Prospecto:information for the patient

Monovo 1 mg/g cream

furoate of mometasone

1.What Monovo is and for what it is used

2.What you need to knowbeforestarting touse Monovo

3.How to use Monovo

4.Possible adverse effects

5.Storage of Monovo

6.Contents of the package andadditional information

The active ingredient of Monovo is furoate mometasone.It belongs to a group of medications called corticosteroids (or steroids).

Topical corticosteroids are divided into four levels of potency:mild, moderate, potent, and very potent.Monovo is classified as a “potent corticosteroid”.

Monovo is indicated in adults, adolescents, and children aged 2 years and older, to relieve symptoms caused by certain inflammatory skin conditions such as psoriasis (except extensive plaque psoriasis) and atopic dermatitis.It is not a curative treatment for your condition, but it will help to relieve symptoms.

Do not use Monovo

• if you or your child are allergic to mometasone furoate or to other corticosteroids or to any of the other components of this medication (listed in section 6),
• to treat other skin problems, as it may worsen them, especially:

• rosacea (skin condition on the face)
• acne
• dermatitis around the mouth (perioral dermatitis)
• pruritus perianal and genital
• diaper dermatitis
• bacterial infections such as impetigo
• viral infections such as cold sores, shingles, and chickenpox
• fungal infections such as athlete's foot (redness, itching, and peeling of the skin on the feet) or candidiasis (vaginal infection that may cause discharge and itching)
• bacterial infections such as tuberculosis (lung infection) or syphilis (sexually transmitted disease)

• if you have any reaction after being vaccinated (e.g. for flu)
• on the eyelids

Warnings and precautions

Consult your doctor or pharmacist before starting to use Monovo.

• Do not apply Monovo on the eyelids.
• Avoid contact of the cream with the eyes. If it occurs, rinse them with plenty of clean water. If eye irritation persists, consult your doctor.
• Do not apply the cream on open wounds or mucous membranes.
• Do not use the cream on the face without your doctor's supervision.
• If irritation or sensitization occurs with the use of Monovo, inform your doctor immediately.
• If this medication is used to treat psoriasis, it may worsen it (e.g. a pustular form of the disease may develop). Regularly visit your doctor for check-ups, as the treatment must be closely monitored.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children (under 2 years)

Monovo cream should not be used in children under 2 years.

Other medications and Monovo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription and other remedies or dietary supplements such as vitamins.

Consult your doctor before taking any medication.

• Do notuse latex products (e.g. condoms, diaphragms) with Monovo in the genital or anal area, as the cream may affect the safety of these products.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.If your doctor prescribes the cream during pregnancy or breastfeeding, do not use it in large doses and only for a short period of time.
• Do notapply Monovo on the breast area during breastfeeding.

Monovo contains alcohol cetoestearílico emulsionante, alcohol cetílico, and butylhydroxytoluene

This medication may cause local skin reactions (such as contact dermatitis) because it contains alcohol cetoestearílico emulsionante and alcohol cetílico.This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor must supervise the treatment regularly.

The recommended dose is:

Adults, including the elderly, adolescents, and children aged 2 years and older:

• Apply a thin layer of cream to the affected area once a day.
• Only use a small amount of product. If you have been prescribed the cream, a dose equivalent to the yolk of a finger (i.e., a line from the tip of the index finger of an adult to the first fold) is sufficient to cover an area corresponding to twice the size of an adult's hand. Do not exceed this amount or frequency as recommended by your doctor or pharmacist.

Adults, including the elderly:

• Do not use the cream on extensive areas of the body (more than 20% of the body surface) or for long periods of time (e.g., every day for three weeks).
• Unless your doctor tells you otherwise, do not apply bandages to the treated area. This would increase the absorption of the preparation and increase the possible adverse effects.

Children (aged 2 years and older):

• Do notuse the cream on children over 2 years old on any part of the body without strict medical supervision.
• Do notapply the cream to more than 10% of the child's body surface.
• Do notuse in skin folds or under bandages that prevent air circulation.
• Do notuse for more than 3 weeks.

Administration form

Monovo is only for topical use (to be applied to the skin).

This medication is exclusively for external use.

If you use more Monovo than you should

• In case of accidental ingestion of the cream, it does not produce adverse effects. However, if you are concerned, consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount ingested.
• If you use the cream more frequently than you should or on extensive areas of the body, it may affect some hormones. In the case of children, it may affect their growth and development.
• Consult your doctor or pharmacist if you did not follow your doctor's instructions, if you used the cream too many times or for too long.

If you forgot to use Monovo

• If you forgot to apply the cream at the scheduled time, apply it as soon as you remember and continue treatment as before.
• Do notapply a double dose of cream to compensate for the missed dose.

If you interrupt treatment with Monovo

• Do not stop treatment abruptly if you have used the cream for a long time, as it may be harmful.
• The treatment should be interrupted gradually, according to your doctor's instructions.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If your symptoms do not improve after using this medicine as instructed by your doctor, or if they worsen, consult your doctor.

The side effects reported in children and adults with the use of topical corticosteroids are:

Frequent: may affect up to 1 in 10 people

Include mild to moderate burning sensation in the application area, tingling/itching, pruritus, bacterial infections, abnormal skin sensations (paresthesia), cutaneous furuncles (furunculosis), skin thinning (skin atrophy).

Rare: may affect up to 1 in 100 people

Include irregular skin marks or striae, skin irritation, abnormal hair growth (hypertrichosis), skin color changes, perioral dermatitis, skin softening and whitening (maceration), contact allergic dermatitis, pus-filled vesicles on the face (papulosa rosacea dermatitis), inflammation (including acne-like reactions), purple or dark skin discoloration (ecchymosis), heat rash (miliaria), dryness, sensitization, folliculitis, and secondary infection.

Very rare: may affect up to 1 in 10,000 people

Widening of skin blood vessels or telangiectasia.

Unknown frequency: cannot be estimated from available data

Blurred vision.

The increased frequency of use, treatment of extensive skin areas, prolonged use, and use under dressings may increase the risk of side effects.

Corticosteroids can affect the normal production of steroids in the body. This is more likely to occur if high doses are used for a prolonged period.

Specifically, children treated with corticosteroid creams and ointments may absorb the product through the skin, which can cause a condition known as Cushing's syndrome, which produces several symptoms, such as moon face and weakness. Children receiving prolonged treatment may grow more slowly than other children. To avoid this, your doctor will prescribe the minimum dose of corticosteroids to control your symptoms effectively.

Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

Do not store at a temperature above 25 °C. Dispose of after 6 months of opening the tube.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Monovo

The active principle is furoate of mometasone.

One gram of cream contains 1 mg of furoate of mometasone (0.1% furoate of mometasone)

The other components are:

Purified water, soft white paraffin (contains butylhydroxytoluene (E321) as an antioxidant), liquid paraffin, 2-methylpentane-2,4-diol, cetostearyl alcohol emulsifier (type A, contains disodium/potassium phosphate for pH adjustment), cetostearyl macrogol ether, cetilic alcohol, glycerol, citric acid, sodium citrate, xanthan gum.

Appearance of the product and packaging contents

Monovo is a white cream. The cream is packaged in PE/aluminum laminated tubes with a white plastic screw cap inside a cardboard box.

Packaging sizes: 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 50 g, 60 g, 70 g, 90 g, and 100 g of cream.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek

Germany

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

Almirall, S.A.

General Mitre, 151

08022 Barcelona - Spain

This medication is authorized in the member states of the European Economic Area with the following trade names:

Last review date of this leaflet: May 2024

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/