Methylprednisolone CINFA 1 mg/g cutaneous emulsion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metilprednisolona cinfa 1mg/g cutaneous emulsion

Metilprednisolone aceponate

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 only, and you must not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Metilprednisolona cinfa is and what it is used for
2. What you need to know before using Metilprednisolona cinfa
3. How to use Metilprednisolona cinfa
4. Possible adverse effects
5. How to store Metilprednisolona cinfa
6. Contents of the pack and other information

1. What Metilprednisolona cinfa is and what it is used for

This medicine contains the active substance, methylprednisolone aceponate.

Metilprednisolona cinfa is an anti-inflammatory medicine (a corticosteroid) for use on the skin.

This medicine reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive multiplication of skin cells (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate in inflamed skin. It also relieves itching, burning, or pain.

It is used in the treatment of acute forms of:

• mild to moderate rash (eczema) related to an external cause, such as:

• allergy to a substance that has come into contact with the skin (allergic contact dermatitis);

• allergic reaction to substances commonly used, such as soap (irritant contact dermatitis);

• coin-shaped rash (nummular eczema);

• itchy rash on hands and feet (dyshidrotic eczema);

• unspecified eczema (vulgar eczema);

• eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis;

• skin rash with inflammation and scaling (seborrheic eczema).

Metilprednisolona cinfa is indicated for use in adults, infants from 4 months of age, children, and adolescents.

2. What you need to know before using Metilprednisolona cinfa

Do not use Metilprednisolona cinfa

• If you are allergic to the active substance methylprednisolone aceponate (MPA) or to any of the other ingredients of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections, for example, chickenpox or herpes.
• On areas of skin affected by red/pink inflammation (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases causing thinning of the skin (atrophic skin diseases).
• On areas of skin showing a reaction due to vaccination, for example, redness or swelling after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless adequately treated with a specific medicine).

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine.

Take special care if your doctor also diagnoses a bacterial or fungal skin infection; in this case, you must also use the additional treatment prescribed for the infection, as otherwise the infection may worsen.

Anti-inflammatory drugs (corticosteroids), such as the active substance methylprednisolone, have significant effects on the body. The use of methylprednisolone aceponate on large areas of skin or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.

To reduce the risk of adverse effects:

• Use the lowest possible dose.
• Use it only for the shortest time necessary to relieve the skin condition.
• Methylprednisolone aceponate must not come into contact with the eyes, mouth, deep open wounds, or mucous membranes (for example, the anal or genital area).
• It must not be used on large areas of skin (more than 40% of the body surface).
• This medicine must not be used under materials impermeable to air and water, including bandages, dressings, non-breathable clothing, or diapers, unless specifically prescribed by your doctor.

If this medicine is used for conditions other than those for which it was prescribed, it may mask symptoms and make correct diagnosis and treatment more difficult.

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

If this medicine is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. Therefore, they may no longer be effective as contraceptives or as protection against sexually transmitted infections, such as HIV. Consult your doctor or pharmacist if you need further information.

Children

Use methylprednisolone aceponate as little as possible to reduce the risk of adverse effects.

This medicine must not be used under materials impermeable to air and water, such as diapers, unless specifically prescribed by your doctor.

Methylprednisolone aceponate may be used in children between 4 months and 3 years of age if prescribed by your doctor. It is not recommended for use in children under 4 months of age.

Other medicines and Metilprednisolona cinfa

No interactions between methylprednisolone aceponate and other medicines are currently known.

Tell 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 and breastfeeding

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.

To avoid any risk to the child, you must not use this medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, unless specifically instructed by your doctor.

If your doctor recommends using this medicine during breastfeeding, do not apply the medicine to the breasts and avoid contact between the child and treated areas.

Driving and using machines

Methylprednisolone aceponate does not affect your ability to drive or operate machinery.

