MOMETASONE VISO FARMACEUTICA 1mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Mometasone Viso Farmacéutica 1mg/g Ointment

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 Mometasone Viso Farmacéutica is and what it is 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 Mometasone Viso Farmacéutica is and what it is 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 aged 2 years and over, Mometasone Viso Farmacéutica is used to reduce redness and itching caused by certain skin problems called psoriasis and atopic eczema (atopic 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. Atopic eczema is a disease caused by the skin's reaction to external agents such as detergents, causing redness of the skin and itching.

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

Do not useMometasone Viso Farmacéutica

• If you are allergic to mometasone or any of the other ingredients of this medicine (listed in section 6).
• In any other skin disorder, as it may 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 and perianal itching
• diaper 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 scaling of the skin on the feet)
• parasitic infections
• cold sores
• herpes
• ulcerated skin
• wounds
• other skin infections

Consult your doctor or pharmacist if you are not sure.

Warnings and precautions

If your skin develops irritation or sensitization when using Mometasone Viso Farmacéutica, you should stop using this medicine and inform your doctor.

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

If this medicine is used for psoriasis, the condition may worsen (i.e., it is possible that a pustular form of the disease may develop). Your doctor should evaluate the progression of your disease at regular intervals, as this treatment requires careful supervision.

If you notice a worsening of your condition during use of 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 soon 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.

Other medicines and Mometasone Viso Farmacéutica

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 and breastfeeding

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

If your doctor prescribes the ointment during pregnancy and breastfeeding, you should avoid using high doses and should only use it for a short period. Mometasone Viso Farmacéutica 1 mg/g ointment should not be applied to the breast area during breastfeeding.

Mometasone Viso Farmacéutica contains propylene glycol and butylhydroxytoluene (E321)

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

3. How to use Mometasone Viso Farmacéutica

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.

Mometasone Viso Farmacéutica should not be used in children under 2 years of age. In general, for adults and children aged 2 years and over, apply a thin layer of Mometasone Viso Farmacéutica to the affected area once a day.

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

Your doctor should evaluate the treatment at regular intervals.

Always follow these instructions when using Mometasone Viso Farmacéutica ointment 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. The treated areas of the face should not be covered with bandages or dressings.
• do not use large amounts of ointment on extensive areas of the body for a long time (e.g., once a day for weeks or months)
• do not use around the eyes, including the eyelids.

Adults

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

Children aged 2 years and over

• should not apply the ointment to children on any part of their body for more than 3 weeks
• should not apply the ointment under diapers, as this facilitates the passage of the medicine 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

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

If you use more Mometasone Viso Farmacéutica than 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 prescribed or to large areas of the body may have hormonal consequences. In children, it may affect their growth and development.

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

If you forget to use Mometasone Viso Farmacéutica

If you forget to apply the ointment at the scheduled time, do so as soon as possible and continue the treatment as usual. Do not apply a double dose, nor apply the ointment twice on the same day to make up for a forgotten application.

If you stop using Mometasone Viso Farmacéutica

If you have been using Mometasone Viso Farmacéutica for 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 experience itching or burning. To avoid this, you should talk to your doctor to gradually reduce the frequency of use of the ointment until you stop treatment completely.

If you have any other questions about 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.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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

• Skin allergic reactions
• Bacterial and secondary infections
• Acne
• Inflammation and/or infection of the hair follicles
• Thinning of the skin
• Redness associated with rash
• Loss of skin pigmentation
• Burning
• Itching
• Pruritus
• Tingling
• Excessive hair growth
• Softening of the skin and stretch marks
• Blurred vision

Other side effects that may occur with the use of topical corticosteroids are dryness of the skin, skin irritation, dermatitis, dermatitis around the mouth, and mild dilation of blood capillaries.

Steroid withdrawal reaction:

If you use this medicine continuously for prolonged 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 sensation or itching, 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) at 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 shown.

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 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 of Mometasone Viso Farmacéutica

• The active substance is mometasone furoate.

Each gram of Mometasone Viso Farmacéutica 1 mg/g ointment contains 1mg of mometasone furoate.

• The other ingredients are: hexylene glycol, concentrated phosphoric acid (for pH adjustment), propylene glycol monopalmitostearate, white beeswax, soft white paraffin; butylhydroxytoluene (E321) (as antioxidant) and purified water.

Appearance of the product and pack contents

Mometasone Viso Farmacéutica 1 mg/g ointment is a white, soft, and translucent ointment. The ointment is filled into aluminum tubes with a white polyethylene screw cap with a piercing tip, which are packed in a cardboard box.

Package sizes: tubes with 10 g, 15 g, 20 g, 30 g, 50 g, 60 g, or 100 g of ointment.

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

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, Hertfordshire, WD18 8YA

United Kingdom

You can ask for more information about 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 European Economic Area under the following names:

Date of last revision of this leaflet:February 2023

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