MOMETASONE KORHISPANA 0.1% CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Mometasone Korhispana 1 mg/g Cutaneous Solution EFG

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

1. What is Mometasone Korhispana and what is it used for
2. What you need to know before you use Mometasone Korhispana
3. How to use Mometasone Korhispana
4. Possible side effects
5. Storage of Mometasone Korhispana
6. Contents of the pack and further information

1. What is Mometasone Korhispana and what is it used for

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

Mometasone Korhispana is indicated for the relief of inflammatory and pruritic manifestations (with itching) 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).

2. What you need to know before you use Mometasone Korhispana

Do not use Mometasone Korhispana

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Mometasone Korhispana.

When treating large body surfaces, when using occlusive dressings, in long-term treatments, or when applying to the skin of the face or skin folds.

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

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

Other medicines and Mometasone Korhispana

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

There are no known data to suggest that the product may affect the ability to drive or operate machinery.

Mometasone Korhispana contains propylene glycol

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

Propylene glycol may cause skin irritation. This medicinal product 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.

3. How to use Mometasone Korhispana

Follow exactly the administration instructions of this medicinal product given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with this medicinal product. Do not stop treatment on your own.

If you think the action of this medicinal product is too strong or too weak, tell your doctor or pharmacist.

This medicinal product is for cutaneous use.

Mometasone Korhispana is applied to the skin or scalp.

The recommended dose is:

Apply a few drops of Mometasone 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 indicated it.

Use in children

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

If you use more Mometasone Korhispana than you should

If you have used more Mometasone 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicinal product and the amount used.

If you forget to use Mometasone Korhispana

Do not use a double dose to make up for forgotten doses. If you forgot to apply this medicinal product at the indicated time, do so as soon as possible and then continue with the treatment as before.

If you stop using Mometasone Korhispana

Do not stop treatment abruptly. As with all highly active steroids, treatment should be stopped gradually.

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

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

The following side effects have been reported and are classified according to their frequency:

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

Common: may affect up to 1 in 10 people;

Uncommon: 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;

Frequency not known: cannot be estimated from the available data.

Disorders of the skin and subcutaneous tissue:

• Common: burning, folliculitis (inflammation of hair follicles), acneiform reaction (acne), pruritus, and signs of cutaneous atrophy
• Uncommon: papules (protuberances), pustules (lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to a blister), and itching
• Rare: irritation, hypertrichosis (excessive hair growth in an area), hypopigmentation (reduction in pigment production), perioral dermatitis (red papules around the mouth), allergic contact dermatitis, skin maceration (excessive loss of the protective horny layer), secondary infection, striae, and miliaria (lesion related to acne in which small, hard, white cysts appear)

Endocrine disorders:

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

Eyedisorders:

• Frequency not known: blurred vision

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Mometasone Korhispana

Keep this medicinal product out of the sight and reach of children.

Storage conditions:No special storage conditions are required.

Do not use this medicinal product after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mometasone Korhispana

The active substance is mometasone furoate. Each gram of solution contains 1 milligram of mometasone furoate.

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

Appearance of the product and contents of the pack

Mometasone Korhispana 1 mg/g cutaneous solution is a clear and colorless solution.

This medicinal product is available in 30 and 60 ml bottles.

Marketing authorization holder and manufacturer

Marketing authorization holder

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

LABORATORIOS SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Or

Grupo Reig Jofré

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the last revision of this leaflet: August 2020

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