Elocon 0.1% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Organon Pharma (Ireland) Limited

ATC code:

D07AC13

INN (International Name):

Mometasone furoate

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

mometasone

Authorization status:

Marketed

Authorization date:

1993-12-20

Patient Information leaflet

ELOCON® Cream
mometasone furoate
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this lea
fl
et. 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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What ELOCON is and what it is used for
2. Before you use ELOCON
3. How to use ELOCON
4. Possible side effects
5. How to store ELOCON
6. Further 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. BEFORE YOU USE ELOCON
DO NOT USE ELOCON
•
if you are allergic (hypersensitive) to mometasone furoate, any of the
other
ingredients of ELOCON, or to other similar medicines.
•
if you are allergic to soya. Elocon Cream may contain trace amounts of
soya.
•
on 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, ulcerated skin, wounds or other skin infections and
widespread plaque
psoriasis. Ask your doctor or pharma

Summary of Product characteristics

Health Products Regulatory Authority
01 October 2021
CRN00C80D
Page 1 of 5
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 (equivalent to 1.0 mg/g)
Elocon cream contains hydrogenated soya phosphatidylcholine (15mg/g).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
White to off-white smooth homogenous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Elocon Cream is indicated for the topical management of corticosteroid
responsive dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including elderly patients and Children: _A thin film should
be applied to the affected areas of skin once daily.
Use of topical corticosteroids in children should be limited to the
least amount compatible with an effective therapeutic
regimen. Safe use in children for more than 6 weeks has not been
established. There are limited data in children under 2 years.
4.3 CONTRAINDICATIONS
Use in acne vulgaris, rosacea, skin atrophy, perioral dermatoses or in
widespread plaque psoriasis. Use in the presence of
untreated infections of bacterial (e.g. impetigo, pyodermas), viral
(e.g. herpes simplex, herpes zoster, chickenpox, verrucae
vulgares, condylomata acuminata, molluscum contagiosum), tuberculous
or parasitical and fungal origin (e.g. candida or
dermatophyte) varicella, syphilis or post-vaccinal reactions.
Dermatoses in children under one year of age, including dermatitis and
napkin eruptions.
Hypersensitivity to the preparation.
Elocon should not be used on wounds or on skin which is ulcerated.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Local and systemictoxicity, includingsuppression of adrenocortical
function mayoccur especiallyfollowingprolonged
continueduse on large areas, in flexures andwith occlusion
(includingnapkin).
Chronic corticosteroid therapymayinterferewith thegrowth and
development of children.
Health Products Regulatory Authority
01 October 2021
CRN00C80D
Page 2 o