Locoid Scalp lotion Cutaneous Solution 1mg/ml

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

HYDROCORTISONE BUTYRATE

Disponible des:

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

Codi ATC:

D07AB02

Designació comuna internacional (DCI):

HYDROCORTISONE BUTYRATE 1 mg/g

formulario farmacéutico:

CUTANEOUS SOLUTION

Composición:

HYDROCORTISONE BUTYRATE 1 mg/g

tipo de receta:

POM

Área terapéutica:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2005-09-23

Informació per a l'usuari

LOCOID
®
scalp lotion 0.1%
Information for the user
We advise you to read this package insert, also if you have used
Locoid lotion before.
The information may have changed.
WHAT IS LOCOID LOTION AND HOW DOES IT
WORK?
_Composition_
Locoid lotion contains as active
ingredient 1 mg hydrocortisone
17-butyrate per gram.
The other ingredients are: isopropanol,
glycerol, povidone, citric acid, sodium
citrate and purified water.
_What does Locoid lotion look like and_
_ _
_how is it supplied ?_
Locoid lotion is a clear colourless liquid
which is packed in bottles of 30 ml.
The bottle is packed in a yellow/grey/
white box imprinted Locoid lotion 0.1%.
_How does Locoid lotion work?_
Locoid lotion contains an adrenal cortex
hormone (corticosteroid) and quickly
decreases 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 lotion 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 lotion is only available on
prescription.
WHAT CAN LOCOID LOTION BE USED FOR?
Locoid lotion may be used for the
treatment of superficial skin diseases
in which itching, redness or scaling are
often pr
esent. Locoid lotion is especially
suitable for the treatment of the hairy
scalp.
WHAT YOU SHOULD KNOW BEFORE USING
LOCOID LOTION
_When should you not use Locoid lotion?_
Locoid lotion 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
previous treatment with corticosteroids,
such as inflammation of the skin around
the mouth, thin skin, possibly with
stripes, fragile blood vessels.
If you are hypersensitive to
hydrocortisone butyrate or one of the
other ingre

Fitxa tècnica

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Locoid
®
oleogel, ointment 1 mg/g
Locoid
®
Lipocream, cream 1 mg/g
Locoid
®
cream,
cream
1
mg/g
Locoid
®
scalp lotion, lotion 1 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid oleogel, Locoid Lipocream and Locoid cream contain 1 mg/g and
Locoid scalp
lotion 1 mg/ml hydrocortisone 17-butyrate.
Locoid oleogel is hydrophobic (greasy); Locoid Lipocream and cream
contain buffered
oil-in-water emulsions (Locoid Lipocream has a higher lipid content
and Locoid cream a
higher water content). The lotion, which is a buffered, slightly
viscous solution, is
prepared on the basis of an isopropanol/water mixture.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Locoid oleogel is an ointment, Locoid Lipocream and Locoid cream are
creams and
Locoid scalp lotion is a solution for cutaneous use.
Locoid oleogel, Locoid Lipocream and Locoid cream are white. Locoid
scalp lotion is
clear and colourless.
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 weak 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 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.
Page 2 of 7
Locoid should be applied evenly in a thin layer onto the affected
skin. It may carefully be
massaged lightly into the skin to promote penetration.
Occlusion may be necessary to obtain a better therapeutic result.
4.3
CONTRAINDICATIONS

Skin lesions caused by:
-
bacterial infections (e.g. pyodermias, luetic and tuberculous lesions)
-
viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares,
verrucae planae, condylomata,