Mometasone Furoate 0.1% w/w Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Auden Mckenzie (Pharma Division) Ltd

ATC code:

D07AC; D07AC13

INN (International Name):

Mometasone furoate

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, potent (group III); mometasone

Authorization status:

Not marketed

Authorization date:

2012-07-20

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOMETASONE FUROATE 0.1% W/W OINTMENT
_ _
_ _
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: _ _
1.
What Mometasone Furoate is and what it is used for
2.
What you need to know before you use Mometasone Furoate
3.
How to use Mometasone Furoate
4.
Possible side effects
5.
How to store Mometasone Furoate
6.
Contents of the pack and other information
1.
WHAT MOMETASONE FUROATE IS AND WHAT IT IS USED FOR
Mometasone Furoate Ointment contains the active substance mometasone
furoate, which belongs
to a group of medicines called topical corticosteroids. Mometasone
Furoate Ointment is classified
as a “potent corticosteroid”. This medicine is put on the surface
of the skin to reduce the redness
and itchiness caused by certain skin problems.
In adults and children aged 6 years and over, Mometasone Furoate
Ointment is used to reduce
redness and itchiness caused by certain skin problems such as
psoriasis (excluding widespread
plaque psoriasis) and some types of 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 MOMETASONE FUROATE
DO NOT USE MOMETASONE FUROATE:

if you are allergic to mometasone furoate, or any of the other
ingredients of this medicine
(listed in Section 6),

Summary of Product characteristics

Health Products Regulatory Authority
17 September 2019
CRN0090QS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate 0.1% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains 1 mg of mometasone furoate (0.1% w/w
mometasone furoate).
Excipient with known effect: 20 mg propylene glycol
monopalmitostearate per gram of ointment (2.0% w/w)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mometasone Furoate 0.1% w/w Ointment is indicated for the treatment of
inflammatory and pruritic manifestations of
psoriasis (excluding widespread plaque psoriasis) and atopic
dermatitis.
This medicinal product is indicated in adults and children above 6
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Adults, including elderly patients, adolescents and children aged 6
years and over: _A thin film of Mometasone Furoate
0.1% w/w Ointment should be applied to the affected areas of skin 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 a weaker corticosteroid is often advisable when there is a
clinical improvement.
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.
_Paediatric population_
Use of topical corticosteroids in children aged 6 years and over, 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.
_Children below 6 years: _Mometasone Furoate 0.1% Ointment is not
recommended for use in children below 6 years of age due
to insufficient data on safety (see section 4.8).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in sec