PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Alpicort E (Alpicort F)
(2 mg + 0.05 mg + 4 mg)/ml, solution for skin application
Prednisolonum + Estradiolum + Acidum salicylicum
Alpicort E and Alpicort F are different brand names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Alpicort E is and what it is used for
Important information before using Alpicort E
How to use Alpicort E
Possible side effects
How to store Alpicort E
Contents of the package and other information

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

Alpicort E is a solution for skin application containing prednisolone, female sex hormones, and salicylic acid, intended for topical application to the scalp.
Indications: In various forms of alopecia, particularly androgenetic 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 medicine (listed in section 6),
in infants, children and adolescents under 18 years of age,
in cases of estrogen-dependent tumours or suspected estrogen-dependent tumours,
in cases of unexplained genital tract bleeding,
on mucous membranes, in the mouth, or near or in the eyes, as well as in the genital area or for internal use,
in cases of chickenpox, specific skin disorders (tuberculosis, syphilis) and inflammatory reactions following vaccinations,
in fungal or bacterial skin infections,
in perioral inflammatory skin disorders (skin irritation around the mouth with redness and nodules) and rosacea (facial redness with possible inflammatory or pustular lesions),
in moist or acute scalp conditions.

Warnings and precautions
Before starting treatment with Alpicort E, consult your doctor or pharmacist.
Due to the presence of isopropyl alcohol, Alpicort E should be used externally only on the scalp.
When treatment lasts longer than 2–3 weeks, special precautions should be taken due to the presence of estrogen in the solution:

in cases of endometriosis (uterine mucosa outside the organ) or mastopathy (breast gland disorders),
in women who are already taking estrogen-containing medications, treatment should be carried out only under strict medical supervision.

Avoid contact of the preparation with eyes and mucous membranes.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.
Alpicort E and other medicines
Due to its composition, Alpicort E may enhance the effect of other topically applied active substances.
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
During pregnancy, Alpicort E should not be used due to the presence of salicylic acid, except when applied to small areas (less than 5 cm²).
Alpicort E should not be used due to the presence of estrogen.
If conception and pregnancy occur during treatment, treatment with Alpicort E should be discontinued immediately. Previous studies have not shown effects on future fertility due to fetal exposure to estrogen. However, prolonged treatment with glucocorticoids – a component of Alpicort E – during pregnancy may not exclude growth disturbances or fetal harm.
Breastfeeding
During breastfeeding, the doctor should consider that prednisolone passes into breast milk.
The doctor will carefully assess whether the use of Alpicort E is necessary during breastfeeding. If prolonged treatment is required, breastfeeding should be discontinued.
During breastfeeding, estrogens may alter the quantity and composition of human milk. Small amounts of estrogens or their metabolites may pass into the milk of breastfeeding women and affect the infant. Glucocorticoids also pass into human milk. Therefore, breastfeeding should not be performed during treatment with Alpicort E, or treatment with Alpicort E should only be initiated after the end of the breastfeeding period.
Driving and operating machinery
Alpicort E has no effect on the ability to drive or operate machinery.
Alpicort E contains propylene glycol
The medicine contains 50 mg of propylene glycol in 1 ml of solution (approximately 180 mg of propylene glycol per single application). Propylene glycol may cause skin irritation.

3. How to use Alpicort E

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Alpicort E should always be used as directed by the physician and according to the instructions
contained in this patient information leaflet. If in doubt, contact your doctor again.
Alpicort E is a solution for topical application to the skin.
Unless otherwise directed by the physician, apply Alpicort E once daily, preferably in the evening. Once inflammatory symptoms have somewhat subsided, application two to three times per week is sufficient.
Each time the medicine is used, follow these steps:

Remove the cap from the applicator.
Turn the bottle with the applicator upside down so that the opening at the top faces downward.
Apply the medicine by moving the applicator with the opening facing downward over the affected areas.
After using Alpicort E, replace the cap on the applicator.
Then massage the scalp gently with fingers for 2–3 minutes.

Duration of treatment
Due to the presence of prednisolone in the solution, treatment duration on small areas should not exceed 2–3 weeks. Clinical experience covers a treatment period of up to 6 months. Studies on the duration of effect after discontinuation of the medicine have not been conducted.
Use of a higher than recommended dose of Alpicort E
If a higher than recommended dose has been used, seek immediate advice from your doctor or pharmacist.
Missed dose of Alpicort E
Do not use a double dose to make up for a missed dose.
Continue treatment by applying the next scheduled dose at the usual time.
Discontinuation of Alpicort E
Discuss further management with your treating physician, as treatment efficacy may be compromised.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Important adverse reactions or symptoms which should be noted, and measures to be taken if they occur:
If any of the symptoms listed below occur, discontinue use of Alpicort E and contact your doctor as soon as possible.
Rare (may occur in less than 1 in 1,000 people): skin hypersensitivity (allergic contact dermatitis)
Other adverse reactions:
Very rare (may occur in less than 1 in 10,000 people): as with any corticosteroid-containing preparations, prolonged use may lead to skin changes (reduction in skin thickness, dilation of small blood vessels, striae, steroid acne, perioral dermatitis, excessive hair growth).
Unknown (frequency cannot be estimated from available data): blurred vision
Additionally, transient skin irritation (e.g. burning, redness) may occur.
With prolonged use in high doses or over large skin areas, and in cases of misuse, systemic corticosteroid effects are possible.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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/
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Alpicort E

Keep this medicine out of sight and reach of children.
Store below 30°C.
Keep in the original packaging in order to protect from light.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Alpicort E contains

The active substances are prednisolone, benzyl estradiol and salicylic acid.
The other ingredients are isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort E looks like and contents of the pack
Alpicort E is a clear, colourless to slightly hazy, brownish-yellow solution.
The pack contains a brown glass bottle with an applicator and a polypropylene closure,
containing 100 ml of the medicinal product, and a leaflet, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Marketing authorisation number in Bulgaria, the country of export: 20011278
Parallel import authorisation number: 389/19