Europe — EMA
Gynoflor
Gynoflor vaginal tablet combines estriol and Lactobacillus acidophilus for treating vulvovaginal atrophy, dryness, and recurrent UTIs in menopausal women.
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What is Estriol, Lactobacillus Acidophilus, Lyophilized?
Gynoflor is a prescription vaginal tablet that combines the estrogen estriol with the probiotic Lactobacillus acidophilus. Each ovule delivers a low‑dose estriol formulation together with lyophilized Lactobacillus to support the vaginal epithelium and normal flora. The product is marketed in the European Union for local treatment of estrogen‑deficiency symptoms of the vagina and is supplied as a sterile tablet for intravaginal use under medical supervision for women.
What is Estriol, Lactobacillus Acidophilus, Lyophilized used for?
Gynoflor is indicated for the local management of estrogen‑related changes in the vaginal tissue that occur after menopause or other causes of low estrogen.
- Relief of vaginal dryness associated with vulvovaginal atrophy. - Reduction of dyspareunia (painful intercourse) caused by thinning of the vaginal lining. - Improvement of urinary symptoms linked to atrophic changes, such as urgency or recurrent urinary tract infections. - Restoration of a healthy vaginal microbiome through the probiotic component. - Prevention of recurrent urinary tract infections in women with a history of atrophic vaginitis.
What are the side effects of Estriol, Lactobacillus Acidophilus, Lyophilized?
The safety profile of Gynoflor reflects the local action of estriol and the probiotic, with most adverse events being mild, transient, and limited to the application site. Systemic absorption is low, so side effects are generally confined to the genital tract.
Common: - Mild vaginal irritation or burning sensation after insertion. - Spotting or light vaginal bleeding. - Increased vaginal discharge that is clear or white. - Temporary increase in vaginal itching. - Temporary sensation of pressure or fullness in the pelvic area.
Serious: - Allergic reaction such as rash, hives, or swelling of the face, lips, or throat. - Signs of estrogen excess, including breast tenderness or uterine bleeding not related to the medication. - Development of endometrial hyperplasia with prolonged use (rare).
What precautions apply to Estriol, Lactobacillus Acidophilus, Lyophilized?
Before prescribing Gynoflor, clinicians should evaluate individual risk factors and consider contraindications related to estrogen exposure and probiotic use.
- Do not use in women with known or suspected estrogen‑dependent neoplasia, such as breast or endometrial cancer. - Avoid in cases of unexplained vaginal bleeding until the cause is identified. - Caution in patients with a history of thromboembolic disorders, as systemic estrogen may increase risk. - Use carefully in women with severe liver disease, which can alter hormone metabolism. - Assess for hypersensitivity to estriol, Lactobacillus acidophilus, or any excipients. - Consider the benefit‑risk balance in pregnant or breastfeeding women, as safety data are limited.
What does Estriol, Lactobacillus Acidophilus, Lyophilized interact with?
Gynoflor may interact with other medications that influence estrogen metabolism or vaginal flora, and certain systemic therapies can affect its safety profile.
Avoid: - Concomitant use of systemic estrogen therapy or high‑dose hormonal contraceptives, which may increase overall estrogen exposure. - Use with potent antifungal or antibacterial vaginal agents that could disrupt the probiotic component.
Use with caution: - Systemic aromatase inhibitors or selective estrogen receptor modulators (SERMs) that alter estrogen pathways. - Anticoagulant therapy, because estrogen can modestly affect clotting factors. - Antibiotics taken orally that may reduce Lactobacillus colonization, potentially diminishing the probiotic benefit.
Frequently asked questions
What is the mechanism of action of Gynoflor vaginal tablets?+
Who can benefit from using Gynoflor?+
How is Gynoflor administered?+
Is Gynoflor available over the counter?+
Can Gynoflor be used together with systemic hormone replacement therapy?+
What are common side effects of Gynoflor?+
Are there any serious risks associated with Gynoflor?+
Should Gynoflor be avoided in women with a history of breast cancer?+
How does the probiotic component of Gynoflor work?+
Is it safe to use Gynoflor during pregnancy?+
Can antibiotics reduce the effectiveness of Gynoflor?+
What should I do if I experience unexpected vaginal bleeding while using Gynoflor?+
Product details
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