Daktarin dermatological 20 mg/g 30 g cream

Daktarin dermatological 20 mg/g 30 g cream is an antifungal cream based on miconazole nitrate , specifically formulated for the treatment of skin and nail infections caused by dermatophytes and fungi of the Candida genus . Thanks to its targeted action, this antifungal cream is indicated to effectively combat skin mycoses , itching, redness and other symptoms typical of fungal infections, offering rapid relief and promoting skin regeneration.

The formulation of Daktarin cream guarantees excellent skin tolerability and high efficacy, thanks to the presence of miconazole nitrate 20 mg/g , an active ingredient known for its powerful action against skin fungi and Gram-positive bacteria that can complicate fungal infections. The cream is easily absorbed, is not greasy and does not stain the skin or clothing, making it ideal for daily use and for the prolonged treatment of mycosis .

Daktarin dermatological 20 mg/g 30 g cream is an easy-to-apply topical antifungal , suitable for both skin infections and nail mycosis . Its effectiveness is supported by a composition that includes selected excipients to promote the penetration of the active ingredient and skin comfort. The product is available in a practical 30 g tube, perfect for a complete and targeted treatment of the affected areas.

Choose Daktarin dermatological cream for effective treatment of skin and nail mycosis , with the safety of an over-the-counter drug widely used and recommended in dermatology. Ideal for those looking for a reliable solution against skin fungi , itching and redness , ensuring visible and long-lasting results.

ACTIVE INGREDIENTS

Active ingredients contained in Daktarin dermatological 20 mg/g 30 g cream - What is the active ingredient of Daktarin dermatological 20 mg/g 30 g cream?

DAKTARIN DERMATOLOGICO 20mg/g cutaneous powder 100 grams of powder contain active ingredient : Miconazole nitrate 2 g. DAKTARIN DERMATOLOGICO 20mg/g cream 100 g of cream contain active ingredient : Miconazole nitrate 2 g. Excipients with known effect: benzoic acid (E210) and butylated hydroxyanisole (E320). Contains 60 mg of benzoic acid in each 30 g tube of cream which is equivalent to 2 mg/g of cream. DAKTARIN DERMATOLOGICO 20mg/g cutaneous solution 100 ml of solution contain active ingredient : Miconazole 2 g. Excipients : propylene glycol, alcohol. DAKTARIN DERMATOLOGICO 20mg/g cutaneous spray, powder 100 grams of powder contain active ingredient : Miconazole nitrate 2 g. Excipient with known effect: 100 mg ethanol in 1 g of skin spray, powder. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Daktarin dermatological 20 mg/g 30 g cream - What does Daktarin dermatological 20 mg/g 30 g cream contain?

Skin powder : zinc oxide, precipitated silica, talc. Skin spray, powder : talc, sorbitan sesquioleate, anhydrous ethanol, steralkonium hectorite, propellant (mixture of propane and butane). Cream : polyethylene glycol palmito stearate, macrogol, glycerol oleate, liquid paraffin, butylated hydroxyanisole, benzoic acid, purified water. Skin solution : acrylic resin (Carboset 525), polymerized acrylic resin (Carboset 515), propylene glycol, alcohol.

DIRECTIONS

Therapeutic indications Daktarin dermatological 20 mg/g 30 g cream - Why is Daktarin dermatological 20 mg/g 30 g cream used? What is it used for?

Skin or nail infections caused by dermatophytes or Candida possibly complicated by superinfections by Gram-positive bacteria.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Daktarin dermatological 20 mg/g 30 g cream - When should Daktarin dermatological 20 mg/g 30 g cream not be used?

Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients listed in section 6.1; Neonates and children (up to 12 years).

DOSAGE

Quantity and method of taking Daktarin dermatological 20 mg/g 30 g cream - How to take Daktarin dermatological 20 mg/g 30 g cream?

