MOMETASONE MEDE 1mg/g CREAM

Introduction

Mometasona Mede 1 mg/g Cream

Mometasone furoate

Read the entire leaflet carefully before starting to use this medicine because 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 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 not listed in this leaflet.

Contents of the leaflet:

1. What is Mometasona Mede and what is it 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

1. Package contents and additional information

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

Mometasona Mede contains the active ingredient mometasone furoate and belongs to the group of medicines called topical corticosteroids (or steroids). This medicine is classified as a "high-potency corticosteroid"

Mometasona Mede is indicated for adults and children over 6 years of age, for the relief of symptoms (redness and itching) caused by certain inflammatory skin disorders such as atopic dermatitis and psoriasis (except for extensive plaque psoriasis).

This medicine is not a curative treatment for your disease, but it should help alleviate the symptoms.

2. What you need to know before starting to use Mometasona Mede 1mg/g Cream

Do not use Mometasona Mede

• If you are allergic (hypersensitive) to mometasone furoate or any of the other components of this medicine (listed in section 6).
• If you have any other skin disorder, as it could worsen, especially:
  • facial rosacea (skin disease that affects the face),
  • acne,
  • perioral dermatitis (dermatitis around the mouth),
  • perianal and genital itching,
  • diaper rash.
  • bacterial infections such as impetigo (skin infection), tuberculosis (lung infection), syphilis (sexually transmitted disease),
  • viral infections (such as cold sores, shingles, chickenpox)
  • fungal infections, such as athlete's foot (red, itchy, and flaky skin on the feet), or candidiasis (vaginal infection that can cause discharge and itching).
  • If you have recently had a reaction after receiving a vaccine (e.g., flu vaccine).

Be careful with Mometasona Mede

• If you or your child is allergic (hypersensitive) to other corticosteroids
• If you develop irritation or sensitization while using Mometasona Mede, inform your doctor immediately.
• Mometasona Mede should not be applied to damaged skin; use only on intact skin. The cream should not be applied to the eyelids, and contact with the eyes should be avoided.
• The cream should not be applied with occlusive dressings, nor in skin folds. When this medicine is used for psoriasis, it may worsen the condition (e.g., a pustular form of the disease may develop), so your doctor should review your progress at regular intervals, as this treatment requires careful supervision. If you notice a change in the appearance of the affected skin, inform your doctor immediately.

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

Using Mometasona Mede with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, or if you may need to use any other medicine, including non-prescription medicines and any other product or dietary supplement, such as vitamins.

Pregnancy and breastfeeding

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

Pregnancy

Although systemic exposure is limited, Mometasona Mede should only be used during pregnancy when clearly necessary, and after careful assessment of the benefit-risk ratio.

Pregnant women should not use the product on large areas of the skin for extended periods.

Breastfeeding

It is unknown if mometasone is excreted in breast milk. However, it is unlikely that topical application of mometasone to limited skin areas would pose a risk to breastfed children. The product should not be applied directly to the breast before breastfeeding. If high-dose or long-term treatment is indicated, breastfeeding should be interrupted.

Ask your doctor before taking any medicine.

Driving and using machines:

Mometasona Mede has no or negligible influence on the ability to drive and use machines.

Mometasona Mede contains propylene glycol monostearate and stearyl alcohol:

This medicine may cause skin irritation because it contains propylene glycol monostearate.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol.

3. How to use Mometasona Mede

Follow your doctor's instructions for using Mometasona Mede exactly. If in doubt, consult your doctor or pharmacist again.

Mometasona Mede is a medicine for topical use (to be used on the skin)

This medicine is for external use only.

Your doctor will review your treatment at regular intervals

The recommended dose is:

Adults and children over 6 years

Apply a thin layer of cream to the affected skin areas once a day and gently massage.

You only need to apply a small amount of the medicine.

Normally, when there is clinical improvement, it is advisable to use a weaker corticosteroid.

Special precautions

• Do not use the cream on the face without your doctor's close supervision. Do not use the cream on the face for more than 5 days.
• Do not apply the cream to large areas of the body (more than 20% of the body surface), nor for an extended period (e.g., every day for more than 3 weeks).
• Avoid getting the cream in contact with the eyes, and do not use it on the eyelid area.
• Do not apply an occlusive dressing or bandage over the treated area, unless your doctor tells you to do so. This would increase the absorption of the medicine and increase the risk of side effects.

Childrenover 6 years and adolescentsThe use of topical corticosteroids in children over 6 years of age, as well as their use on the face, should be limited to the smallest amount compatible with an effective therapeutic regimen.

• Do not apply the cream to any part of the child's body without medical supervision.
• Do not use it for more than 5 days.
• Do not apply the cream to an area larger than 10% of the child's body.

Children under 6 years

The use of this medicine is not recommended in children under 6 years of age due to the lack of data on its safety.

If you use moreMometasonaMedethan you should:

If you use the cream more frequently than you should, or on large areas of the body, it may affect some of your hormones. In children, this can affect their growth and development.

If you have not followed the recommended dosage instructions or your doctor's advice and have used the cream too frequently and/or for a long time, you should inform your doctor or pharmacist.

In case of accidental ingestion of the product, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to useMometasonaMede

If you forget to use the cream at the scheduled time, apply it as soon as possible and then continue with the established schedule.

Do not use a double dose to make up for forgotten doses.

If you stop treatment withMometasonaMede

Do not stop treatment with Mometasona Mede abruptly, if you have been using it for a long time, as it may be harmful. Treatment should be discontinued gradually, following your doctor's instructions

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

4. Possible side effects

Like all medicines, Mometasona Mede can cause side effects, although not everybody gets them.

If your symptoms do not start to improve after using this preparation for 2-3 weeks, or if they worsen, consult your pharmacist or doctor.

Side effects may occur with certain frequencies, which are defined below:

Side effects in children and adults described with the use of topical corticosteroids include:

Prolonged use, treatment of large skin areas, and use under occlusive dressings may increase the risk of side effects. Corticosteroids may affect the body's normal production of steroids. This is more likely to occur with high doses and if used for a long period. Children, in particular, treated with topical corticosteroids in the form of ointments and creams, may absorb the product through the skin, leading to a condition known as Cushing's syndrome, which includes several symptoms, such as "moon face" and weakness. Children with long-term treatment may experience delayed growth. Your doctor will help you avoid this by prescribing the minimum dose of steroids with which the symptoms are well controlled. Cases of increased pressure in the skull (intracranial hypertension) have been described in children who received topical corticosteroids. Symptoms may include headache, bulging fontanelles, and visual problems, including blurred vision, blind spots, and double vision (bilateral papilledema).

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Mometasona Mede

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

Do not store above 30°C

Do not use this medicine after the expiration date shown on the carton after EXP. The expiration date is the last day of the month indicated.

Once opened, discard the tube with the remaining cream after 6 months.

Medicines should not be disposed of via wastewater or household waste. Deposit 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. Package contents and additional information

Composition ofMometasona Mede

The active ingredient is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate

The other components (excipients) are: soft white paraffin, white beeswax, propylene glycol monostearate, stearyl alcohol, and Polyoxyl 20 cetostearyl ether, hexylene glycol, titanium dioxide (E-171), cornstarch octenyl succinate, aluminum, phosphoric acid, and purified water.

Appearance of the product and package contents

Mometasona Mede is a white or off-white cream. It is available in 30 and 60 gram tubes.

Marketing authorization holder and manufacturer:

Laboratorio Reig Jofré, SA

C/ Gran Capitán, 10

08970 Sant Joan Despí

Barcelona

Spain

Date of the last revision of this leaflet:April 2013

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/