Metilprednisolona cinfa emulsion contains benzyl alcohol

This medicine contains 12.5 mg of benzyl alcohol per gram.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Metilprednisolona cinfa emulsion

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

Unless otherwise directed by your doctor, the dosage is generally as follows:

• Apply metilprednisolone aceponate, in a thin layer, once daily, to the affected area, gently rubbing it in.
• In general, the duration of treatment with this medicine should not exceed two weeks. Always keep the treatment as short as possible.
• If you are using metilprednisolone aceponate for an inflammatory skin rash with scaling (seborrheic eczema) on the face, do not treat for longer than one week.
• If the skin becomes excessively dry, please consult your doctor. A moisturizing ointment may eventually need to be applied as well.

Use in children

Metilprednisolone aceponate may be used in children between 4 months and 3 years of age if prescribed by your doctor. Dose adjustments are not required.

The use of this medicine is not recommended in children under four months of age due to lack of safety data.

If you use more Metilprednisolona cinfa emulsion than you should

No risk is expected after a single overdose of metilprednisolone aceponate (too large amount, too large skin area, or too frequent use). Repeated overdoses may cause adverse effects (see section 4. Possible side effects).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Metilprednisolona cinfa emulsion

Do not use a double dose to make up for missed doses; if you have forgotten a dose, continue with your regular schedule as directed by your doctor or as described in this leaflet.

If you stop using Metilprednisolona cinfa emulsion

If you stop using metilprednisolone aceponate prematurely, the original symptoms of your skin condition may reappear. Please contact your doctor or pharmacist before stopping treatment with this medicine.

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 can cause adverse effects, although not everyone experiences them.

• Frequent (may affect up to 1 in 10 people):

  • Local skin irritations (e.g. burning sensation).

• Uncommon (may affect up to 1 in 100 people):

  • pain,
  • itching,
  • small blisters and pustules,
  • peeling,
  • superficial skin lesions (erosion),
  • worsening or recurrence of eczema,
  • skin cracking.

• Frequency not known (cannot be estimated from available data):
  The use of anti-inflammatory medicines called corticosteroids (such as the active substance methylprednisolone aceponate) on the skin may lead to the following adverse effects (frequency not known):

  • thinning of the skin (atrophy),
  • dry skin,
  • redness (erythema),
  • appearance of red spots,
  • inflammation of hair follicles (folliculitis),
  • stretch marks (striae),
  • acne,
  • specific skin inflammation around the upper lip and chin (perioral dermatitis),
  • skin allergic reaction (contact dermatitis),
  • changes in skin color,
  • increased body hair growth,
  • adverse effects may occur not only in the treated area but also in completely different areas of the body. This may happen if the active substance (a corticosteroid) passes into the body through the skin (is absorbed). For example, this could increase eye pressure (glaucoma),
  • blurred vision.

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 Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metilprednisolona cinfa emulsion

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

This medicine does not require special storage conditions.

Do not refrigerate or freeze.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Period of validity after first opening of the tube: 6 months

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metilprednisolona cinfa emulsion

• The active substance is methylprednisolone aceponate (MPA).
• The other components are: medium-chain triglycerides, hard fat, macrogol-2-stearyl ether, macrogol-21-stearyl ether, benzyl alcohol (E 1519), disodium edetate, glycerol (85%), and purified water.

Appearance of the product and contents of the pack

Metilprednisolona cinfa is a homogeneous, oily emulsion, white to off-white in colour, for cutaneous application (similar to a milky cream), and is available in tubes of:

• 20 g
• 50 g
• 100 g
• 10 x 50 g and
• 10 x 100 g.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Paul W. Beyvers GmbH

Schaffhausener Str. 26 - 34

12099 Berlin

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria Skinatan, 1 mg/g Emulsion zur Anwendung auf der Haut

Czech Republic Methylprednisolon Skin Care Pharma, 1 mg/g Kožní emulze

Italy Metilprednisolone Skin Care, 1 mg/g Emulsione cutanea

Poland Skinatan, 1 mg/g Emulsja na skóre

Portugal Skinatan, 1 mg/g Emulsão cutânea

Spain Metilprednisolona cinfa 1 mg/g emulsión cutánea

Date of the most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address https://cima.aemps.es/cima/dochtml/p/86310/P_86310.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86310/P_86310.html