Prospect: Information for the User

Mometasona Viso Pharmaceutical 1mg/g Cream

Furoate of Mometasona

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they 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 prospect. See section 4.

Content of this prospect:

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

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 Farmacéutica belongs to a group of medications known as 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 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-

Poriasis is a skin disease in which itching, flaking, and pink patches 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, for example, detergents, causing skin redness and itching.

No useMometasona Viso Farmacéutica

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

• In any other skin disorder, 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 itching,
• diaper rash,
• herpes labialis,
• shingles,
• chickenpox,
• warts,
• ulcerated skin,
• cuts,
• other skin infections.

Consult your doctor or pharmacist if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before using this medication.

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

• If you develop irritation or sensitization with the use of this medication, discontinue use 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 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 discontinuing 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 reinitiating treatment.

Children and adolescents

This medication should not be used in children under 2 years old.

Use of Viso Farmacéutica with other medications

Inform your doctor or pharmacist if you are using, have recently used, 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, lactation, and fertility

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

Driving and operating machinery

The influence of Mometasona on the ability to drive and operate machinery is negligible or insignificant.

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

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

• A small amount of the medication is sufficient.
• An amount similar to the yolk of a finger (an amount that covers from the tip to the first joint of the index finger of an adult) is enough to cover a surface equivalent to twice the size of an adult's hand. Do not 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 adverse effects.
• Consult your doctor before covering the treated area with bandages or dressings. Do not cover the treated areas of the face or in children with bandages or dressings.
• Do not apply the cream to large areas of the body for a prolonged period (for example, 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 medication is not recommended for children under 2 years of age.

If you use moreMometasona Viso Farmacéuticathan 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you use the cream more frequently than you should or on large areas of the body, it may affect you hormonally. In the case of children, it may affect their growth and development.

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

If you forgot to useMometasona Viso Farmacéutica

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

If you interrupt the treatment withMometasona Viso Farmacéutica

If you have been using this medication 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 notice itching or burning. To avoid this, you should talk to your doctor to reduce the frequency of cream use 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 will experience them.

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

- skin allergic reactions
- bacterial and secondary skin infections
- acne
- inflammation and/or infection of hair follicles
- skin thinning
- redness associated with hives
- skin color loss
- itching
- prickling
- tingling
- excessive hair growth
- skin softening and stretch marks

- blurred vision

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

Withdrawal Reaction from Steroids:

If you use this medication continuously for prolonged periods, a withdrawal reaction may occur when treatment is stopped, with some of the following symptoms: skin redness that may extend beyond the initially treated area, burning or itching 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 a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use, https://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.

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

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

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMometasona Viso Pharmaceutical

• The active ingredient is furoate of mometasona. Each gram of cream contains 1 mg of furoate of mometasona.
• The other components (excipients) are: hexylenglycol, purified water, white beeswax (E901), hydrogenated soy lecithin, titanium dioxide (E171), octenil succinate of cornstarch and aluminum, phosphoric acid and white soft paraffin.

Appearance of the product and contents of the package

Mometasona Viso Pharmaceutical is a white, soft, and translucent cream.

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von Guericke-Allee 1

D-39179 Barleben, Germany

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 Myoto,

Czech Republic

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

Viso Pharmaceutical, S.L.U.

C/ Retama 7, 7th Floor,

28045 Madrid,

Spain

This medication is authorized in the EEA member states with the following names:

Denmark Mometasonfuroat Glenmark 1 mg/g Creme

Finlandia Mometasonifuroaatti Glenmark 1mg/g emulsiovoide

Germany Mometasonfuroat Glenmark 1 mg/g Creme

Italy Mometasone Glenmark 1 mg/g Crema

Norway Mometason Glenmark 0.1%Krem

Spain Mometasona Viso Pharmaceutical1mg/g cream

Sweden Mometason Glenmark 1mg/g kräm

United Kingdom Mometasone Furoate 0.1% w/w Cream

PolandEztom, 1 mg/g, Cream

Last review date of this leaflet: February 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/