Mometasone Viso Farmaceutica 1 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Mometasona Viso Farmacéutica 1mg/g ointment

Mometasone furoate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse 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 years and older, Mometasona Viso Farmacéutica is used to reduce redness and itching caused by certain skin conditions known as psoriasis and atopic eczema (atopic 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. Atopic eczema is a condition caused by the skin's reaction to external agents such as, for example, detergents, leading to skin redness and itching.

2. What you need to know before using Mometasona Viso Farmacéutica

Do not use Mometasona Viso Farmacéutica

• If you are allergic to mometasone or to any of the other ingredients of this medicine (listed in section 6).

• For 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 (inflammation around the mouth)

• genital or 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 peeling of the skin on the feet)

• parasitic infections

• if you have recently had a reaction to 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 develops irritation or sensitization while using Mometasona Viso Farmacéutica, you should stop using this medicine and inform your doctor.

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

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

If you notice a worsening of your condition during treatment with 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 to do so. 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.

Other medicines and Mometasona Viso Farmacéutica

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 and breastfeeding

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

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

Mometasona Viso Farmacéutica contains propylene glycol and butylated hydroxytoluene (E321)

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

3. How to use Mometasona Viso Farmacéutica

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

If you have been prescribed the ointment, the fingertip unit (a line of ointment from the tip of an adult's finger to the first crease of the finger) is sufficient to cover an area equal to twice the size of an adult's hand. Do not apply more than this amount or more frequently than recommended by your doctor or pharmacist.

Your doctor should evaluate your treatment at regular intervals.

Always follow these instructions when using Mometasona Viso Farmacéutica ointment for yourself or your child:

• Do not use the ointment on the face for longer than 5 days.
• Consult your doctor before covering the treated area with bandages or dressings. Treated areas on the face must not be covered with bandages or dressings.
• Do not use large amounts of ointment over large areas of the body for prolonged periods (e.g., once daily for weeks or months).
• Do not use around the eyes, including on the eyelids.

Adults

• Do not use the ointment for prolonged periods (more than 3 weeks) or over large areas of the body (more than 20% of body surface area).

Children aged 2 years and older

• Do not apply the ointment to children on any part of their body for longer than 3 weeks.
• Do not apply the ointment under the diaper, as this may enhance absorption of the medicine through the skin and may lead to more adverse effects.
• Treated areas in children must 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 more Mometasona Viso Farmacéutica than you should

Accidental ingestion of the ointment is unlikely to cause problems. However, consult your doctor or pharmacist if you are concerned.

Applying the ointment more frequently than recommended or over large areas of the body may lead to hormonal side effects. In children, this could affect growth and development.

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

If you forget to use Mometasona Viso Farmacéutica

If you forget to apply the ointment at the scheduled time, do so as soon as possible and then continue with your normal treatment schedule. Do not apply a double amount, nor apply the ointment twice on the same day to make up for a missed dose.

If you stop treatment with Mometasona Viso Farmacéutica

If you have been using Mometasona Viso Farmacéutica for a long time and your skin condition has improved, do not stop using the ointment suddenly. Doing so may cause your skin to become red and you may experience stinging or burning. To avoid this, you should speak with your doctor about gradually reducing the frequency of 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 experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

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

Other adverse effects that may occur following the use of topical corticosteroids include dry skin, skin irritation, dermatitis, perioral dermatitis, and mild dilation of cutaneous blood 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 initially treated area, burning or stinging sensation, intense itching, skin peeling, open sores with exudate.

Reporting of 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

After opening, discard the tube with any 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. Return unused medicines and their containers to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Mometasona Viso Farmacéutica

• The active substance is mometasone furoate.

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

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

Appearance of the medicinal product and contents of the container

Mometasona Viso Farmacéutica 1 mg/g ointment is a white, soft and translucent ointment. The ointment is filled into aluminium tubes fitted with a white polyethylene screw cap with a piercing point, which are then placed into a cardboard carton.

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

Not all container 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

Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom

For further information on this medicinal product, please contact 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 European Economic Area under the following names:

Date of the last review of this leaflet: February 2023

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