Elocon 0.1% w/w Ointment

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Mometasone furoate

Dostupno od:

PCO Manufacturing Ltd.

ATC koda:

D07AC; D07AC13

INN (International ime):

Mometasone furoate

Doziranje:

0.1 percent weight/weight

Farmaceutski oblik:

Ointment

Područje terapije:

Corticosteroids, potent (group III); mometasone

Datum autorizacije:

2021-06-25

Uputa o lijeku

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOCON
® 0.1% W/W OINTMENT
mometasone furoate
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 effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Elocon is and what it is used for
2. Before you use Elocon
3. How to use Elocon
4. Possible side effects
5. How to store Elocon
6. Further 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. BEFORE YOU USE ELOCON
DO NOT USE ELOCON
•
if you are allergic (hypersensitive) to
mometasone furoate, any of the other
ingredients of Elocon or to other similar
medicines.
•
on any other skin problems as it could make
them worse especially rosacea (a skin condition
affecting the face), acne, skin atrophy (thinning
of the skin), dermatitis around the mouth, genital
itching, nappy rash, cold sores, chickenpox,
shingles, ulcerated skin, wounds or other skin
infections and widespread plaque psoriasis. Ask
your doctor or pharmacist if you are not sure.
•
to treat skin problems in c

Svojstava lijeka

Health Products Regulatory Authority
12 July 2022
CRN00D0NM
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elocon 0.1% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone Furoate 0.1% w/w (equivalent to 1.0 mg/g)
Excipient with known effect: propylene glycol stearate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
_Product imported from Spain:_
A white to off-white, opaque ointment.
4 CLINICAL PARTICULARS
As per PA23198/010/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/010/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hexylene glycol
Phosphoric acid
Propylene glycol stearate
White beeswax
White soft paraffin
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
6.5 NATURE AND CONTENTS OF CONTAINER
30 g aluminium tube with low density polyethylene cap in a carton.
Health Products Regulatory Authority
12 July 2022
CRN00D0NM
Page 2 of 2
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/268/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
June 2021
10 DATE OF REVISION OF THE TEXT
July 2022