CLOBAVATE 0.05 %w/w Ointment

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

CLOBETASONE BUTYRATE

Commercializzato da:

Auden Mckenzie (Pharma Division) Ltd

Codice ATC:

D07AB01

INN (Nome Internazionale):

CLOBETASONE BUTYRATE

Dosaggio:

0.05 %w/w

Forma farmaceutica:

Ointment

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Corticosteroids, very potent (group IV)

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-01-18

Foglio illustrativo

PACKAGE LEAFLET   

PATIENT INFORMATION LEAFLET   

CLOBAVATE 0.05% W/W OINTMENT   
(CLOBETASONE BUTYRATE) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.   
_  _ 

  Keep this leaflet. 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 effects become serious,
or if you notice any side effects not listed in 
this leaflet, please tell your doctor or pharmacist.     
_  _ 
IN THIS LEAFLET:   
1. What is Clobavate and what is it used for?     
2. Before you use Clobavate     
3. How to use Clobavate   
4. Possible side effects     
5. Storing Clobavate   
6. Further information     

1. WHAT IS CLOBAVATE AND WHAT IS IT USED FOR?   

Clobavate Ointment contains the active ingredient
clobetasone butyrate. This belongs to a 
group of medicines called steroids. It helps to
reduce swelling and irritation.   

Clobavate Ointment is used to help reduce the redness and itchiness
of certain skin problems. 
It is used for mild skin problems or to keep your skin problems
under control. These skin 
problems include eczema, dermatitis or insect bites.    It is also
used to help reduce 
inflammation of the outer ear.     

2. BEFORE YOU USE CLOBAVATE   

DO NOT USE CLOBAVATE:   

  if you are allergic
(hypersensitive) to clobetasone butyrate or any of the other 
ingredients of Clobavate (listed in Section 6).   

  to treat any of the following skin problems, it could
make them worse:   

  viral infections, such as cold sores, herpes or chicken pox   

  fungal infections, such as ringworm, athletes
f

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clobavate 0.05% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains clobetasone butyrate 0.05% w/w (0.5 mg/g)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clobavate is suitable for the treatment of corticosteroid sensitive dermatoses, including atopic eczema, photodermatitis,
otitis externa, primary irritant and allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic
dermatitis and insect bite reactions.
Clobavate may be used as maintenance therapy between courses of one of the more active topical steroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Topical application
ADULTS, ELDERLY, CHILDREN AND INFANTS
OINTMENT
Ointments are especially appropriate for dry, lichenified or scaly lesions. Apply thinly and gently rub in using only
enough to cover the entire affected area once or twice a day until improvement occurs, then reduce the frequency of
application or change the treatment to a less potent preparation. Allow adequate time for absorption after each
application before applying an emollient.
Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient
continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with
potent preparations.
DURATION OF TREATMENT FOR ADULTS AND ELDERLY
Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not
improve within four weeks, treatment and diagnosis should be re-evaluated.
HEALTH PRODUCTS REGULATORY AUTHORITY
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