Mometasone 0.1% ointment

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Mometasone furoate

Dostępny od:

Teva UK Ltd

Kod ATC:

D07AC13

INN (International Nazwa):

Mometasone furoate

Dawkowanie:

1mg/1gram

Forma farmaceutyczna:

Cutaneous ointment

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 13040000; GTIN: 5017007010906 5017007010913

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
(MOMETASONE FUROATE 0.1% W/W OINTMENT)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE:
-
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. 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 effect gets seriouss, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What Mometasone Furoate 0.1% w/w Ointment is and what it is used for
2.
Before you use Mometasone Furoate 0.1% w/w Ointment
3.
How to use Mometasone Furoate 0.1% w/w Ointment
4.
Possible side effects
5.
How to store Mometasone Furoate 0.1% w/w Ointment
6.
Further information
1.
WHAT MOMETASONE FUROATE 0.1% W/W OINTMENT IS AND
WHAT IT IS USED FOR
Mometasone
Furoate
0.1%
w/w
Ointment
contains
the
active
substance
mometasone
furoate,
which
belongs
to
a
group
of
medicines
called
topical
corticosteroids (or steroids).
Topical corticosteroids can be divided into four degrees of strength
or potency:
mild, moderate, potent and very potent. Mometasone Furoate 0.1% w/w
Ointment
is classified as a “potent corticosteroid”.
In adults and children, aged 6 years and over, Mometasone Furoate 0.1%
w/w
Ointment
is
used
to
reduce
symptoms
caused
by
certain
inflammatory
skin
disorders such as psoriasis (excluding widespread plaque psoriasis)
and atopic
dermatitis. This preparation is generally used to treat very dry,
scaly and cracked
skin complaints. It is not a cure for your condition, but should help
to relieve your
symptoms.
2.
BEFORE
YOU
USE
MOMETASONE
FUROATE
0.1%
W/W
OINTMENT
DO NOT USE MOMETASONE FUROATE 0.1% W/W OINTMENT
If you, or your child are allergic (hypersensitive) to the active
substance, mometasone, or
other corticosteroids or to any of the other ingredients included in
section 6: Further
information on what Mometasone Furoate 0.1% w/w Ointment co

Charakterystyka produktu

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