DiproSone

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAMETHASONE

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

D07AC01

INN (International Name):

BETAMETHASONE 0.05 % (W/W)

Pharmaceutical form:

CUTANEOUS LIQUID

Composition:

BETAMETHASONE 0.05 % (W/W)

Prescription type:

POM

Therapeutic area:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-11-06

Patient Information leaflet

SUBMISSION
2.1                   347759
PRODUCTNAME
Diprosone Lotion
CONCENTRATION
0,05 % w/w
PRESENTATION
30/100 ml
CODE
Read all of this leafl et carefully before you start using this
medicine.
–  Keep this leafl et. You may need to read it again.
–  If you have any further questions, ask your doctor or
pharmacist.
–  This medicine has been prescribed for you. Do not pass it on to
others. It may 
harm them, even if their symptoms are the same as yours.
–  If any of the side eff ects gets serious, or if you notice
any side eff ects not listed 
in this leafl et, please tell your doctor or pharmacist.
In this leafl et:
1.  What Diprosone Lotion is and what it is used for
2.  Before you use Diprosone Lotion
3.  How to use Diprosone Lotion
4.  Possible side eff ects
5.  How to store Diprosone Lotion
6. Further information
1.  WHAT DIPROSONE LOTION IS AND WHAT IT IS USED FOR
Diprosone Lotion contains the active ingredient 0.064% w/w
betamethasone 
dipropionate.
Betamethasone dipropionate belongs to a group of medicines called
topical 
corticosteroids which are used on the surface of the skin to reduce
the redness 
and itchiness caused by certain skin problems.
In adults and children, Diprosone Lotion is used to treat skin
problems aff ecting 
the scalp, including eczema, all types of dermatitis and psoriasis of
the scalp.
Eczema is a common skin disease, which causes the skin to become red
and 
itchy. Dermatitis is infl ammation of the skin. Psoriasis is a skin
disease in which 
itchy, scaly, pink patches develop on the elbows, knees, scalp and
other parts of 
the body.
2.  BEFORE YOU USE DIPROSONE LOTION
Do not use Diprosone Lotion
–  if you are allergic (hypersensitive) to betamethasone
dipropionate or any of the 
other ingredients of Diprosone Lotion.
–  on any other skin problem as it could make it worse especially
rosacea (a 
skin condition aff ecting the face), acne, dermatitis around the
mouth, genital 
itching, nappy rash, c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Diprosone Lotion  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Betamethasone Dipropionate 0.064% w/w* 

(* equivalent to 0.05% Betamethasone) 

3. 
PHARMACEUTICAL FORM 

Lotion 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Diprosone Lotion is indicated for eczema and dermatitis of all types effecting the scalp 
including atopic eczema, photodermatitis, primary irritant and allergic dermatitis, lichen 
planus, lichen simplex, discoid lupus erythematosus, erythroderma. 

It is also indicated for psoriasis of the scalp. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and Children :  

A few drops of Diprosone Lotion should be applied to the affected areas twice daily and 
massaged gently and thoroughly into the affected area.  For some patients adequate 
maintenance therapy may be achieved with less frequent application. 

4.3 
CONTRAINDICATIONS 

Rosacea, acne, perioral dermatitis, perianal and genital pruritus.  Hypersensitivity to any of 
the ingredients of the Diprosone presentations contraindicates their use as does tuberculous 
and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella.  Diprosone 
should not be used in napkin eruptions, fungal or bacterial skin infections without suitable 
concomitant anti-infective therapy. 

4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Local and systemic toxicity is common, especially following long continuous use on large 
areas of damaged skin, in flexures or with polythene occlusion.  If used in children or on the 
face courses should be limited to 5 days.  Long term continuous therapy should be avoided 
in all patients irrespective of