Mometasone MeDe 0.1% cutaneous solution EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Mometasona Mede 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Mometasona Mede is and what it is used for
- What you need to know before using Mometasona Mede
- How to use Mometasona Mede
- Possible adverse effects
- How to store Mometasona Mede
- Contents of the pack and other information
1. What Mometasona Mede is and what it is used for
This medicine contains mometasone furoate as the active substance, which belongs to the group of topical glucocorticoids and acts as an anti-inflammatory and antipruritic agent in skin conditions.
Mometasona Mede 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 Mede
Do not use Mometasona Mede
If you are allergic to the active substance mometasone furoate, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Mometasona Mede.
Take special care when treating large body surface areas, when using occlusive dressings, during long-term treatment, or when applying to the skin of the face 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 Mede
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
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 Mede should be avoided in pregnant or breastfeeding women, except under medical advice.
Driving and using machines
There are no known data suggesting that this product may affect the ability to drive or operate machinery.
Mometasona Mede contains propylene glycol
This medicine contains 300 mg of propylene glycol in each 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 exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will advise you on the duration of treatment with 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.
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 daily and gently massage until it disappears.
Do not cover or bandage the treated area unless instructed by your doctor.
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 Toxicology Information Service at telephone number 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 missed doses. Continue with your usual dosing schedule. If you have missed many doses, consult your doctor or pharmacist immediately.
If you interrupt treatment with Mometasona Mede:
Avoid abrupt discontinuation of treatment. As with all highly potent steroids, treatment should be tapered off gradually.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone will experience 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:
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Endocrine disorders:
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Ocular disorders: Frequency not known: blurred vision |
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mometasone 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. Dispose of unused medicines and their containers at the Punto Sigre 
in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Mometasona Mede
The active substance 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 contents of the container
Mometasona Mede 1 mg/g cutaneous solution is a clear, colorless solution.
This medicinal product is available in 30 ml and 60 ml bottles of cutaneous solution. Marketing Authorization Holder and Manufacturer: Laboratorio Reig Jofré S.A Gran Capitán, 10 08970 Sant Joan Despí (Barcelona) Spain Date of the most recent review of this leaflet: October 2020 Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/ |