Monovo 1 mg/g Cutaneous Emulsion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Mometasone furoate

Disponibil de la:

Almirall Hermal GmbH

Codul ATC:

D07AC; D07AC13

INN (nume internaţional):

Mometasone furoate

Dozare:

1 milligram(s)/gram

Forma farmaceutică:

Cutaneous emulsion

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Corticosteroids, potent (group III); mometasone

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2012-04-27

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOVO 1 MG/G CUTANEOUS EMULSION
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.

If you get any side effects, talk to you 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 the active substance mometasone furoate, which 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. The active ingredient of Monovo is classified as a
“potent corticosteroid”.
In adults and children, aged 6 years and over, Monovo is used to
reduce symptoms caused by certain
inflammatory skin problems such as psoriasis (excluding widespread
plaque psoriasis) and some types
of dermatitis. In addition, Monovo is used to reduce symptoms caused
by certain inflammatory and
itching skin problems of the scalp such as scalp psoriasis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MONOVO
DO NOT USE MONOVO

if you, or your child are allergic to mometasone furoate, other
corticosteroids or to 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

skin atrophy (thinning of the skin)

dermatitis around the mouth

itching around the

Caracteristicilor produsului

Health Products Regulatory Authority
10 November 2019
CRN0093JX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monovo 1 mg/g Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cutaneous emulsion contains 1 mg mometasone furoate (0.1%
w/w mometasone furoate).
Each drop of the cutaneous emulsion contains 0.05 mg of mometasone
furoate.
Excipient with known effect:
30 mg of propylene glycol caprylate per gram cutaneous emulsion
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion
A white cutaneous emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Monovo is indicated for the symptomatic treatment of inflammatory skin
conditions which respond to topical treatment with
corticosteroids, such as atopic dermatitis and psoriasis (excluding
widespread plaque psoriasis).
Monovo is indicated for the symptomatic treatment of inflammatory and
pruritic diseases of the scalp such as scalp psoriasis.
Monovo is indicated in adults and children above 6 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For application on the skin (cutaneous use).
Adults (including elderly patients) and children aged 6 years and over
Monovo should be applied to the affected skin area (e.g. on the scalp)
once daily.
The bottle should be turned upside down and gently squeezed.
10 to 12 drops are enough to cover an area twice the size of an adult
hand.
Massage gently and thoroughly until the medication disappears.
Potent topical corticosteroids should not be applied to the face
except in special circumstances under 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 a
maximum of 10 % of the body surface area should be treated. It should
not be used occlusively or in intertriginous areas. Use
of a weaker corticosteroid is often advisable when there is a clinical
improvement.
Children below 6 years
The safety and efficacy of Monovo in children aged belo