Product Information for the User

Mometasona Mede1 mg/g topical cream EFG

furoate of mometasone

Read this entire product information carefully before starting to use the medication, because it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you personally and should not be given to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Mometasona Mede and how is it used

2. What you need to know before starting to use Mometasona Mede

3. How to use Mometasona Mede

4. Possible adverse effects

5. Storage of Mometasona Mede

6. Contents of the package and additional information

This medication contains furoate of mometasone 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 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 Mometasona Mede

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

Warnings and precautions

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

Be especially careful with this medication 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.

Notify your doctor if you experience blurry vision or other visual disturbances

Other medications and Mometasona Mede

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.Mometasona Mede should be avoided in pregnant women or in breastfeeding women, except on medical prescription.

Driving and operating machinery

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

Mometasona Mede contains propylene glycol

This medication contains 300 mg of propylene glycol in each gram of topical solution.

Propylene glycol may cause skin irritation.

This medication 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of treatment with this medication. Do not discontinue treatment on your own.

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

Mometasona Mede is for topical 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 instructed you to do so.

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 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 Mometasona Mede:

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.

If you interrupt treatment with Mometasona Mede

Avoid abrupt discontinuation of treatment. Like all very active steroids, treatment should be discontinued gradually.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been described 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 available data)

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of 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 System for Pharmacovigilance of Medicinal Products for Human Use: https://notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Expiration Date:Do not use this medication after the expiration date indicated on the label and on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mometasona Mede

The active ingredient is furoate of mometasona. Each gram of topical solution contains 1 milligram of furoate of mometasona.

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

Appearance of the product and contents of the packaging

Mometasona Mede 1 mg/g topical solution, is a transparent and colorless solution.