Summary of Product Characteristics (SmPC) - Daktarin Aktiv spray powder
1 NAME OF THE MEDICINAL PRODUCT
Daktarin Aktiv Spray Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 0.16% w/w
(Each gram of spray contains 1.6 mg of miconazole nitrate)
Excipient with known effect: 1 g of powder contains 255 mg (10% w/w) ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray powder
Spray leaving a white powdery residue
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cutaneous administration for the treatment and prevention of athlete’s foot.
4.2 Posology and method of administration
Apply to infected area twice daily until the lesions are healed.
Method of Administration: Cutaneous use.
4.3 Contraindications
Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1
Not to be used on hair infections, nail infections or broken skin.
4.4 Special warnings and precautions for use
The spray should be kept away from the eyes and mucous membranes.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole and with other miconazole topical formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
Daktarin Aktiv Spray Powder contains talc. Avoid inhalation of the powder to prevent irritation of the airways. In particular, when treating infants and children, careful application should be used to prevent inhalation by the child.
Daktarin Aktiv Spray Powder contains ethanol. This medicine contains 255 mg (10% w/w) ethanol in each gram of powder. It may cause burning sensation on damaged skin.
Miconazole administered systemically is known to inhibit CYP3A4/2C9, which can lead to prolonged effects of warfarin or other vitamin K antagonists. While systemic absorption is limited with topical formulations, the concomitant use of Daktarin Aktiv Spray Powder and warfarin or other vitamin K antagonists should be done with caution and the anticoagulant effect should be carefully monitored and titrated. Patients should be advised of the symptoms of bleeding events and to immediately stop treatment with miconazole and seek medical advice should they occur (see section 4.5).
If symptoms persist or get worse, or if new symptoms occur, stop use and consult a doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on warfarin or other vitamin K antagonists, caution should be exercised and anticoagulant effect should be monitored.
4.6 Fertility, pregnancy and lactation
Pregnancy
In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.
Breast-feeding
Topically applied miconazole is minimally absorbed into the systemic circulation and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.
Patients who are pregnant or breastfeeding should seek advice from a doctor before using miconazole.
4.7 Effects on ability to drive and use machines
It is not known if miconazole or miconazole nitrate has an effect on the ability to drive or use machines.
4.8. Undesirable effects
Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency, using the following convention:
Very common > 1/10
Common > 1/100 and < 1/10
Uncommon > 1/1,000 and <1/100
Rare > 1/10,000, < 1/1,000
Very rare < 1/10,000
Not known (cannot be estimated from the available data)
The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.
Immune system disorders
Very rare: anaphylactic reaction, hypersensitivity,
Skin and subcutaneous tissue disorders
Very rare: Angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation
General disorders and administration site conditions
Rare: application site reactions, including application site irritation
Reporting of suspected adverse reactions
Reporting suspected adverse reactions 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Miconazole (topical) is intended for cutaneous use, not for oral use. Should accidental oral ingestion of large quantities of these products occur, use appropriate supportive care.
Accidental inhalation of talc-containing powder: Massive accidental aspiration of miconazole (topical) powder may cause impaction blockage of airways. Respiratory arrest should be treated with intensive supportive therapy and oxygen. If respiration is compromised, endotracheal intubation, removal of impacted material, and assisted breathing should be considered.
Keep out of reach of children. If swallowed, get medical help straight away.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: (Antifungals for dermatological/topical use; imidazole derivative), ATC code: D01A C02.
Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.
5.2 Pharmacokinetic properties
Absorption: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application.
Systemic absorption has also been demonstrated after repeated application of miconazole to infants with diaper dermatitis. Plasma levels of miconazole were undetectable or low in all infants.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism: No studies have been found describing the metabolism of topical miconazole in humans.
Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stearalkonium hectorite
Ethanol
Hydrocarbon propellant
Sorbitan sesquioleate
Talc
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Keep out of the sight and reach of children. Caution Flammable
Pressurised container
Protect from light
Do not expose to temperatures exceeding 50ºC
6.5 Nature and contents of container
Three piece tinplate aerosol container with epoxy-phenolic lining and welded side seam with protective polyester side strip. 1 inch opening to accommodate a standard aerosol valve.
The aerosol container contains 100g of product.
6.6 Special precautions for disposal and other handling
Shake well. Hold can 3 inches from skin, then generously spray affected area.
Pressurised container: Protect from sunlight and do not expose to temperatures exceeding 50°C.
Do not pierce or burn, even after use.
Do not spray on or near a naked flame or any incandescent material. Keep away from sources of ignition - No smoking. Do not spray near, or place on, polished or painted surfaces.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited
1 Station Hill Square
Station Hill
Reading
RG1 1LN
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 15513/0306
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/08/2008
10 DATE OF REVISION OF THE TEXT
18/09/2026