Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences 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 is and what it is used for
Important information before using Alpicort
How to use Alpicort
Possible side effects
How to store Alpicort
Contents of the pack and other information

1. What Alpicort is and what it is used for

Alpicort is a topical solution containing prednisolone, intended for application to the skin.
Indications: hair loss occurring in the course of diseases such as psoriasis of the scalp, seborrheic dermatitis, seborrhea, alopecia areata, diffuse hair loss, as well as after systemic infections.

2. Important information before using Alpicort medicine

When not to use Alpicort:

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
in infants and children under 12 years of age,
on mucous membranes, in the oral cavity, in or around the eyes, genital areas, or for internal use,
in cases of chickenpox, specific skin disorders (tuberculosis, syphilis), or inflammatory reactions following vaccinations,
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).

Warnings and precautions
Before starting treatment with Alpicort, consult your doctor or pharmacist.
Due to its content of isopropyl alcohol, Alpicort must be used externally only.
If the patient experiences blurred vision or any other visual disturbances, medical advice should be sought immediately.

Children and adolescents
In children, the daily dose of 0.2 g of salicylic acid (= 50 ml of Alpicort) must not be exceeded.
Protect eyes and mucous membranes from contact with Alpicort.

Alpicort and other medicines
Due to its composition, Alpicort 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
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.
Alpicort should not be used during pregnancy due to its content of salicylic acid.
If a doctor decides to prescribe Alpicort during pregnancy, it should be applied only on small skin areas (surface area less than 5 cm²) and for short durations only.
During breastfeeding, the doctor should consider that prednisolone passes into breast milk.
The doctor will decide whether Alpicort use is necessary during breastfeeding. If prolonged treatment is required, breastfeeding should be discontinued.

Driving and operating machinery
Alpicort has no effect on the ability to drive motor vehicles or operate machinery.

Alpicort contains propylene glycol
The medicine contains 50 mg of propylene glycol per 1 ml of solution (approximately 180 mg of propylene glycol with a single application). Propylene glycol may cause skin irritation.

3. How to use Alpicort

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Alpicort is a solution for topical application to the skin.
Unless otherwise advised by your doctor, Alpicort should be applied 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 plastic 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, replace the plastic 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 skin areas should not exceed 2–3 weeks. Clinical experience covers treatment periods up to 6 months. There have been no studies on how long the effect persists after discontinuation of the medicine.
Use in children and adolescents
Alpicort is contraindicated for use in children under 12 years of age.
In adolescents over 12 years of age, the medicine should be used only for short periods and on small skin areas.
Use of a higher than recommended dose of Alpicort
Alpicort is generally well tolerated, even at high doses when used for short durations. No special precautions are required.
If more medicine than recommended has been used, consult your doctor or pharmacist immediately.
Missed dose of Alpicort
Do not apply a double dose to make up for a missed dose.
Continue treatment by applying the next scheduled dose at the usual time.
Stopping Alpicort
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 can cause adverse effects, although not everyone will experience them.
Important adverse effects or symptoms to be aware of, and actions to be taken if they occur:
If any of the symptoms listed below occur, discontinue use of Alpicort 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 effects:
Very rare (may occur in less than 1 in 10,000 people): skin changes (reduction in skin thickness, dilation of small blood vessels, stretch marks, steroid acne, perioral dermatitis, excessive hair growth)
Unknown (frequency cannot be determined from available data): blurred vision
In addition, transient skin irritation (e.g. burning, redness) may occur.
With prolonged use (more than 2–3 weeks), application over large areas (e.g. entire scalp) or 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 medicine

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 packaging.
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 packaging and other information

What Alpicort contains

The active substances in the medicine are prednisolone and salicylic acid. 1 ml of the cutaneous solution contains 2 mg of prednisolone and 4 mg of salicylic acid.
Other components: isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort looks like and contents of the pack
Alpicort is a cutaneous solution.
Packaging
The medicine is packaged in a brown glass bottle (type III) with an applicator and a polypropylene cap, placed in a cardboard box.
Available pack size: 100 ml glass bottle.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Latvia, 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, Poland
Repackaged at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Latvia, country of export: 95-0182
Parallel Import Licence Number: 399/25