Alpicort

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Alpicort

(2 mg + 4 mg)/ml, liquid for the skin
Prednisolone + Salicylic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Alpicort and what is it used for
• 2. Important information before using Alpicort
• 3. How to use Alpicort
• 4. Possible side effects
• 5. How to store Alpicort
• 6. Contents of the packaging and other information

1. What is Alpicort and what is it used for

Alpicort is a liquid for the skin containing prednisolone, for use on the skin.
Indications: hair loss 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

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, on or near the eyes, and on the genital area or internally,
• in the case of chickenpox, certain skin diseases (tuberculosis, syphilis), and inflammatory reactions to vaccinations,
• in the case of fungal and bacterial skin infections,
• in the case of perioral inflammatory skin diseases (symptoms of skin irritation around the mouth with redness and nodules) and rosacea (redness of the face with possible inflammatory or purulent pimples).

Warnings and precautions

Before starting to use Alpicort, you should discuss it with your doctor or pharmacist.
Alpicort, due to its isopropyl alcohol content, should only be used externally.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

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 and other medicines

Alpicort, due to its composition, may enhance the effect of other externally used active substances.
You should tell your doctor or pharmacist about all medicines that the patient is currently using or has recently used, as well as any medicines that the patient plans to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
During pregnancy, Alpicort should not be used due to its salicylic acid content.
If the doctor decides to use Alpicort during pregnancy, it may only be used on small areas of skin (surface area less than 5 cm) and for a short period.
During breastfeeding, the doctor should consider that prednisolone passes into breast milk.
The doctor will decide whether it is necessary to use Alpicort during breastfeeding. If long-term treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

Alpicort does not affect the ability to drive vehicles or operate machinery.

Alpicort contains propylene glycol

The medicine contains 50 mg of propylene glycol in 1 ml of solution (which is approximately equivalent to 180 mg of propylene glycol in 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 you are unsure, consult your doctor or pharmacist.
Alpicort is a liquid for use on the skin.
If the doctor does not recommend otherwise, Alpicort should be used once a day, preferably in the evening.
As soon as the inflammatory symptoms have subsided, it is sufficient to use 2 to 3 times a week.
During each use, proceed as follows:

• Remove the plastic cap from the applicator.
• Turn the bottle with the applicator over your head so that the opening at the top is facing downwards.
• Apply the medicine, drawing the applicator with the opening facing downwards, over the treated areas.
• After using Alpicort, put the plastic cap back on the applicator.
• Then massage the scalp with your fingers for 2-3 minutes.

Duration of use

The duration of treatment of small areas should not be longer than 2-3 weeks due to the presence of prednisolone in the solution. Clinical experience includes treatment duration of up to 6 months. No studies have been conducted on the duration of action after discontinuation of the medicine.

Use in children and adolescents

Alpicort is contraindicated for use in children under 12 years of age.
In children over 12 years of age, the medicine should only be used for a short period and on small areas of skin.

Using a higher dose of Alpicort than recommended

Alpicort is usually well-tolerated even in high doses for short-term use. No special precautions are required.
In case of using a higher dose of Alpicort than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Alpicort

You should not use a double dose to make up for a missed dose.
You should continue treatment, using the next planned dose at the usual time.

Stopping use of Alpicort

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alpicort can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for and measures to be taken if they occur: