- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
GYNO-PEVARYL 150 mg Vaginal Pessaries
2. Qualitative and quantitative composition
Vaginal pessaries each containing 150 mg econazole nitrate.For a full list of excipients, see section 6.1.
3. Pharmaceutical form
White to off-white torpedo-shaped pessaries.
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:One pessary should be inserted high into the vagina each evening for three consecutive days. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl 150 mg vaginal pessaries.
Children:Gyno-Pevaryl 150 mg vaginal pessaries are 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 150mg vaginal pessaries.
4.4 Special warnings and precautions for use
For intravaginal use only. This preparation is not for 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 (see section 4.5).Gyno-Pevaryl 150mg vaginal pessaries 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
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.Contact between latex products such as contraceptive diaphragms or condoms and this product must be avoided since the constituents of the product may damage the latex. Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.4).
4.6 Fertility, pregnancy and lactation
PregnancyIn 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, animal studies have shown reproductive toxicity (see section 5.3). Because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.
Breast-feedingFollowing 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 150mg vaginal pessaries if the patient is breast-feeding
FertilityResults of econazole animal reproduction studies showed no effects on fertility.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The safety of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries was evaluated in 3630 patients who participated in 32 clinical trials.Based on pooled safety data from these clinical trials, the most commonly reported adverse reactions were (with % incidence) pruritus (1.2%) and skin burning sensation (1.2%). Including the above mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries 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 adverse reactions with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence are from post-marketing data.
|System Organ Class||Adverse Reactions|
|Common (≥1/100 to <1/10)||Uncommon (≥1/1,000 to <1/100)||Rare (≥1/10,000 to <1/1,000)||Not known|
|Immune System Disorders||Hypersensitivity|
|Skin and Subcutaneous Tissue Disorders||Pruritus, Skin burning sensation||Rash||Erythema||Angioedema, Urticaria, Contact dermatitis, Skin exfoliation|
|Reproductive System and Breast Disorders||Vulvovaginal burning sensation|
|General Disorders and Administration Site Conditions||Application site pain, Application site irritation, Application site swelling|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Adverse events associated with overdose or misuse of Gyno-Pevaryl Vaginal Pessaries 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.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)ATC code: G01A F05Econazole nitrate has no anti-inflammatory action, no effects on the circulation, no central or autonomic nervous effects, no effects on respiration, no effect on α or β receptors, no anticholinergic or antiserotonic 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 fungal 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.
5.2 Pharmacokinetic properties
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. Metabolites are excreted in the urine. Five major and two minor metabolites have been identified.
5.3 Preclinical safety data
Low neonatal survival and foetal toxicity was associated with high doses. In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents at maternal subcutaneous doses of 20 mg/kg/day and at maternal oral doses of 10 mg/kg/day. The significance of this in humans is unknown. In repeat dose toxicity studies in rats, at high subcutaneous doses (50 mg/kg/day, 300 mg/m2/day) the liver was identified as a target organ with minimal toxicity and full recovery. The human to animal safety margin for liver toxicity (based on Human Equivalent Dose taking into account normalisation of body surface area) is 32 to 126x for a 50 to 70 kg human based on 2.5 to 7% absorption in humans and 83% bioavailability in rats. No significant topical toxicity, phototoxicity, local dermal irritation, vaginal irritation or sensitization was noted. Only mild ocular irritation was noted with a cream formulation.
6. Pharmaceutical particulars
6.1 List of excipients
Wecobee M Wecobee FS
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 30°C.Keep out of reach and sight of children.
6.5 Nature and contents of container
Available in PVC/PE strips containing three pessaries.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Janssen-Cilag Ltd 50-100 Holmers Farm WayHigh WycombeBuckinghamshireHP12 4EGUK
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
1st October 1995/June 2003
10. Date of revision of the text
29 July 2016
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
+44 (0)1494 567 568
Medical Information Direct Line
+44 (0)800 731 8450
Customer Care direct line
+44 (0)800 731 5550