Methylprednisolone Skin Care

PACKAGE LEAFLET

Package leaflet: Information for the patient

Metilprednisolone Skin Care

1 mg/g cutaneous emulsion
Generic medicine
Please read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is and what it is used for
2. What you need to know before using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
3. How to use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
4. Possible side effects
5. How to store Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
6. Package contents and other information

1. What Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is and what it is used for

Metilprednisolone Skin Care 1 mg/g cutaneous emulsion contains the active substance methylprednisolone acetonide.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is a topical anti-inflammatory medicine (a corticosteroid).
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive skin cell proliferation (hyperproliferation).
It relieves redness (erythema), fluid accumulation (edema), and leakage of fluid from inflamed skin. It also relieves itching, burning sensation, or pain.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is used for the treatment of acute conditions such as:
Mild to moderate skin rashes (eczema) caused by external agents, including:

• Allergic reaction to substances that have come into contact with your skin (allergic contact dermatitis),
• Allergic reaction to everyday substances, e.g. soaps (irritant contact dermatitis),
• Skin rash with coin-shaped patches (nummular eczema),
• Itchy rash on hands and feet (dyshidrotic eczema),
• Non-specific eczema (common eczema),
• Eczema due to internal causes in the patient (endogenous eczema), such as atopic dermatitis or neurodermatitis,
• Scaly and inflamed skin rash (seborrheic eczema).

The cutaneous emulsion is indicated in adults, infants aged 4 months and older, children, and adolescents.

2. What you should know before using Metilprednisolone Skin Care 1 mg/g emulsion

cutaneous
Do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion

• if you are allergic to the active substance, methylprednisolone aceponate, or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from tuberculosis, syphilis, or viral infections, e.g. herpes or varicella;
• on skin areas affected by red/rosacea-type skin inflammation (rosacea), ulcers, inflammatory diseases of the sebaceous glands (acne vulgaris), or skin conditions associated with thinning of the skin (cutaneous atrophy);
• on areas showing skin reactions to vaccinations, i.e. red or inflamed areas following vaccination;
• on specific inflammations around the upper lip or chin (perioral dermatitis);
• in the presence of bacterial or fungal skin infections (unless treated with an appropriate medication);

Warnings and precautions
Talk to your doctor or pharmacist before using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
Be cautious with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion if your doctor has diagnosed you with a concurrent skin infection (bacterial or fungal). In such cases, it will be necessary to take additional prescribed medications to treat the infection, which might otherwise worsen.
Anti-inflammatory medicines (corticosteroids), such as the active substance methylprednisolone aceponate contained in Metilprednisolone Skin Care 1 mg/g cutaneous emulsion, may have significant effects on the body. The use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion over large body surface areas or for prolonged periods is not recommended, as this increases the risk of adverse effects.
To reduce the risk of adverse effects:

• limit the use of the medicine as much as possible;
• use only for the time strictly necessary to relieve the skin condition;
• avoid contact of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion with the eyes, mouth, deep open wounds, or mucous membranes (e.g. the anal and genital areas);
• do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion on extensive body surfaces (more than 40% of the body surface area);
• do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion under non-breathable or impermeable materials, including plasters, non-breathable dressings, clothing, or diapers, unless specifically prescribed by a doctor.

Using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion to treat conditions other than those for which it was prescribed may mask symptoms and hinder accurate diagnosis and treatment.
Contact your doctor or pharmacist if blurred vision or other visual disturbances occur.
If Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is applied to the anal or genital area, some of its ingredients may damage latex products such as condoms or diaphragms. Therefore, these products may no longer be effective as contraceptives or for protection against sexually transmitted diseases such as HIV infection. Speak to your doctor or pharmacist if you need further information.
Children
Limit the use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion as much as possible to reduce the risk of side effects.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion must not be used under non-breathable or impermeable materials such as diapers, unless specifically prescribed by a doctor.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion may be used in children aged between 4 months and 3 years only if prescribed by a doctor.
The use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is not recommended in children under 4 months of age.
Other medicines and Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
No interactions between Metilprednisolone Skin Care 1 mg/g cutaneous emulsion and other medicines are currently known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
To avoid risks to your baby's health, do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion if you are pregnant, breastfeeding, or think you may be pregnant, unless otherwise directed by your doctor.
If your doctor recommends using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion during breastfeeding, do not apply the medicine on the breast. Avoid contact of the baby with treated areas of the body.
Driving and using machines
The use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion does not affect the ability to drive or operate machinery.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion contains benzyl alcohol (E 1519).
This medicine contains 1.25 mg of benzyl alcohol per 1 g. Benzyl alcohol may cause allergic reactions and/or mild local irritation.

