Daktarin 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Miconazole nitrate

Available from:

McNeil Products Ltd

ATC code:

D01AC02

INN (International Name):

Miconazole nitrate

Dosage:

20mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5027097372426

Patient Information leaflet

TOP
■
This medicine is used to treat fungal and bacterial
infections of the skin and nails.
■
This medicine is for use by adults and children of all ages.
■
DO NOT USE THIS MEDICINE:
■
There are some people who should not use this
medicine. _To find out if you are one of them._ _See _
_Section 2_ ▶
■
If you are allergic to the active substance, other similar
antifungal medicines or any of the other ingredients of
this medicine (listed in section 6)
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions mentioned in
_Section 2_ ▶
■
If you are taking any OTHER MEDICINES. _See Section 2_ ▶
■
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT
CAREFULLY. _See Section 3_ ▶
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
1 WHAT THE MEDICINE IS FOR
Daktarin 2% Cream is a medicine which is used in the
treatment of fungal and associated bacterial infections
of the skin and nails. Skin infections may appear on the
hands, feet, outer ear, trunk or groin and include athlete’s
foot, dhobie itch and intertrigo. Daktarin 2% Cream is also
effective against infected nappy rash. The cream contains
miconazole nitrate which works by destroying both the
fungus that causes the infection and some of the
associated bacteria which may also be present. It also has
moisturising properties to help soothe cracked, red skin.
This medicine is for use in adults and children of all ages.
2 BEFORE USING THIS MEDICINE
This medicine is suitable for most adults and children but
a few people should not use it. If you are in any doubt,
talk to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
■
If you are allergic to the active substance, other
similar antifungal medicines or any of the other
ingredients of this medicine (listed in section 6)
If this applies to you, GET ADVICE FROM A DOCTOR OR
PHARMACIST WITHOUT USING DAKTARIN 2% CREAM.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU ARE
TAKING…
■
_Oral anticoagulants_ (drugs used to THIN THE BLOO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Daktarin 2% Cream.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w
(Each gram of cream contains 20mg of miconazole nitrate).
Excipients: Also contains 2 mg/g of Benzoic acid (E210) and 0.052 mg/g
of
Butylated hydroxyanisole (E320).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White homogeneous cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mycotic infections of the skin and nails and
superinfections due to Gram-positive bacteria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: _Cutaneous use.
Recommended dosage:
For all ages:
Fungal infections of the skin: 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.
Nail infections: Apply the cream once or twice daily to the lesions.
Treatment
should be prolonged for 10 days after all lesions have disappeared to
prevent
relapse.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, other imidazole derivatives
or to any
of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Daktarin 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 Cream and with other
miconazole topical formulations (see Adverse Reactions). If a reaction
suggesting hypersensitivity or irritation should occur, the treatment
should be
discontinued.
This medicine contains 2 mg of Benzoic acid (E210) per gram. Benzoic
acid
may cause local irritation. Benzoic acid may increase jaundice
(yellowing