Summary of Product Characteristics (SmPC) - Gynoxin 600 mg vaginal capsules
1 NAME OF THE MEDICINAL PRODUCT
Gynoxin 600 mg Vaginal Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal capsule contains 600 mg of the active ingredient fenticonazole nitrate. Excipients with known effect: ethyl parahydroxybenzoate sodium, sodium propyl parahydroxybenzoate, soy lecithin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vaginal capsule, soft
Ivory white, opaque, soft gelatin capsules
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Treatment of vulvovaginal candidiasis.
4.2. Posology and method of administration
Route of Administration:
Intravaginal
Adults:
One 600 mg vaginal capsule once only, at bedtime.
The capsule must be introduced deeply into the vagina.
Gynoxin is not greasy, does not soil and can easily be removed with water.
Paediatric population
The safety and efficacy of Gynoxin children under 16 years have not been established. No data are available. The dose recommendation for children aged 16 years or above is the same as for adults.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.
Gynoxin contains soya lecithin. This medicinal product should not be used in patients allergic to peanut or soya.
4.4 Special warnings and precautions for use
Some excipients of the vaginal capsules (parahydroxybenzoates) may cause allergic reactions (possibly delayed). Should local sensitisation or an allergic reaction occur, the treatment should be discontinued.
The patients should be advised to consult their physician if:
- the symptoms have not been relieved within one week
- in case of recurrent symptoms (more than 2 infections in the last 6 months)
- previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease
- age over 60
- known hypersensitivity to imidazoles or other vaginal antifungal products
- any abnormal or irregular vaginal bleeding
- any blood staining of a vaginal discharge
- any vulval or vaginal sore, ulcer or blisters
- any associated lower abdominal pain or dysuria
- any adverse effects such as erythema, pruritus or rash associated with treatment.
The vaginal capsules should not be used in conjunction with barrier contraceptives, spermicides, intravaginal douches or other vaginal products (see section 4.5). Appropriate therapy is indicated when the partner is also infected.
Fenticonazole should be used in pregnancy and breast-feeding under the supervision of a physician (see section 4.6).
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fat excipients and oils contained in the vaginal capsules could damage contraceptives made of latex. Patients should be advised to use alternative contraceptive methods/precautions while using this product.
Associations not recommended:
- Spermicides: any local vaginal treatment is likely to inactivate a local contraceptive spermicide.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are a limited amount of data from the use of fenticonazole in pregnant women. Studies in animals have shown no teratogenic effects, and embryotoxic and foetotoxic effects have been observed only at very high doses administered orally. Low systemic exposure of fenticonazole is expected following vaginal treatment (see section 5.2). Fenticonazole should be used in pregnancy under the supervision of a physician.
Breast-feeding
Animal studies via the oral route have shown that fenticonazole and/or its metabolites can be excreted in the milk. With regard to the negligible absorption of fenticonazole after vaginal administration (see 5.2) any significant transfer into breast milk is not expected. However, as there are no data in humans on fenticonazole and/or its metabolites excretion into the milk following this route of administration, a risk for the baby cannot be excluded. Fenticonazole should be used during the lactation under the supervision of a physician.
Fertility
No human studies of the effects of fenticonazole on fertility have been conducted, however animal studies have not demonstrated any effects of the drug on fertility.
4.7 Effects on ability to drive and use machines
Gynoxin has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
When used as recommended, Gynoxin is only poorly absorbed and systemic undesirable reactions are not expected. A mild, transient burning sensation may occur after application. Prolonged use of topical products can cause sensitisation (see section 4.4).
In the table below, adverse reactions are reported and listed by MedDRA system organ class and frequency: 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); not known (frequency cannot be estimated from available data).
| System Organ Class | Frequency | Preferred Terms |
| Reproductive system and breast disorders | Very rare | Vulvovaginal burning sensation |
Skin and subcutaneous tissue disorders | Very rare | Erythema Pruritus Rash |
| General disorders and administration site conditions | Not known | Application site hypersensitivity |
Reporting of suspected adverse reactions
Reporting 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.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No case of overdose has been reported.
Gynoxin is intended for local application and not for oral use. In the event of accidental oral ingestion abdominal pain and vomiting may occur.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
ATC code: G01A F12
Fenticonazole is a broad-spectrum antimycotic agent.
In vitro: high fungistatic and fungicidal activity against Candida albicans
In vivo: healing of vaginal mycoses due to Candida within 5 days in mice.
5.2. Pharmacokinetic properties
Pharmacokinetic studies in humans have shown that systemic absorption of fenticonazole nitrate after vaginal administration is minimal.
5.3. Preclinical safety data
LD50 mice: oral>3000mg/kg; i.p 1276mg/kg (M), 1265mg/kg (F) LD50 rats: oral>3000mg/kg; s.c.>750mg/kg; i.p. 440mg/kg (M), 309mg/kg (F)
Chronic toxicity: following oral administration of 40-80-160mg/kg/day for 6 months in rats and dogs, fenticonazole was well tolerated, although some evidence of light and moderate general toxicity occurred (increase in liver weight at 160mg/kg without histopathological alterations in rats, and a transient increase in serum SGPT at 80 and 160mg/kg, together with an increase in liver weight in dogs).
Fenticonazole does not interfere with the function of male and female gonads, and does not modify the first phases of reproduction. Studies in reproductive toxicology revealed, as for other imidazole derivatives, an embryolethal effect at high dosages (>20mg/kg). Fenticonazole has shown no teratogenic effects in rats and rabbits and has revealed no mutagenic potential in six mutagenicity tests.
Satisfactory results were obtained in tolerability tests performed in guinea pigs, rabbits as well as in mini-pigs, the skin of which is similar to that of humans, as far as morphology, functionality and sensitivity to irritating agents are concerned.
Fenticonazole has shown no evidence of sensitisation, phototoxicity and photoallergy.
Pharmacokinetic studies have revealed no transcutaneous absorption either in man or in animals and a very low vaginal absorption.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Paraffin, light liquid
White petrolatum
Soya lethicin
Shell constituents:
Gelatin
Glycerol
Titanium dioxide
Ethyl parahydroxybenzoate sodium (E215)
Sodium propyl parahydroxybenzoate (E217)
6.2. Incompatibilities
Not applicable
6.3. Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze. Store in the original package.
6.5. Nature and Contents of Container
Blister pack of PVC/PVdC + aluminium foil, in packs of 1.
6.6 Special precautions for disposal
None.
7. MARKETING AUTHORISATION HOLDER
Recordati Industria Chimica e Farmaceutica SpA Via Matteo Civitali
1-20148 Milano
Italy
8. MARKETING AUTHORISATION NUMBER
PL 04595/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/10/2004
10 DATE OF REVISION OF THE TEXT
09/05/2022