Product Information for the User

Mometasona Viso Pharmaceutical 1mg/g Ointment

Mometasona, furoate

Read this entire product information carefully before starting to use the medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

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

3.How to use Mometasona Viso Pharmaceutical

4.Possible adverse effects

5.Storage of Mometasona Viso Pharmaceutical

6.Contents of the package and additional information

Mometasona Viso Farmacéuticabelongs to a group of medications called topical corticosteroids. It is classified as a “high potency corticosteroid”. These medications are applied to the skin to reduce redness and itching caused by certain skin conditions.

In adults and children 2 years of age or older, MometasonaViso Farmacéuticais used to reduce redness and itching caused by certain skin conditions, known as psoriasis and atopic eczema (atopic dermatitis).

Poriasis is a skin disease in which itching, flaking, and pink patches develop on the elbows, knees, scalp, and other parts of the body. Atopic eczema is a disease caused by the skin's reaction to external agents such as, for example, detergents, causing skin redness and itching.

No useMometasona Viso Farmacéutica

• If you are allergic to mometasona or any of the other components of this medication(listed in section 6).
• On any other skin condition, as it may worsen, particularly in cases of:

- rosacea (a skin condition that affects the face)

- acne

- skin atrophy (skin thinning)

- dermatitis around the mouth

- genital and perianal itching

- nappy rash

- bacterial infections such as impetigo, tuberculosis (lung infection), syphilis (a sexually transmitted disease), viral infections such as warts, herpes, and chickenpox

- fungal infections such as athlete's foot (redness, itching, and peeling of the skin on the feet)

-parasitic infections

- if you have recently had a reaction to a vaccination

- cold sores

- herpes

- ulcerated skin

- wounds

- other skin infections

Consult your doctor or pharmacist if you are unsure.

Warnings and precautions

If your skin becomes irritated or sensitized after using Mometasona Viso Farmacéutica, you should stop using this medication and inform your doctor.

This medicationshould not be used in the eyes or around them. It should not be applied to the eyelids.

If this medication is used for psoriasis, the condition may worsen (i.e., a pustular form of the disease may develop). You should allow your doctor to evaluate the progression of your condition at regular intervals, as this treatment requires careful monitoring.

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

If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not use the cream again without consulting your doctor, unless your doctor has previously instructed you to do so. 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.

Other medications and Mometasona Viso Farmacéutica

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially if you are taking medications that contain cobicistat, ritonavir (used to treat HIV), or itraconazole (used to treat fungal infections).

Pregnancy and breastfeeding

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

If your doctor prescribes the ointment during pregnancy and breastfeeding, you should avoid using high doses and use it only for a brief period of time. MometasonaViso Farmacéutica1 mg/g ointment should not be applied to the breast area during breastfeeding.

Mometasona Viso Farmacéuticacontains propylenglycol and butylhydroxytoluene (E321)

Mometasona Viso Farmacéutica 1 mg/g ointment contains propylenglycol, which may cause skin irritation, and butylhydroxytoluene (E321), which may cause local reactions in the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

MometasonaViso Farmacéuticashould not be used in children under 2 years of age. In general, for adults and children 2 years of age or older, apply a thin layer of Mometasona Viso Farmacéutica to the affected area once a day.

If you have been prescribed the ointment, the amount of the tip of your finger (a line from the end of the finger of an adult to the line of the first phalanx) is sufficient to cover an area the size of two times the hand of an adult. Do not apply more than this amount or more frequently than recommended by your doctor or pharmacist.

Your doctor should evaluate the treatment at regular intervals.

Always follow these instructions when using MometasonaViso Farmacéuticaointment for yourself or your child:

• do not use the ointment on the face for more than 5 days
• consult your doctor before covering the treated area with bandages or dressings. Do not cover the treated areas of the face with bandages or dressings
• do not use large amounts of ointment on extensive body surfaces for a long time (for example, once a day for weeks or months)
• do not use around the eyes, including the eyelids.

Adults

• do not use the ointment for long periods of time (more than 3 weeks) or on extensive body surfaces (more than 20% of the body surface).

Children 2 years of age or older

• do not apply the ointment to children, anywhere on their body, for more than 3 weeks
• do not apply the ointment under the diaper, as this facilitates the passage of the medication through the skin and may cause more side effects
• the treated areas in children should not be covered with any bandage or dressing.

Children under 2 years of age

• do not use the ointment in children under 2 years of age.

If you use moreMometasonaViso Farmacéuticathan you should

Accidental ingestion of the ointment should not cause any problems. However, consult your doctor or pharmacist if you are concerned.

Applying the ointment more frequently than recommended or to large areas of the body could have hormonal consequences. In the case of children, it could affect their growth and development.

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

If you forgot to use MometasonaViso Farmacéutica

If you forget to apply the ointment at the indicated time, do it as soon as possible and continue with the normal treatment. Do not apply double the amount, nor apply the ointment twice the same day to compensate for the forgotten application.

If you interrupt treatment with MometasonaViso Farmacéutica

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Some people may experience any of the following adverse effects after using mometasona:

• Skin allergic reactions
• Bacterial and secondary infections
• Acne
• Inflammation and/or infection of hair follicles
• Thinning of the skin
• Rashes associated with itching
• Loss of skin pigmentation
• Burning sensation
• Itching
• Buzzing
• Excessive hair growth
• Softening of the skin and striae
• Blurred vision

Other adverse effects that may appear after using topical corticosteroids include dry skin, skin irritation, dermatitis, dermatitis around the mouth, and mild dilation of blood vessels.

Withdrawal reaction from steroids:

If you use this medication continuously for prolonged periods, you may experience a withdrawal reaction after stopping treatment with some of the following symptoms: redness of the skin that may extend beyond the initially treated area, burning or stinging sensation, intense itching, skin peeling, open sores that suppurate.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Do not store above 30°C. Do not refrigerate or freeze.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofMometasona Viso Pharmaceutical

• The active ingredient is furoate of mometasona.

Each gram of Mometasona Viso Pharmaceutical 1 mg/g ointment contains 1mg of furoate of mometasona.

• The other components are: hexylenglycol, concentrated phosphoric acid (to adjust the pH), monopalmitoestearate of propylene glycol, white beeswax, white soft paraffin; butylhydroxytoluene (E321) (as an antioxidant) and purified water.

Aspect of the product and content of the package

Mometasona Viso Pharmaceutical 1 mg/g ointment is a white, soft, and translucent ointment. Theointment is introduced in aluminum tubeswith a screw-on cap of polyethylene of white color with a piercing point, which are introduced in a cardboard box.

Sizes of the packages: tubes with 10 g, 15 g, 20 g, 30 g, 50 g, 60 g or 100 g ofointment.

It is possible that not all tube sizes will be marketed.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for the manufacture:

Accord Healthcare Ltd,

Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF,

United Kingdom

or

Glenmark Pharmaceuticals Europe Limited,

Building 2, Croxley Green Business Park,

Croxley Green, Hertfordshire, WD18 8YA,

United Kingdom

or

Glenmark Pharmaceuticals s.r.o,

Fibichova, 143

56617 Vysoke Myto,

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Pharmaceutical, S.L.U.

c/ Retama 7, 7th Floor,

28045 Madrid,

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this prospectus:February 2023

The detailed information about this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/