Daktarin Aktiv Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Daktarin Aktiv Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2.0% w/w
(Each gram of cream contains 20mg of miconazole nitrate)
For excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Cream
White homogeneous cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of athlete's foot.
4.2 Posology and method of administration
For all ages.
Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended. The duration of therapy varies from 2 to 6 weeks depending on the localisation and
the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.
Method of administration: Cutaneous application.
4.3 Contraindications
Hypersensitivity to the active substances(s), other imidazole derivatives or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Daktarin Aktiv Cream must not come into contact with the mucosa of the eyes.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Aktiv Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
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
None known
4.8 Undesirable effects
Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 doubleblind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1. 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 and <1/1,000
Very rare <1/10,000, including isolated reports
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.
Table 1: Adverse reactions in ^ clinical trials and post-marketing experience
|
System Organ Class |
Adverse Reactions | |
|
Frequency Category | ||
|
Uncommon (>1/1,000 to <1/100) |
Not known | |
|
Immune System Disorders |
Anaphylactic reaction Hypersensitivity | |
|
Skin and Subcutaneous Tissue Disorders |
Skin burning sensation Skin inflammation Skin hypopigmentation |
Angioedema Urticaria Contact dermatitis Rash Erythema Pruritus |
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 Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.
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
General Disorders and Administration Site Conditions
Application site irritation Application site burning Application site pruritus Application site reaction NOS
Application site warmth
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
PEG-6, PEG-32 and glycol stearate Oleoyl macroglycerides Liquid paraffin Benzoic acid (E210)
Butylated hydroxyanisole (E320) Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
24 months.
6.4
Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.
Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g*. *Not all pack sizes may be marketed.
6.6 Special precautions for disposal <and other handling>
Not applicable.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 15513/0304
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT
10
08/08/2016