DAKTARIN CUT 30ML 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) This medicine 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 For the full list of excipients, see paragraph 6.1

Excellent

Skin powder : zinc oxide, precipitated silica, talc. Skin spray, powder : talc, sorbitan sesquioleato, ethanol anidro, steralconio ettorite, propellant (mix of propane and butane). Cream : polyethyleneglycol palmito stearato, macrogol, glycerol oleate, liquid paraffin, hydroxyanisol butilato, 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 ingredient, other derivatives of imidazole or any of the excipients listed in the paragraph 6.1. Infants and children (up to 12 years).

Population

Skin infections The treatment must be continued daily and continuously until at least one week after the disappearance of symptoms, and can last from 2 to 6 weeks, depending on the type and extension 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 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 enough to use both powder and cream once a day. In foot infections it is recommended to sprinkle your feet daily with DAKTARIN DERMATOLOGICAL powder during and after treatment with other topical formulation (DAKTARIN DERMATOLOGICO cream), in particular the spaces between the fingers, and also the 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, dust, skin solution : Store at a temperature not exceeding 25°C. Skin powder: no particular condition of conservation

Warnings

If sensitization or irritation occur, stop treatment and establish suitable therapy. Avoid contact with eyes. Carefully wash your hands after each application, unless the treatment interests the same hands. Because the skin solution contains alcohol, avoid contact with open wounds and mucous membranes. In these cases, use DAKTARIN It's a skin cream. DAKTARIN DERMATOLOGICAL skin powder contains talc: avoid inhaling the powder that 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 infection of other people; - regularly change clothing that comes into contact with the infected area to avoid reinfection. DAKTARIN DERMATOLOGICO does not spot the skin or clothing. Reactions of severe hypersensitivity, including anaphylaxis and angioedema, were 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 get in touch with the mucosa of the eyes. Important information about some excipients DAKTARIN DERMATOLOGICAL cream contains benzoic acid Benzoic acid can cause local irritation. DAKTARIN DERMATOLOGICAL cream contains hydroxyanisol butilate Butylated hydroxine only can cause reactions to localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. DAKTARIN DERMATOLOGICAL skin solution contains propylene glycol that can cause skin irritation. The solution also contains ethyl alcohol: avoid contact with open wounds and mucous membranes.

Interactions

It is known that systemic miconazole inhibits CYP3A4/2 C9. Since, following local application, the presence of the drug in the blood is limited (see paragraph 5.2 Pharmactical Properties) the interactions considered relevant from a clinical point of view are very rare. However, in patients treated with oral anticoagulants, such as warfarin, care should be taken and monitor anticoagulant action. The efficacy and side effects of other drugs (e.g. oral and phenytoin hypoglycemizers), if administered at the same time to miconazole, may be increased and, therefore, special caution is required.

Effects

Data from clinical trials The following table shows the percentage of side effects considered related to the drug reported by 834 patients who were administered miconazole 20mg/g cream (426 patients) vs. placebo (408 patients), enrolled in 21 clinical trials performed in double blind.

	% side effects
Organ/system	Miconazole cream 20mg/g	Placebo - basic 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

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. Accidental ingestion of DAKTARIN 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 lactation

Source: Farmadati