Locoid Ointment 0.1%

Država: Malta

Jezik: angleščina

Source: Medicines Authority

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Navodilo za uporabo Navodilo za uporabo (PIL)
09-05-2024
Lastnosti izdelka Lastnosti izdelka (SPC)
09-05-2024

Aktivna sestavina:

hydrocortisone butyrate 1 mg/g

Dostopno od:

Astellas Pharma Europe B.V.

Koda artikla:

D07AB02

INN (mednarodno ime):

hydrocortisone butyrate

Farmacevtska oblika:

ointment

Status dovoljenje:

Authorised

Datum dovoljenje:

2005-09-23

Navodilo za uporabo

                                1 
 
LOCOID
® 
0.1 % ointment 
 
 
Information for the user
                                 
_________________________________________ 
 
We advise you to read this package insert, also if you have
used Locoid ointment before. 
The information may have changed. 
 
WHAT IS LOCOID OINTMENT AND HOW 
DOES IT WORK? 
 
_Composition _
Locoid ointment contains as active 
ingredient 1 mg hydrocortisone 
17-butyrate per gram. 
The other ingredients are: liquid paraffin 
and polyethylene. 
 
_What does Locoid ointment look like and _
_how is it supplied ? _
Locoid ointment is white and is packed in 
tubes of 30 g. The tube is packed in a 
yellow/grey/white box imprinted Locoid 
ointment. 
 
_How does Locoid ointment work? _
Locoid ointment 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. 
The ointment base provides for the skin 
disorder to become less moist. 
_ _
_Authorization holder and manufacturer _
Locoid ointment has been registered in 
the name of and is manufactured by 
Astellas Pharma Europe B.V. 
 Leiden, The Netherlands 
Locoid ointment is only available on 
prescription. 
 
WHAT CAN LOCOID OINTMENT BE USED 
FOR? 
Locoid ointment may be used for the 
treatment of superficial skin diseases 
in which itching, redness or scaling are 
often present. 
Locoid ointment contains much fat and is 
therefore suitable for disorders with dry 
and scaly skin. 
 
WHAT YOU SHOULD KNOW BEFORE USING 
LOCOID OINTMENT 
 
_When should you not use Locoid _
_ointment? _
Locoid ointment should not be used for: 
- Skin disorders caused by bacterial, 
viral, fungal, yeast or parasitic 
infections. These disorders might 
aggr
                                
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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 

                                
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