Modrasone Cream 0.05% w/w

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Alclometasone dipropionate

Disponible des:

European Regulatory Affairs t/a Ivowen

Codi ATC:

D07AB; D07AB10

Designació comuna internacional (DCI):

Alclometasone dipropionate

Dosis:

0.05 percent weight/weight

formulario farmacéutico:

Cream

Área terapéutica:

Corticosteroids, moderately potent (group II); alclometasone

Estat d'Autorització:

Not marketed

Data d'autorització:

1984-08-13

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
MODRASONE
® CREAM 0.05% W/W
Alclometasone Dipropionate
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 Modrasone Cream is and what it is used for
2.
What you need to know before you use Modrasone Cream
3.
How to use Modrasone Cream
4.
Possible side effects
5.
How to store Modrasone Cream
6.
Contents of the pack and other information
1.
WHAT MODRASONE CREAM IS AND WHAT IT IS USED FOR
Modrasone Cream contains an active ingredient called alclometasone
dipropionate which belongs to a group
of medicines called topical corticosteroids. These medicines are used
on the surface of the skin to reduce
the redness and itchiness caused by certain skin problems.
In adults and children, Modrasone Cream is used to reduce redness and
itchiness caused by certain skin
problems including eczema.
Eczema is a common skin disease, which causes the skin to become red
and itchy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MODRASONE CREAM
DO NOT USE MODRASONE CREAM

if you are allergic to alclometasone dipropionate or any of the other
ingredients of this medicine (listed in
section 6).

for any other skin problems as it could make them worse, especially
rosacea (a skin condition affecting
the face), acne, dermatitis (skin inflammation) around the mouth, cold
sores, chickenpox, or skin
infections.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Modrasone Cream if you
are concerned about any of the
following:

This medicine should not be used u

Fitxa tècnica

Health Products Regulatory Authority
19 August 2021
CRN00CG1C
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Modrasone Cream 0.05% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alclometasone Dipropionate 0.05% w/w
Excipients with known effect:
25% w/w propylene glycol, 0.1% w/w chlorocresol and 7.2% w/w
cetostearyl alcohol.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth, white to off-white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Modrasone Cream is indicated in adults and children for the treatment
of inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly) and children_
A thin film of Modrasone Cream should be applied to the affected area
two or three times daily or as directed by the
physician. Massage gently into the skin until the medication
disappears.
Method of administration
For topical administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Use in the presence of untreated infections of bacterial, viral
tuberculous or fungal origin.
Use in acne rosacea, acne vulgaris or in perioral dermatoses.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For dermatologic use only.
Long term continuous therapy should be avoided in all patients
irrespective of age due to increased risk of adrenocortical
suppression. Continuous treatment for longer than two weeks should be
avoided in children.
Prolonged use of uninterrupted occlusion or use with extensive
occlusive dressings may supress adrenocortical function.
If irritation or sensitization develops with the use of Modrasone
products, treatment should be discontinued and appropriate
therapy instituted.
Any of the side effects that have been reported following systemic use
of corticosteroids, including adrenal suppression, may
also occur with topical corticosteroids, especially in infants and
children.
Health P