Prospect: Information for the User

Mometasona Korhispana 1 mg/g topical solution EFG

furoate of mometasona

Read this prospect carefully before starting to use this medication, 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 medication has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- Ifyou experience adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospect. See section 4.

This medication contains the active ingredientfuroate of mometasone, which belongs to the group of topical glucocorticoids and acts as an anti-inflammatory and antipruritic in skin conditions.

Mometasona Korhispana is indicated for the relief of inflammatory and pruritic manifestations (with itching or stinging) of dermatoses that respond to treatment with glucocorticoids such as psoriasis (a skin disease characterized by scaling) and atopic dermatitis (a chronic skin condition, characterized by the appearance of scaly eruptions, accompanied by itching).

Do not use Mometasona Korhispana

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mometasona Korhispana.

When treating extensive body surfaces, when using occlusive dressings, in long-term treatments or in applications on the skin of the face or skin folds.

Avoid contact with the eyes. In case of accidental contact, wash the eyes with plenty of water.

Contact your doctor if you experience blurred vision or other visual disturbances.

Other medications and Mometasona Korhispana

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

Pregnancy, breastfeeding and fertility

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

Mometasona Korhispana should be avoided in pregnant women or breastfeeding women, except on medical prescription.

Driving and operating machinery

No known data suggests that the product may affect the ability to drive or operate machinery.

Mometasona Korhispanacontainspropylene glycol

This medication contains 300 mg of propylene glycol in each milliliter of solution equivalent to 18 g per unit (bottle of 60 ml) and 9 g per unit (bottle of 30 ml).

Propylene glycol may cause skin irritation. This medication contains propylene glycol, do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

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

Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment on your own.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

This medication is for topical use.

Mometasona Korhispana is applied to the skin or scalp.

The recommended dose is:

Apply a few drops of Mometasona Korhispana to the affected areas once a day and gently massage until it disappears.

Do not cover or bandage the treated area unless your doctor has instructed you to do so.

Use in children

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

If you use more Mometasona Korhispana than you should

If you have used more Mometasona Korhispana than indicated, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Mometasona Korhispana

Do not use a double dose to compensate for the missed dose. If you forgot to apply this medication at the indicated time, do it as soon as possible and continue with the treatment as before.

If you interrupt treatment with Mometasona Korhispana

Do not discontinue treatment abruptly. Like all very active steroids, treatment should be discontinued gradually.

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

Like all medications, this medication may have adverse effects, although not everyone may experience them.

The following adverse effects have been described and are classified according to their frequency:

Very frequent:may affect more than 1 in 10 people;

Frequent:may affect up to 1 in 10 people;

Infrequent:may affect up to 1 in 100 people;

Rare:may affect up to 1 in 1,000 people;

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

Unknown frequency: cannot be estimated from available data.

Dermatological and subcutaneous tissue disorders:

• Frequent: burning sensation, folliculitis (inflammation of hair follicles), acneiform reaction (acne), pruritus, and signs of cutaneous atrophy
• Infrequent: papules (protuberances), pustules (small, inflamed, pus-filled lesions), and itching
• Rare: irritation, hirsutism (excessive hair growth in an area), hypopigmentation (reduced pigment production), perioral dermatitis (red papules around the mouth), allergic contact dermatitis, skin maceration (excessive loss of the protective corneal layer), secondary infection, striae, and miliaria (acne-related lesions with small, white, hard, and static quistes)

Endocrine disorders:

• Rare: adrenal suppression (suppression of steroid hormone secretion)

Eye disorders:

• Unknown frequency: blurred vision

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 for Medicinal Products 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.

Storage Conditions:No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Mometasona Korhispana

The active ingredient is furoate of mometasone. Each gram of solution contains1milligram of furoate of mometasone.

The other components are: isopropyl alcohol, propylene glycol (E-1520), hydroxypropylcellulose, dihydrogen phosphate of sodium dihydrate, phosphoric acid and purified water.

Appearance of the product and contents of the packaging

Mometasona Korhispana 1 mg/g topical solution, is a transparent and colorless solution.

This medicine is presented in bottles of30and60 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

KORHISPANA, S.L.

Ctra. Castellvell,24

43206 REUS (Tarragona)

Responsible for manufacturing

LABORATORIOS SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Or

Grupo Reig Jofré

C/ Gran Capitán,10

08970Sant Joan Despí (Barcelona)

Last review date of this leaflet: August 2020.

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