FLUGENIL 600 — Vaginal Ovules

Medical device | Dosage form: Vaginal ovules | Pack size: 10 ovules (2 g each)

Medical Description

FLUGENIL 600 is a vaginal medical device formulated as an adjunct in the management of recurrent mycotic vulvovaginal infections and associated vaginal irritation. Its combination of boric acid, Terpinen-4-ol, sodium hyaluronate, Dragocalm® (Avena sativa), rice oil, vitamin E, and triglycerides provides complementary vaginal care.

Boric acid contributes to the formulation's local vaginal environment-supporting properties, while Terpinen-4-ol is a naturally occurring component of tea tree oil known for its antimicrobial properties. Sodium hyaluronate helps maintain vaginal hydration and supports mucosal tissue integrity through its water-retaining and moisturizing properties.

Dragocalm® (Avena sativa), rice oil, and vitamin E contribute soothing, emollient, and antioxidant properties, while the triglyceride blend provides an oily vehicle that helps support the formulation's local protective and moisturizing action.

Together, these ingredients are intended to help relieve itching, redness, and irritation associated with mycotic vaginal infections, support vaginal mucosal hydration, and help maintain a favorable vaginal environment.

Composition

Each vaginal ovule (2 g) contains:

Pack size: 10 vaginal ovules (2 g each).

Indications and Potential Benefits

• Adjunctive Management of Recurrent Mycotic Vulvovaginitis: Supports local vaginal care in women experiencing recurrent fungal infections.
• Relieves Vaginal Itching and Irritation: Helps alleviate discomfort, itching, redness, and irritation associated with mycotic vaginal conditions.
• Supports Vaginal pH Balance: Boric acid helps restore the vaginal pH and maintain the physiological vaginal environment.
• Maintains Vaginal Moisture: Sodium hyaluronate helps hydrate and protect the vaginal mucosa.
• Soothes Vaginal Mucosa: Dragocalm® and rice oil provide soothing and emollient properties.
• Provides Antioxidant Support: Vitamin E contributes antioxidant protection against oxidative damage.
• Supports Vaginal Mucosal Protection: The combination of moisturizing and protective ingredients helps maintain the integrity of vaginal mucosal tissues.

Directions for Use

According to the manufacturer's instructions:

During an active fungal infection:

- Insert 1 vaginal ovule once daily, preferably in the evening before bedtime, for 15 days.

Maintenance treatment for recurrent infections:

- Insert 1 vaginal ovule twice weekly for 8 weeks, following the initial treatment course when recommended by a healthcare professional.

Method of administration:

1. Wash the genital area and hands thoroughly.
2. Remove one ovule from its protective blister.
3. Gently insert the ovule deep into the vagina, preferably before bedtime.

For vaginal use only. Do not swallow. Follow the supplied package leaflet and your healthcare professional's instructions.

Warnings and Precautions

• Do not use in case of known hypersensitivity or allergy to any of the ingredients.
• Pregnancy: Do not use during the first trimester of pregnancy. During later pregnancy, use only after consulting a physician and evaluating the potential benefits and risks.
• Breastfeeding: Consult a healthcare professional before use.
• Discontinue use if local irritation, burning, or sensitization occurs.
• Avoid simultaneous use with other vaginal medical devices or locally administered medications unless specifically recommended by a healthcare professional.
• Not intended for pediatric use.
• Keep out of sight and reach of children.
• Do not use if the packaging is damaged or the product has expired.

Important: Recurrent vaginal symptoms require appropriate medical evaluation to confirm the underlying cause. FLUGENIL 600 is an adjunctive medical device and should not replace prescribed antifungal treatment when indicated.

Storage Conditions

Store below 30°C in a cool, dry place, protected from excessive heat and direct sunlight. Keep the ovules in their original packaging until use.

References

1. Centers for Disease Control and Prevention (CDC) – Vulvovaginal Candidiasis: Diagnosis and Treatment Guidelines. View CDC reference.
2. National Center for Complementary and Integrative Health (NCCIH) – Information on complementary approaches and women's health. Visit NCCIH.
3. Sakura Italia – Official Manufacturer – FLUGENIL 600 Vaginal Ovules: Composition, indications, directions, and precautions. View manufacturer's information.
4. CDC – Treatment of Candidiasis. View treatment guidelines.

Patient Disclaimer

FLUGENIL 600 is a vaginal medical device intended for adjunctive use in the management of recurrent mycotic vulvovaginal conditions and associated vaginal discomfort. It is not intended to replace prescribed antifungal medications or appropriate medical treatment. The described benefits relate to the properties and intended functions of its individual ingredients and do not guarantee the prevention or cure of vaginal infections. Consult a qualified healthcare professional before use, particularly during pregnancy or breastfeeding, or if symptoms persist, worsen, or recur.