Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
If you have any questions, please 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any 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 side effects
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 topical solution containing prednisolone, female sex hormones, and salicylic acid, intended for application to the scalp skin.
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 bleeding,
on mucous membranes, in the mouth, or in or around the eyes and genital areas, or for internal use,
in cases of chickenpox, specific skin diseases (tuberculosis, syphilis) and inflammatory reactions following vaccination,
in fungal or bacterial skin infections,
in perioral dermatitis (skin irritation around the mouth with redness and papules) 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 a doctor or pharmacist.
Due to its content of isopropyl alcohol, Alpicort E should be used exclusively externally on the scalp skin.
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 (endometrial tissue outside the uterus) or mastopathy (breast gland disorders),
in women already receiving estrogen-containing medications, treatment should be conducted only 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, contact a doctor immediately.

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 (less than 5 cm²).
Alpicort E should not be used 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, available studies have not shown effects on future fertility. However, prolonged treatment with glucocorticoids – a component of Alpicort E – during pregnancy cannot exclude the possibility of impaired fetal growth 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 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 end of the breastfeeding period.

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

Alpicort E contains propylene glycol
This medicine contains 50 mg of propylene glycol in 1 ml of solution (approximately equivalent to 180 mg of propylene glycol with a single application). Propylene glycol may cause skin irritation.

3. How to use Alpicort E

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Alpicort E should always be used according to your doctor's instructions and the information provided in this leaflet. If you have any doubts, contact your doctor again.
Alpicort E is a topical solution for 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 is 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 faces downward.
Apply the medicine by moving the applicator with the opening facing downward over the affected areas.
After applying Alpicort E, replace the cap on the applicator.
Then massage the scalp 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 on how long the therapeutic effect persists after discontinuation of the medicine.
Use of more than the recommended dose of Alpicort E
If more medicine than recommended has been used, contact your doctor or pharmacist immediately.
Missed dose of Alpicort E
Do not use a double dose to make up for a missed dose.
Continue treatment as scheduled with the next planned 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 effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Important adverse effects or symptoms that require attention, 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 affect up to 1 in 1,000 people): skin hypersensitivity (allergic contact dermatitis).
Other adverse effects:
Very rare (may affect up to 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).
Not known (frequency cannot be estimated from available data): blurred vision.
Additionally, transient skin irritation (e.g. burning, redness) may occur.
With prolonged use at high doses or over large areas of skin, and in cases of misuse, systemic corticosteroid effects are possible.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 effects 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.
Do not store above 30°C. Store 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 stated month.
Medicines must 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 pack and other information

What Alpicort E contains

The active substances in this medicine 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 liquid. The pack contains an amber glass bottle (hydrolytic class III) with an applicator and a polypropylene closure, containing 100 ml of the medicine, and a package leaflet.
For further detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Bulgaria, the country of export: 20011278
Parallel import licence number: 22/17