Cutivate 0.05% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluticasone propionate

Available from:

Waymade Healthcare Plc

ATC code:

D07AC17

INN (International Name):

Fluticasone propionate

Dosage:

500microgram/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

62000000043588
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 6)
•
on an infant under 3 months
•
to treat any of the following skin problems, it could make
them worse:
-
acne
-
severe flushing of skin on and around your nose (rosacea)
-
spotty red rash around your mouth (perioral dermatitis)
-
itching around your back passage or private parts
-
infected skin (unless the infection is being treated with an
anti-infective medicine at the same time)
-
itchy skin which is not inflamed
Do not use if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Cutivate 0.05% w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone Propionate (micronised) HSE 0.05% w/w.
Excipients with known effect:
Cetostearyl Alcohol
Propylene Glycol
Imidurea
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF INFLAMMATORY DERMATOSES
ADULTS:
Fluticasone propionate cream 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 cream is indicated for the
relief of the
inflammatory and pruritic manifestations of atopic dermatitis under
the
supervision of a specialist. Expert opinion should be sought prior to
the use of
Cutivate cream 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
Cream
Creams are especially appropriate for moist or weeping surfaces.
TREATMENT OF INFLAMMATORY DERMATOSES
Apply thinly and gently rub in using only enough to cover the entire
affected area
once or twice a day for up to 4 weeks 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 apply