METILPREDNISOLONE 1 mg /G Топическая Эмульсия

Содержание инструкции

1. Metilprednisolone Skin Care
   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 emulsion
   3. How to take 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. Contents of the pack and other information

Metilprednisolone Skin Care

1 mg/g cutaneous emulsion
Equivalent medicinal product
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
• 3. How to take 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. Contents of the pack 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 ingredient methylprednisolone
aceponate.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is a topical anti-inflammatory
(corticosteroid) medicine.
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 replication
(hyperproliferation).
It relieves redness (erythema), fluid accumulation (edema) and fluid leakage 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
of:

• mild to moderate skin rashes (eczema) caused by external agents, such as:
• allergy 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 spots (nummular eczema),
• itchy rash on hands and feet (dyshidrotic eczema);
• non-specific eczema (vulgar eczema);
• eczema due to internal causes in the patient (endogenous eczema), such as atopic dermatitis or neurodermatitis; skin rash with scaling and inflammation (seborrheic eczema).

Cutaneous emulsion is indicated in adults, in neonates aged 4 months or older, in children
and adolescents.

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

cutaneous
Do not useMetilprednisolone Skin Care 1 mg/g cutaneous emulsion

• if you are allergic to the active ingredient 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 chickenpox;
• on skin areas characterized by redness/rosacea skin inflammation, on ulcers, in case of inflammatory diseases of the sebaceous glands (acne vulgaris) or skin diseases accompanied by thinning of the skin (skin atrophy);
• on areas characterized by skin reactions to vaccinations, i.e. reddened or inflamed areas after vaccination;
• on specific inflammation in the upper lip or chin area (perioral dermatitis);
• in the presence of bacterial or fungal skin infections (unless treated with an appropriate medication);

Warnings and precautions
Consult your doctor or pharmacist before using Metilprednisolone Skin Care 1 mg/g emulsion
cutaneous
Be careful with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion if your doctor has diagnosed you with a concomitant skin infection (bacterial or fungal). In this case, it will be
necessary to take the additional medications prescribed to treat the infection, which could otherwise
worsen.
Anti-inflammatory drugs (corticosteroids), such as the active ingredient methylprednisolone aceponate
contained in Metilprednisolone Skin Care 1 mg/g cutaneous emulsion, appear to have significant
effects on the body. The use of Metilprednisolone Skin Care 1 mg/g
cutaneous emulsion on extensive areas of the body or for prolonged periods of time is not recommended, as this will
increase the risk of side effects.
To reduce the risk of side effects:

• limit the use of the drug 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 area);
• do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion on extensive body surfaces (more than 40% of the body surface);
• do not use Metilprednisolone Skin Care 1 mg/g cutaneous emulsion under non-breathable or waterproof materials, including plasters, poorly breathable bandages, clothing or diapers, unless prescribed by your doctor.

Using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion to treat conditions
other than those for which it has been prescribed may mask symptoms and hinder accurate diagnosis and
therapy.
Contact your doctor or pharmacist if you experience blurred vision or other visual disturbances.
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 as
protection against sexually transmitted diseases such as HIV infections. Talk to your
doctor or pharmacist if you need more 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 should not be used under non-breathable or
waterproof materials, such as diapers, unless prescribed by your
doctor.
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion can be used in children between 4 months and
3 years of age, 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
To date, no interactions of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion with other
medicines are known.
Inform your doctor or pharmacist if you are taking or have recently taken or may take
any other medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
To avoid risks to your baby's health, you should not use Metilprednisolone Skin Care 1 mg/g
emulsion if you are pregnant or breastfeeding, if you suspect or are planning a pregnancy
unless otherwise prescribed by your doctor.
If your doctor recommends the use of Metilprednisolone Skin Care 1 mg/g emulsion during
breastfeeding, do not apply the medicine to the breast. Avoid contact of the baby with
the treated areas of the body.

Driving and operating machinery
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 emulsioncontains benzyl alcohol (E 1519).
This medicine contains 1.25 mg of benzyl alcohol per 1 g. Benzyl alcohol
can cause allergic reactions and/or mild local irritation.

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

Take this medicine following strictly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the general dosage is as follows:

• apply a thin layer of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion once a day to the affected areas, massaging gently;
• generally, the duration of treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion should not exceed two weeks. Always limit the period of use as much as possible.
• in case of using Metilprednisolone Skin Care 1 mg/g cutaneous emulsion for scaling and inflamed skin rashes (seborrheic eczema) on the face, the treatment should not last more than one week;
• if excessive skin dryness occurs, consult your doctor or pharmacist. It may be necessary to apply an additional liporestoring ointment.

Use in children
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion can be used in children between 4 months and 3 years of age, if prescribed by the doctor. No dosage adjustments are required.
The use of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is not recommended in children under 4 months of age due to the lack of safety data.

If you take 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 to too extensive areas or too frequent use). Repeated overdoses may cause undesirable effects (see section 4. “Possible undesirable effects”).

If you forget to take Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
Do not use a double dose of Metilprednisolone Skin Care 1 mg/g cutaneous emulsion to compensate for the forgetfulness at the next application, but continue the application as prescribed by your doctor,

If you stop taking Metilprednisolone Skin Care 1 mg/g cutaneous emulsion
If you stop the treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion too early, the primary symptoms of the skin disease may reappear. Before stopping the treatment with Metilprednisolone Skin Care 1 mg/g cutaneous emulsion, ask your doctor or pharmacist.
If you have 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 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;
• scaling
• superficial wounds (erosion);
• worsening or recurrence of eczema; skin cracks.

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

• Thinning of the skin (atrophy)
• skin dryness,
• redness (erythema),
• appearance of red spots,
• inflammation of hair follicles (folliculitis),
• stretch marks,
• acne,
• specific skin inflammation in the area of the upper lip or chin (perioral dermatitis);
• allergic skin reactions (contact dermatitis),
• changes in skin color,
• abnormal hair growth on the body,
• side effects may occur not only in the treated area, but also in other areas of the body. This happens if the active ingredient (a corticosteroid) is absorbed by the body through the skin. This can, for example, increase intraocular pressure (glaucoma),
• blurred vision.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system 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 particular storage conditions.
Do not refrigerate or freeze.
Do not use this medicine after the expiry date which is stated on the package after Exp. The expiry
date refers to the last day of that month.
After first opening the tube, the emulsion must be used within 6 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Metilprednisolone Skin Care 1 mg/g cutaneous emulsion contains

• The active ingredient is methylprednisolone aceponate (MPA)
• The other ingredients are Medium chain triglycerides, Triglycerides of caprylic-capric-myristic-stearic acids, 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 content of the pack
Metilprednisolone Skin Care 1 mg/g cutaneous emulsion is a homogeneous spreadable emulsion, from
white to off-white for cutaneous application (similar to a milky cream), and is available in
packs of:

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
denominations
Austria Skinatan, 1 mg/g Emulsion for cutaneous application
Czech Republic Skinatan, 1 mg/g Skin emulsion
Italy Metilprednisolone Skin Care, 1 mg/g Cutaneous emulsion
Poland Skinatan, 1 mg/g Emulsion for skin
Portugal Skinatan, 1 mg/g Cutaneous emulsion
Spain Metilprednisolona cinfa, 1 mg/g Cutaneous emulsion