Daktarin Gold 2% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketoconazole

Available from:

McNeil Products Ltd

ATC code:

D01AC08

INN (International Name):

Ketoconazole

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: 5027097953311

Patient Information leaflet

TOP
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This medicine is used to treat Athlete’s Foot, dhobie itch and
sweat rash skin infections.
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This medicine is for use by adults.
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DO NOT USE THIS MEDICINE:
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There are some people who should not use this medicine. _To _
_find out if you are one of them._ _See Section 2_
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If you have ever had a BAD REACTION to any of the ingredients.
_For the list of ingredients._ _See Section 6_
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SPEAK TO YOUR DOCTOR:
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If you suffer from any of the conditions mentioned in _Section 2_
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If you are taking any OTHER MEDICINES. _See Section 2_
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FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See _
_Section 3_
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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 Gold 2% Cream is a medicine which is used to treat
skin infections which may appear on the feet (Athlete’s Foot), in
the groin area (Dhobie itch/tinea cruris) or between skin folds
(Sweat Rash infected with a yeast infection ‘thrush’).
The cream rapidly relieves the itching which these fungal infections
cause. It also provides long lasting protection from Athlete’s Foot,
as it will continue to work even after you have stopped using it.
The cream contains the active substance, ketoconazole, which
works by destroying the fungi and yeasts that cause the infection.
If you have Athlete’s Foot, the skin between your toes will be red
and itchy. Your skin may flake and crack and often the infection
causes an unpleasant ‘cheesy’ smell. It is encouraged by moist,
warm conditions and can be recognised by redness, irritation and
itchiness between the toes.
Tinea cruris or Dhobie Itch is a fungal infection that occurs in the
groin area and causes intense itching and inflammation (redness and
soreness). In men, the skin of the scrotum is often affected.
Candidal intertrigo or sweat rash which has been infected with
a yeast infection (‘thrush’) is usually found under the breasts
and
where fleshy areas around the wais

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Daktarin Gold 2% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 2% w/w.
Excipients with known effect: Propylene glycol 20% w/w; Cetyl alcohol
2%
w/w; Stearyl alcohol 7.5% w/w.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following mycotic infections of the skin:
tinea pedis,
tinea cruris and candidal intertrigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ketoconazole cream is for use in adults.
For the treatment of tinea pedis (athlete’s foot) and tinea cruris
(dhobie itch) and
candidal intertrigo (sweat rash).
Tinea cruris, candidal intertrigo and_ _tinea pedis_: _It is
recommended that
Daktarin Gold 2% Cream be applied once or twice daily to cover the
affected
and immediate surrounding area.
The usual duration of treatment is tinea cruris 2-4 weeks, candidal
intertrigo_ _2-
4 weeks_,_ tinea pedis 4-6 weeks.
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BV 3000
Treatment should be continued, until a few days after disappearance of
all
symptoms. The diagnosis should be reconsidered if no clinical
improvement is
noted after 4 weeks of treatment.
Method of administration: Cutaneous use.
Paediatric patients
The safety and efficacy of Daktarin Gold 2% Cream in children (17
years and
younger) has not been established.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Daktarin Gold 2% cream is not for ophthalmic use.
To prevent a rebound effect after stopping a prolonged treatment with
topical
corticosteroids it is recommended to continue applying a mild topical
corticosteroid in the morning and to apply Daktarin Gold 2% cream in
the
evening, and to subsequently and gradually withdraw the steroid
therapy over
a period of 2-3 weeks.
This medicine contains cetyl alcohol and stearyl alcohol which may
cause
loc