KONEX 1mg/g CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

KONEX 1 mg/g cutaneous solution EFG

Read the package leaflet carefully before starting to use the medicine.

• Keep this package 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What is KONEX and what is it used for
2. Before using KONEX
3. How to use KONEX
4. Possible side effects
5. Storage of KONEX
6. Further information.

1. What is KONEX and what is it used for

Mometasone furoate belongs to the group of topical glucocorticoids and acts as an anti-inflammatory and antipruritic in skin conditions.

KONEX 1 mg/g cutaneous solution 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).

2. Before using KONEX

Do not use KONEX:

If you are allergic to mometasone furoate or any other glucocorticoid, or to any of the components of this specialty.

Be careful with KONEX

When treating extensive 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.

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

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

KONEX 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.

Important information about some of the components of KONEX:

This medicine contains propylene glycol, which may cause skin irritation.

3. How to use KONEX

Follow the administration instructions exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to use your medicine.

Your doctor will indicate the duration of treatment with Mometasone furoate in cutaneous solution. Do not stop treatment on your own.

If you think the action of Mometasone furoate in cutaneous solution is too strong or too weak, tell your doctor or pharmacist.

Avoid sudden cessation of treatment.

KONEX is applied to the skin or scalp.

Apply a few drops of KONEX 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.

If you use more KONEX than you should:

If you have used more KONEX 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 medicine and the amount used.

If you forget to use KONEX:

Do not use a double dose to make up for forgotten doses, continue with the usual schedule and if you have forgotten many doses, consult your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, KONEX can cause side effects, although not everyone gets them.

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

Very common: at least 1 in 10 people

Common: at least 1 in 100 people but less than 1 in 10

Uncommon: at least 1 in 1,000 people but less than 1 in 100

Rare: at least 1 in 10,000 people but less than 1 in 1,000

Very rare: less than 1 in 10,000 people.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them 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 medicine.

5. Storage of KONEX

Keep out of the reach and sight of children.

Storage conditions:No special storage conditions are required.

Expiry date:Do not use KONEX after the expiry date stated on the label and carton. The expiry date is the last day of the month indicated.

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

6. Further information

Composition of KONEX:

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

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

Appearance of the product and packaging contents:

Clear and colorless solution.

KONEX is available in 30 and 60 ml bottles.

Marketing authorization holder:

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 Reus (Tarragona)

Manufacturer:

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

or

Marketing authorization holder and manufacturer:

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, nº 24

43206 Reus (Tarragona)

This package leaflet was approved in November 2017.

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