Gyno-Pevaryl 1 Vaginal Pessary.

Each pessary contains econazole nitrate PhEur 150 mg.

Light beige torpedo shaped pessary

Vaginitis due to Candida Albicans and other yeasts.

For vaginal administration.

Adults:

Insert one pessary high into the vagina at night prior to retiring.

Children:

Gyno-Pevaryl 1 pessary is 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-Pevaryl 1 vaginal pessary.

This preparation is not for oral uses

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 1 vaginal pessary 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.

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 1 vaginal pessaries 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 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 classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)

ATC code: G01A F05

Econazole is an imidazole derivative. The compound acts by damaging the membranes of bacterial and fungal cells; both the cellular and subcellular membranes are affected. Econazole apparently disturbs the permeability characteristics of the membrane which allow leakage of potassium and sodium ions and other intra cellular components. Macro-molecular synthesis may also be inhibited. Econazole is active against dermatophytes, yeast, moulds and Gram positive bacteria. Gram negative bacteria are generally resistant to econazole.

Econazole nitrate is poorly absorbed after vaginal application. Using radiolabelled techniques, it has been determined that between 2.5% and 7% of vaginally applied econazole nitrate is absorbed. However, no antimycotic activity could be detected in the serum after vaginal application of 5 g or 1% econazole nitrate cream or a suppository containing 50 mg econazole nitrate.

No relevant information other than that contained elsewhere in the Summary of Product Characteristics.

Polygel

Colloidal silicon dioxide

Witepsol H19

Wecobee FS

Stearyl heptanoate

None stated.

3 years.

Do not store above 30°C.

Multi-plast strip or PVC/PE moulds, containing one pessary.

1 applicator

Gyno-Pevaryl 1 Vaginal Pessary (PL 0242/0226) is also contained in:

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

(PL 0242/0226 & PL 0242/0229)

Not applicable.

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 00242/0226

1 October 1995/June 2003

25^th January 2012