MOMETASONE VISO FARMACEUTICA 1 mg/g cream

Introduction

Package Leaflet: Information for the User

Mometasone Viso Farmacéutica 1mg/g Cream

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.

Contents of the pack and other information:

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

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

Mometasone 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 problems.

In adults and children from 2 to 18 years, Mometasone Viso Farmacéutica is used to reduce redness and itching caused by certain skin disorders, called psoriasis or dermatitis.

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

Dermatitis is a disease caused by the skin's reaction to external agents such as detergents, causing redness and itching of the skin.

2. What you need to know before you use Mometasone Viso Farmacéutica

Do not useMometasone Viso Farmacéutica

• If you are allergic (hypersensitive) to mometasone furoate, to any of the otheringredients 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 that affects the face),
• acne,
• skin atrophy (thinning of the skin)
• 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 not sure.

Warnings and precautions

Consult your doctor or pharmacist before using this medicine.

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

• If you develop irritation or sensitization while using this medicine, you should 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 different treatment.

If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not reuse the cream without consulting your doctor, unless your doctor has previously indicated it. If your condition has resolved and, in case of recurrence, the redness extends beyond the initial treatment area and you experience a burning sensation, consult a doctor before restarting treatment.

Children and adolescents

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

Using Viso Farmacéutica with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially if you are taking medicines that contain cobicistat, ritonavir (used to treat HIV) or itraconazole (used to treat fungal infections).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Mometasone has no or negligible influence on the ability to drive and use machines.

3. How to use Mometasone Viso Farmacéutica

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

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

• It is sufficient to apply a small amount of the medicine.
• A quantity similar to the fingertip (a quantity that covers from the tip to the first joint of the index finger of an adult) is enough to cover an area equivalent to twice the size of an adult's hand. Never apply more than this amount, nor more frequently than indicated by your doctor or pharmacist.

Be especially careful:

• Do not use the cream on the face for more than 5 days.
• Do not use the cream on children in any area of the body for more than 5 days. Do not use the cream under your child's diaper, as this makes it easier for the active ingredient to pass through the skin and may cause some side effects.
• Consult your doctor before covering the treated area with bandages or dressings. Areas of the face or in children should not be covered with bandages or dressings.
• Do not apply the cream to large areas of the body for a prolonged period (e.g., every day for several weeks or months).
• Do not use the cream in the eyes or around them, including the eyelid area.

Use in children

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

If you use moreMometasone Viso Farmacéuticathan you should

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

In case of accidental ingestion of the product, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you use the cream more frequently than you should or on large areas of the body, it could affect you hormonally. 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 if you have used it too often and/or for too long.

If you forget to useMometasone Viso Farmacéutica

If you forget to apply the cream at the indicated time, do so as soon as possible and continue the treatment normally.

If you stop usingMometasone Viso Farmacéutica

If you have been using this medicine for a long time and your skin problems have improved, do not stop using the cream suddenly. If you do, your skin may redden and you may experience itching or burning. To avoid this, you should talk to your doctor to reduce the frequency of use of the cream until you stop treatment completely.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Steroid withdrawal reaction:

If you use this medicine continuously for long periods, you may experience a withdrawal reaction when you stop treatment with some of the following symptoms: redness of the skin that may extend beyond the initially treated area, burning or itching sensation, intense itching, skin peeling, open sores that ooze.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, 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 which is stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

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

Once opened, discard the tube with the remaining cream after 12 weeks.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofMometasone Viso Farmacéutica

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

Appearance of the product and contents of the pack

Mometasone Viso Farmacéutica is a white or almost white fluid cream.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova, 143

56617 Vysoke Myto

Czech Republic

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorised 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 1mg/g crema

Sweden Mometason Glenmark 1mg/g kräm

United Kingdom Mometasone Furoate 0.1% w/w Cream

Poland Eztom, 1 mg/g, Krem

Date of last revision of this leaflet:July 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/