Mundoson

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mundoson 1 mg/g cream

Mometasone furoate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 using 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 as its active ingredient mometasone furoate, which belongs to a group of
medicines called topical corticosteroids (or steroids).
Topical corticosteroids are classified into four potency classes: mild, moderate, potent,
and very potent. Mundoson is classified as a "potent corticosteroid".
In adults and children from 2 years of age, Mundoson is used to reduce symptoms caused by certain
inflammatory skin diseases such as psoriasis (excluding extensive plaque psoriasis) and atopic dermatitis.
It is not a cure for your condition, but it can help relieve its symptoms.

2. WHAT YOU SHOULD KNOW BEFORE USING MUNDOSON

Do not use Mundoson

• if you or your child are allergic (hypersensitive) to the active substance, mometasone furoate, or to other corticosteroids or to any of the other ingredients of this medicine listed in section 6,
• if you have skin diseases that may worsen, especially:
• rosacea (a skin condition affecting the face)
• acne
• perioral dermatitis (skin inflammation around the mouth)
• pruritus in the perianal and genital areas
• diaper rash erythema
• bacterial infections such as impetigo
• viral infections such as facial herpes, herpes zoster, or chickenpox
• fungal infections such as athlete’s foot (red, scaly, itchy skin on the feet) or candidiasis (vaginal infection that may cause discharge and itching)
• bacterial infections such as tuberculosis (lung infection) or syphilis (a sexually transmitted disease)
• if you recently had a skin reaction following vaccination (e.g. for influenza)
• on the eyelids

Warnings and precautions
Talk to your doctor or pharmacist before using Mundoson.

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

Children (under 2 years of age)
Mundoson must not be used in children under 2 years of age.
Other medicines and Mundoson
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription, and any other treatments or
dietary supplements, such as vitamins. Ask your doctor for advice before taking any
medication.
Do not use latex-based 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, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
If your doctor prescribes the cream during pregnancy or while breastfeeding, do not use large
amounts and use it only for a limited period.
Do not apply the cream to the breast while breastfeeding.
Mundoson contains cetearyl alcohol (emulsifying agent), cetyl alcohol, and butylated hydroxytoluene
Mundoson cream contains cetearyl alcohol (emulsifying agent) and cetyl alcohol, which may cause
skin reactions (e.g. contact dermatitis), and butylated hydroxytoluene, 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 (apply to the skin).
This medicinal product is for external use only.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Your doctor should monitor you at regular intervals.

Adults, including elderly and children aged 2 years and older
Apply a thin layer of Mundoson cream once daily to the affected area.
Use only a small amount of the medicine. If prescribed the cream, a quantity equal to one fingertip unit (the distance from the tip to the first crease of an adult's index finger) is sufficient to cover an area equal to twice the surface of an adult's hand. Never use more than this amount or more frequently than recommended by your doctor or pharmacist.

Adults, including elderly:
The cream should not be used on extensive areas of the body (greater than 20% of body surface area) or for prolonged periods (e.g., daily for more than three weeks).
Unless otherwise directed by a doctor, do not apply dressings or coverings to the treated area: this increases absorption of the product and the risk of possible adverse effects.

Children (aged 2 years and older)
Do not apply the cream to children over 2 years of age on any part of the body without strict medical supervision.
Do not apply the cream to more than 10% of the child’s body surface area.
Do not apply in skin folds or under occlusive (non-breathable) dressings.
Do not use for longer than 3 weeks.

If you use more Mundoson than you should

• If you (or anyone else) accidentally ingest the cream, adverse effects are unlikely. However, if you are concerned, contact your doctor or pharmacist.
• If you use the cream more often than recommended or over too large an area of the body, effects on certain hormones may occur. In children, this could affect their growth and development.
• If you have not followed the correct dosing instructions 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, then continue as before.
• Do not apply a double amount or apply twice in the same day to make up for a missed dose.

If you stop using Mundoson

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Mundoson may cause adverse effects, although not everyone experiences them. If your symptoms do not improve after using the product as directed by your doctor, or if they worsen, contact your doctor.

Adverse effects reported in children and adults 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, unusual sensation on the skin (paresthesia), blisters on the skin (furunculosis), thinning of the skin (cutaneous atrophy).

Uncommon (may affect up to 1 in 100 people)
Irregular marks/stripes 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 face (papulopustular rosacea-type dermatitis), inflammation (including acneiform reactions), red or dark blue skin discoloration (ecchymosis), heat rash (miliaria), dryness, sensitization, inflammation of hair follicles (folliculitis), and secondary infections.

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

Frequency not known (cannot be estimated from the available data)
Blurred vision

Increased use, treatment of large skin areas, prolonged use, and use under an occlusive dressing may increase the risk of side effects.

Corticosteroids may affect the body's normal steroid production; this is more likely with high doses applied over long periods.

In particular, children treated with creams and ointments containing corticosteroids may absorb the product through the skin, which can lead to a condition called Cushing's syndrome, characterized by various symptoms such as weight gain, facial swelling, and weakness. Children undergoing prolonged treatment may grow more slowly than normal. These effects may be prevented by the doctor prescribing the lowest effective steroid dose that adequately controls symptoms.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report adverse effects directly via the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse 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 stated on the carton and tube after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Discard the tube and any remaining cream 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required.
This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Mundoson contains
The active substance is mometasone furoate.
One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone furoate).
The other components are:
purified water, white soft paraffin (containing butylated hydroxytoluene (E321) as antioxidant), liquid paraffin, 2-methylpentane-2,4-diol, emulsifying cetostearyl alcohol (type A, containing 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 packaging contents
Mundoson is a white cream. The cream is contained in a laminated PE/aluminum tube with a white plastic screw cap, packed in a cardboard box.
Pack sizes: 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 European Member States under the following names: