DAKTARIN CREAM DERM 30G 20MG/G

DAKTARIN DERMATOLOGY 20 MG/G

active ingredients

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

Excellent

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.

Therapeutic indications

Infections of the skin or nails caused by dermatophytes or Candida possibly complicated by overinfections from Gram-positive bacteria.

Contraindications

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).

Population

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 well.Treat not only the infected part, but also the area around it.Wash your hands thoroughly after each application to avoid transferring the germs to other parts of the body or to other people.Generally, they are used in combination DAKTARIN DERMATOLOGICAL powder or skin spray, powder with DAKTARIN It's a skin cream. Skin Powder - Skin Spray, Powder They are indicated for the treatment of wet injuries. Apply enough dust to cover the affected area 2 times a day. In case you are using it in combination DAKTARIN DERMATOLOGICAL cream, it is sufficient to use both the powder and the cream once a day.In case of 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 socks and shoes. Cream Apply on the lesion 1 centimeter of cream (or more depending on the lesion extension) 2 times a day, then smear with your fingers, until completely absorbed. In case you are using it DAKTARIN DERMATOLOGICAL powder, it is recommended to apply both formulations once a day. Nail infections Cut your 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 injuries (rarely before 3 months). You may also need to associate a treatment with other drugs. Skin solution DAKTARIN DERMATOLOGICO solution applies 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, it is necessary to clean the nail with acetone. If this process is not performed, the overlapping layers become too thick and DAKTARIN DERMATOLOGICAL solution can no longer reach the nail. Cream Apply some cream 1-2 times a day on the infected nail, then smear with your fingers; cover the nail with a non-perforated occlusive bandage.

Conservation

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

Warnings

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 such 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 hygienic 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 DERMATOLOGICAL does not stain the skin or clothing.Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with DAKTARIN DERMATOLOGICAL and other topical formulations based on miconazole. If a reaction resulting from hypersensitivity or irritation occurs, the treatment must be stopped. DAKTARIN DERMATOLOGICAL 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 may cause local irritation. DAKTARIN DERMATOLOGICAL cream contains butylated hydroxyanisole Butylated hydroxine only can cause reactions to localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. DAKTARIN DERMATOLOGICAL cutaneous solution contains propylene glycol which can cause skin irritation. The solution also contains ethyl alcohol: avoid contact with open wounds and mucous membranes. DAKTARIN DERMATOLOGICAL skin 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 can cause burning sensation on damaged skin. This medicine is flammable, it should not be approached to flames.

Interactions

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 should be monitored.The efficacy and adverse effects of other drugs (e.g. oral hypoglycaemics and phenytoin) when administered concomitantly with miconazole may be increased and particular caution is therefore required.

Effects

Data collected 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
Alterations of the skin and subcutaneous tissue
• Feeling of skin burning	0,2	0,7
• Inflammation of skin	0,2	-
• Skin Ipopigmentation	0,2	-
General disorders and alterations of the administration site
• Irritation to the application site	0,7	0,5
• Burn to the application site	0,2	0,2
• Prurito to the application site	0,2	-
• Reactions to the application site	0,2	-
• Heat to the application site	0,2	-

Note: Individual patients may have reported more than one adverse event. Post-marketing data Below are the undesirable effects detected by post-marketing spontanee signals, around the world, organized according to the MedDRA classification. Undesirable effects are classified according to the frequency according to the following convention: very common (≥ 1/10); common (≥ 1/100 and Immune system disorders Very rare: anaphylactic reactions, hypersensitivity. Pathologies of skin and subcutaneous tissue Very rare: angioedema, hives, contact dermatitis, rash, erythema, itching, skin burning sensation. Systemic pathologies and conditions for administration Very rare: irritation or other reactions to the application site. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms and signs In general, excessive use of DAKTARIN DERMATOLOGICAL can cause skin irritation that generally disappears with the interruption of therapy. Treatment In the case of accidental ingestion: DAKTARIN DERMATOLOGICAL is intended for local application and not for oral use. In case of accidental ingestion of large quantities of DAKTARIN DERMATOLOGICAL Use appropriate support therapy. The accidental ingestion of DAKTAARIN DERMATOLOGICAL skin solution can cause gastric irritation. A specific antidote is not available. Treatment is symptomatic and supportive. Moreover, since the cutaneous solution contains alcohol, it is necessary to consider the amount of alcohol that may be ingested, especially in children. DAKTARIN DERMATOLOGICAL powder and skin spray, powder contain talc: the accidental inhalation of large amounts of medicine may cause occlusion of the respiratory tract. A respiratory arrest can be treated with intense support and oxygen therapy. If breathing is compromised, endotracheal intubation, removal of obstructive material and assisted breathing are recommended.

Pregnancy

DAKTARIN DERMATOLOGICAL, applied by topic, is minimally absorbed in the systemic circle (bioavailability

Food

Miconazole, applied by topical means, is minimally absorbed in the systemic circle and is not known if the miconazole is excreted in human milk. We recommend caution in using topical products containing miconazole during breastfeeding.

Source: Farmadati