Mometasone 0.1% cream

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Mometasone furoate

Dostępny od:

Glenmark Pharmaceuticals Europe Ltd

Kod ATC:

D07AC13

INN (International Nazwa):

Mometasone furoate

Dawkowanie:

1mg/1gram

Forma farmaceutyczna:

Cutaneous cream

Droga podania:

Cutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 13040000; GTIN: 5060204160479 5060204160493

Ulotka dla pacjenta

Mometasone Cream 100 G
UK
180 mm x 27 mm
180 mm x 290 mm
40 GSM BIBLE PAPER
Black
Revised as per variation number
UK/H/2272/001/II/022/G.
PEXXXXX
1018-1
BADDI
SAME SIZE ARTWORK
L: 180 mm x H: 290 mm
180 mm
290 mm
MOMETASONE FUROATE 0.1% W/W CREAM
PACKAGE LEAFLET: INFORMATION FOR THE USER
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:
The
name
of
your
medicine
is
“Mometasone
Furoate
0.1%
w/w
Cream”
but
will
mostly
be
referred
to
as
“Mometasone Cream” throughout this leaflet.
1. What Mometasone Cream is and what it is used for
2. What you need to know before you use Mometasone
Cream
3. How to use Mometasone Cream
4. Possible side effects
5. How to store Mometasone Cream
6. Contents of the pack and other information
1.
WHAT MOMETASONE CREAM IS AND WHAT IT
IS USED FOR
Mometasone Cream is one of a group of medicines called
topical corticosteroids. Mometasone Cream 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 above aged 2 to 18 years, Mometasone
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
MOMET

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 1 mg of mometasone furoate (0.1 % w/w
mometasone
furoate).
Excipient(s) with known effect:
80 mg propylene glycol monopalmitostearate per gram cream
70 mg stearyl alcohol per gram cream
Traces, up to a maximum of 0.015mg Butylated hydroxytoluene (E321) per
gram
cream
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream
White to off-white, smooth cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mometasone furoate 0.1% w/w Cream is indicated for the treatment of
inflammatory
pruritic manifestations of and 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 Mometasone furoate 0.1% w/w Cream should be applied to
the affected
areas of skin area once daily. One fingertip unit (a line from the tip
of an adult index
finger to the first crease) is enough to cover an area twice the size
of an adult hand.
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
Hypersensitivity to the active substance, to other corticosteroids or
to any of the
excipients listed in section 6.1.
Mometasone Furoate 0.1% w/w Cream 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.
Mometasone Furoate 0.1% w/w Cream should not be used on wounds or on
skin
which is ulcerated.
4.4
SPECIAL