MUNDOSON 1 mg /G Krem

Treść ulotki

1. Mundoson 1 mg/g cream
   1. WHAT MUNDOSON IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING MUNDOSON
   3. HOW TO USE MUNDOSON
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MUNDOSON
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Mundoson 1 mg/g cream

Mometasone furoate

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Mundoson is and what it is used for
• 2. What you need to know before you use Mundoson
• 3. How to use Mundoson
• 4. Possible side effects
• 5. How to store Mundoson
• 6. Contents of the pack and other information

1. WHAT MUNDOSON IS AND WHAT IT IS USED FOR

Mundoson contains mometasone furoate as its active ingredient, which belongs to a group of
medicines called topical corticosteroids (or steroids).
Topical corticosteroids belong to four classes of strength or potency: mild, moderate, potent
and very potent. Mundoson is classified as a “potent corticosteroid”.
In adults and children from 2 years of age and over, Mundoson is used to reduce the symptoms caused by certain
inflammatory skin conditions such as psoriasis (excluding plaque psoriasis) and
atopic dermatitis. It is not a cure for your condition, but it can relieve the symptoms.

2. WHAT YOU NEED TO KNOW BEFORE USING MUNDOSON

Do not use Mundoson

• if you, or your child, are allergic (hypersensitive) to the active ingredient, mometasone furoate, or to other corticosteroids or to any of the other ingredients of this medicine listed in section 6,
• if you have skin conditions that may worsen, especially:
• rosacea (a skin condition that affects the face)
• acne
• dermatitis around the mouth (perioral dermatitis)
• anal and genital itching
• nappy rash
• bacterial infections such as impetigo
• viral infections such as facial herpes, herpes Zoster and chickenpox
• fungal infections such as athlete's foot (red, scaly and itchy skin on the foot) or candidiasis (vaginal infection that can cause discharge and itching)
• bacterial infections such as tuberculosis (lung infection) or syphilis (sexually transmitted disease)
• if you have recently had a skin reaction following a vaccination (e.g. for the flu)
• on the eyelids

Warnings and precautions
Consult your doctor or pharmacist before using Mundoson.

• Mundoson should not be applied to the eyelids
• Be careful not to apply any cream to your eyes. If this happens, rinse thoroughly with clean water. If eye irritation persists, consult your doctor.
• The cream should not be applied to skin lesions and mucous membranes
• Do not use the cream on your face without the strict supervision of your doctor.
• If irritation or sensitization occurs with the use of Mundoson, inform your doctor immediately.
• When this medicine is used for psoriasis, your condition may worsen (e.g. pustular forms may occur). Allow your doctor to regularly check your condition as this treatment requires careful monitoring.
• Contact your doctor if you experience blurred vision or other visual disturbances

Children (under 2 years of age)
Mundoson should not be used in children under 2 years of age.

Other medicines and Mundoson
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including over-the-counter medicines, and any other treatment or
dietary supplements, such as vitamins. Ask your doctor for advice before taking any
medicine.

Do not uselatex products (e.g. condoms, diaphragms) together with Mundoson
in the genital or anal area, as this may compromise the safety of these
products.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
If your doctor prescribes the cream during pregnancy or while breastfeeding, do not
use large doses and use it for a limited period.

Do not applythe cream to the breast while breastfeeding.

Mundoson contains cetostearyl alcohol emulsifying, cetyl alcohol and butylhydroxytoluene
Mundoson cream contains cetostearyl alcohol emulsifying and cetyl alcohol which may cause
skin reactions (e.g. contact dermatitis) and butylhydroxytoluene which may cause skin
reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. HOW TO USE MUNDOSON

Route of administration
Mundoson cream is for cutaneous use (use on the skin).
This medicine is only for external use.
Always use this medicine exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist. Your doctor should check you at regular intervals.

Adults, including the elderly and children 2 years and older
Apply a thin layer of Mundoson cream once a day to the affected area.
You should use a small amount of medicine. If you have been prescribed the cream, an
amount equal to a phalanx (the distance between the tip and the first crease of the index finger of an
adult) is sufficient to cover an area equal to twice the hand of an adult. Do not
ever apply more than this amount or more often than recommended by your doctor or
pharmacist.

