GYNO-DAKTARIN VC* CREAM

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Janssen Pharmaceutica (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CREAM

Composition:

EACH 100 g CREAM CONTAINS MICONAZOLE 2 g

Authorization status:

Canceled

Authorization date:

1975-07-06

Patient Information leaflet

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_PAGE 1 OF 4 _
PATIENT INFORMATION LEAFLET
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_ _
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
This medicine is available without a doctor’s prescription, for you
to treat a mild illness. Nevertheless you
still need to use DAKTARIN® cream carefully to get the best results
from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve after
_one week._
S1
DAKTARIN
® CREAM
Miconazole 20mg/g
_ _
1.
WHAT DAKTARIN CREAM CONTAINS_ _

The active substance is miconazole nitrate._ _

The other ingredients are water, PEG-6 (and) PEG-32 (and) glycol
stearate, oleoyl
macrogolglycerides, liquid paraffin, benzoic acid, and butylated
hydroxyanisole._ _
_ _
_ _
2.
WHAT DAKTARIN CREAM IS USED FOR
DAKTARIN is a medicine used for treating infection of the skin by
fungi including yeasts.
_ _
DAKTARIN cream is used in infections of the scalp, the beard, the
trunk, the feet and hands and the
groin. It is also used for napkin rash in babies.
3.
BEFORE YOU USE DAKTARIN CREAM
-
Wash your hands carefully after you have used DAKTARIN Cream, except
if the treatment is for
the hands.
-
Keep a towel and a washcloth for your own use. In this way you AVOID
INFECTING OTHER PEOPLE.
-
Regularly change clothing, which comes into contact with the infected
skin in order to avoid re-
infecting yourself.
-
DO NOT APPLY DAKTARIN CREAM TO THE EYES.
_ _
_ _
DO NOT USE DAKTARIN CREAM:

if you are hypersensitive (allergic) to _miconazole _or any of the
other ingredients of DAKTARIN
cream _(see _WHAT DAKTARIN CREAM CONTAINS_)._
_ _
_ _
PREGNANCY AND BREAST-FEEDING
DAKTARIN cream is minimally absorbed into the body when applied on the
skin, however, safety in
pregnancy has not been demonstrated.
Safety has not been demonstrated in breastfeeding women.
If you are pregnant or breast feeding your baby while using this
medicine, please consult your doctor,
pharmacist or other

Summary of Product characteristics

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_PAGE 1 OF 5 _
PACKAGE INSERT
SCHEDULING STATUS
Schedule 1
PROPRIETARY NAME AND DOSAGE FORM
DAKTARIN
®
cream
COMPOSITION
Miconazole nitrate 20 mg/g.
Preservative: Benzoic acid 0,2 % m/m
PHARMACOLOGICAL CLASSIFICATION
A. 13.9.2 Dermatological preparations. Fungicides.
PHARMACOLOGICAL ACTION
PHARMACODYNAMICS
Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. _
In vitro_, low concentrations of miconazole
nitrate are fungistatic against all Phycomycetes, Ascomycetes and
Adelomycetes tested (e.g. Saprolegnia,
Candida,
Cryptococcus,
Aspergillus,
Dermatophytes,
Phialophora,
Sporotrichum)
and
fungicidal
against
_Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton
floccosum, Trichophyton interdigitale_ and
_Microsporum canis_.
Thus the miconazole nitrate is a broad-spectrum anti-fungal agent. As
yet there is no evidence of drug
resistance developing to miconazole nitrate.
Miconazole nitrate also possesses some antibacterial activity against
gram-positive organisms.
In addition, miconazole nitrate has a very rapid alleviating effect on
the pruritis, which frequently accompanies
infection.
PHARMACOKINETICS
Absorption:
Systemic absorption of miconazole is limited, with a bioavailability
of less than 1% following topical application of
miconazole.
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 feces as both unchanged drug
and metabolites over a four-day post-administration period. Smaller
amounts of unchanged drug and
metabolites also appear in urine.
INDICATIONS
Dermatomycoses, e.g.:
-
Tinea pedis (athlete's foot)
-
Tinea corporis (Tinea circinata)
-
Tinea manuum
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_PAGE 2 OF 5 _
Tinea cruris due to:
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Trichophyton mentagrophytes
-
Trichophyton rubrum
-
Microsporum audouinii
-
Epidermophyton floccosum
Candidial infections:
Infections of the skin (.e.g. intertrigo)
Perianal infections
Stomatitis angularis (cheilitis, perleche)
Balanopos