Mometasone 0.1% ointment

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Mometasone furoate

Tilgjengelig fra:

Dowelhurst Ltd

ATC-kode:

D07AC13

INN (International Name):

Mometasone furoate

Dosering :

1mg/1gram

Legemiddelform:

Cutaneous ointment

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13040000

Informasjon til brukeren

_S1493 LEAFLET Elocon 20191011 _
PACKAGE LEAFLET: INFORMATION FOR USER
ELOCON
® OINTMENT / MOMETASONE FUROATE 0.1%
OINTMENT
(mometasone furoate)
Your medicine is known as Elocon
®
Ointment / Mometasone
Furoate 0.1% Ointment but will be referred to as Elocon throughout
the following 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 Ointment 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 Ointment 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:

an allergy (hypersensitivity) to mometasone furoate or any of
the other ingredients in this medicine (listed in section 6) or to
other similar medicines.

any other skin probl

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 1 mg of mometasone furoate (0.1 % w/w
mometasone furoate).
Excipients with known effect: 20mg propylene glycol
monopalmitostearate/gram
ointment and traces, up to a maximum of 0.015mg Butylated
hydroxytoluene
(E321)/ gram ointment.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
A translucent white soft ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mometasone Furoate 0.1% w/w Ointment is indicated for the symptomatic
treatment
of inflammatory skin conditions which respond to external treatment
with
glucocorticoids, such as atopic dermatitis and psoriasis (excluding
widespread plaque
psoriasis).
Mometasone Furoate 0.1% w/w Ointment should be preferably used to
treat very dry,
scaly and cracked skin complaints where a topical mometasone
preparation is
indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including older people and children aged 6 years and over_: A
thin
film of Mometasone Furoate 0.1% w/w Ointment should be applied to the
affected skin area once daily.
_ _
Strong topical corticosteroids generally should not be applied to the
face
without close monitoring by the physician.
Mometasone Furoate 0.1% w/w Ointment should not be used for long
periods
(over 3 weeks) or on large areas (over 20% of body surface area). In
children a
maximum of 10% of body surface area should be treated.
Use of a weaker corticosteroid is often advisable when there is a
clinical
improvement.
Children below 6 years:
Mometasone Furoate 0.1% w/w Ointment is a potent group III
glucocorticoid.
It is not recommended for use in children below 6 years due to
insufficient
data on safety.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance mometasone furoate or to any
of the
excipients listed in section 6.1.
•
Mometasone Furoate 0.1% w/w Ointment is contraindicated in facial
rosacea, acne
vulga