Mometasone Korhispana 0.1% cutaneous solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mometasona Korhispana 1 mg/g cutaneous solution EFG

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, consult 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains as the active substance mometasone furoate, 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 (with stinging or itching) manifestations 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 rashes accompanied by itching).

2. What you need to know before using Mometasona Korhispana

Do not use Mometasona Korhispana

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

Warnings and precautions

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

When treating large body surface areas, when using occlusive dressings, during long-term treatment, or when applying to facial skin or skin folds.

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

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

Other medicines and Mometasona Korhispana

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

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

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

Driving and using machines

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

Mometasona Korhispana contains propylene glycol

This medicine contains 300 mg of propylene glycol in each 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 medicine 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 Mometasona Korhispana

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should use this medicine. Do not stop treatment on your own.

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

This medicine is for topical use only.

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 daily and gently massage until it disappears.

Do not cover or bandage the treated area unless instructed by your doctor.

Use in children

This medicine must 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, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Mometasona Korhispana

Do not use a double dose to make up for missed doses. If you forget to apply this medicine at the scheduled time, do so as soon as possible and then continue the treatment as before.

If you stop treatment with Mometasona Korhispana

Do not stop treatment abruptly. As with all highly active corticosteroids, treatment should be discontinued gradually.

If you have any 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.

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

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.

Skin and subcutaneous tissue disorders:

• Common: burning sensation, folliculitis (inflammation of hair follicles), acneiform reaction (acne), pruritus, and signs of cutaneous atrophy
• Uncommon: papules (bumps), pustules (lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to blisters), and itching
• Rare: irritation, hypertrichosis (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 horny layer), secondary infection, striae, and miliaria (a condition related to acne in which small, hard, static white cysts appear)

Endocrine disorders:

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

Eye disorders:

• Frequency not known: blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone Korhispana

Keep this medicine out of the sight and reach of children.

Storage conditions: No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mometasone Korhispana

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

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

Appearance of the medicinal product and contents of the pack

Mometasone Korhispana 1 mg/g cutaneous solution is a clear, colourless solution.

This medicine is available in 30 ml and 60 ml bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: August 2020.

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