GYNOXIN

Route of Administration:

Intravaginal Adults: One 200 mg vaginal capsule at bedtime for 3 days The capsule must be introduced deeply into the vagina. Gynoxin is not greasy, does not soil and can easily be removed with water. Paediatric population The safety and efficacy of Gynoxin in children under 16 years have not been established.

No data are available. The dose recommendation for children aged 16 years or above is the same as for adults.

When used as recommended, Gynoxin is only poorly absorbed and systemic undesirable reactions are not expected. A mild, transient burning sensation may occur after application. 4). In the table below, adverse reactions are reported and listed by MedDRA system organ class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from available data).

System Organ Class Frequency Preferred Terms Reproductive system and breast disorders Very rare Vulvovaginal burning sensation Skin and subcutaneous tissue disorders Very rare Erythema Pruritus Rash General disorders and administration site conditions Not known Application site hypersensitivity Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Some excipients of the vaginal capsules (parahydroxybenzoates) may cause allergic reactions (possibly delayed). Should local sensitisation or an allergic reaction occur, the treatment should be discontinued. The patients should be advised to consult their physician if: - the symptoms have not been relieved within one week - in case of recurrent symptoms (more than 2 infections in the last 6 months) - previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease - age over 60 - known hypersensitivity to imidazoles or other vaginal antifungal products - any abnormal or irregular vaginal bleeding - any blood staining of a vaginal discharge - any vulval or vaginal sore, ulcer or blisters - any associated lower abdominal pain or dysuria - any adverse effects such as erythema, pruritus or rash associated with treatment.

5). Appropriate therapy is indicated when the partner is also infected. 6).

1.