METHYLPREDNISOLONE CINFA 1 mg/g CUTANEOUS EMULSION

2. What you need to know before you use Methylprednisolone Cinfa

Do not useMethylprednisolone Cinfa

• If you are allergic to the active ingredient methylprednisolone aceponate (MPA) or 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.
• In areas of the skin affected by inflammation that is red/pink (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophic skin diseases).
• In areas of the skin that show a reaction due to a vaccine, for example, redness or inflammation after vaccination.
• In specific skin inflammation around the upper lip and chin (perioral dermatitis).
• In bacterial or fungal infections (unless they are adequately treated with a specific medicine).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

Be especially careful if your doctor diagnoses a skin infection with bacteria or fungi; then, you should also use the additional treatment prescribed for the infection, because if not, the infection may worsen.

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

To reduce the risk of side effects:

• Use it at the lowest possible dose.
• Use it only for the time absolutely necessary to relieve the skin condition.
• Methylprednisolone aceponate should not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., anal or genital area).
• It should not be used on large areas of skin (more than 40% of the body surface).
• It should not be used under airtight and waterproof materials, including bandages, dressings, non-breathable clothing, or diapers, unless prescribed by your doctor.

If you use this medicine for diseases other than those for which it has been prescribed, it may mask the symptoms and make the correct diagnosis and treatment difficult.

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

If you apply this medicine 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 protection against sexually transmitted diseases, such as HIV infection. Consult your doctor or pharmacist if you need more information.

Children

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

It should not be used under airtight and waterproof materials, such as diapers, unless prescribed by your doctor.

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

Other medicines and Methylprednisolone Cinfa

No interactions of methylprednisolone aceponate with other medicines are known at present.

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

To avoid any risk to the child, do not use this medicine if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, unless your doctor advises you to.

If your doctor recommends the use of this medicine during breastfeeding, do not apply the medicine to the breasts; do not let the child come into contact with treated areas.

Driving and using machines

Methylprednisolone aceponate does not affect your ability to drive or use machines.

Methylprednisolone 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 Methylprednisolone Cinfa emulsion

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Unless your doctor has told you otherwise, the dosage is, in general, as follows:

• Apply methylprednisolone aceponate, in a thin layer, once a day, to the affected area, rubbing gently.
• Generally, the duration of treatment with this medicine should not exceed two weeks. Always make the treatment as short as possible.
• If you use methylprednisolone aceponate for a skin rash with inflammation (seborrheic eczema) and scaling of the face, do not treat for more than one week.
• If the skin becomes too dry, please consult your doctor. You may need to apply, in addition, a regulating greasy ointment.

Use in children

Methylprednisolone aceponate can be used in children between 4 months and 3 years if prescribed by your doctor. No dose adjustments are required.

The use of this medicine is not recommended in children under 4 months of age due to lack of safety data.

If you use more Methylprednisolone Cinfa emulsion than you should

No risk is expected after a single overdose of methylprednisolone aceponate (too much, too large an area of skin, or too frequent use). Repeated overdoses may produce side effects (see section 4. Possible side effects).

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

If you forget to use Methylprednisolone Cinfa emulsion

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

If you stop using Methylprednisolone Cinfa emulsion

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Common (may affect up to 1 in 10 people):
• • Local skin irritation (e.g., burning sensation).

• Uncommon (may affect up to 1 in 100 people):
• • pain,
  • itching,
  • small blisters and pustules,
  • scaling,
  • superficial wounds (erosion),
  • worsening or return of eczema,
  • skin cracking.

The use of anti-inflammatory drugs, called corticosteroids (such as the active ingredient methylprednisolone aceponate) on the skin, may cause the following side effects (frequency not known):

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Methylprednisolone Cinfa emulsion

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

This medicine does not require any special storage conditions.

Do not refrigerate or freeze.

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month stated.

Shelf life after first opening of the tube: 6 months

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Methylprednisolone Cinfa emulsion

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

Appearance of the product and pack contents

Methylprednisolone Cinfa is a homogeneous, white to off-white, cutaneous emulsion (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.

Not all 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 medicine 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 Aristo, 1 mg/g Kožní emulze

Italy Metilprednisolone Aristo, 1 mg/g Emulsione cutanea

Poland Skinatan, 1 mg/g Emulsja na skóre

Portugal Metilprednisolona Aristo, 1 mg/g Emulsão cutânea

Spain Metilprednisolona cinfa 1 mg/g emulsión cutánea

Date of last revision of this leaflet: August 2021

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.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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