Daktarin 2% Vaginal Cream 20 mg/g Miconazole Nitrate Antifungal 78g+16 Applicators

2% vaginal cream based on Miconazole nitrate.

Therapeutic indications

Daktarin Vaginal Cream is used in the treatment of Candida vulvovaginal infections. Due to its antibacterial action on Gram-positive bacteria, Daktarin can be used for the treatment of mycoses with superinfections by these microorganisms.

Dosage and Posology

Introduce once a day (in the evening before going to bed) the contents of the applicator (about 5 g of cream) deeply into the vagina. Treatment should be continued for at least 10 days, even if itching and leucorrhoea disappeared after 3 days. In case of lack of effect it is advisable to repeat the microbiological tests to confirm the diagnosis.

The safety and efficacy of Daktarin in children and adolescents aged less than 18 years have not yet been established.

How to use

Please do the following:

1. To open the tube, unscrew the cap and turn it upside down, pierce the aluminum foil with the perforating wedge.
2. Screw the applicator onto the tube instead of the cap.
3. Lightly press the tube at its lower end to let the cream into the applicator. If the plunger offers some resistance, pull it gently. Unless otherwise prescribed by the doctor, the applicator must be completely filled.
4. Remove the applicator from the tube, which must be closed with the cap.
5. In a lying position, keep your knees raised and spread, gently introduce the applicator into the vagina as deeply as possible. Push the piston fully. You then withdraw the applicator and throw it away.

Local treatment with Daktarin is usually well tolerated. The introduction of the vaginal applicator is painless and easy to perform

Overdose

In case of accidental ingestion of large quantities of Daktarin cream, use appropriate supportive care.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Babies and children (up to 12 years).

Side effects

The safety of Daktarin was evaluated in a total of 537 women who participated in two single-blind clinical studies. A total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g. vulvovaginal itching, burning / irritation) or signs of vulvar erythema, edema, excoriation, erythema or vaginal edema were treated with vaginal miconazole: quite randomly it is each of them was assigned a single 1200 mg capsule or a 7-day application of 2% vaginal cream.

Pregnancy and breastfeeding

Although intravaginal absorption is limited, Daktarin should only be used in the first trimester of pregnancy if, in the judgment of the physician, the expected benefit outweighs the potential risk.

There are no known data on the excretion of miconazole nitrate in breast milk, therefore great caution should be exercised when administering Daktarin during the lactation period.

Special warnings

1. To open the tube, unscrew the cap, turn it upside down and pierce the aluminum operculum with the perforating wedge.
2. Screw the applicator onto the tube instead of the cap.
3. Slightly press the tube at its lower end to allow the cream to penetrate the applicator. If the plunger offers some resistance, gently pull it out. Unless prescribed by the treating physician, the applicator must be completely filled.
4. Remove the applicator from the tube, which must be immediately closed with the cap.
5. In the lying position, the raised knees spread, gently introduce the applicator into the vagina as deeply as possible. Push the piston completely. Then withdraw the applicator and throw it away.

Should sensitization or an allergic reaction occur, the treatment should be discontinued. Adequate therapy should also be followed by the partner if he is infected. Daktarin does not stain either skin or clothing. The use of latex condoms or diaphragms during treatment with anti-infective vaginal preparations may decrease the effectiveness of latex contraceptives. Therefore, Daktarin cream should not be used at the same time as condoms or a latex diaphragm. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin or other topical miconazole formulations. If a reaction due to hypersensitivity or irritation occurs, the treatment should be discontinued.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 25 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Daktarin 2% Vaginal Cream solution contain:

Active principle

Miconazole 2 g

Excipients

Polyethylene glycol palmito stearate, macrogol, glycerol oleate, liquid paraffin, butylated hydroxyanisole, benzoic acid, purified water.