Locoid Cream 0.1 % w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE BUTYRATE

Available from:

LEO Pharma A/S

ATC code:

D07AB; D07AB02

INN (International Name):

HYDROCORTISONE BUTYRATE

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, moderately potent (group II); hydrocortisone butyrate

Authorization status:

Marketed

Authorization date:

1977-10-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCOID
®
CREAM 0.1% W/W
Hydrocortisone butyrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Locoid
®
Cream is and what it is used for
2. What you need to know before you use Locoid
®
Cream
3. How to use Locoid
®
Cream
4. Possible side effects
5. How to store Locoid
®
Cream
6. Contents of the pack and other information
1. WHAT LOCOID
® CREAM IS AND WHAT IT IS USED FOR
The active substance in Locoid Cream (hydrocortisone butyrate) is a
corticosteroid which
when made up as a cream is for use on the skin. This is known as
topical application. Topical
corticosteroids are ranked as mildly potent, moderately potent, potent
and very potent; Locoid
Cream is classed as potent. Topical corticosteroids are able to reduce
the inflammation
caused by a variety of skin conditions, and so allow it to get better.
They can also
affect the cause of the condition, which can lead to its healing.
Locoid Cream is indicated in adults, children and infants above 3
months of age. It is used to
treat a variety of skin conditions which are not caused by
micro-organisms. Among these are
eczema and dermatitis (itching) of all types including atopic
(childhood) eczema,
photodermatitis (itching caused by exposure to light) and dermatitis
caused by skin irritants
and allergies.
It can also be used in the treatment of psoriasis, a condition
resulting in thickening of areas of
the skin. It is important that you follow your doctor’s instructions
particularly in psorias

Summary of Product characteristics

Health Products Regulatory Authority
09 November 2020
CRN009VFL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid Cream 0.1 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of cream contains 1 mg of hydrocortisone butyrate.
Excipient(s) with known effect:
Cetostearyl alcohol 7.2% w/w; propyl parahydroxybenzoate (E216) 0.1%
w/w and butyl parahydroxybenzoate (E218) 0.05% 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
The product is recommended for the treatment of inflammatory skin
disorders not caused by micro-organisms e.g. eczema,
dermatitis and psoriasis.
Locoid is indicated in adults, children and infants above 3 months of
age.
Topical corticosteroids are acceptable in psoriasis excluding
widespread plaque psoriasis provided warnings are given, see
section 4.4 Special warnings and special precautions for use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical application.
Dosage: to be applied evenly and sparingly one to two times daily.
Application may be made under occlusion in the more resistant lesions
such as thickened psoriatic plaques on elbows and
knees. Overnight occlusion is usually sufficient to give a
satisfactory response.
Adults and older people: 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.
Children and infants: long term treatment, occlusion and prolonged
treatment should be avoided. Courses should be limited
to seven days.
4.3 CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the excipients listed
in section 6.1.
This preparation is contraindicated in the presence of untreated viral
or fungal infections (mycotic yeast) or parasitic infections,
tubercular or syphilitic lesions ulcerous skin lesions, peri-oral
dermatitis, acne vulgaris and rosacea and in bacterial infections
unless used in connection with appropriate chemotherapy.
4.4