Cutivate Ointment 0.005%

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

FLUTICASONE PROPIONATE

Mevcut itibaren:

Glaxo Wellcome UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC kodu:

D07AC17

INN (International Adı):

FLUTICASONE PROPIONATE

Farmasötik formu:

OINTMENT

Kompozisyon:

FLUTICASONE PROPIONATE

Reçete türü:

POM

Terapötik alanı:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2005-11-15

Bilgilendirme broşürü

Reason for Update: QRD version 9 
MHRA Approval Date: 20/02/14 
Text Date: 15/01/14 
Issue No.: 2 
Draft No.: 2 
[GlaxoSmithKline Logo] 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CUTIVATE 0.005% W/W

OINTMENT 
FLUTICASONE PROPIONATE 

READ ALL OF THIS
LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE
IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 
•  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 only. Do
not pass it on to others. It 
may harm them, even if their signs of illness are the
same as yours. 
•  If you get any side effects, talk
to your doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. See
section 4. 
WHAT IS IN THIS LEAFLET:  
1  What Cutivate is and what it is used for 
2  What you need to know before you use Cutivate 
3  How to use Cutivate 
4  Possible side effects 
5  How to store Cutivate 
6  Contents of the pack and other information 

1. 
WHAT CUTIVATE IS AND WHAT IT IS USED FOR 
Cutivate contains a medicine called fluticasone
propionate. It belongs to a group of 
medicines called steroids. It helps to reduce swelling and
irritation.  
Cutivate is used to help reduce the redness and
itchiness of certain skin problems. 
•  For adults these skin problems include eczema, psoriasis, dermatitis, insect bites 
or ‘prickly heat’. 
•  For infants and children
it is used for dermatitis that has not responded to milder 
steroid creams or ointments, following doctors advice.  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE CUTIVATE  
DO NOT USE CUTIVATE: 
•  if you are allergic to fluticasone
propionate or any of the other ingredients of this 
medicine (listed in Section

Ürün özellikleri

Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
NAME OF THE MEDICINAL PRODUCT 

Cutivate 0.005% w/w Ointment. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Fluticasone Propionate (micronised) HSE 0.005% w/w. 

Excipients with known effect: 
Propylene Glycol 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Ointment. 

CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

 TREATMENT OF INFLAMMATORY DERMATOSES  

ADULTS:  
Fluticasone propionate ointment is a potent topical corticosteroid
indicated for the relief of the 
inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses; these include the 
following:  

• Atopic dermatitis  
• Nummular dermatitis (discoid eczemas)  
• Prurigo nodularis  
• Psoriasis (excluding widespread plaque psoriasis)  
• Lichen simplex chronicus (neurodermatitis) and lichen planus  
• Seborrhoeic dermatitis  
• Irritant or allergic contact dermatitis  
• Discoid lupus erythematosus  
• An adjunct to systemic steroid therapy in generalised
erythroderma  
• Insect bite reactions  
• Miliaria (prickly heat)  

CHILDREN:  
For children and infants aged three months and over who
are unresponsive to lower potency 
corticosteroids, Cutivate ointment is indicated for the relief
of the inflammatory and pruritic 
Page 2 of 9 

manifestations of atopic dermatitis under the supervision of
a specialist. Expert opinion should be 
sought prior to the use of Cutivate ointment in
other corticosteroid-responsive dermatoses in 
children.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

 Route of administration: Cutaneous  

ADULTS, ELDERLY, CHILDREN AND INFANTS AGED 3 MONTHS AND OVER  

_OINTMENT  _
Ointments are especially appropriate for dry, lichenified or
scaly lesions. 
Apply thinly and gently rub in using only e