Mometasone Furoate Cream 1mg/g

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

MOMETASONE FUROATE

Beschikbaar vanaf:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC-code:

D07AC13

INN (Algemene Internationale Benaming):

MOMETASONE FUROATE 0.1 % (W/W)

farmaceutische vorm:

CREAM

Samenstelling:

MOMETASONE FUROATE 0.1 % (W/W)

Prescription-type:

POM

Therapeutisch gebied:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2016-03-07

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mometasone Furoate – 1 A Pharma 1mg/g cream
Mometasone Furoate
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 symptoms 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:
1.
What Mometasone Furoate – 1 A Pharma is and what it is used for
2.
What you need to know before you take Mometasone Furoate – 1 A
Pharma
3.
How to use Mometasone Furoate – 1 A Pharma
4.
Possible side effects
5.
How to store Mometasone Furoate – 1 A Pharma
6.
Contents of the pack and other information
1.
WHAT MOMETASONE FUROATE – 1 A PHARMA IS AND WHAT IS USED FOR
Mometasone Furoate – 1 A Pharma 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 – 1 A Pharma is classified as a “potent
corticosteroid”.
In adults and children, aged 2 years and over, Mometasone Furoate –
1 A Pharma 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETASONE FUROATE – 1 A PHARMA
DO NOT USE MOMETASONE FUROATE – 1 A PHARMA

If you are allergic to mometasone furoate, or other corticosteroids or
to any of the other
ingredients of

Productkenmerken

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate – 1 A Pharma 1mg/g cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 1 mg of mometasone furoate (0.1 % w/w
mometasone furoate).
Excipients 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 butylhydroxytoluene (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 – 1 A Pharma is indicated in adults, adolescents
and children aged 2 years
and above 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, see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For application on the skin (cutaneous use).
ADULTS, INCLUDING ELDERLY PATIENTS AND CHILDREN AGED 2 YEARS AND OVER:
A thin film of Mometasone Furoate – 1 A Pharma should be applied to
the affected areas of skin
once daily.
Strong topical corticosteroids generally should not be applied to the
face without close monitoring
by the physician.
Mometasone Furoate – 1 A Pharma should not be used for long periods
(over 3 weeks)
or on
large areas (over 20% of body surface area). In children aged 2 years
and older a maximum of 10%
of body surface area should be treated.
Page 2 of 7
It should not be used occlusively or intertriginously. Treatment
duration is limited to a maximum of
3 weeks.
Use of a weaker corticosteroid is often advisable when there is a
clinical improvement.
Local and systemic toxicity is more common following prolonged
continuous application over large
areas of damaged skin, in flexures and under occlusive dressings (see
section 4.4).
PAEDIATRIC POPULATION
CHILDREN BELOW 2 YEARS:
Mometasone Furoate – 1 A Pharma is a potent gr