Symptoms
Gynezol 7 vaginal capsules are intended for local application and not for oral use. In case of accidental ingestion, no problems are expected.
Treatment
In the event of accidental ingestion of large quantities, use appropriate supportive care.
None known.
The safety of Gynezol 7 was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse reactions reported by >1% of Gynezol 7-treated subjects in these trials are shown in Table 1.
In the table, the frequencies are provided according to the following convention:
| Very common | >1/10 |
| Common | >1/100 and < 1/10 |
| Uncommon | >1/1,000 and <1/100 |
| Rare | >1/10,000 and <1/1,000 |
| Very rare | <1/10,000 |
Table 1. Adverse Reactions Reported by Gynezol 7-treated Subjects in 2 Single Blind Clinical Trials
| Body System/Organ Class Frequency Category | Undesirable effects |
| Skin and Subcutaneous Tissue Disorders | |
| Common | Rash |
| Uncommon | Rash pruritic, urticaria |
| Reproductive System and Breast Disorders | |
| Very common | Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort |
| Common | Dysmenorrhoea |
A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling of the face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.
Table 2. Adverse Reactions Identified During Postmarketing Experience with Gynezol 7 by Frequency Category Estimated from Spontaneous Reporting Rates
| Immune System Disorders | |
| Not known | Hypersensitivity including Anaphylactic and Anaphylactoid reactions |
| Skin and Subcutaneous Tissue Disorders | |
| Not known | Angioedema, Pruritus |
| Reproductive System and Breast Disorders | |
| Not known | Vaginal irritation, pelvic cramps |
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 at: www.mhra.gov.uk/yellowcard.
Preclinical data reveal no special hazard for humans based on studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
For the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria.
Pharmacotherapeutic classification:
(Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivative)
ATC code: G01A F04
Miconazole is a synthetic imidazole antifungal agent with a broad spectrum of activity against pathogenic fungi (including yeasts and dermatophytes) and gram-positive bacteria (staphylococcus and streptococcus spp). Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.
After the capsule has been inserted into the vagina, the outer covering rapidly disintegrates and the active suspension is almost instantaneously released.
Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The apparent elimination half-life ranges from 15 to 49 hours in most subjects and likely reflects both absorption from the site of application and metabolism/excretion of the drug.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Gynezol 7 vaginal capsule and with other miconazole formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
Appropriate therapy is indicated when the sexual partner is also infected.
Gynezol 7 vaginal capsules do not stain skin or clothes.
The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gynezol 7 vaginal capsules should not be used concurrently with a latex condom or latex diaphragm.
None known.
Gynezol 7 vaginal capsules are for intravaginal administration.
Adults (aged 18 years and older)
One soft vaginal capsule to be inserted high in the vagina at bedtime, as a single dose. This is best done in the reclining position.
Paediatrics (aged under 18 years)
The safety and efficacy of Gynezol 7 vaginal capsule in children and adolescents has not been studied.
No special requirements.
