MOMETASONE MEDE 0.1% CUTANEOUS SOLUTION

Introduction

Leaflet: information for the user

Mometasona Mede1 mg/g cutaneous solution EFG

mometasone furoate

Read the entire leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Mometasona Mede is and what it is used for
2. What you need to know before starting to use Mometasona Mede
3. How to use Mometasona Mede
4. Possible side effects
5. Storage of Mometasona Mede
6. Package contents and additional information

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

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

Mometasona Mede is indicated for the relief of inflammatory and pruritic manifestations (with itching or scratching) 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 starting to use Mometasona Mede

Do not use Mometasona Mede

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

Warnings and precautions

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

Be particularly careful with this medicine when treating large body surfaces, when using occlusive dressings, in long-term treatments, or when applying it to the skin of the face or skin folds. Avoid contact with the eyes. In case of accidental contact, wash your eyes with plenty of water.

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

Other medicines and Mometasona Mede

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, including those purchased without a prescription.

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 medicine. Mometasona Mede 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.

Mometasona Mede contains propylene glycol

This medicine contains 300 mg of propylene glycol per gram of cutaneous solution.

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 Mede

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Mometasona Mede is for cutaneous use (applied to the skin or scalp).

The recommended dose is:

Apply a few drops of Mometasona Mede 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 Mometasona Mede than you should:

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

In case of overdose or accidental ingestion, go 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 Mometasona Mede:

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

If you stop treatment with Mometasona Mede

Avoid sudden cessation of treatment. As with all highly active steroids, treatment should be discontinued gradually.

If you have any other doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can have side effects, although not everyone 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)

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasona Mede

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

No special storage conditions are required.

Expiry date: Do not use this medicine after the expiry date stated on the label and 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. Deposit the containers and medicines you no longer need at the collection point in your 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. Package contents and additional information

Composition of Mometasona Mede

The active ingredient is mometasone furoate. Each gram of cutaneous 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 product and package contents

Mometasona Mede 1 mg/g cutaneous solution is a clear and colorless solution.