Adults, including the elderly:
The cream should not be used on extensive areas of the body (more than 20% of the
body surface) or for prolonged periods (e.g. every day for more than three weeks).
Unless indicated by your doctor, do not apply bandages or dressings to the treated area: this
increases the absorption of the product and possible adverse events.

Children (2 years and older)
Do not applythe cream to children over 2 years of age to any part of the body unless
under strict medical supervision.

Do not applythe cream to more than 10% of the child's body surface.

Do not applyin skin folds or under non-breathable dressings.

Do not usefor more than 3 weeks.

If you use more Mundoson than you should

• If you (or anyone else) accidentally swallow the cream, no undesirable effects should occur. However, if you are concerned, contact your doctor or pharmacist.
• If you use the cream more often than you should, or on an area that is too extensive, there may be effects on some hormones. In children, this can affect their growth and development.
• If you have not followed the instructions for correct dosage or your doctor's advice and have used the cream too frequently and/or for too long, inform your doctor or pharmacist.

If you forget to apply Mundoson

• If you forget to apply the cream at the scheduled time, do so as soon as you remember and then continue as usual.
• Do notapplya double dose or twice in the same day to make up for the forgotten dose

If you stop using Mundoson

• Do not suddenly stop treatment if you have been using it for a long time, as this could be dangerous.
• Treatment should be discontinued gradually, as suggested by your doctor. If you have any doubts about using Mundoson, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mundoson can cause side effects, although not everybody gets them.
If your symptoms do not improve after using the product as directed by your doctor, or if they
worsen, contact your doctor.

Side effects in children and adults reported following the use of
topical corticosteroids include:
Common (may affect up to 1 in 10 people)
Mild to moderate burning at the application site, tingling/irritation, itching, bacterial infections,
strange sensation on the skin (paresthesia), blisters on the skin (furunculosis), thinning
of the skin (skin atrophy).

Uncommon (may affect up to 1 in 100 people):
Irregular marks/streaks on the skin (striae), skin irritation, unusual hair growth (hypertrichosis),
change in skin color, dermatitis around the mouth (perioral dermatitis), softening
and whitening of the skin (maceration), allergic contact dermatitis, pus-filled blisters
on the skin of the face (rosacea papulosa type dermatitis), inflammation (including acne-like reactions),
red or dark blue discoloration of the skin (ecchymosis), heat rash (miliaria),
dryness, sensitization, inflammation of hair follicles (folliculitis) and secondary infections.

Very rare(may affect up to 1 in 10,000)
Dilatation of blood vessels on the skin or capillaries.

Frequency not known(the frequency cannot be estimated from the available data)
Blurred vision
Increased use, treatment of large areas of skin, prolonged use and use with a bandage
may increase the risk of side effects.
Corticosteroids can affect the normal production of steroids in the body; this is more likely to
occur with high doses applied for long periods.
In particular, children treated with creams and ointments containing corticosteroids may absorb
the product through the skin and this can cause a condition called Cushing's syndrome which is
characterized by many symptoms such as weight gain, facial swelling and weakness. Children
undergoing prolonged treatment may grow more slowly than others. The doctor can
prevent these phenomena by prescribing the lowest steroid dose at which symptoms are
well controlled.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. HOW TO STORE MUNDOSON

Keep this medicine out of the sight and reach of children.
Do not use Mundoson after the expiry date which is stated on the package and the tube after “Exp.”
The expiry date refers to the last day of the month.
Do not store at a temperature above 25 ºC
Discard the opened tube and any remaining cream after 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use.
This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Mundoson contains
The active ingredient is mometasone furoate.
One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone furoate).
The other ingredients are:
purified water, white soft paraffin (contains butylhydroxytoluene (E321) as an
antioxidant), liquid paraffin, 2-methylpentane-2,4-diol, emulsifying cetostearyl alcohol (type
A, contains disodium phosphate/ potassium hydrogen phosphate for pH adjustment), macrogol
cetostearyl ether, cetyl alcohol, glycerol, anhydrous citric acid, sodium citrate, xanthan gum.

Description of the appearance of Mundoson and contents of the pack
Mundoson is a white cream. The cream is contained in a laminated PE/aluminium tube with a
white plastic screw cap in a cardboard box.
Packs of 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 50 g, 60 g, 70 g, 90 g and 100 g of cream.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany
Tel: +49 40 727 04 0
Fax: +49 40 72 704 329
e-mail: [email protected]

This medicinal product is authorised in the following Member States of the European Union with the following names: