Emulprea

Package leaflet: Information for the user

Emulprea 1 mg/g cutaneous emulsion

methylprednisolone aceponate
Equivalent medicine
Please read this leaflet carefully before using 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet
1 What Emulprea is and what it is used for

2. What you need to know before using Emulprea
3. How to use Emulprea
4. Possible side effects
5. How to store Emulprea
6. Contents of the pack and other information

1. What Emulprea is and what it is used for

Emulprea contains the active substance methylprednisolone aceponate.
Emulprea is an anti-inflammatory medicine (a corticosteroid) intended for use on the skin.
Emulprea reduces inflammation and allergic reactions of the skin, as well as reactions associated with excessive cell division in the skin (hyperproliferation). It therefore reduces redness (erythema), fluid accumulation (edema), and leakage of fluid from inflamed skin. It also relieves itching, burning sensation, or pain you may experience.
Emulprea is used for the acute-phase treatment of:

• mild to moderate skin rash (eczema) caused by an external factor, such as:
  • allergy to a substance that has come into contact with the skin (allergic contact dermatitis),
  • allergic reaction to substances used daily, for example soap (irritant contact dermatitis),
  • coin-shaped skin rash (nummular eczema),
  • itchy rash occurring on hands and feet (dyshidrotic eczema),
  • unspecified eczema (common eczema);
• eczema caused by internal factors in the patient (endogenous eczema), such as atopic dermatitis or neurodermatitis;
• scaling and severely inflamed skin rash (seborrheic eczema).

Emulprea can be used in adults, adolescents, children, and infants aged 4 months and older (see sections "What you need to know before using Emulprea" and "How to use Emulprea").

2. What you need to know before using Emulprea

Do not use Emulprea

• if you are allergic to methylprednisolone aceponate (MPA), benzyl alcohol, or any of the other ingredients of this medicine (listed in section 6);
• if you have tuberculosis, syphilis, or viral infections such as herpes or chickenpox;
• on skin areas affected by red/pink skin inflammation (rosacea), ulcers, inflammatory conditions of the sebaceous glands (acne vulgaris), or skin diseases associated with skin thinning (atrophy skin conditions);
• on skin areas showing a reaction to vaccination, i.e. redness or inflammation after vaccination;
• on specific skin inflammations around the upper lip and chin (perioral dermatitis);
• on bacterial or fungal skin infections (unless appropriately treated with a suitable medicine).

Warnings and precautions
Talk to your doctor or pharmacist before using Emulprea.
Pay special attention when using Emulprea if your doctor has diagnosed a concurrent bacterial or fungal skin infection. In such cases, you must also use the prescribed medicines for the infection; otherwise, the infection may worsen.
Anti-inflammatory medicines (corticosteroids) such as the active substance methylprednisolone aceponate in Emulprea have strong effects on the body. It is not advisable to use Emulprea over large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.
To reduce the risk of side effects:

• Use Emulprea as little as possible.
• Use this medicine only for the minimum time necessary to relieve your skin condition.
• Avoid getting Emulprea into the eyes, mouth, deep wounds, or onto mucous membranes (e.g. the anal and genital area).
• Emulprea must not be used over large body surface areas (more than 40% of the body surface).
• Emulprea must not be used under airtight and/or waterproof coverings such as bandages, non-breathable dressings, clothing, or diapers unless specifically prescribed by your doctor.

If you use Emulprea for conditions other than those for which it was prescribed, it may mask symptoms and interfere with proper diagnosis and treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.
When Emulprea is applied to the anal or genital area, some of its other ingredients may damage latex products such as condoms or diaphragms. Therefore, these may no longer be effective for contraception or protection against sexually transmitted diseases such as HIV infection. Talk to your doctor or pharmacist if you need further information.

Children
To reduce the risk of adverse effects, use as little as possible.
Emulprea must not be used under airtight and/or waterproof coverings such as diapers unless specifically prescribed by a doctor.
Emulprea is not recommended for use in children under 4 months of age.
Emulprea may be used in children aged between 4 months and 3 years only if prescribed by a doctor.

Other medicines and Emulprea
Currently, no interactions between Emulprea and other medicines are known.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
To avoid any risk to the baby, do not use Emulprea if you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning a pregnancy, unless your doctor advises otherwise.
If your doctor recommends using Emulprea while breastfeeding, do not apply the medicine to the breast.
Avoid contact between the treated areas and the baby.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
The use of Emulprea does not affect or affects only slightly the ability to drive vehicles or operate machinery.
However, the active substance may cause visual disturbances. Patients experiencing this side effect should refrain from driving or operating machinery.

Emulprea contains benzyl alcohol
This medicine contains 12.5 mg of benzyl alcohol per gram.
Benzyl alcohol may cause mild local irritation.
Benzyl alcohol may cause allergic reactions.

Doping
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to use Emulprea

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

If not otherwise prescribed by your doctor, the usual dosage is as follows:

• Apply Emulprea in a thin layer and with gentle massage once daily to the affected areas of the skin.
• In general, Emulprea should not be used for longer than two weeks. Always keep the treatment period as short as possible.
• If you are using Emulprea for flaking and inflamed skin rash (seborrheic eczema) of the face, do not use it for more than one week.
• If the skin becomes excessively dry, consult your doctor. Over time, additional application of an ointment regulating skin fats may become necessary.

Dose adjustments are not required when Emulprea is administered to infants aged 4 months and older, children, and adolescents. Emulprea may be used in children between 4 months and 3 years of age only if prescribed by a doctor.
Emulprea is not recommended for use in infants under 4 months of age due to lack of safety data.

If you use more Emulprea than you should
No risk is expected from a single overdose (excessive amount, too large skin area, or too frequent use). Repeated overdosing may cause adverse effects (see section 4. “Possible side effects”).

If you forget to use Emulprea
Do not apply a double dose of Emulprea to make up for a missed dose. Continue using it as prescribed by your doctor or described in this leaflet.

If you stop using Emulprea
If you stop using Emulprea prematurely, the original skin disease symptoms may recur. Please contact your doctor or pharmacist before stopping treatment with Emulprea.

If you have any doubts about how to use this medicine, consult 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
• Skin peeling
• Superficial wounds (erosion)
• Worsening or recurrence of eczema
• Skin cracking

Application to the skin of corticosteroids (which include the active substance in Emulprea) may generally lead to the following side effects (the frequency is unknown):

• Thinning of the skin (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 area (perioral dermatitis)
• Allergic skin reactions (contact dermatitis)
• Changes in skin colour
• Increased body hair growth
• Side effects may occur not only at the site of treatment, but also in completely different areas of the body. This may happen if the active substance (a corticosteroid) is absorbed into the body through the skin. For example, this could increase pressure in the eye (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 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 Emulprea

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton (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 via wastewater. 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 Emulprea contains
The active substance is: methylprednisolone aceponate (MPA).
The other components are:
medium-chain triglycerides, semi-synthetic solid glycerides, macrogol-2-stearyl ether,
macrogol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol (85%), purified water.

Description of the appearance of Emulprea and contents of the pack
Emulprea is a white emulsion for cutaneous application (similar to a milky cream), available in packs containing tubes of 20 g, 50 g and 100 g.
Not all pack sizes may be marketed.

Marketing Authorization Holder
mibe pharma Italia S.r.l.
Via Leonardo da Vinci 20/B
39100 Bolzano, BZ
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria: Avatop Milch 1 mg/g Emulsion zur Anwendung auf der Haut
Germany: Avatop Milch 1 mg/g Emulsion zur Anwendung auf der Haut
Italy: Emulprea
Spain: Avatop 1 mg/g emulsión cutánea