Gyno-Pevaryl™ Cream.

Each 100 g of cream contains 1 g econazole nitrate Ph.Eur. (1% w/w).

Vaginal Cream.

For the treatment of mycotic vulvovaginitis and mycotic balanitis.

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.

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.

Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any of the ingredients of Gyno-Pevaryl cream.

Not for ophthalmic or 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-Pevaryl Cream should not be used in conjunction with other internal or external treatment of the genitalia

Gyno-Pevaryl Cream is not indicated for use in children under the age of 16 years.

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 considered.

Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.

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, because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.

Lactation

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 Gyno-Pevaryl Cream if the patient is breast-feeding

None known.

The most frequently reported adverse events in clinical trials were application site reactions, such as burning and stinging sensations, pruritus, and erythema.

Including the above mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of Gynaecological Formulation 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 ADRs with a known incidence (common or uncommon) are from clinical trial data and all ADRs with an unknown incidence are from post-marketing data.

Adverse Drug Reactions

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

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

ATC code: G01A F05

Econazole nitrate has no anti-inflammatory action, no effect on circulation, no central or autonomic nervous effects, no effects on respiration, no effect on α or β receptors, no anticholinergic or antiserotonergic 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 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, the metabolites excreted in the urine.

Five major and two minor metabolites have been identified.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Tefose 63

Labrafil M 1944 CS

Mineral oil

Butylated hydroxyanisole

Benzoic acid

Purified water

None stated.

24 months.

Do not store above 25°C.

Aluminium lacquered tubes.

Pack sizes 78 g, 30g, 15g.

Gyno-Pevaryl Cream (PL 0242/0229) is also contained in:

Gyno-Pevaryl 150 Combined Vaginal Pessaries and Cream

(PL 0242/0227 & PL 0242/0229)

Gyno-Pevaryl 1 C.P. PACK Vaginal Pessary and Cream

(PL 0242/0226 & PL 0242/0229)

None stated.

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 00242/0229

22 September 1995/June 2003

25 January 2012