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 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 further questions, ask 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
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 packaging 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 conditions such as: psoriasis of the scalp, seborrheic dermatitis, seborrhea, alopecia areata, diffuse hair loss, as well as following systemic infections.

2. Important information before using Alpicort

When not to use Alpicort:
if the patient is allergic to prednisolone, salicylic acid, or 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 and genital areas, 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 papules) and rosacea (facial redness with possible inflammatory or pustular lesions).

Warnings and precautions
Before starting to use Alpicort, consult your doctor or pharmacist.
Due to the presence of isopropyl alcohol, Alpicort must be used only externally.
If the patient experiences blurred vision or other visual disturbances, contact a doctor 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 the eyes and mucous membranes from contact with Alpicort.

Alpicort with 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 the patient is currently using or has recently used, as well as any medicines planned for future 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 salicylic acid content.
If a doctor decides Alpicort must be used during pregnancy, it should be applied only to small skin areas (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 the use of Alpicort 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 your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Alpicort is a liquid for topical application to the skin.
Unless otherwise directed by your doctor, apply Alpicort once daily, preferably in the evening.
Once inflammatory symptoms have somewhat subsided, application two to three 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 gliding 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 therapeutic effect persists after discontinuation of the medicine.

Use in children and adolescents
Alpicort is contraindicated in children under 12 years of age.
In adolescents over 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 you use more than the recommended dose, contact your doctor or pharmacist immediately.

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.

Stopping Alpicort treatment
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 medicinal product may 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 use of Alpicort and inform your doctor as soon as possible.
Rare (may affect up to 1 in 1,000 people): skin hypersensitivity (allergic contact dermatitis).
Other adverse reactions:
Very rare (may affect up to 1 in 10,000 people): skin changes (reduction in skin thickness, dilation of small blood vessels, striae, steroid acne, perioral dermatitis, excessive body 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 (more than 2–3 weeks), application over large areas (e.g. the entire scalp), or misuse, systemic corticosteroid effects are possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Alpicort medicine

Keep this medicine out of sight and reach of children.
Store below 30°C.
Store 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. These measures will help protect the environment.

6. Package contents and other information

What Alpicort contains
The active substances in this medicinal product are prednisolone and salicylic acid.
1 ml of the topical solution contains 2 mg of prednisolone and 4 mg of salicylic acid
(100 ml of solution contains 0.2 g of prednisolone and 0.4 g of salicylic acid).
The other ingredients are: isopropyl alcohol, propylene glycol, arginine, purified water.

What Alpicort looks like and contents of the pack
Alpicort is a topical solution – clear, colourless or slightly cloudy, brownish-yellow liquid.

Packaging
The medicinal product is packaged in an amber glass bottle with an applicator and a polypropylene closure, containing 100 ml of the solution, placed in a cardboard carton.

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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Bulgaria, the country of export: 9800250
Parallel Import Licence Number: 739/15