Clotrimazole cream for external use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clotrimazole

Available from:

GlaxoSmithKline Pharmaceuticals S.A.

ATC code:

D01AC01

INN (International Name):

clotrimazole

Dosage:

10mg/g

Pharmaceutical form:

cream for external use

Units in package:

20g aluminium tube

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2015-09-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clotrimazole cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clotrimazole, 10 mg/g, cream _
Each 1 gram of cream contains 10 mg of clotrimazole.
3.
PHARMACEUTICAL FORM
_Clotrimazole, 10 mg/g, cream_
Smooth, white mass with homogeneous consistence.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
For the topical treatment of:

infections due to superficial dermatophytes

fungal infections due to _Candida _
4.2.
Posology and Method of Administration
Cream should be applied on clean dry areas of affected skin (to be
washed by neutral pH soap). If applied
to the feet they should be thoroughly washed, dried and then the cream
should be applied between the
toes.
Patients should notify their physician if there is no improvement
after 4 weeks of treatment.
For cutaneous use.
ADULTS AND CHILDREN OVER 12 YEARS OF AGE
Cream should be applied to the affected area two or three times daily.
To prevent relapse, treatment should be continues for at least two
weeks after disappearance of all signs
of infection.
The following additional Dosage and Administration information is also
present in some local markets:
The duration of treatment depends on the severity of the disease, its
location and the treatment efficacy.
Suggested treatment duration:

dermatophytes infections - at least one month

_Candida_ infection - at least two weeks
The duration of treatment will vary according to individual
circumstances but should not be less than 3
weeks. To prevent recurrence of the infection it is important to
continue treatment for 1-2 weeks after
disappearance of all signs of infection.
If symptoms do not improve after 7 days of treatment medical advice
should be sought.
CHILDREN
There are no relevant data available.
ELDERLY
There are no relevant data available.
RENAL IMPAIRMENT
There are no relevant data available.
HEPATIC IMPAIRMENT
There are no relevant data available.
4.2
Contra-indications
Clotrimazole is contraindicated in:

hypersensitivity to c