Janssen-Cilag Ltd

Section 4.5    Interactions with other Medicaments and other forms of Interaction

Econazole is a known inhibitor of CYP3A4/2C9. Although not studied, based on the chemical similarity of econazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists.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 on taking oral anticoagulants, such as warfarin  and 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.

Section 4.9 Overdose

Overdose with econazole nitrate has not been reported to date. 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.

4.3 Contraindications

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

4.4 Special warnings and precautions 

Addition of :

Not for ophthalmic or oral use. Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.  (moved from section 4.5). 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.

4.5.      Interaction with other Medicaments and other forms of Interactions

Addition of:the anticoagulant effect should be considered monitored more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.

4.6-Preganancy and Lactation  Addition of: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.

 4.8       Undesirable effects : Addition of table 

4.9       Overdose  Updated statement