1. Name Of The Medicinal Product
Gyno-Pevaryl 1 Vaginal Pessary.
2. Qualitative And Quantitative Composition
Each pessary contains econazole nitrate PhEur 150 mg.
3. Pharmaceutical Form
Light beige torpedo shaped pessary,
4. Clinical Particulars
4.1 Therapeutic Indications
Vaginitis due to Candida Albicans and other yeasts.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients of Gyno-Pevaryl 1 vaginal pessary.
4.4 Special Warnings And Precautions For Use
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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 5.2. Pharmacokinetic Properties), clinically relevant interactions are unlikely to occur. In patients on oral anticoagulants, such as warfarin and 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.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
None known
4.8 Undesirable Effects
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 (
Adverse drug reactions
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4.9 Overdose
This product is intended for vaginal use. Overdose with econazole nitrate has not been reported to date. In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
No relevant information other than that contained elsewhere in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Polygel
Colloidal silicon dioxide
Witepsol H19
Wecobee FS
Stearyl heptanoate
6.2 Incompatibilities
None stated.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 30°C.
6.5 Nature And Contents Of Container
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)
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
8. Marketing Authorisation Number(S)
PL 00242/0226
9. Date Of First Authorisation/Renewal Of The Authorisation
1 October 1995/June 2003
10. Date Of Revision Of The Text
23rd March 2011
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