Skin infections Treatment should be continued daily and continuously for at least a week after the symptoms have disappeared, and can last from 2 to 6 weeks, depending on the type and extent of the infection. Wash the affected area and dry it thoroughly. Treat not only the infected part, but also the area around it. Wash your hands thoroughly after each application to avoid transferring germs to other parts of the body or to other people. Generally, DAKTARIN DERMATOLOGICO powder or skin spray, powder are used in combination with DAKTARIN DERMATOLOGICO cream. Skin powder - Skin spray, powder They are indicated for the treatment of moist lesions. Apply an amount of powder sufficient to cover the affected area 2 times a day. If you are also using DAKTARIN DERMATOLOGICO cream in combination, it is sufficient to use both the powder and the cream once a day. In foot infections, it is recommended to sprinkle the feet with DAKTARIN DERMATOLOGICO powder daily during and after treatment with another topical formulation (DAKTARIN DERMATOLOGICO cream), especially the spaces between the toes, and also socks and shoes. Cream Apply 1 centimetre of cream to the lesion (or more depending on the extent of the lesion) 2 times a day, then spread with the fingers, until completely absorbed. If you are also using DAKTARIN DERMATOLOGICO powder, it is recommended to apply both formulations once a day. Nail infections Cut infected nails as short as possible. Continue treatment uninterrupted even after the infected nail falls off (usually after 2-3 weeks), until it has completely grown back and the lesions have healed definitively (rarely before 3 months). It may also be necessary to combine treatment with other drugs. Skin solution DAKTARIN DERMATOLOGICO solution is applied with the brush inserted into the bottle cap. 1-2 times a day brush the solution on the infected nail, all around it and, if possible, under it and let it dry. Once dry, the solution forms an occlusive film on the nail. Before the next application, it is necessary to clean the nail with acetone. If this procedure is not carried out, the overlapping layers become too thick and DAKTARIN DERMATOLOGICO solution can no longer reach the nail. Cream Apply a little cream 1-2 times a day to the infected nail, then spread with your fingers; cover the nail with a non-perforated occlusive dressing.

CONSERVATION

Storage Daktarin dermatological 20 mg/g 30 g cream - How to store Daktarin dermatological 20 mg/g 30 g cream?

Cream, Skin spray, powder, skin solution : store at a temperature not exceeding 25°C. Skin powder : no special storage conditions.

WARNINGS

Warnings Daktarin dermatological 20 mg/g 30 g cream - About Daktarin dermatological 20 mg/g 30 g cream it is important to know that:

If sensitization or irritation occurs, discontinue treatment and initiate appropriate therapy. Avoid contact with eyes. Wash hands thoroughly after each application, unless the hands are being treated. Since the cutaneous solution contains alcohol, avoid contact with open wounds and mucous membranes. In these cases, use DAKTARIN DERMATOLOGICO cream. DAKTARIN DERMATOLOGICO cutaneous powder contains talc: avoid inhaling the powder which could cause irritation of the respiratory tract. It is advisable to apply the following hygiene measures to avoid sources of infection or reinfection: - keep towels and underwear for personal use in order to avoid infecting other people; - regularly change clothing that comes into contact with the infected area to avoid reinfection. DAKTARIN DERMATOLOGICO does not stain the skin or clothing. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with DAKTARIN DERMATOLOGICO and other topical formulations containing miconazole. If a reaction due to hypersensitivity or irritation occurs, treatment should be discontinued. DAKTARIN DERMATOLOGICO should not come into contact with the mucous membranes of the eyes. Important information about some of the excipients DAKTARIN DERMATOLOGICO cream contains benzoic acid Benzoic acid may cause local irritation. DAKTARIN DERMATOLOGICO cream contains butylated hydroxyanisole Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. DAKTARIN DERMATOLOGICO cutaneous solution contains propylene glycol which may cause skin irritation. The solution also contains ethyl alcohol: avoid contact with open wounds and mucous membranes. DAKTARIN DERMATOLOGICO cutaneous spray, powder contains ethanol This medicine contains 105 mg of alcohol (ethanol) in each dose (1050 mg) which is equivalent to 100 mg/g (10% w/w). It may cause a burning sensation on damaged skin. This medicine is flammable, it should not be brought near flames.

