Locoid Cream 0.1%

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

hydrocortisone butyrate 1 mg/g

Доступно од:

Astellas Pharma Europe B.V.

АТЦ код:

D07AB02

INN (Међународно име):

hydrocortisone butyrate

Фармацеутски облик:

cream

Статус ауторизације:

Authorised

Датум одобрења:

2005-09-23

Информативни летак

1 

LOCOID
® 
0.1 % cream 
Information 
for 
the 
user        

________________________________________________________________________________________________________________ 

We advise you to read this package insert, also if you have
used Locoid cream before. 
The information may have changed. 

WHAT IS LOCOID CREAM AND HOW DOES IT 
WORK? 

_Composition _
Locoid cream contains as active 
ingredient 1 mg hydrocortisone 
17-butyrate per gram. 
The other ingredients are: cetostearyl 
alcohol, cetomacrogol 1000, liquid 
paraffin, white soft paraffin, 
propylparahydroxybenzoate, 
buthylparahydroxybenzoate, citric acid, 
sodium citrate and purified water. 

_What does Locoid cream look like and _
_how is it supplied ? _
Locoid cream is white and is packed in 
tubes of 30 g. The tube is packed in a 
yellow/grey/white box imprinted Locoid 
cream. 

_How does Locoid cream work? _
Locoid cream 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. The cream base 
provides for the skin disorder to become 
less moist. 

_Authorization holder and manufacturer _
Locoid cream has been registered in the 
name of and is manufactured by 
Astellas Pharma Europe B.V. 
 Leiden, The Netherlands. 
Locoid cream is only available on 
prescription. 

WHAT CAN LOCOID CREAM BE USED FOR? 
Locoid cream may be used for the 
treatment of superficial skin diseases in 
which itching, redness or scaling are often 
present. Locoid cream contains little fat 
and is therefore suitable for those skin disorders 
in which the skin is red and wet. 

WHAT YOU SHOULD KNOW BEFORE USING 
LOCOID CREAM 
_When should you not use Locoid cream? _
Locoid cream should not be used for: 
-

Карактеристике производа

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 
1. NAME OF THE MEDICINAL PRODUCT 
Locoid
®
 ointment 0.1% 
Locoid Lipocream
®
, cream 0.1% 
Locoid
®
 cream 0.1% 
Locoid Crelo
®
, cutaneous emulsion 0.1% 
Locoid
®
 scalp lotion 0.1% 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Locoid ointment and cream, Locoid Lipocream and Locoid Crelo
contain 1 mg/g and Locoid lotion 
1mg/ml hydrocortisone 17-butyrate. 
The ointment base is hydrophobic (fat); Locoid cream, Locoid
Lipocream and Locoid Crelo contain 
buffered oil-in-water emulsions (Locoid Lipocream contains more fat,
Locoid cream and Locoid 
Crelo more water). The lotion is buffered, somewhat viscous and
based on isopropanol-water. 

3. PHARMACEUTICAL FORM 
Ointment, cream, cutaneous emulsion and cutaneous solution. 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Superficial, corticosteroid responsive dermatoses, which are not
caused by micro-organisms.  
Follow-up or maintenance treatment of dermatoses which have
been suppressed previously by a 
stronger corticosteroid. 
4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Apply 1-3 times daily a small amount of Locoid to the skin.  
After improvement of the disorder, application once daily or two
to three times a week is usually 
adequate. 
Do not use more than 30-60 g per week in general. 
Locoid should be applied evenly in a thin layer onto the diseased
skin. 
To promote penetration it may be lightly massaged into the skin. 
Occlusion may be necessary to obtain a better therapeutic result. 

Page 2 of 6 
4.3 CONTRAINDICATIONS 
-  Skin lesions caused by: 
o
  bacterial infections (e.g. pyodermias, luetic
and tuberculous processes) 
o
  viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares, verrucae 
planae, condylomata, mollusca contagiosa) 
o
  mycotic and yeast infections 
o
  parasitic infections (e.g. scabies) 
-  Ulcerous skin lesions, wounds