Alpicort E

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

AlpicortE(Alpicort F)
(2 mg + 0.05 mg + 4 mg)/ml, liquid for the skin
Prednisolone + Estradiol + Salicylic Acid
Alpicort E and Alpicort F are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Alpicort E and what is it used for
• 2. Important information before using Alpicort E
• 3. How to use Alpicort E
• 4. Possible side effects
• 5. How to store Alpicort E
• 6. Contents of the packaging and other information

1. What is Alpicort E and what is it used for

Alpicort E is a liquid for the skin, containing prednisolone, female sex hormones, and salicylic acid for use on the scalp.
Indications: in the course of various forms of alopecia, especially androgen-dependent alopecia.

2. Important information before using Alpicort E

When not to use Alpicort E:

• if the patient is allergic to prednisolone, salicylic acid, estradiol benzoate, or any of the other ingredients of this drug (listed in section 6),
• in infants, children, and adolescents under 18 years of age,
• in cases of estrogen-dependent tumors or suspected estrogen-dependent tumors,
• in cases of unexplained bleeding from the reproductive organs,
• on mucous membranes, in the mouth, on or near the eyes, or on the genitals, or internally,
• in cases of chickenpox, certain skin diseases (tuberculosis, syphilis), and inflammatory reactions to vaccinations,
• with fungal and bacterial skin infections,
• in cases of perioral inflammatory skin diseases (symptoms of skin irritation around the mouth with redness and nodules) and rosacea (redness of the face with possible inflammatory or purulent pimples),
• in wet or acute scalp diseases.

Warnings and precautions

Before starting to use Alpicort E, you should discuss it with your doctor or pharmacist.
Alpicort E may be used, due to its isopropyl alcohol content, only externally on the scalp.
When treating for a period longer than 2-3 weeks, due to the estrogen content in the solution, special precautions should be taken:

• in cases of endometriosis (endometrium outside the uterus) or mastopathy (changes in breast tissue),
• in women who are already taking estrogen-containing preparations, treatment should be carried out only under strict medical supervision.

Protect your eyes and mucous membranes from contact with the preparation.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Alpicort E and other drugs

Alpicort E, due to its composition, may enhance the effect of other topically applied active substances.
You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
In pregnancy, Alpicort E should not be used due to its salicylic acid content, except when used on small areas (surface area less than 5 cm²).
Alpicort E should not be used due to its estrogen content.
If the patient becomes pregnant during treatment, the treatment with Alpicort E should be stopped immediately. However, previous studies have not shown any effect on subsequent fertility due to exposure to estrogen. During long-term treatment with glucocorticoids - a component of Alpicort E - during pregnancy, growth disturbances and damage to the unborn child cannot be excluded.
Breastfeeding
The doctor should consider that prednisolone passes into breast milk.
The doctor will carefully assess whether it is necessary to use Alpicort E during breastfeeding. If long-term treatment is necessary, breastfeeding should be stopped.
During breastfeeding, estrogens may change the amount and composition of human milk. Small amounts of estrogens or their metabolites may pass into the milk of breastfeeding women and affect the child. Glucocorticoids also pass into human milk. Therefore, during treatment with Alpicort E, breastfeeding should not be performed, or treatment with Alpicort E should only be started after the end of the breastfeeding period.

Driving and using machines

Alpicort E does not affect the ability to drive vehicles or operate machines.

Alpicort E contains propylene glycol

The drug contains 50 mg of propylene glycol in 1 ml of solution (which approximately corresponds to 180 mg of propylene glycol in a single application). Propylene glycol may cause skin irritation.

3. How to use Alpicort E

This drug should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Alpicort E should always be used according to the doctor's recommendations and the instructions contained in this information leaflet. In case of doubts, you should contact your doctor again.
Alpicort E is a solution for use on the skin.
If the doctor does not recommend otherwise, Alpicort E should be used once a day, preferably in the evening. As soon as the inflammatory symptoms subside, it is sufficient to use 2 to 3 times a week.
During each use, proceed as follows:

• Remove the cap from the applicator.
• Turn the bottle with the applicator over your head so that the opening at the top is facing down.
• Apply the drug by drawing the applicator with the opening facing down over the treated areas.
• After using Alpicort E, put the cap back on the applicator.
• Then massage your scalp with your fingers for 2-3 minutes.

Duration of use

The duration of treatment of small areas should not be longer than 2-3 weeks due to the presence of prednisolone in the solution. Clinical experience includes a treatment period of up to 6 months. No studies have been conducted on the duration of action after discontinuation of the drug.

Using a higher dose of Alpicort E than recommended

In case of using a higher dose of the drug than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Alpicort E

You should not use a double dose to make up for a missed dose.
You should continue treatment using the next planned dose at the usual time.

Stopping the use of Alpicort E

You should discuss further action with your attending physician, as the effectiveness of the treatment is at risk.
In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug may cause side effects, although not everyone will experience them.

Important side effects or symptoms to watch out for and measures to be taken if they occur:

If one of the following symptoms occurs, you should stop using Alpicort E and notify your doctor as soon as possible.
Rarely(may occur in less than 1 in 1,000 people): skin hypersensitivity (allergic contact dermatitis)

Other side effects:

Very rarely(may occur in less than 1 in 10,000 people): as with the use of any corticosteroid preparations, long-term use may lead to skin changes (reduction of skin thickness, widening of small blood vessels, formation of striae, steroid acne, perioral inflammatory skin disease, excessive body hair).
Unknown(frequency cannot be estimated from available data): blurred vision
Additionally, short-term skin irritations (e.g., burning, redness) are possible.
During long-term use in high doses or on large areas, as well as in cases of use inconsistent with the intended use, systemic corticosteroid effects are possible.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl/
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Alpicort E

The drug should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Store in the original packaging to protect from light.
Do not use this drug after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Drugs should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Alpicort E contains

• The active substances of the drug are prednisolone, estradiol benzoate, and salicylic acid.
• The other ingredients are: isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort E looks like and what the packaging contains

Alpicort E is a clear, colorless to cloudy, brownish-yellow solution.
The packaging contains a brown glass bottle with an applicator and a polypropylene closure, containing 100 ml of the drug, and a leaflet, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany

Manufacturer:

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 20011278
Parallel import authorization number: 389/19

Date of leaflet approval: 07.10.2024

[Information about the trademark]