INTERACTIONS

Interactions Daktarin dermatological 20 mg/g 30 g cream - Which medicines or foods can modify the effect of Daktarin dermatological 20 mg/g 30 g cream?

Systemically administered miconazole is known to inhibit CYP3A4/2C9. Since the drug is present in the blood following local application (see section 5.2 Pharmacokinetic properties), interactions considered clinically relevant are very rare. However, in patients treated with oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant action monitored. The efficacy and adverse effects of other drugs (e.g. oral hypoglycaemics and phenytoin), if administered concomitantly with miconazole, may be increased and particular caution is therefore required.

SIDE EFFECTS

Like all medicines, Daktarin dermatological 20 mg/g 30 g cream can cause side effects - What are the side effects of Daktarin dermatological 20 mg/g 30 g cream?

Data from clinical studies The following table shows the percentage of adverse reactions considered drug-related reported by 834 patients administered miconazole 20 mg/g cream (426 patients) vs. placebo (base cream) (408 patients), enrolled in 21 double-blind clinical studies.

Organ/system	% side effects
	Miconazole cream 20mg/g	Placebo - base cream
Total	1.9	1,2
Skin and subcutaneous tissue changes
• Burning sensation of the skin	0.2	0.7
• Inflammation of the skin	0.2	-
• Hypopigmentation of the skin	0.2	-
General disorders and administration site conditions
• Irritation at the application site	0.7	0.5
• Burning at the application site	0.2	0.2
• Itching at the application site	0.2	-
• Application site reactions	0.2	-
• Warmth at the application site	0.2	-

Note: Individual patients may have reported more than one adverse event. Post-marketing data The following adverse reactions have been reported through spontaneous post-marketing reports worldwide, organised according to the MedDRA classification. The adverse reactions are classified by frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 and <1/10); uncommon (≥ 1/1000 and <1/100); rare (≥ 1/10000 and < 1/1000); very rare (< 1/10000, including isolated reports).

Immune system disorders

Very rare: anaphylactic reactions, hypersensitivity.

Skin and subcutaneous tissue disorders

Very rare: angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, burning sensation of the skin.

Systemic disorders and conditions related to the administration site

Very rare: irritation or other reactions at the application site.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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 national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Daktarin dermatological 20 mg/g 30 g cream - What are the risks of Daktarin dermatological 20 mg/g 30 g cream in case of overdose?

Symptoms and signs In general, excessive use of DAKTARIN DERMATOLOGICO may cause skin irritation which generally disappears with discontinuation of therapy. Treatment In case of accidental ingestion: DAKTARIN DERMATOLOGICO is intended for local application and not for oral use. In case of accidental ingestion of large quantities of DAKTARIN DERMATOLOGICO use appropriate supportive therapy. Accidental ingestion of DAKTAARIN DERMATOLOGICO cutaneous solution may cause gastric irritation. There is no specific antidote. Treatment is symptomatic and supportive. In addition, since the cutaneous solution contains alcohol, it is necessary to consider the amount of alcohol possibly ingested, especially in children. DAKTARIN DERMATOLOGICO powder and skin spray, powder contain talc: accidental inhalation of large quantities of the medicine may cause occlusion of the airways. Respiratory arrest can be treated with intensive supportive therapy and oxygen. If breathing is compromised, endotracheal intubation, removal of obstructing material, and assisted respiration are recommended.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Daktarin dermatological 20 mg/g 30 g cream.

Pregnancy DAKTARIN DERMATOLOGICO, applied topically, is minimally absorbed into the systemic circulation (bioavailability < 1%). However, although there is no evidence of embryotoxicity or teratogenicity in animals, the potential risks of prescribing DAKTARIN DERMATOLOGICO during pregnancy must be weighed against the potential therapeutic benefits. Breastfeeding Miconazole, applied topically, is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human milk. Caution is advised when using topical products containing miconazole during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Daktarin dermatological 20 mg/g 30 g cream before driving or using machines - Does Daktarin dermatological 20 mg/g 30 g cream affect driving or using machines?

No effects on the ability to drive or use machines have been reported.