3. How to use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the usual dosage is as follows:

• apply a thin layer of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion once daily to the affected areas, gently massaging it in;
• generally, treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion should not last longer than two weeks. Always keep the duration of use as short as possible.
• when using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion for scaly, inflamed skin eruptions (seborrheic eczema) on the face, treatment should not exceed one week;
• if excessive skin dryness occurs, consult your doctor or pharmacist. You may need to additionally apply a liporeplenishing ointment.

Use in children
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion may be used in children aged between 4 months and 3 years if prescribed by a doctor. Dose adjustment is not required.
The use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is not recommended in children under 4 months of age due to lack of safety data.

If you use more Metilprednisolone Skin Care 1 mg/g cutaneous emulsion than you should
No risks are expected following a single application of an excessive amount of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion (excessive quantity, application over too large an area, or too frequent use). Repeated overdosage may cause undesirable effects (see section 4. "Possible side effects").

If you forget to use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
Do not apply a double dose of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion to make up for a missed application. Continue using the medicine as prescribed by your doctor, pharmacist, or as described in the package leaflet.

If you stop treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
If you stop treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion too early, the initial symptoms of the skin condition may return. Consult your doctor or pharmacist before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Common side effects (may affect up to 1 in 10 people):

• Local skin irritation (for example, burning sensation)

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

• Pain;
• Itching;
• Blisters and pustules;
• Skin peeling;
• Superficial wounds (erosion);
• Worsening or recurrence of eczema; skin cracking.

Frequency not known: cannot be estimated based on available data.
Topical use of anti-inflammatory drugs, the so-called corticosteroids (such as the active substance in Metilprednisolone Skin Care 1 mg/g cutaneous emulsion) may cause the following adverse events (frequency not known):

• Thinning of the skin (atrophy);
• Dry skin;
• Redness (erythema);
• Appearance of red spots;
• Inflammation of hair follicles (folliculitis);
• Striae;
• Acne;
• Specific skin inflammation around the upper lip or chin (perioral dermatitis);
• Allergic skin reactions (contact dermatitis);
• Changes in skin colour;
• Abnormal growth of body hair.

Side effects may occur not only in the treated area but also in other parts of the body. This may happen if the active substance (a corticosteroid) is absorbed into the body through the skin. This could, for example, increase intraocular pressure (glaucoma), blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metilprednisolone Skin Care 1 mg/g cutaneous 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 stated on the packaging after Exp. The expiry date refers to the last day of that month.
After first opening of the tube, the emulsion must be used within 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metilprednisolone Skin Care 1 mg/g cutaneous emulsion contains

• The active substance is methylprednisolone aceponate (MPA)
• The other components are medium-chain triglycerides, caprylic-capric-miristic-stearic acid triglycerides, macrogol (2) stearyl ether, macrogol (21) stearyl ether, benzyl alcohol, disodium edetate, glycerol 85%, purified water

Description of the appearance of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion and package contents
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is a homogeneous, spreadable emulsion, white to off-white, for topical application (similar to a milky cream), and is available in the following pack sizes:

• 20 g
• 50 g
• 100 g
• 10 × 50 g and
• 10 × 100 g tubes. Not all pack sizes may be marketed.

Marketing Authorization Holder
Skin Care Pharma GmbH
Kastanienallee 46
15344 Strausberg
Germany

Manufacturer
Paul W. Beyvers GmbH Chemisch-Pharmazeutische Fabrik
Schaffhausener Str. 26-34
12099 Berlin
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Skinatan, 1 mg/g Emulsion for application to the skin
Czech Republic Skinatan, 1 mg/g Cutaneous emulsion
Italy Metilprednisolone Skin Care, 1 mg/g Cutaneous emulsion
Poland Skinatan, 1 mg/g Emulsion for the skin
Portugal Skinatan, 1 mg/g Cutaneous emulsion
Spain Metilprednisolone cinfa, 1 mg/g Cutaneous emulsion