Fludroxycortide 0.0125% ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fludroxycortide

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

D07AC07

INN (International Name):

Fludroxycortide

Dosage:

125microgram/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

_Colours_
_(Printed)_
_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Fludroxycortide 0.0125% w/w Ointment
FO/TY/PIL
08/11/15
148(W) x 300(H)
27/03/19
_Colours_
_(Non printed)_
PROCESS
BLACK
REFERENCE
TRIM
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUDROXYCORTIDE 0.0125% W/W OINTMENT
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 Fludroxycortide 0.0125% w/w Ointment is and what it is used
for
2. What you need to know before you use Fludroxycortide 0.0125% w/w
Ointment
3. How to use Fludroxycortide 0.0125% w/w Ointment
4. Possible side effects
5. How to store Fludroxycortide 0.0125% w/w Ointment
6. Contents of the pack and other information 1. WHAT FLUDROXYCORTIDE 0.0125% W/W OINTMENT IS AND WHAT IT IS USED
FOR
Fludroxycortide 0.0125% w/w Ointment is a white ointment for
application to the skin. Fludroxycortide
0.0125% w/w Ointment belongs to a group of medicines called topical
steroids and is used to treat skin
conditions such as eczema and dermatitis of all types, especially when
the skin is dry and scaly.
Fludroxycortide 0.0125% w/w Ointment can be used in adults and
children. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUDROXYCORTIDE 0.0125% W/W
OINTMENT
DO NOT USE FLUDROXYCORTIDE 0.0125% W/W OINTMENT
• for skin tuberculosis.
• for rosacea of the face.
• for acne.
• for dermatitis around the mouth.
• for itchiness of the genitals or anus.
• for skin conditions in babies including eczema or napkin rash.
• for bacterial skin infections such as impetigo.
• for viral skin infection

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Haelan Ointment
Fludroxycortide 0.0125% w/w Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fludroxycortide 0.0125% w/w.
Excipient with known effect
Cetyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment for topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults and children: Eczema and dermatitis of all types including
childhood
and adult atopic eczema, photodermatitis, primary irritant and
allergic
dermatitis, lichen planus, lichen simplex, prurigo nodularis, discoid
lupus
erythematosus, necrobiosis lipoidica, pretibial myxoedema and
erthroderma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For dry, scaly lesions, the ointment should be applied as a thin film
to the affected
area two or three times daily.
Method of administration
The elderly: As the skin is likely to be thin, apply sparingly to
avoid development of
atrophy.
Dilution is not recommended, but if considered necessary, white soft
paraffin BP may
be used.
4.3
CONTRAINDICATIONS
Tuberculosis of the skin, facial rosacea, acne vulgaris, perioral
dermatitis, perianal
and genital pruritus, dermatoses in infancy including eczema,
dermatitic napkin
eruption, bacterial (impetigo), viral (herpes simplex) and fungal
(candida or
dermatophyte) infections.
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Preparations of Haelan are not intended for ophthalmic use.
Local and systemic toxicity is common especially following long-term
continuous
use, continued use on large areas of damaged skin, flexures and with
polythene
occlusion.
Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression (see section
4.8).
Therefore, patients receiving a large dose of a potent topical steroid
applied to a
large surface area or under an occlusive dressing should be evaluated
periodical