Ecoza (Topical)

Vaginitis due to Candida albicans and other yeasts.

For vaginal administration.

Adults:

One pessary should be inserted high into the vagina each evening for three consecutive days. Pregnant women should thoroughly wash their hands before self-administering Gyno-Ecoza (Topical) 150 mg vaginal pessaries.

Children:

Gyno-Ecoza (Topical) 150 mg vaginal pessaries are not indicated for use in children under the age of 16 years.

Elderly:

No specific dosage recommendations or precautions apply.

Hypersensitivity to any imidazole preparation, other vaginal antifungal products, or to any ingredients of Gyno-Ecoza (Topical) 150mg vaginal pessaries.

For intravaginal use only. This preparation is not for oral use.

Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued.

Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.

Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.

Gyno-Ecoza (Topical) 150mg vaginal pessaries should not be used in conjunction with other internal or external treatment of the genitalia.

None known.

The safety of Gyno-Ecoza (Topical) Vaginal Cream and Vaginal Pessaries was evaluated in 3630 patients who participated in 32 clinical trials.

Based on pooled safety data from these clinical trials, the most commonly reported adverse reactions were (with % incidence) pruritus (1.2%) and skin burning sensation (1.2%).

Including the above mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of Gyno-Ecoza (Topical) Vaginal Cream and Vaginal Pessaries from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:

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); and not known (cannot be estimated from the available clinical trial data). All adverse reactions with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence are from post-marketing data.

Adverse Reactions

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 at: www.mhra.gov.uk/yellowcard.

In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically.

Pharmacotherapeutic classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)

ATC code: G01A F05

Econazole nitrate has no anti-inflammatory action, no effects on the circulation, no central or autonomic nervous effects, no effects on respiration, no effect on α or β receptors, no anticholinergic or antiserotonic reactions.

A broad spectrum of antimycotic activity has been demonstrated against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.

Econazole acts by damaging fungal cell membranes. The permeability of the fungal cell is increased. Sub-cellular membranes in the cytoplasm are damaged. The site of action is most probably the unsaturated fatty acid acyl moiety of membrane phospholipids.

Econazole nitrate is poorly absorbed from the vagina and skin. If given orally, peak plasma levels occur six hours after dosing. About 90% of the absorbed dose is bound to plasma proteins. Metabolism is limited, but primarily occurs in the liver. Metabolites are excreted in the urine. Five major and two minor metabolites have been identified.

Low neonatal survival and foetal toxicity was associated with high doses. In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents at maternal subcutaneous doses of 20 mg/kg/day and at maternal oral doses of 10 mg/kg/day. The significance of this in humans is unknown. In repeat dose toxicity studies in rats, at high subcutaneous doses (50 mg/kg/day, 300 mg/m²/day) the liver was identified as a target organ with minimal toxicity and full recovery. The human to animal safety margin for liver toxicity (based on Human Equivalent Dose taking into account normalisation of body surface area) is 32 to 126x for a 50 to 70 kg human based on 2.5 to 7% absorption in humans and 83% bioavailability in rats. No significant topical toxicity, phototoxicity, local dermal irritation, vaginal irritation or sensitization was noted. Only mild ocular irritation was noted with a cream formulation.

None stated.

Not applicable.