal women after repeated use.

Q: Is Gynoflor a treatment for Bacterial Vaginosis (BV)?

Gynoflor is indicated for the restoration of vaginal flora following anti-infective therapy and for abnormal vaginal flora. Studies have examined its use in repetitive courses for the prevention of recurring bacterial vaginosis, which relates to a common imbalance in the vaginal flora.

Q: Can Gynoflor interact with products like vaginal washes or douches?

Regulatory guidelines include the instruction that deep vaginal irrigation, such as douching, must be avoided during treatment with Gynoflor. This restriction is in place to support the local action and effectiveness of the vaginal tablet.

Q: Is Gynoflor used to prevent future occurrences?

The product is indicated for use to help prevent recurrent vaginal infections in women. Clinical studies have specifically examined its use in repetitive courses for the long-term prevention of recurrent bacterial vaginosis.

Q: Has Gynoflor been studied in pregnant women?

Official product leaflets state that use during pregnancy and breastfeeding is generally considered. Clinical reviews of the product have noted that the combination did not raise major safety concerns, even when considered during pregnancy.

Q: Does Gynoflor help with vaginal dryness?

The product is indicated for the treatment of symptoms of vaginal atrophy due to estrogen deficiency, which includes the symptom of vaginal dryness. The estriol component's mechanism involves promoting the proliferation and maturation of the vaginal lining.

Q: Is Gynoflor considered a hormone replacement therapy (HRT)?

Gynoflor is described as an ultra-low dose estriol and probiotic combination. Unlike systemic hormone replacement therapies (HRT), the estriol component is intended to have a specific local effect on the vagina without stimulating the uterine lining.

Q: How long after finishing the treatment can I expect the benefits to last?

Research has investigated the durability of the product's benefits, specifically in relation to vaginal atrophy. Research found that maintenance therapy was utilized to support the initial benefits by applying a maintenance dose over a longer period.

Q: Are there any long-term consequences of using Gynoflor?

Due to the ultra-low dose of estriol and local application, systemic estrogen effects are described as unlikely. However, official risk management plans note that potential long-term risks associated with systemic estrogen, such as endometrial hyperplasia, require ongoing monitoring.

Q: Is the estriol component of Gynoflor absorbed into the rest of the body?

Regulatory data indicates that after a single application, the plasma concentration of estriol increases only briefly. After repeated use over a course of treatment, accumulation was not detected, with plasma levels remaining within the normal range of endogenous levels found in post-menopausal women.

Q: Is Gynoflor a form of antibiotic?

Gynoflor is classified by regulatory authorities as a 'Gynecological Anti-infective and Antiseptic.' This is a broad category that includes treatments targeting various pathogens and restoring the natural environment.

Q: Is Gynoflor available over the counter or is it prescription-only?

The dispensing status of Gynoflor can vary significantly depending on the region. Official regulatory documents indicate that in some areas it may be available without a prescription, while in others it is classified as a prescription-only drug.

Q: What is the difference between Gynoflor and other probiotic vaginal suppositories?

Official product descriptions state that Gynoflor is characterized by the combination of both estriol (a hormone) and Lactobacillus acidophilus. This combination provides both the probiotic component and a local trophic effect on the vaginal lining.

Q: Can Gynoflor be used alongside an oral antifungal medication?

Official product information states that Lactobacillus acidophilus is sensitive to various anti-infective agents, including those that may be taken systemically (orally). Simultaneous use of Gynoflor with these types of medications may reduce the effectiveness of the Lactobacillus component.

Q: Can Gynoflor be used during menstruation?

Regulatory guidelines contain a restriction against using vaginal suppositories during menstruation. The instructions suggest waiting until the menstrual period is completely over before continuing the treatment.

Q: What happens if a tablet is missed?

Official instructions address missed doses by stating the dose may be used as soon as remembered; however, if it is nearly time for the next dose, the instruction is to skip the missed one. The instructions also state that a double dose must not be used to compensate.

Q: Are there specific storage instructions for Gynoflor, like refrigeration?

Regulatory instructions specify that the product must be stored under refrigeration, typically between 2 C – 8 C. However, official information describes that storage at room temperature for short periods, such as 1 – 2 weeks, is not reported to compromise efficacy.

Q: Does Gynoflor contain any ingredients that might cause an allergic reaction?

Official contraindications warn against using Gynoflor if a patient is allergic or hypersensitive to any of the listed active ingredients or excipients. This is a standard caution found in official product documentation.

Q: How is Gynoflor different from oral probiotics?

The difference lies primarily in the route of administration and the inclusion of estriol. Gynoflor is applied locally for a more pronounced effect on the vaginal lining, aiming for local results without the systemic effects that can be associated with oral products.

Q: Do you need to use a panty liner while using Gynoflor?

Usage guidelines note that a pad or sanitary napkin may be utilized when inserting Gynoflor. This is because the excipients may not completely dissolve, and some medication residue may be noticed.

Q: Can men use Gynoflor?

The official patient information leaflet explicitly states that Gynoflor is not intended for use by men or boys. The product is consistently described for use in women.

Q: What are the inactive ingredients in Gynoflor?

Official regulatory documents list the excipients (inactive ingredients) in the tablet. These often include substances like microcrystalline cellulose, anhydrous disodium phosphate, lactose monohydrate, magnesium stearate, and sodium glycolate starch.

Q: What does 'vaginal atrophy' mean in relation to Gynoflor?

Vaginal atrophy is a condition related to estrogen deficiency that the product is indicated to treat. The purpose of the product's action in this context is to promote the proliferation and maturation of the vaginal lining.

How should Gynoflor be stored and disposed of?

How to Store and Dispose of Gynoflor

Official regulatory documents define the required storage and disposal procedures for Gynoflor vaginal tablets.

Storage Requirements

The product must be stored at a refrigerated temperature, specifically between 2 C and 8 C. The blister strip must be kept protected in the outer carton until the time of use.

Condition Requirement
Temperature 2 C to 8 C (Refrigerated)
Packaging Keep in original outer carton
Stability Note Efficacy is not affected by storage at room temperature for one to two weeks

All medicines, including Gynoflor, must be stored out of the sight and reach of children.

Disposal

Unused or expired Gynoflor must be handled as pharmaceutical waste. Official instructions state that the medicine should be returned to the pharmacist for disposal. It must not be thrown away in household waste or disposed of in drains or sewerage systems.

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

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