Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Alpicort
(2 mg + 4 mg)/ml, solution for cutaneous use
Prednisolonum + Acidum salicylicum
Please read all of this leaflet carefully 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, 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 someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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, for application to the skin.
Indications: hair loss occurring in the course of diseases such as scalp psoriasis,
seborrheic dermatitis, seborrhea, alopecia areata, diffuse hair loss, as well as following
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 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), 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 the patient intends to use.

Pregnancy and breastfeeding
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 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 areas of skin (less than 5 cm²) and for a short duration.
During breastfeeding, the doctor should consider that prednisolone passes into breast milk.
The doctor will decide whether Alpicort treatment is necessary during breastfeeding. If prolonged treatment is required, breastfeeding should be discontinued.

Driving and operating machinery
Alpicort has no influence on the ability to drive 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. In case of doubt, consult your doctor or pharmacist.
Alpicort is a liquid for 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 the medicine is used, 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 of small skin areas should not last longer than 2–3 weeks. Clinical experience covers treatment duration up to 6 months. Studies on the persistence of therapeutic effect after discontinuation of the medicine have not been conducted.

Use in children and adolescents
Alpicort is contraindicated in children under 12 years of age.
In adolescents above 12 years of age, Alpicort 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 a higher than recommended dose of Alpicort is used, seek immediate advice from your doctor or pharmacist.

Missed dose of Alpicort
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
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 to be aware of, and actions to take 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 out of 1,000 people): skin hypersensitivity (allergic contact dermatitis)
Other adverse reactions:
Very rare (may occur in less than 1 out of 10,000 people): skin changes (reduction in skin thickness, dilation of small blood vessels, development of stretch marks, steroid acne, perioral dermatitis, excessive body hair growth)
Unknown (frequency cannot be estimated from available data): blurred vision
In addition, transient skin irritation (e.g. burning, redness) may occur.
With prolonged use (more than 2–3 weeks), use over large areas (e.g. entire scalp) or misuse, systemic corticosteroid effects may occur.
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

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 freeze.
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 helps protect the environment.

6. Contents of the package and other information

What Alpicort contains

The active substances are prednisolone and salicylic acid. 1 ml of the topical solution contains 2 mg of prednisolone and 4 mg of salicylic acid.
The excipients are: isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort looks like and contents of the pack
Alpicort is a topical solution.
Packaging
The medicinal product is packaged in a 100 ml amber glass bottle with an applicator and a closure made of polypropylene, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, the country of export: 46/150/94-C
Parallel import authorisation number: 176/13