Locoid Lipocream Cream 1mg/g

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

HYDROCORTISONE BUTYRATE

Fáanlegur frá:

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

ATC númer:

D07AB02

INN (Alþjóðlegt nafn):

HYDROCORTISONE BUTYRATE

Lyfjaform:

CREAM

Samsetning:

HYDROCORTISONE BUTYRATE 1 milligram(s)/gram

Gerð lyfseðils:

POM

Lækningarsvæði:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Leyfisstaða:

Authorised

Leyfisdagur:

2005-09-23

Upplýsingar fylgiseðill

LOCOID LIPOCREAM
®
0.1%
Keep this leaflet, as you may need it again.
Consult your doctor or pharmacist if you have any questions.
This medicine has been prescribed for you personally so do not give it
to anyone else.
It could be harmful to them even if their symptoms are similar to
yours.
CONTENTS OF THIS LEAFLET
1.
What Locoid Lipocream is and what it is
used for
2.
What you should know before using Locoid
Lipocream
3.
How Locoid Lipocream is used
4.
Possible side-effects
5.
How to store Locoid Lipocream
LOCOID LIPOCREAM
®
0.1%, CREAM
Hydrocortisone 17-butyrate.
The active substance is 1 mg hydrocortisone
17-butyrate per gram cream.
Present as excipients are cetostearyl alcohol,
macrogol 25 cetostearyl ether, liquid paraffin,
white vaseline, propylparahydroxybenzoate
(E216), benzyl alcohol, citric acid (E330),
sodium citrate (E331) and purified water.
_Marketing Authorization holder:_
LEO Pharma A/S, Industriparken 55, 2750
Ballerup, Denmark_Manufacturer:_
Astellas Pharma Europe B.V., Sylviusweg 62,
2333 BE Leiden, The Netherlands
Locoid Lipocream is only available on
prescription.
1.
WHAT LOCOID LIPOCREAM IS AND WHAT IT IS
USED FOR
WHAT LOCOID LIPOCREAM LOOKS LIKE AND
HOW IS IT PACKED
Locoid Lipocream is white and is packed in
tubes of 30 grams. The tube is in a yellow/
grey/white pack imprinted with ‘Locoid
Lipocream 0.1%’.
HOW LOCOID LIPOCREAM WORKS
Locoid Lipocream contains a corticosteroid
and quickly suppresses symptoms of certain
skin conditions such as itching, redness and
scaling. Corticosteroids do not generally
remove the cause of the symptoms.
The Lipocream base ensures that the skin
condition becomes less moist.
WHAT LOCOID LIPOCREAM CAN BE USED FOR?
Locoid Lipocream can be used for the
treatment of superficial skin conditions where
itching, redness and scaling are often present.
It contains more lipid than normal and is
therefore suitable for those skin conditions
where the skin can be partly dry yet still partly
moist.
2.
WHAT YOU SHOULD KNOW BEFORE USING
LOCOID LIPOCREAM
DO NOT USE LOCOID L

Vara einkenni

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Locoid
®
Lipocream,
cream
1
mg/g
Locoid
®
cream, cream 1 mg/g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid Lipocream and Locoid cream contain 1 mg/ml hydrocortisone
17-butyrate.
Locoid Lipocream and cream contain buffered
oil-in-water emulsions (Locoid Lipocream
has a higher lipid content and Locoid cream a higher water content).
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Locoid Lipocream and Locoid cream are creams
Locoid Lipocream and Locoid cream are 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 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, 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
lat