Monovo 1 mg/g zalf

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

MOMETASONFUROAAT

Available from:

Almirall Hermal GmbH

ATC code:

D07AC13

INN (International Name):

MOMETASONFUROAAT

Pharmaceutical form:

Zalf

Composition:

CETOSTEARYLALCOHOL, EMULGEREND, TYPE A ; CITROENZUUR 0-WATER (E 330) ; HEXYLEENGLYCOL ; PARAFFINE, VLOEIBAAR (E905) ; PARAFFINE, ZACHT (E 905) ; PROPYLEENGLYCOLMONOPALMITOSTEARAAT (E 477) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; WITTE BIJENWAS (E 901),

Administration route:

Cutaan gebruik

Therapeutic area:

Mometasone

Product summary:

Hulpstoffen: CETOSTEARYLALCOHOL, EMULGEREND, TYPE A; CITROENZUUR 0-WATER (E 330); HEXYLEENGLYCOL; PARAFFINE, VLOEIBAAR (E905); PARAFFINE, ZACHT (E 905); PROPYLEENGLYCOLMONOPALMITOSTEARAAT (E 477); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD; WITTE BIJENWAS (E 901);

Authorization date:

2011-04-20

Patient Information leaflet

April 2017
PACKAGE LEAFLET
2
April 2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MONOVO 1MG/G ZALF
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 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. Monovo is classified as a “potent corticosteroid”.
In adults, adolescents and children, aged 6 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. This preparation is generally used to treat very dry,
scaly and cracked skin complaints. 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 dermatiti

Summary of Product characteristics

April 2017
SUMMARY OF PRODUCT CHARACTERISTICS
2
April 2017
1.
NAME OF THE MEDICINAL PRODUCT
Monovo 1 mg/g ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 1 mg of mometasone furoate (0.1 %
mometasone furoate).
Excipients with known effect:
25.00 mg propylene glycol monopalmitostearate and 50.00 mg emulsifying
cetostearyl alcohol (type A)/ 1
g ointment.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment
An off-white, transparent ointment.
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 preferably used to treat very dry, scaly and cracked
skin complaints where a topical
mometasone preparation is indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults, including elderly patients, adolescents and children aged 6
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 6 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 6 years: _
Monovo is a potent group III glucocorticoid. It should not be used in
children below 6 years due to
insufficient data on safety.
For application on the skin (cutaneous use).
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April 2017
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