Locoid Crelo Cutaneous Emulsion 1mg/g

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

HYDROCORTISONE BUTYRATE

Tillgänglig från:

LEO Pharma A/S Industriparken 55, 2750-DK Ballerup, Denmark

ATC-kod:

D07AB02

INN (International namn):

HYDROCORTISONE BUTYRATE 1 mg/g

Läkemedelsform:

CUTANEOUS EMULSION

Sammansättning:

HYDROCORTISONE BUTYRATE 1 mg/g

Receptbelagda typ:

POM

Terapiområde:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2005-09-23

Bipacksedel

LOCOID CRELO
®
0.1% topical emulsion
Information for the user
We advise you to read this package insert, also if you have used
Locoid Crelo before.
The
information may have changed.
WHAT IS LOCOID CRELO AND HOW DOES IT
WORK?
_Composition_
Locoid Crelo topical emulsion contains as
active ingredient 1 mg hydrocortisone
17-butyrate per gram. The other
ingredients are: cetomacrogol 1000,
cetostearyl alcohol, white soft paraffin,
hard paraffin, borage oil, butyl hydroxy-
toluene, propylene glycol, sodium citrate,
citric acid, propyl hydroxybenzoate, butyl
hydroxybenzoate and purified water.
_What does Locoid Crelo look like and how _
_is it supplied ?_
Locoid Crelo topical emulsion is white and
is packed in bottles of 30 g. The bottle is
packed in a yellow/grey/white box
imprinted Locoid Crelo 0,1%.
_How does Locoid Crelo topical emulsion_
_ _
_work?_
Locoid Crelo contains an adrenal cortex
hormone (corticosteroid) and decreases
quickly the symptoms, such as itching,
redness or scaling of the skin, which
occur in certain skin disorders.
Corticosteroids in general do not cure the
underlying disease.
_Authorization holder and manufacturer_
_ _
Locoid Crelo has been registered in the
name of LEO Pharma A/S, Industriparken
55, 2750 Ballerup, Denmark and is
manufactured by
Astellas Pharma
Europe B.V., Leiden,
The Netherlands.
Locoid Crelo 0.1% topical emulsion is
only available on
prescription.
WHAT CAN LOCOID CRELO BE USED FOR?
Locoid Crelo topical emulsion may be
used for the treatment of superficial skin
diseases in which itching, redness or
scaling are often present. Locoid Crelo is
especially suitable for the treatment of
hairy skin.
WHAT YOU SHOULD KNOW BEFORE USING
LOCOID CRELO
_When should you not use Locoid Crelo? _
Locoid Crelo topical emulsion should not
be used for:
- Skin disorders caused by bacterial, viral,
fungal, yeast or parasitic infections.
These disorders might aggravate or be
masked.
- Acne, also with redness of the skin.
- Wounds, fish skin (ichthyosis).
- Skin disorders which might result from
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Produktens egenskaper

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Locoid Crelo
®
, cutaneous emulsion 1 mg/g.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid Crelo contains 1 mg hydrocortisone 17-butyrate per gram, in a
buffered oil-in-
water emulsion.
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous emulsion. The emulsion is white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Superficial, corticosteroid-responsive dermatoses that are not caused
by microorganisms
and that are expected to respond inadequately to weaker products.
Follow-up or maintenance treatment of dermatoses that have been
suppressed previously
by a stronger corticosteroid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply a small amount of Locoid Crelo to the skin 1 - 3 times daily.
Once the disorder has
improved, application once daily or two to three times a week is
usually sufficient.
Generally, not more than 30-60 g per week should be used.
Locoid Crelo is suitable for the treatment of weeping skin lesions on
uncovered areas of
skin and lesions affecting hairy skin.
Locoid Crelo can be removed by washing.
Locoid Crelo should be applied evenly in a thin layer onto the
affected skin. It may
carefully be massaged lightly into the skin to promote penetration. It
may be advisable to
subsequently cover weeping lesions with a compress.
4.3
CONTRAINDICATIONS

Skin lesions caused by:
Page 2 of 6
-
bacterial infections (e.g. pyodermias, luetic and tuberculous lesions)
-
viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares,
verrucae planae, condylomata, mollusca contagiosa)
-
fungal and yeast infections
-
parasitic infections (e.g. scabies)

Ulcerous skin lesions, wounds.

Adverse reactions induced by corticosteroids (e.g. dermatitis
perioralis, striae
atrophicae).

Ichthyosis, juvenile dermatosis plantaris, acne vulgaris, acne
rosacea, fragility of the
skin vessels, skin atrophy.

Allergic hypersensitivity to components of the vehicle or to
corticosteroids (the latte