PATIENT INFORMATION LEAFLET

KONEX 1 mg/g Topical Solution EFG

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same, as it may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

KONEX 1 mg/g topical 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).

Do not use KONEX:

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

Be cautious with KONEX

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.

Consult your doctor if you experience blurry vision or other visual alterations.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those acquired without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

KONEX should be avoided in pregnant women or during breastfeeding, except on medical prescription.

Driving and operating machinery:

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

Important information about one of the components of KONEX:

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

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

Remember to use your medication.

Your doctor will indicate the duration of treatment with Mometasona furoate topical solution. Do not discontinue treatment on your own.

If you estimate that the action of Mometasona furoate topical solution is too strong or too weak, inform your doctor or pharmacist.

Avoid abrupt treatment discontinuation.

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 instructed by your doctor.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use KONEX:

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

Like all medications, KONEX, may cause adverse effects, although not all people may experience them.

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

Very Frequent:at least 1 in 10 people

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

Infrequent:at least 1 in 1000 people but less than 1 in 100

Rare:at least 1 in 10000 people but less than 1 in 1000

Very Rare:less than 1 in 10000 people.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 out of reach and sight of children.

Storage Conditions:No special storage conditions are required.

Expiration Date:Do not use KONEX after the expiration date indicated on the label and in the packaging. The expiration date is the last day of the month indicated.

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

KONEX Composition:

The active principle is Mometasona furoate. Each gram of solution contains 1 milligram of mometasona furoate.

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

Product Appearance and Packaging Contents:

Transparent and colorless solution.

KONEX is presented 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 leaflet was approved inNovember 2017.

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