- 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 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.
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 pessary.
Children:Gyno-Pevaryl 150 mg 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 150mg vaginal pessaries.
4.4 Special warnings and precautions for use
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 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, because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.
LactationFollowing 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
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 ADRs were (with % incidence) pruritus (1.2%) and skin burning sensation (1.2%). Including the above mentioned adverse drug reactions (ADRs), the following table displays ADRs 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 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
|System Organ Class||Adverse Drug 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 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
No relevant information other than that contained elsewhere in the Summary of Product Characteristics.
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
18 July 2014
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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