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DAKTARIN AKTIV SPRAY POWDER

Active substance(s): MICONAZOLE NITRATE / MICONAZOLE NITRATE / MICONAZOLE NITRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Daktarin Aktiv Spray Powder

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 0.16% w/w
(Each gram of powder contains 1.6 mg of miconazole nitrate)
For 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(s), 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 Daktarin Aktiv Spray Powder and
with other miconazole topical formulations (see Adverse Reactions). 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.

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 oral anticoagulants, such as warfarin, 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.

4.7

Effects on ability to drive and use machines
Not applicable.

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, including isolated reports
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.

4.9

Overdose
Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears
after discontinuation of therapy.
Treatment
Daktarin Aktiv Spray Powder is intended for cutaneous use, not for oral use. If
accidental ingestion of large quantities of the product occurs, an appropriate method
of gastric emptying may be used if considered necessary.
Accidental inhalation of talc-containing powder: Massive accidental aspiration of
Daktarin Aktiv Spray 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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic classification: (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: There is little absorption through skin or mucous membranes when
miconazole nitrate is applied topically.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red
blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is
eliminated predominantly in faeces as both unchanged drug and metabolites.

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
24 months.

6.4

Special precautions for storage
Keep out of reach and sight 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 aerosol container with epoxy 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
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

7

MARKETING AUTHORISATION HOLDER
MCNEIL PRODUCTS LIMITED
FOUNDATION PARK
ROXBOROUGH WAY
MAIDENHEAD
BERKSHIRE
SL6 3UG
UNITED KINGDOM

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

08/08/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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