GYNO-DAKTARIN Vaginal cream Ref.[6992] Active ingredients: Miconazole

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Gyno-Daktarin vaginal cream and with other miconazole formulations (see section 4.8). 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.

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

Gyno-Daktarin vaginal cream contains benzoic acid and butylated hydroxyanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

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 cream since the constituents of the cream may damage the latex (see section 4.4).

Pregnancy

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

Breastfeeding

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

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 reactions 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 and <1/1,000, Very rare <1/10,000.

Table 1. Adverse Reactions Reported by Gyno-Daktarin-treated Subjects in 2 Single Blind Clinical Trials:

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 Gyno-Daktarin 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.