GNH USA

Europe — EMA

Gynoflor®

Gynoflor® vaginal tablet combines estriol and probiotic Lactobacillus acidophilus to treat vulvovaginal atrophy and menopause-related dryness.

Estriol, Lactobacillus Acidophilus, Lyophilized

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What is Estriol, Lactobacillus Acidophilus, Lyophilized?

Gynoflor® is a prescription vaginal tablet that combines estriol and lyophilized Lactobacillus acidophilus. The formulation delivers a local estrogen effect and a probiotic component to support the vaginal epithelium and microbiome. Each tablet provides a calibrated estriol dose that binds vaginal estrogen receptors, while the probiotic restores a lactobacilli‑dominant flora, lowering pH and enhancing comfort.

What is Estriol, Lactobacillus Acidophilus, Lyophilized used for?

Gynoflor® is indicated for the local treatment of estrogen‑deficient conditions of the vagina that commonly occur after menopause.

- Relief of vulvovaginal atrophy symptoms such as dryness, itching, and burning. - Management of genitourinary syndrome of menopause, including dyspareunia and urinary irritation. - Restoration of a normal vaginal microbiome through probiotic activity. - Improvement of vaginal epithelial maturation and lubrication. - Adjunct therapy after systemic hormone replacement when localized effect is preferred.

What are the side effects of Estriol, Lactobacillus Acidophilus, Lyophilized?

Side effects of Gynoflor® are generally mild and related to its local estrogen or probiotic components, and they usually resolve without medical intervention.

Common: - Mild vaginal irritation or spotting after insertion. - Transient increase in vaginal discharge. - Temporary mild abdominal cramping. - Slight burning sensation during intercourse that diminishes with continued use. - Mild itching of the vulvar area.

Serious: - Signs of estrogen excess such as breast tenderness or swelling. - Unexplained vaginal bleeding. - Allergic reaction with rash, itching, or swelling of the face. - Severe pelvic pain or persistent headache.

What precautions apply to Estriol, Lactobacillus Acidophilus, Lyophilized?

Before using Gynoflor® patients should consider several precautions to ensure safe and effective therapy.

- Use only as prescribed; it is a prescription‑only product. - Do not use if you have a known hypersensitivity to estriol or Lactobacillus acidophilus. - Avoid prolonged continuous use beyond the recommended treatment cycle without medical review. - Women with a history of estrogen‑dependent neoplasia should discuss risks with their clinician. - Not recommended during pregnancy or lactation unless specifically advised by a healthcare professional. - Monitor for any unexpected vaginal bleeding and report it promptly.

What does Estriol, Lactobacillus Acidophilus, Lyophilized interact with?

Gynoflor® may interact with other medications or products that influence estrogen activity or vaginal environment.

Avoid: - Systemic estrogen therapy (e.g., oral estradiol) that could increase overall estrogen exposure. - Antifungal or antibacterial vaginal products used concurrently, which may disrupt probiotic colonization. - Hormonal contraceptives containing estrogen if combined systemic estrogen is not indicated. - Topical estrogen creams applied to the same area, which could lead to excess local estrogen.

Use with caution: - Oral selective estrogen receptor modulators (SERMs) such as tamoxifen. - Anticoagulant therapy, as estrogen can affect clotting factors. - Systemic corticosteroids, which may alter mucosal healing. - Antibiotics that may affect the vaginal microbiome, potentially reducing probiotic efficacy.

Frequently asked questions

What is the mechanism by which Gynoflor® relieves vaginal dryness?+
Gynoflor® contains estriol, which binds to estrogen receptors in the vaginal epithelium, promoting cell maturation and increased natural lubrication. The lyophilized Lactobacillus acidophilus helps re‑establish a healthy lactobacilli‑dominant flora, lowering vaginal pH and further supporting moisture.
How should Gynoflor® be inserted for optimal effect?+
The tablet is inserted vaginally, preferably at bedtime, using an applicator or clean fingertip. It should be placed as far up the vaginal canal as comfortably possible to allow even distribution of the active ingredients.
Can Gynoflor® be used together with systemic hormone replacement therapy?+
Yes, it can be used alongside systemic HRT, but clinicians often limit combined estrogen exposure. Patients should discuss the overall estrogen dose with their healthcare provider to avoid excess.
Is Gynoflor® safe for women who have had breast cancer?+
Women with a history of estrogen‑dependent breast cancer should only use Gynoflor® after a thorough risk‑benefit assessment by their oncologist, as estriol is a form of estrogen.
How long does a typical treatment course with Gynoflor® last?+
A common regimen involves daily use for two weeks, followed by a maintenance schedule (e.g., twice weekly). The exact duration should be individualized by a prescriber.
Will Gynoflor® affect menstrual cycles in pre‑menopausal women?+
Because the product delivers estrogen locally, systemic absorption is minimal, and it usually does not alter menstrual patterns in pre‑menopausal women.
What should I do if I experience spotting after using Gynoflor®?+
Mild spotting is a common, transient side effect. If bleeding persists, becomes heavy, or is accompanied by pain, contact a healthcare professional.
Can Gynoflor® be used during pregnancy?+
Gynoflor® is not recommended during pregnancy or lactation unless a physician specifically advises it, because estriol is an estrogen.
Does the probiotic component survive storage and insertion?+
The lyophilized (freeze‑dried) Lactobacillus acidophilus is formulated to remain viable until the tablet dissolves in the vaginal environment, where it can colonize the mucosa.
Are there any dietary restrictions while using Gynoflor®?+
No specific dietary restrictions are required, but maintaining a balanced diet that supports overall vaginal health is advisable.
How quickly can I expect symptom improvement after starting Gynoflor®?+
Many women notice reduced dryness and irritation within a few days, with maximal benefit typically observed after two weeks of consistent use.
Is Gynoflor® available over the counter in the EU?+
No, Gynoflor® is a prescription‑only medication in the European Union and must be prescribed by a qualified healthcare professional.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Estriol, Lactobacillus Acidophilus, Lyophilized
Route
Vaginal Use
Manufacturer
Gedeon Richter Plc.
Origin
EU

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