Modrasone Ointment 0.05% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alclometasone dipropionate

Available from:

Morningside Healthcare (Malta) Limited

ATC code:

D07AB; D07AB10

INN (International Name):

Alclometasone dipropionate

Pharmaceutical form:

Ointment

Therapeutic area:

Corticosteroids, moderately potent (group II); alclometasone

Authorization status:

Not marketed

Authorization date:

1984-08-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MODRASONE
® OINTMENT 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 Ointment is and what it is used for
2.
What you need to know before you use Modrasone Ointment
3.
How to use Modrasone Ointment
4.
Possible side effects
5.
How to store Modrasone Ointment
6.
Contents of the pack and other information
1.
WHAT MODRASONE OINTMENT IS AND WHAT IT IS USED FOR
Modrasone Ointment 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 Ointment is used to reduce redness
and itchiness caused by certain skin
problems (for example eczema. and dermatitis):
•
Eczema is a common skin disease, which causes the skin to become red
and itchy.
•
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 MODRASONE OINTMENT
DO NOT USE MODRASONE OINTMENT
•
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 around the mouth, cold sores,
chickenpox, or skin infections
(includin

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2024
CRN00DY5P
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Modrasone Ointment 0.05% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alclometasone Dipropionate 0.05% w/w
Excipients with known effect:
2.0% w/w Propylene glycol monostearate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A smooth, colourless to light yellow, homogenous ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Modrasone Ointment 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 Ointment 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.
Health Products Regulatory Authority
05 January 2024
CRN00DY5P
Page 2 of 4
Any of the side effects that have been reported following systemic use
of corticosteroids, including adrenal suppression, may
also occur with