LOCOID Cream Ref.[27966] Active ingredients: Hydrocortisone butyrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

4.1. Therapeutic indications

Locoid Cream is indicated in adults, children and infants above 3 months of age. The product is recommended for treatment of inflammatory skin disorders not caused by micro-organisms e.g. eczema, dermatitis and psoriasis.

Topical corticosteroids are acceptable in psoriasis, excluding widespread plaque psoriasis provided warnings are given, see section 4.4 Special warnings and precautions for use.

4.2. Posology and method of administration

Posology

Adults and older people

A thin and even layer should be applied to the affected area of the skin, 1 to 2 times daily.

The same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.

Paediatric population

Long term treatment, large amounts, and occlusion should be avoided.

Infants

Therapy should be limited to a maximum of seven days.

Method of administration

For cutaneous use.

Application may be made under occlusion in the more resistant lesions such as thickened psoriatic plaques on elbows and knees.

4.9. Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5. Nature and contents of container

Collapsible aluminium tubes containing either 30 g, 50 g, 100 g or 200 g packed in a carton.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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