CANDIPLAS H Cream Ref.[28051] Active ingredients: Hydrocortisone Miconazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2017  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

  • For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, e.g. intertrigo and infected eczema.
  • Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.
  • Intertriginous eczema including inflammatory intertrigo, perianal and genital dermatitis.

Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (e.g. Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

4.2. Posology and method of administration

Posology

The properties of Candiplas H cream indicate it particularly for the initial stages of treatment. Because of its corticosteroid content avoid long-term treatment with Candiplas H cream. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with miconazole nitrate 20 /g cream or powder. Treatment should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks).

If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.

The same dosage applies to both adults and children.

Elderly

Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

Paediatric population

In infants and children, caution is advised when is applied to extensive surface areas or under occlusive dressings including baby napkins (diapers). In infants, long term continuous topical corticosteroid therapy should be avoided (see section 4.4).

Method of administration

For topical administration.

Apply the cream two or three times a day to the affected area, rubbing in gently until the cream has been absorbed by the skin.

4.9. Overdose

Symptoms

Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

Lacquered collapsible aluminium tubes, crimped at bottom and sealed with a polypropylene screw cap containing 15 g and 30g of cream packed in a carton box.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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