DAKTARIN POLV CUT 30G 20MG/G

DAKTARIN DERMATOLOGICAL 20 MG/G

active principles

DAKTARIN DERMATOLOGICAL 20mg/g skin powder 100 grams of powder contain active principle: Miconazole nitrate 2 g DAKTARIN DERMATOLOGICAL 20mg/g cream 100 g of cream contain active principle: Miconazole nitrate 2 g Excipients with known effect benzoic acid (E210) and butylated hydroxyanisole (E320) This medicinal product contains 60 mg of benzoic acid in each 30 g tube of cream which is equivalent to 2 mg/g of cream DAKTARIN DERMATOLOGICAL 20mg/g skin solution 100 ml of solution contain active principle: Miconazole 2 g excipients: propylene glycol, alcohol DAKTARIN DERMATOLOGICAL 20mg/g skin spray, powder 100 grams of powder contain active principle: Miconazole nitrate 2 g For the full list of excipients, see section 6.1

Exceptions

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

Therapeutic indications

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

Contraindications

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

Posology

Skin infections Treatment should be continued daily and uninterrupted for at least one 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 well. 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, they are used in combination DAKTARIN DERMATOLOGICAL powder or cutaneous spray, powder with DAKTARIN DERMATOLOGICAL cream. Cutaneous powder - Cutaneous spray, powder They are indicated for the treatment of wet lesions. Apply enough powder to cover the affected area 2 times a day. In case you are using in combination too DAKTARIN DERMATOLOGICO cream, it is sufficient to use both the powder and the cream once a day. In foot infections it is recommended to sprinkle the feet daily with DAKTARIN DERMATOLOGICAL powder during and after treatment with another topical formulation (DAKTARIN DERMATOLOGICAL cream), especially the spaces between the toes, and also the socks and shoes. Cream Apply 1 cm of cream to the lesion (or more depending on the extent of the lesion) 2 times a day, then spread with your fingers until completely absorbed. In case 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 the treatment uninterruptedly even after the fall of the infected nail (mostly after 2-3 weeks), until its complete regrowth and definitive healing of the lesions (rarely before 3 months). It may also be necessary to combine treatment with other drugs. Cutaneous solution DAKTARIN DERMATOLOGICAL solution is applied with the brush inserted in 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, you need to clean the nail with acetone. If this procedure is not carried out, the superimposed layers become too thick and DAKTARIN DERMATOLOGICAL solution can no longer reach the nail. Cream Apply a little cream 1-2 times a day on the infected nail, then spread with your fingers; cover the nail with a non-perforated occlusive dressing.

Storage

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

Warnings

If sensitization or irritation should occur, discontinue treatment and institute appropriate therapy. Avoid contact with eyes. Wash hands carefully after each application, unless the treatment affects the same hands. As the cutaneous solution contains alcohol, avoid contact with open wounds and mucous membranes. In these cases, use DAKTARIN DERMATOLOGICAL cream. DAKTARIN DERMATOLOGICAL skin 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; - change clothes that come into contact with the infected area regularly to avoid getting reinfected. DAKTARIN DERMATOLOGICO does not stain the skin or clothing. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with DAKTARIN DERMATOLOGICAL and with other topical formulations based on miconazole. If a reaction suggestive of hypersensitivity or irritation should occur, the treatment should be discontinued. DAKTARIN DERMATOLOGICO must not come into contact with the mucous membrane of the eyes. Important information about some excipients DAKTARIN DERMATOLOGICAL cream contains benzoic acid Benzoic acid can cause local irritation. DAKTARIN DERMATOLOGICO cream contains butylated hydroxyanisole Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. DAKTARIN DERMATOLOGICAL solution for skin application contains propylene glycol which may cause skin irritation. The solution also contains ethyl alcohol: avoid contact with open wounds and mucous membranes.

Interactions

Systemically administered miconazole is known to inhibit CYP3A4/2C9. Since, following local application, the presence of the drug in the blood is limited (see section 5.2 Pharmacokinetic properties) interactions judged to be relevant from a clinical point of view 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 undesirable effects of other drugs (e.g. oral hypoglycaemic agents and phenytoin) may be increased when administered concomitantly with miconazole and therefore particular caution is required.

Effects

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

	% side effects
Organ/system	Miconazole cream 20mg/g	Placebo - basic 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
• Application site irritation	0.7	0.5
• Burning at the application site	0.2	0.2
• Application site pruritus	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. Postmarketing data The undesirable effects reported from post-marketing spontaneous reports, worldwide, organized according to the MedDRA classification, are presented below. Undesirable effects are ranked by frequency according to the following convention: very common ≥ 1/10 common ≥ 1/100 and Immune system disorders Very rare: anaphylactic reactions, hypersensitivity Skin and subcutaneous tissue disorders Very rare: angioedema, urticaria, dermatitis contact, rash, erythema, pruritus, skin burning sensation General disorders and administration site conditions Very rare: Application site irritation or other reactions Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdose

Symptoms and signs In general, excessive use of DAKTARIN DERMATOLOGICAL can cause skin irritation which generally disappears upon 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 DERMATOLOGICAL use appropriate supportive care. Accidental ingestion of DAKTARIN DERMATOLOGICAL cutaneous solution may cause gastric irritation. There is no specific antidote available. Treatment is symptomatic and supportive. Furthermore, since the cutaneous solution contains alcohol, it is necessary to consider the amount of alcohol possibly ingested, especially in children. DAKTARIN DERMATOLOGICAL powder and cutaneous spray, powder contain talc: accidental inhalation of large quantities of medicine can cause respiratory tract occlusion. A respiratory arrest can be treated with intensive supportive care and oxygen. If respiration is compromised, endotracheal intubation, removal of obstructing material, and assisted respiration are recommended.

Pregnancy

DAKTARIN DERMATOLOGICAL, applied topically, is minimally absorbed into the systemic circulation (bioavailability

Feeding time

Topically applied miconazole 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 while breastfeeding

Source: Farmadati