Monovo 1mg/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Almirall Hermal GmbH

ATC code:

D07AC; D07AC13

INN (International Name):

Mometasone furoate

Dosage:

1 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids, potent (group III); mometasone

Authorization status:

Not marketed

Authorization date:

2011-11-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MONOVO 1 MG/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 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 Monovo is and what it is used for
2.
What you need to know before you use Monovo
3.
How to use Monovo
4.
Possible side effects
5.
How to store Monovo
6.
Contents of the pack and other information
1.
WHAT MONOVO IS AND WHAT IT IS USED FOR
Monovo contains mometasone furoate as the active substance. This
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. Monovo is classified as a “potent corticosteroid”.
In adults, adolescents and children, aged 2 years and older, Monovo is
used to reduce symptoms caused by
certain inflammatory skin disorders such as psoriasis (excluding
widespread plaque psoriasis) and atopic
dermatitis. It is not a cure for your condition, but should help to
relieve your symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MONOVO
DO NOT USE MONOVO

if you, or your child are allergic to mometasone furoate, or other
corticosteroids or any of the other
ingredients of this medicine (listed in section 6),

on any other skin problems as it could make them worse especially:
–
rosacea (a skin condition affecting the face)
–
acne
–
dermatitis around the mouth (perioral dermatitis)
–
perianal and genital itching
–
nappy rash
–
bacterial infections such as impetigo, viral infections such as cold
s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monovo 1mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone
furoate).
Excipients with known effect:
72.00 mg of cetostearyl alcohol (type A), emulsifying; 10.00 mg of
cetyl alcohol and 13 microgram of butylated
hydroxytoluene /1 gram cream.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Monovo is indicated 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).
Monovo should be used to treat skin complaints where a topical
mometasone preparation is indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including elderly patients adolescents and children aged 2
years and older:_
A thin film of Monovo should be applied to the affected skin area once
daily.
Strong topical corticosteroids generally should not be applied to the
face without close monitoring by the physician.
Monovo 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 the body
surface area should be treated. 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.
_Children below 2 years:_
Monovo is a potent group III glucocorticoid. It is not recommended for
use in children below 2 years due to insufficient
data on safety.
For application on the skin (cutaneous use).
4.3 CONTRAINDICATIONS
Monovo is contraindicated in patients with
hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
facial rosacea
acne vulgaris
perioral dermatitis
perianal and genital pruritus
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