Elocon 0.1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mometasone furoate

Available from:

Waymade Healthcare Plc

ATC code:

D07AC13

INN (International Name):

Mometasone furoate

Dosage:

1mg/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

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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side effects not listed
in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1. What Elocon is and what it is used for
2. What you need to know before you use Elocon
3. How to use Elocon
4. Possible side effects
5. How to store Elocon
6. Contents of the pack and other information
1.
WHAT ELOCON IS AND WHAT IT IS USED FOR
Elocon Cream is one of a group of medicines called topical
corticosteroids. It is classified as a “potent corticosteroid”.
These medicines are put on the surface of the skin to reduce the
redness and itchiness caused by certain skin problems.
In adults and children, Elocon Cream is used to reduce redness and
itchiness caused by certain skin problems called
psoriasis or dermatitis.
Psoriasis is a skin disease in which itchy, scaly, pink patches
develop on the elbows, knees, scalp and other parts of
the body. Dermatitis is a condition brought on by the skin reacting to
outside agents e.g. detergents, causing the skin
to become red and itchy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELOCON
Do not use Elocon if you have any of the following:
•
an allergy (hypersensitivity) to mometasone furoate, any of the other
ingredients of this medicine (listed in section 6)
or to other similar medicines.
•
any other skin problems as it could make them worse especially:
•
rosacea (a skin condition affecting the face)
•
acne
•
skin atrophy (thinning of the skin)
•
dermatitis around the mouth
•
genital itching
•
nappy rash
•
cold sores
•
chickenpox
•
shingles
•
warts
•
ulcerated skin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Elocon 0.1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate 0.1% w/w
For full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Cream
4.1
THERAPEUTIC INDICATIONS
Elocon Cream is indicated for the treatment of inflammatory and
pruritic
manifestations of psoriasis (excluding widespread plaque psoriasis)
and atopic
dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including elderly patients and Children :_ A thin film of
Elocon Cream should be
applied to the affected areas of skin once daily.
Use of topical corticosteroids in children or on the face should be
limited to the least
amount compatible with an effective therapeutic regimen and duration
of treatment
should be no more than 5 days.
4.3
CONTRAINDICATIONS
Elocon is contraindicated in facial rosacea, acne vulgaris, skin
atrophy,
perioral
dermatitis, perianal and genital pruritis, napkin eruptions, bacterial
(e.g. impetigo,
pyodermas), viral (e.g. herpes simplex, herpes zoster and chickenpox
verrucae vulgares,
condylomata acuminata, molluscum contagiosum), parasitical and fungal
(e.g. candida
or dermatophyte) infections, varicella, tuberculosis, syphilis or
post-vaccine reactions.
Elocon should not be used on wounds or on skin which is ulcerated.
Elocon should not
be used in patients who are sensitive to mometasone furoate or to
other corticosteroids or
to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation or sensitisation develop with the use of Elocon,
treatment should be
withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or
antibacterial agent
should be instituted. If a favourable response does not occur
promptly, the corticosteroid
should be discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteriods can produce reversible
hypothalamic-
pituitaryadrenal (HPA) axis suppression with the potential