Locoid Lipocream 0.1% w/w Cream

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

HYDROCORTISONE BUTYRATE

Tilgængelig fra:

LEO Pharma A/S

ATC-kode:

D07AB; D07AB02

INN (International Name):

HYDROCORTISONE BUTYRATE

Dosering:

0.1 percent weight/weight

Lægemiddelform:

Cream

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Corticosteroids, moderately potent (group II); hydrocortisone butyrate

Autorisation status:

Marketed

Autorisation dato:

1984-05-04

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCOID
®
LIPOCREAM 0.1% W/W CREAM
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
®
Lipocream is and what it is used for
2. What you need to know before you use Locoid
®
Lipocream
3. How to use Locoid
®
Lipocream
4. Possible side effects
5. How to store Locoid
®
Lipocream
6. Contents of the pack and other information
1. WHAT LOCOID
® LIPOCREAM IS AND WHAT IT IS USED FOR
The active substance in Locoid Lipocream (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
Lipocream 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 Lipocream 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�

Produktets egenskaber

Health Products Regulatory Authority
09 November 2020
CRN009VFL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid Lipocream 0.1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of cream contains 1 mg of hydrocortisone butyrate.
Excipient(s) with known effect:
Cetostearyl alcohol 6% w/w, propyl parahydroxybenzoate (E216) 0.05%
w/w and benzyl alcohol 0.5% w/w.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
A practically 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.
Due to the formulation of the base the product may be used both for
dry scaly lesions and for moist or weeping lesions.
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
derm