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

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Recordati Industria Chimica e Farmaceutica SpA, Via Matteo Civitali, 20148, Milan, Italy

4.1. Therapeutic indications

In the topical treatment of vulvo vaginal infections due to superficial dermatophytes of C. albicans, sensitive to the drug.

4.2. Posology and method of administration

Dosage

One 200 mg vaginal capsule at bedtime for 3 days or one 600 mg vaginal capsule at bedtime once only. If necessary treatment may be repeated after 3 days.

Administration

Intravaginal, inserted deeply into vagina.

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.

4.9. Overdose

No case of overdose has been reported.

Gynoxin is intended for local application and not for oral use. In the event of accidental oral ingestion abdominal pain and vomiting may occur.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C. Do not refrigerate or freeze. Store in the original package.

6.5. Nature and contents of container

Blister pack of PVC/PVdC + aluminium foil, in packs of 3.

6.6. Special precautions for disposal and other handling

No special requirements.

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