Gyno-Daktarin 1200 mg vaginal capsule

Each capsule contains 1200 mg miconazole nitrate

For full list of excipients, see section 6.1.

Vaginal capsule, soft.

White egg-shaped soft vaginal capsule containing a white to cream coloured hydrophobic mass.

For the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria.

Gyno-Daktarin vaginal capsules are for intravaginal administration.

Adults and Elderly

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.

Children

Not recommended.

Gyno-Daktarin vaginal capsule is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the soft vaginal capsule.

Should local sensitisation or an allergic reaction occur, treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Gyno-Daktarin 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 Gyno-Daktarin vaginal capsules should not be used concurrently with a latex condom or latex diaphragm.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin vaginal capsules since the constituents of the vaginal capsules may damage the latex (see section 4.4)

Pregnancy

Although intravaginal absorption is limited, Gyno-Daktarin vaginal capsules should only be used in the first trimester of pregnancy if, in the judgment of the physician, the potential benefits outweigh the possible risks.

Lactation

It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Daktarin vaginal capsules during lactation.

None known.

The safety of GYNO-DAKTARIN 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 Drug Reactions (ADRs) reported by 1% of GYNO-DAKTARIN-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, <1/1,000

Very rare <1/10,000, including isolated reports

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 face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.

Symptoms

In case of accidental ingestion, no problems are expected.

Treatment

In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.

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 mean apparent elimination half-life is 57 hours.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Capsule:

Liquid paraffin

White petrolatum

Lecithin

Capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171),

Sodium ethylparahydroxybenzoate (E215),

Sodium propyl parahydroxybenzoate (E217)

Medium chain triglycerides

None known.

24 months

Do not store above 30°C.

Gyno-Daktarin vaginal capsule is supplied in a blister strip (PVC-LDPE-PVDC/Alu) containing one soft vaginal capsule.

No special requirements.

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 0242/0121

Date of first authorization: 30/01/86

Renewal of the Authorisation: 07/01/02

21^st December 2011