Mometasone Viso Farmaceutica 1 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Mometasona Viso Farmacéutica 1mg/g cream

Mometasone furoate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Mometasona Viso Farmacéutica is and what it is used for

Mometasona Viso Farmacéutica belongs to a group of medicines called topical corticosteroids. It is classified as a "high-potency corticosteroid". These medicines are applied to the skin to reduce redness and itching caused by certain skin conditions.

In adults and children aged 2 to 18 years, Mometasona Viso Farmacéutica is used to reduce redness and itching caused by certain skin disorders known as psoriasis or dermatitis.

Psoriasis is a skin disease in which itching, scaling, and pinkish patches develop on the elbows, knees, scalp, and other parts of the body.

Dermatitis is a condition caused by the skin's reaction to external agents such as, for example, detergents, resulting in skin redness and itching.

2. What you need to know before starting to use Mometasona Viso Farmacéutica

Do not use Mometasona Viso Farmacéutica

• If you are allergic (hypersensitive) to mometasone furoate, to any of the other components of this medicine (listed in section 6), or to similar medicines.

• In any other skin disorder, as it could worsen, particularly in cases of:

• rosacea (a skin condition affecting the face),

• acne,

• skin atrophy (thinning of the skin),

• perioral dermatitis (dermatitis around the mouth),

• genital itching,

• diaper rash,

• cold sores,

• shingles,

• chickenpox,

• warts,

• ulcerated skin,

• wounds,

• other skin infections.

Consult your doctor or pharmacist if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before using this medicine.

• When this medicine is used for psoriasis, as the condition may worsen (for example, a pustular form of the disease may develop). Therefore, your doctor should review the progression of your condition at regular intervals, as this treatment requires careful monitoring.

• If you develop irritation or sensitization while using this medicine, you must stop using it and inform your doctor immediately.

• Contact your doctor if you experience blurred vision or other visual disturbances.

If you notice a worsening of your condition while using this medicine, consult your doctor; you may be experiencing an allergic reaction, have an infection, or your condition may require a different treatment.

If your condition recurs shortly after stopping treatment, within 2 weeks, do not restart the cream without consulting your doctor, unless your doctor has previously instructed you otherwise. If your condition has resolved and, upon recurrence, redness spreads beyond the initial treatment area and you experience a burning sensation, consult a doctor before restarting treatment.

Children and adolescents

This medicine must not be used in children under 2 years of age.

Using Viso Farmacéutica with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking medicines containing cobicistat, ritonavir (used for the treatment of HIV), or itraconazole (used for the treatment of fungal infections).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The effect of Mometasone on the ability to drive and use machines is none or negligible.

3. How to use Mometasone Viso Farmacéutica

Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

In adults and children over 2 years of age, gently apply a thin layer of cream to the affected areas of skin once daily.

• It is sufficient to use a small amount of the medicine.
• An amount equivalent to the fingertip unit (a quantity covering from the tip to the first joint of an adult's index finger) is enough to cover a surface area equal to twice the size of an adult's hand. Never apply more than this amount, or more frequently than indicated by your doctor or pharmacist.

Take special care:

• Do not use the cream on the face for longer than 5 days.
• Do not use the cream in children on any part of the body for longer than 5 days. Do not use the cream under your child's diaper, as this may increase the absorption of the active substance through the skin and could cause certain adverse effects.
• Consult your doctor before covering the treated area with bandages or dressings. Treated areas on the face or in children must not be covered with bandages or dressings.
• Do not apply the cream to large areas of the body over a prolonged period (for example, every day for several weeks or months).
• Do not use the cream in or around the eyes, including the eyelid area.

Use in children

This medicine is not recommended for children under 2 years of age.

If you use more Mometasone Viso Farmacéutica than you should

If you (or someone else) accidentally ingest the cream, it should not cause any problems. However, consult your doctor.

In case of accidental ingestion of the product, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you use the cream more frequently than recommended or on large areas of the body, it could affect your hormonal system. In children, it could affect their growth and development.

Consult your doctor if you have not followed the instructions for use of the cream and have used it too frequently and/or for too long.

If you forget to use Mometasone Viso Farmacéutica

If you forget to apply the cream at the scheduled time, do so as soon as possible and then continue treatment as normal.

If you stop using Mometasone Viso Farmacéutica

If you have been using this medicine for a long time and your skin condition has improved, you should not stop using the cream suddenly. If you do, your skin may become red and you may experience stinging or burning. To avoid this, you should speak with your doctor about gradually reducing the frequency of cream application until treatment is completely stopped.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some people may experience some of the following side effects after using mometasone:

• skin allergic reactions - bacterial and secondary skin infections - acne - inflammation and/or infection of hair follicles - skin thinning - redness associated with rash - loss of skin color - stinging - itching - tingling - excessive hair growth - softening of the skin and stretch marks
• blurred vision

Other side effects that may occur with topical corticosteroids include dry skin, skin irritation, dermatitis, perioral dermatitis, and mild dilation of small blood vessels (capillaries).

Steroid withdrawal reaction:

If you use this medicine continuously for prolonged periods, you may develop a steroid withdrawal reaction when stopping treatment, with some of the following symptoms: skin redness that may spread beyond the area initially treated, burning or stinging sensation, intense itching, skin peeling, open sores that ooze.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for human medicinal products: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone Viso Farmacéutica

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required. Do not refrigerate or freeze.

After first opening, discard the tube with any remaining cream after 12 weeks.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Mometasona Viso Farmacéutica

• The active substance is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other components (excipients) are: hexylene glycol, purified water, white beeswax (E901), hydrogenated soybean lecithin, titanium dioxide (E171), octenyl succinate starch aluminum, phosphoric acid, and soft white paraffin.

Appearance of the product and contents of the package

Mometasona Viso Farmacéutica is a fluid cream, white or almost white in colour.

It is available in tubes containing 10 g, 15 g, 20 g, 30 g, 50 g, 60 g or 100 g of cream.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova, 143

56617 Vysoke Myto

Czech Republic

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the EEA under the following names:

Denmark Mometasonfuroat Glenmark 1 mg/g Creme

Germany Mometasonfuroat Glenmark 1 mg/g Creme

Italy Mometasone Glenmark 1 mg/g Crema

Norway Mometason Glenmark 0.1% Krem

Spain Mometasona Viso Farmacéutica 1 mg/g cream

Sweden Mometason Glenmark 1 mg/g kräm

United Kingdom Mometasone Furoate 0.1% w/w Cream

Poland Eztom, 1 mg/g, Krem

Date of the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/