GYNO-PEVARYL Vaginal cream Ref.[8023] Active ingredients: Econazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Therapeutic indications

For the treatment of mycotic vulvovaginitis and mycotic balanitis.

Posology and method of administration

Route of Administration

For vaginal/penile administration.

Females: One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be applied to the vulva. The full 14 days treatment should be carried out even if the symptoms of vaginal itching or discharge have disappeared.

In pregnant women, it is recommended that administration takes place without the use of an applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl cream.

Males: Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days.

The sexual partner should also be treated.

Overdose

Adverse events associated with overdose or misuse of Gyno-Pevaryl Cream 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.

If the product is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

Shelf life

24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Aluminium lacquered tubes.

Pack sizes 78 g, 30g, 15g.

Special precautions for disposal and other handling

None stated.

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