Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Alpicort E
(2 mg + 0.05 mg + 4 mg)/ml, cutaneous solution
Prednisolonum + Estradiolum + Acidum salicylicum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your 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 adverse reactions
How to store Alpicort E
Contents of the pack and other information

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

Alpicort E is a cutaneous solution 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 tumors or suspected estrogen-dependent tumors,
in cases of unexplained genital bleeding,
on mucous membranes, in the mouth, or around or in the eyes, and 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 dermatitis (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 its content of isopropyl alcohol, Alpicort E should be used externally only on the scalp skin.
When treating for longer than 2–3 weeks, special precautions should be taken due to the presence of estrogen in the solution:

in cases of endometriosis (endometrial tissue outside the uterus) or mastopathy (breast gland disorders),
in women who are already taking estrogen-containing medications, treatment should be conducted under strict medical supervision.

Protect the eyes and mucous membranes from contact with the product.
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 effects of other topically applied active substances.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Alpicort E should not be used during pregnancy due to its content of salicylic acid, except when applied to small areas (surface area less than 5 cm²).
Alpicort E should not be used during pregnancy due to its content of estrogen.
If conception and pregnancy occur during treatment, Alpicort E therapy should be discontinued immediately. Regarding fetal exposure to estrogen, previous studies have not shown effects on future fertility.
Prolonged treatment with glucocorticoids – a component of Alpicort E – during pregnancy may not exclude impaired fetal growth or fetal damage.

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 nursing mothers and may 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 breastfeeding period has ended.

Driving and operating machinery
Alpicort E has no influence on the ability to drive or operate machinery.

Alpicort E contains propylene glycol
The medicine contains 50 mg of propylene glycol per 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 your doctor. If in doubt, consult your
doctor or pharmacist.
Alpicort E should always be used in accordance with your doctor's instructions and the information provided
in this patient leaflet. If you have any doubts, contact your
doctor again.
Alpicort E is a solution for topical application to the skin.
Unless otherwise directed by your doctor, apply Alpicort E once daily, preferably in the evening.
Once inflammatory symptoms have somewhat subsided, application 2 to 3 times per week may be sufficient.
Each time you use the medicine, follow these steps:

Remove the cap from the applicator.
Turn the bottle with the applicator upside down so that the opening at the top points downward.
Apply the medicine by moving the applicator with its opening pointing downward over the affected areas.
After using Alpicort E, replace the cap on the applicator.
Then massage the scalp gently with your 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. There have been no studies investigating how long the therapeutic effect persists after discontinuation of the medicine.
Use of more than the recommended dose of Alpicort E
If more than the 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.
Stopping Alpicort E treatment
Discuss further management with your doctor, as treatment effectiveness 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 everyone experiences them.
Important adverse reactions or symptoms to be aware of, and actions to be taken if they occur:
If any of the symptoms listed below occur, discontinue Alpicort E and inform 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 the use of 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 the available data): blurred vision.
Additionally, transient skin irritation (e.g. burning, redness) may occur.
With prolonged use at high doses or over large body surface 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 Drug Reactions 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.
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 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 month indicated.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Alpicort E contains

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

What Alpicort E looks like and contents of the pack
Alpicort E is a clear, colourless solution. The pack contains an amber glass bottle with an applicator and a polypropylene closure, containing 100 ml of the medicinal product, and a package leaflet.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, country of export: 20011278
Parallel Import Licence Number: 281/15