Gyno-Coryl is indicated for the treatment of vaginitis due to Candida albicans and other yeasts.

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-Coryl 150 mg vaginal ovules.
Children:
Gyno-Coryl 150 mg vaginal ovules are not indicated for use in children under the age of 16 years.
Elderly:
No specific dosage recommendations or precautions apply.
Method of administration:
For vaginal administration

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 (see section 4.5).
Econazole nitrate vaginal ovules should not be used in conjunction with other internal or external treatment of the genitalia.

Econazole is a known inhibitor of CYP3A4/2C9. Due to the limited systemic availability after vaginal application (see section 5.2. Pharmacokinetic Properties), clinically relevant interactions are unlikely to occur but have been reported with oral anticoagulants. In patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.

Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with
econazole.
Contact between latex products such as contraceptive diaphragms or condoms and this product must
be avoided since the constituents of the product may damage the latex. Patients using spermicidal
contraceptives should consult their physician since any local vaginal treatment may inactivate the
spermicidal contraceptive

Pregnancy
In animals, econazole nitrate has shown no teratogenic effects but is foetotoxic at high doses. The significance of this to man is unknown as there is no evidence of an increased risk when taken in human pregnancy. However, animal studies have shown reproductive toxicity (see section 5.3).
Because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.
Breast-feeding
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using econazole nitrate vaginal ovules if the patient is breast-feeding
Fertility
Results of econazole animal reproduction studies showed no effects on fertility.

None known

The safety of econazole nitrate vaginal cream and vaginal ovules 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 econazole nitrate cream and vaginal ovules from either clinical trial or post-marketing experiences. Frequencies are defined using 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), not known (cannot be estimated from the available 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.

Immune System Disorders:

Not known : Hypersensitivity

Skin and Subcutaneous Tissue Disorders :

Common (≥1/100 to <1/10) : Pruritus, Skin burning sensation.

Uncommon (≥1/1,000 to <1/100) : Rash

Rare (≥1/10,000 to<1/1,000) : Erythema

Not known : Angioedema, Urticaria, Contact dermatitis, Skin exfoliation

Reproductive System and Breast Disorders : 

Uncommon (≥1/1,000 to <1/100) : Vulvovaginal burning sensation

General Disorders and Administration Site Conditions:

Not known : Application site pain, Application site irritation, Application site swelling

Adverse events associated with overdose or misuse of econazole nitrate vaginal ovules are expected to be consistent with adverse drug reactions already listed in section 4.8. (Undesirable effects).
In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat
symptomatically.

Pharmacotherapeutic group: 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 ß 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.

Colloidal silica
Hard fat

Not applicable

Store below 30◦C

Available in PVC/PE cavities strips containing three ovules.

No special requirements