Europe — EMA
Gynofort
Gynofort is a 2% butoconazole nitrate vaginal cream for treating vulvovaginal candidiasis. Learn uses, side effects, precautions and interactions.
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What is Butoconazole Nitrate?
Gynofort is a prescription vaginal cream containing 2 % butoconazole nitrate, an azole antifungal agent. It is formulated for intravaginal use to treat fungal infections of the female genital tract. The product is marketed in the European Union and is classified as a prescription‑only medication. Its mechanism of action involves inhibition of ergosterol synthesis, which disrupts fungal cell membranes and helps restore normal vaginal flora.
What is Butoconazole Nitrate used for?
Gynofort is indicated for the treatment of vaginal yeast infections caused by susceptible Candida species.
- Acute vulvovaginal candidiasis (yeast infection of the vagina). - Symptomatic relief of itching, burning, and discharge associated with candidal infection. - Treatment of recurrent vulvovaginal candidiasis when prescribed by a healthcare professional. - Use as part of a comprehensive management plan for fungal vaginitis in adult women. - Adjunct therapy for mixed infections where a fungal component is confirmed.
What are the side effects of Butoconazole Nitrate?
Possible adverse reactions to Gynofort may occur locally in the vagina or systemically, although systemic effects are rare.
Common: - Mild irritation or burning at the application site. - Vaginal itching or redness. - Slight increase in vaginal discharge that is watery or white. - Unpleasant odor from the cream.
Serious: - Severe allergic reaction such as rash, hives, or swelling of the face, lips, or tongue. - Persistent or worsening vaginal irritation. - Signs of secondary bacterial infection (e.g., fever, foul‑smelling discharge).
What precautions apply to Butoconazole Nitrate?
Before using Gynofort, certain precautions should be considered to ensure safe and effective treatment.
- Confirm diagnosis of Candida infection; avoid use for bacterial or viral vaginitis. - Do not use if you are allergic to butoconazole nitrate or any azole antifungal. - Discuss pregnancy or breastfeeding status with a healthcare provider, as safety data are limited. - Avoid using other intravaginal products (e.g., douches, spermicides) during treatment. - If symptoms persist beyond the recommended course, seek medical advice. - Keep the cream out of reach of children and store at room temperature.
What does Butoconazole Nitrate interact with?
Gynofort may interact with other medications or products applied to the vagina, potentially affecting efficacy or safety.
Avoid: - Concurrent use of other intravaginal antifungal agents, which may increase local irritation. - Use with vaginal contraceptives containing spermicidal agents, as they can reduce the effectiveness of the cream.
Use with caution: - Systemic azole antifungals (e.g., fluconazole) because combined antifungal activity may increase risk of adverse effects. - Hormonal contraceptives, although no direct interaction, monitor for any changes in menstrual symptoms. - Topical corticosteroids applied vaginally, which could mask irritation signs.
Frequently asked questions
What is the active ingredient in Gynofort and how does it work?+
How is Gynofort applied for vulvovaginal candidiasis?+
Can Gynofort be used during pregnancy?+
Is Gynofort available over the counter?+
What are common side effects of Gynofort?+
When should I seek medical attention while using Gynofort?+
Can I use other vaginal products while treating with Gynofort?+
Does Gynofort interact with oral antifungal medications?+
How long does it take for symptoms to improve after starting Gynofort?+
What should I do if my symptoms do not improve after treatment?+
Is Gynofort safe for breastfeeding mothers?+
How should Gynofort be stored?+
Product details
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