GYNOXIN Vaginal capsule, soft Ref.[49938] Active ingredients: Fenticonazole

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.

The vaginal capsules should not be used in conjunction with barrier contraceptives, spermicides, intravaginal douches or other vaginal products (see section 4.5). Appropriate therapy is indicated when the partner is also infected.

Fenticonazole should be used in pregnancy and breast-feeding under the supervision of a physician (see section 4.6).

No interaction studies have been performed.

Fat excipients and oils contained in the vaginal capsules could damage contraceptives made of latex.

Patients should be advised to use alternative contraceptive methods/precautions while using this product.

Associations not recommended:

• Spermicides: any local vaginal treatment is likely to inactivate a local contraceptive spermicide.

Pregnancy

There are a limited amount of data from the use of fenticonazole in pregnant women. Studies in animals have shown no teratogenic effects, and embryotoxic and foetotoxic effects have been observed only at very high doses administered orally. Low systemic exposure of fenticonazole is expected following vaginal treatment (see section 5.2). Fenticonazole should be used in pregnancy under the supervision of a physician.

Breast-feeding

Animal studies via the oral route have shown that fenticonazole and/or its metabolites can be excreted in the milk. With regard to the negligible absorption of fenticonazole after vaginal administration (see 5.2) any significant transfer into breast milk is not expected. However, as there are no data in humans on fenticonazole and/or its metabolites excretion into the milk following this route of administration, a risk for the baby cannot be excluded. Fenticonazole should be used during the lactation under the supervision of a physician.

Fertility

No human studies of the effects of fenticonazole on fertility have been conducted, however animal studies have not demonstrated any effects of the drug on fertility.

None.

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. Prolonged use of topical products can cause sensitisation (see section 4.4).

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).

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 HPRA Pharmacovigilance. Website: www.hpra.ie.

Not applicable.