Fluticasone 0.05% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluticasone propionate

Available from:

Alliance Healthcare (Distribution) Ltd

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUTICASONE PROPIONATE 0.05% CREAM
Fluticasone
The name of your medicine is fluticasone propionate 0.05% cream which
will be referred to as
fluticasone throughout the rest of the leaflet.
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 this medicine is and what it is used for
2.
What you need to know before you use this medicine
3.
How to use this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Fluticasone propionate 0.05% cream is one of a group of medicines
known as corticosteroids, which
have a high anti-inflammatory effect when used topically.
Fluticasone is a potent corticosteroid that is applied to the skin to
treat a wide variety of inflammatory
skin diseases. It is used for the relief of inflamed skin, redness and
itching in several skin problems
not caused by germs and responsive to corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
Do not use this medicine:
•
If you are allergic to fluticasone propionate or any of the other
ingredients of this medicine
(listed in section 6).
•
If you suffer from rosacea (flushing and inflammation of the facial
skin), acne vulgaris or
perioral dermatitis (inflammatory rash around the mouth).
•
If you have infections of the skin with viruses such as herpes simplex
or chickenpox.
•
If you suffer from perianal or genital pruritus (itching around the
back passage and genitals).
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluticasone propionate 0.05% cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g of cream contains:
Fluticasone propionate 0.05g.
Excipients with known effect:
Cetostearyl alcohol 5.25 g
Imidurea 0.20 g
Propylene glycol 10.00 g
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
White, viscous and homogeneous cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adults and children aged 1 year and over:
Fluticasone propionate is indicated for symptomatic treatment of
inflammatory
dermatoses not caused by micro-organisms and responsive to
corticosteroids
such as:


Eczema including atopic and discoid eczemas


Psoriasis (excluding widespread plaque psoriasis)


Lichen planus


Lichen


Contact sensitivity reactions


Discoid lupus erythematosus


As adjunct to systemic steroid therapy in generalised erythroderma
Children
For children aged 1 year and over who are unresponsive to lower
potency
corticosteroids, this medicine 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 this
medicine in
other corticosteroid responsive dermatoses in children.
Children
For children aged 1 year and over who are unresponsive to lower
potency
corticosteroids, this medicine is indicated for the relief of the
inflammatory and
pruritic manifestations of atopic dermatitis under the supervision of
a specialist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
For adults and children aged 1 year and over, apply a thin film of
fluticasone
cream to the affected skin areas one to twice daily (see 4.4).
Duration of use:
Daily treatment should be continued until adequate control of the
condition is
achieved.
Frequency of application should thereafter be reduced to the lowest
effective
dose.
When fluticasone cream is used in the treatment of c